Analysis of Polyethylene-Related Revisions After Total Ankle Replacements Reported in US Food and Drug Administration Medical Device Adverse Event Database

Abstract

Background:

There are 2 general types of total ankle replacement (TAR) designs with respect to the polyethylene insert, mobile-bearing (MB) and fixed-bearing (FB) TARs. The aim of this study is to compare polyethylene-related adverse events (AEs), particularly revisions, reported for MB TARs and FB TARs using the US Food and Drug Administration’s (FDA’s) Manufacturer and User Facility Device Experience (MAUDE) database.

Methods:

A text mining method was applied to the medical device reporting (MDR) in the MAUDE database from 1991 to 2020, followed by manual reviews to identify, characterize, and describe all polyethylene-related AEs, including revisions, reported for MB and FB TARs.

Results:

We found 1841 MDRs for MB (STAR Ankle only) and 1273 MDRs for 40+ FB TARs approved/cleared by the FDA. For the MB design, 33% (606/1841) of the AEs reported related to the polyethylene component, compared to 24% (291/1273) of the AEs reported for FB designs. Polyethylene fractures were reported in 11.3% (208/1841) for the MB designs compared to 0.2% (2/1273) for the FB designs. Half of the polyethylene-related revisions occurred within an average of 4.1 years after implantation for the MB design compared within an average of 5.2 years for FB designs.

Conclusion:

Analysis of this database revealed a higher proportion of reported polyethylene fractures and greater need for earlier revisions for polyethylene-related issues with use of the primary MB design in the database as compared with FB TAR designs. Further study of device-related complications with more recent designs for both MB and FB ankle replacement components are needed to improve the outcomes of total ankle replacement.

Level of Evidence:

Level III, retrospective comparative study.

Keywords

total ankle replacement TAR adverse event revision polyethylene-related adverse events polyethylene fractures polyethylene wear FDA FDA Manufacturer and User Facility Device Experience MAUDE MDR ultrahigh molecular weight polyethylene UHMWPE

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References

Brunner

Barg

Knupp

, et al. The Scandinavian Total Ankle Replacement: long-term, eleven to fifteen-year, survivorship analysis of the prosthesis in seventy-two consecutive patients. J Bone Joint Surg Am. 2013;95(8):711-718. doi: 10.2106/JBJS.K.01580

Carlsson

. SwedAnkle The Swedish Ankle Registry - Annual Report for 2018. 2019. http://rcsyd.se/swedankle/wp-content/uploads/sites/14/2021/04/Annual-report-2018.pdf.

Daniels

Mayich

Penner

MJ.

Intermediate to long-term outcomes of total ankle replacement with the Scandinavian Total Ankle Replacement (STAR). J Bone Joint Surg Am. 2015;97(11):895-903. doi: 10.2106/JBJS.N.01077

Food and Drug Administration. FDA approval letter for Scandinavian Total Ankle Replacement System (STAR ankle). 2009. https://www.accessdata.fda.gov/cdrh_docs/pdf5/P050050A.pdf.

Food and Drug Administration. FDA approval letter for Hintermann Series H3™ total ankle replacement system. 2019. https://www.accessdata.fda.gov/cdrh_docs/pdf16/P160036A.pdf.

Food and Drug Administration. Summary of safety and effectiveness data (SSED) of Hintermann Series H3™ total ankle replacement system. 2019. https://www.accessdata.fda.gov/cdrh_docs/pdf16/P160036b.pdf.

Food and Drug Administration. Risk of device component breaking in patients with Stryker’s STAR Ankle: FDA safety communication. 2021. https://www.fda.gov/medical-devices/safety-communications/risk-device-component-breaking-patients-strykers-star-ankle-fda-safety-communication.

Food and Drug Administration. About Manufacturer and User Facility Device Experience (MAUDE). 2022. https://www.fda.gov/medical-devices/mandatory-reporting-requirements-manufacturers-importers-and-device-user-facilities/about-manufacturer-and-user-facility-device-experience-maude.

