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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); 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.
 
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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 Key9452429
MDR Text Key185248651
Report Number1818910-2019-120021
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 Received01/13/2020
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
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