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

Catalog Number UNK ANKLE TALAR

Device Problem Loss of or Failure to Bond (1068)

Patient Problems Inadequate Osseointegration (2646); 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.

Event Description

The literature article entitled bone augmentation for revision total ankle arthroplasty with large bone defects.A technical note on 10 cases¿, by monika horisberger, et al, published in acta orthopaedica in 2015; was reviewed.The purpose of the article was to show how to perform revision taa in patients with substantial bone loss.The procedures described in the article were performed as a one stage or two stage revision.Two of the ten cases noted in the article were taa that were revised from an agility prosthesis (depuy).The indications for revision for all cases was aseptic loosening of the taa associated with extensive bone loss at the tibia, the talus, or both.In all cases preoperative diagnosis was posttraumatic osteoarthritis (oa).There were no intraoperative or postoperative complications.The two cases with agility prosthesis are noted below: patient 1: two years until revision, one stage revision with bone augmentation of the tibia: 2x monocortical.Patient 8: eight years until revision, one stage revision with bone augmentation of the tibia: 2x biocortical.At final follow-up, the tibial and talar components were radiographically stable.Patient 1: two years until revision, one stage revision with bone augmentation of the tibia: 2x monocortical.

Manufacturer Narrative

Depuy synthes is submitting this report pursuant to the provision of 21 cfr, part 803.The report may be based on the 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.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.Based on previous investigations, this complication of joint replacement is unlikely to have been the result of a device failing to meet required specifications.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.Device history lot: null.Device history batch: null.Device history review: null.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: 9428387
• MDR Text Key: 185092960
• Report Number: 1818910-2019-121624
• 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: health professional,literatur
• 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: 01/07/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention