MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US UNKNOWN ANKLE TALAR

Catalog Number UNK ANKLE TALAR

Device Problems Use of Device Problem (1670); Osseointegration Problem (3003)

Patient Problems Unspecified Infection (1930); Osteolysis (2377); Inadequate Osseointegration (2646)

Event Date 06/11/2021

Event Type  Injury  

Manufacturer Narrative

Product complaint # (b)(4).Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, 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 medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

This complaint is from a literature source.The following literature cite has been reviewed: jennison t, king a, hutton c, sharpe i.A prospective cohort study comparing functional outcomes of primary and revision ankle replacements.Foot ankle int.2021 oct;42(10):1254-1259.Doi: 10.1177/10711007211010188.Epub 2021 jun 11.Pmid: 34112014.Objective and methods: the primary aim is to compare the functional outcomes of revision ankle replacements and primary ankle replacements in 33 patients divided into primary ankle cohort and revision ankle cohort implanted between 2015 and 2018, with at least 2 years¿ follow-up.Secondary outcomes are to compare reoperations, complications, and further operative procedures.The revision ankle cohort utilized only competitor devices and will be excluded from this complaint.The primary ankle cohort included 23 patients who received 9 depuy ankles (8 mobility and 1 agility) and 14 competitor constructs.The reasons for primary revision include: 9 loosening of unknown device, 5 instances of osteolysis, 6 cases of infection, m cases of malposition.The authors do not specify reasons for revision by construct manufacturer.The actual number of ankles with depuy devices that received revisions is 9 but the exact reason and specific devices revised is not known.This complaint will capture each reason for revision with a quantity of one.Lot, model and catalog number are not available, but the suspected depuy device possibly associated with reported adverse events: agility or mobility ankle: tibial component, tibial insert, talar component.Adverse event(s) and provided interventions associated with depuy devices: 1 loosening of talar and tibial component, 1 malposition of tibial and talar component, 1 osteolysis, 1 infection.

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary : no device associated with this report was received for examination.This complaint was opened to document complaints derived through a journal article review.Follow-ups were done to try and obtain additional information from the author of the journal article.No further information was received.Device history lot : a manufacturing record evaluation (mre), was not possible because the required lot code was not provided.

• Brand Name: UNKNOWN ANKLE TALAR
• Type of Device: UNKNOWN ANKLE TALAR
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• Manufacturer (Section G): DEPUY ORTHOPAEDICS, INC. 1818910; 700 orthopaedic dr.; warsaw IN 46581 0988
• Manufacturer Contact: kate karberg ; 700 orthpaedic dr.; warsaw, IN 46581 ; 3035526892
• MDR Report Key: 15175061
• MDR Text Key: 297336324
• Report Number: 1818910-2022-15210
• Device Sequence Number: 1
• Product Code: HSN
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature,Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 08/05/2022

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?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNK ANKLE TALAR
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/23/2022
• Initial Date FDA Received: 08/05/2022
• Supplement Dates Manufacturer Received: 08/25/2022
• Supplement Dates FDA Received: 08/26/2022
• 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