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

Catalog Number UNK ANKLE TALAR

Device Problem Migration (4003)

Patient Problems Joint Disorder (2373); Osteolysis (2377); No Code Available (3191)

Event Date 01/01/2014

Event Type  Injury  

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary
=
> no device associated with this report was received for examination.A worldwide lot specific complaint database search, or device history record (dhr) review, was not possible because the required lot number was not provided.The information received will be retained for potential series investigations if triggered by trend analysis, post market surveillance, or other events within the quality system.If information is obtained that was not available for the initial medwatch, a follow-up medwatch, a follow-up medwatch will be filed as appropriate.

Manufacturer Narrative

(b)(4).If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.(b)(4).

Event Description

The literature article entitled ¿management of extensive talar osteolysis with agility total ankle replacement systems using geometric metal-reinforced polymethylmethacrylate cement augmentation¿, by thomas s.Roukis, dpm, phd, facfs, et al, published in the journal of foot and ankle surgery, 53 (2014), 108-113; was reviewed.The purpose of the article was to describe a technique for the management of massive cystic changes and bone loss secondary to aseptic osteolysis and subsidence of the talar component of failed agility total ankle replacement systems.The article describes this as an management of extensive talar osteolysis associated with failed agility total ankle replacement systems, they used geometric metal-reinforced polymethylmethacrylate cement augmentation.This technique preserves the subtalar joint and provides immediate component stability and restoration of component alignment and height.It is also a cost-effective alternative to the other available options and still allows for additional revision should late failure occur.The options for revision of the talar component depend on whether the failed system was an agility or agility lp tars.The revisions included a talar component and an insert; sizes were determined based upon which implant was being revised.The authors also report that this technique has not been thoroughly studied to date for revision total ankle replacement.Although, it has worked well in the three patients they have treated, additional study is warranted before widespread use can be advocated.

Manufacturer Narrative

Product complaint # : (b)(4).Depuy synthese is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthese has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthese or its employees that the report constitutes an admission that the device, depuy synthese, or its employees caused or contributed to the potential event described in this report.  patient code: no code available (3191) used to capture medical device removal and surgical intervention patient codes if information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: UNKNOWN ANKLE TALAR
• Type of Device: ANKLE TALAR
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 9468370
• MDR Text Key: 185636807
• Report Number: 1818910-2019-118939
• 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: literature
• Type of Report: Initial,Followup,Followup
• Report Date: 11/19/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/13/2019
• 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
• Date Manufacturer Received: 01/08/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention