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.

• Brand Name: UNKNOWN WRIST IMPLANT
• Type of Device: WRIST IMPLANT
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• Manufacturer (Section G): JTE WARSAW MFG SITE; 700 orthopaedic drive; warsaw IN 46582
• Manufacturer Contact: kara ditty-bovard ; 700 orthopaedic drive; warsaw, IN 46581-0988 ; 6107428552
• 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
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: literature
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 11/18/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/11/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes

Device Operator

• Device Catalogue Number: UNK WRIST
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 01/13/2020
• 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 Treatment Data

Date Received: 12/11/2019 Patient Sequence Number: 1