MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US UNKNOWN WRIST IMPLANT

Catalog Number UNK WRIST

Device Problem Loss of or Failure to Bond (1068)

Patient Problems Pain (1994); Inadequate Osseointegration (2646); No Code Available (3191)

Event Date 02/01/2016

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 "wrist arthrodesis for failed total wrist arthroplasty¿, written by brian d.Adams, md et al, published in the journal of hand surgery am, in 2016; was reviewed.This article reports on a study that evaluates the radiographic results of a surgical technique for conversion of a failed arthroplasty to an arthrodesis.The purpose of the study was to assess the radiographic outcome and complications in a series of failed twa¿s converted to a complete wrist arthrodesis using a surgical technique consisting of a contoured cancellous femoral head structural allograft, a wrist arthrodesis plate, and optional supplementation with demineralized bone matrix and corticocancellous bone chips.Patients were treated with the biaxial prosthesis (two patients), depuy, and the other 16 patients were treated with non-depuy products.The biaxial prosthesis in both patients failed due to distal component loosening.Case 1 and case 13 were identified as having depuy products in the article.All patients claimed to have no pain, or mild pain at the final follow-up.No other complications were specified with the depuy joint reconstruction products within the article.

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 : the device associated with this report was not received for examination.Depuy synthes considers the investigation closed at this time.Should additional information be received, the information will be reviewed and the investigation may be re-opened as necessary.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: UNKNOWN WRIST IMPLANT
• Type of Device: WRIST IMPLANT
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 9452429
• MDR Text Key: 185248651
• Report Number: 1818910-2019-120021
• Device Sequence Number: 1
• Product Code: JWJ
• 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: 11/18/2019

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 WRIST
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 11/18/2019
• Initial Date FDA Received: 12/11/2019
• Supplement Dates Manufacturer Received: 01/13/2020
• Supplement Dates FDA Received: 01/14/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention