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

Catalog Number UNK WRIST

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Pain (1994); Loss of Range of Motion (2032); No Code Available (3191)

Event Date 01/01/2012

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 "total wrist replacement: a retrospective comparative study¿ written by william cooney, md, et al; published in the journal of wrist surgery vol.1 no.2 in 2012; was reviewed.The purpose of the study is to report the institution¿s experience with resectional arthroplasty versus resurfacing arthroplasty.The patients in the study were identified through the institutions total joint registry¿s database.Between 1994 and 2006, 39 patients with 47 total wrist replacements were identified.One was excluded leaving 46 implants in 39 patients.Surgeries were performed by five different surgeons.There were three different implants used; the biaxial wrist replacement (depuy), and two other non-depuy implants.There were eight failures with the biaxial wrist prosthesis.One loose biaxial was successfully salvaged with a non-depuy total wrist replacement.Two biaxial arthroplasties with instability were salvaged by revision of the distal component.Five of the seven biaxial wrists with distal loosening ultimately required wrist fusion.Pain was improved in all patients.

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.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.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.

• 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: 9452407
• MDR Text Key: 170307082
• Report Number: 1818910-2019-119823
• 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

• Date FDA Received: 12/11/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNK WRIST
• 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