Fuchs

Sandmann

Skwara

Chylarecki

Quality of life 20 years after arthrodesis of the ankle. A study of adjacent joints. J Bone Joint Surg Br. 2003;85(7):994-998. doi: 10.1302/0301-620x.85b7.13984

10.

Furnes

Gjertsen

Hallan

, et al. Norwegian Arthroplasty Register - annual report 2019. National Service Centre for Medical Quality Registers. 2019. https://helse-bergen.no/seksjon/Nasjonal_kompetansetjeneste_leddproteser_hoftebrudd/Share%20point%20Documents/Rapport/Report%202019_english.pdf.

11.

Henricson

Carlsson

Survival analysis of the single- and double-coated STAR ankle up to 20 years: long-term follow-up of 324 cases from the Swedish Ankle Registry. Foot Ankle Int. 2015;36(10):1156-1160.

12.

Kerkhoff

Kosse

Metsaars

Louwerens

JW.

Long-term functional and radiographic outcome of a mobile bearing ankle prosthesis. Foot Ankle Int. 2016;37(12):1292-1302. doi: 10.1177/1071100716661477

13.

Lalani

Kunwar

Kinard

Dhruva

Redberg

RF.

Reporting of death in US Food and Drug Administration medical device adverse event reports in categories other than death. JAMA Intern Med 2021;181(9):1217-1223. doi: 10.1001/jamainternmed.2021.3942

14.

Lawton

Butler

Dekker

2nd Prescott

Kadakia

AR.

Total ankle arthroplasty versus ankle arthrodesis—a comparison of outcomes over the last decade. J Orthop Surg Res 2017;12(1):76. doi: 10.1186/s13018-017-0576-1

15.

Loewy

Sanders

Walling

AK.

Intermediate-term experience with the STAR Total Ankle in the United States. Foot Ankle Int. 2019;40(3):268-275. doi: 10.1177/1071100718808743

16.

Nunley

Adams

Easley

DeOrio

JK.

Prospective randomized trial comparing mobile-bearing and fixed-bearing total ankle replacement. Foot Ankle Int. 2019;40(11):1239-1248. doi: 10.1177/1071100719879680

17.

Nunley

Caputo

Easley

Cook

Intermediate to long-term outcomes of the STAR Total Ankle Replacement: the patient perspective. J Bone Joint Surg Am. 2012;94(1):43-48. doi: 10.2106/JBJS.J.01613

18.

Randsborg

Jiang

Mao

, et al. Two-year revision rates in total ankle replacement versus ankle arthrodesis. JBJS Open Access. 2022;e21(00136):10. doi: 10.2106/JBJS.OA.21.00136

19.

Singh

Ramachandran

Time trends in total ankle arthroplasty in the USA: a study of the National Inpatient Sample. Clin Rheumatol 2016;35(1):239-245. doi: 10.1007/s10067-014-2703-2

20.

UK National Joint Registry. The 18th annual report 2021 - surgical data to 31 December 2020. National Joint Registry. 2021. https://reports.njrcentre.org.uk/Portals/0/PDFdownloads/NJR%2018th%20Annual%20Report%202021.pdf.

21.

Vakhshori

Sabour

Alluri

Hatch

3rd Tan

EW.

Patient and practice trends in total ankle replacement and tibiotalar arthrodesis in the United States from 2007 to 2013. J Am Acad Orthop Surg. 2019;27(2):e77-e84. doi: 10.5435/JAAOS-D-17-00526

22.

Veljkovic

Daniels

Glazebrook

, et al. Outcomes of total ankle replacement, arthroscopic ankle arthrodesis, and open ankle arthrodesis for isolated non-deformed end-stage ankle arthritis. J Bone Joint Surg Am. 2019;101(17):1523-1529. doi: 10.2106/JBJS.18.01012

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