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U.S. Department of Health and Human Services

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

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DEPUY ORTHOPAEDICS INC US UNKNOWN WRIST IMPLANT Back to Search Results
Catalog Number UNK WRIST
Device Problem Loss of or Failure to Bond (1068)
Patient Problems Pain (1994); Loss of Range of Motion (2032); Inadequate Osseointegration (2646); No Code Available (3191)
Event Date 01/01/2012
Event Type  Injury  
Manufacturer 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. 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.
 
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.
 
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Brand NameUNKNOWN WRIST IMPLANT
Type of DeviceWRIST 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 Key9452397
MDR Text Key185342728
Report Number1818910-2019-119822
Device Sequence Number1
Product Code JWJ
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
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 Received12/11/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberUNK 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 Received01/08/2020
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
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