MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US UNKNOWN ANKLE TIBIAL INSERT

Catalog Number UNK ANKLE TIBIAL INSERT

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Bone Fracture(s) (1870); Impaired Healing (2378); Joint Laxity (4526); Unspecified Tissue Injury (4559)

Event Date 12/01/2013

Event Type  Injury  

Manufacturer Narrative

Product complaint # (b)(4).D4: the device catalog number is unknown; therefore, udi is unavailable.This report is being submitted pursuant to the provisions of 21 cfr, part 803 (and/or part 4, as applicable).This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by depuy synthes, or its employees that the report constitutes an admission that the product, depuy synthes, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.

Event Description

This complaint is from a literature source.The following literature cite has been reviewed: lee kt, jegal h, park yu, kim jb, lee yk, yeo ed, yang ss, yoon sa.Comparison of sagittal subluxation in two different three-component total ankle replacement systems.Foot ankle int.2013 dec;34(12):1661-8.Doi: 10.1177/1071100713505752.Epub 2013 sep 24.Pmid: 24064519.Objective and methods: total ankle replacement (tar) is a high-risk procedure with significant revision rates, post-op complications and implant failures.This study compared sagittal malalignment between the mobility and a competitor total ankle systems and assessed the positional stability of the implant components over time.Methods: the study included 50 cases each of total ankle replacement arthroplasty with a competitor construct and mobility total ankle systems performed between may 2008 and june 2010.The mobility group included 24 men and 25 women and the competitor group included 50 patients.Three independent observers with different levels of training evaluated the radiographs and performed the measurements independently.This complaint will capture the results associated with the depuy mobility taa.The results associated with non-depuy devices will be excluded.Lot, model and catalog number are not available, but the suspected depuy device possibly associated with reported adverse events: cementless depuy mobility ankle including a talar, tibial, and poly insert.Adverse event(s) and provided interventions associated with depuy devices: 8 cases of intraoperative malleolar fractures treated with 1 cannulated screw and k-wire.2 cases of delayed wound healing- treatment not specified.2 reports of post-op medial impingement- treatment unspecified.2 reports of postoperative varus deformity- treatment unspecified.1 achilles tendon rupture- treatment unspecified.

Manufacturer Narrative

Product complaint (b)(4).Investigation summary: an analysis of the product could not be performed, since a physical sample was not received for evaluation.An evaluation of the manufacturing record could not be performed, as the required product identification number was not provided to complete the evaluation.As part of our company quality system process, all devices are manufactured, inspected and distributed to approved specifications.Additional complaint information, monitoring for potential safety signals will be conducted through complaint trending as part of the post-market surveillance.However, if the product or product id numbers are received at a later date, the investigation will be updated as applicable.

• Brand Name: UNKNOWN ANKLE TIBIAL INSERT
• Type of Device: ANKLE TIBIAL INSERT
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• Manufacturer (Section G): JTE WARSAW MFG SITE; 700 orthopaedic drive; warsaw IN
• Manufacturer Contact: kate karberg ; 700 orthopaedic dr.; warsaw, IN 46581-0988 ; 3035526892
• MDR Report Key: 18290557
• MDR Text Key: 330041045
• Report Number: 1818910-2023-24974
• Device Sequence Number: 1
• Product Code: JWH
• Combination Product (y/n): N
• Reporter Country Code: KS
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature,Health Professional
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 12/08/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNK ANKLE TIBIAL INSERT
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 11/20/2023
• Initial Date FDA Received: 12/08/2023
• Supplement Dates Manufacturer Received: 01/15/2024
• Supplement Dates FDA Received: 01/15/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention