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

Catalog Number UNK ANKLE TALAR

Device Problems Loss of or Failure to Bond (1068); Device Dislodged or Dislocated (2923); Migration (4003)

Patient Problems Bone Fracture(s) (1870); Pain (1994); Joint Dislocation (2374); Osteolysis (2377); No Code Available (3191)

Event Date 01/01/2015

Event Type  Injury  

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 ¿intraoperative and perioperative complications during revision arthroplasty for salvage of a failed total ankle arthroplasty¿, written by joan r.Williams et al, published in foot and ankle international, volume 36(2) 135-142, 2015; was reviewed.The purpose of the study within the article was to review a series of failed agility taa revised to another competitor¿s implant and identify the reasons for revision as well as perioperative complications.The article reports the associated perioperative complications that clinicians encounter when revising failed agility taa are not well documented.A retrospective chart and radiographic review of 35 consecutive failed agility taa revised to a competitor¿s implant in 34 patients was performed for this study.All cases were completed between june 2011 and march 2013, allowing for a minimum of six months follow-up.Inclusion criteria included patients who presented with pain and a failed agility taa that was revised.Five patients were excluded because they revised to another agility taa, one patient excluded due to revision to another implant and nine were excluded because their procedure only involved polymer exchanges and cyst debridement with retention of the primary taa implants.34 patients met the inclusion criteria for the study.One patient had bilateral revisions.13 patients had a revision procedure, either complete revision or polymer exchange, prior to the conversion to the competitor implant.15 patients had additional procedures performed on the operative ankle prior to revision, which included realignment osteotomies, gutter debridement, and antibiotic cement spacer placement for infection.The initial agility taa was retained for an average of 49.6 months (7.2-113.0 months) prior to any revision surgery.Indications for revisions primarily involved mechanical loosening of the prosthesis, talar subsidence and osteolysis.All patients had symptoms of ankle joint pain and some had additional complaints of instability on clinical presentation.There was also one patient who suffered a dislocation of the ankle prosthesis and three who experienced a periprosthetic fracture.

Manufacturer Narrative

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.H10 additional 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 will be filed as appropriate.

• 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
• MDR Report Key: 9430511
• MDR Text Key: 185502036
• Report Number: 1818910-2019-119252
• 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
• Report Date: 11/15/2019

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
• Initial Date Manufacturer Received: 11/15/2019
• Initial Date FDA Received: 12/06/2019
• Supplement Dates Manufacturer Received: 01/07/2020
• Supplement Dates FDA Received: 01/20/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention