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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US BIAX WRIST POROCOAT SM RT WRIST IMPLANT

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DEPUY ORTHOPAEDICS INC US BIAX WRIST POROCOAT SM RT WRIST IMPLANT Back to Search Results
Catalog Number 115604000
Device Problem Fracture (1260)
Patient Problem No Code Available (3191)
Event Date 01/01/2020
Event Type  malfunction  
Manufacturer Narrative
Product complaint #: (b)(4). Depuy orthopaedics, inc. 1818910. If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
 
Event Description
It was reported by the patient that in 1997 the surgeon operated patient's left wrist because off serious damage through rheumatoid arthritis. Patient got a biax- prothese. (produced by depuy). Now 23 years later the plastic is broken. Current doctor intends to do an arthodesis. That means substancial limitations in use of patient's hands.
 
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Brand NameBIAX WRIST POROCOAT SM RT
Type of DeviceWRIST IMPLANT
Manufacturer (Section D)
DEPUY ORTHOPAEDICS INC US
700 orthopaedic drive
warsaw IN 46581 0988
Manufacturer (Section G)
DEPUY ORTHOPAEDICS, INC. 1818910
700 orthopaedic dr.
warsaw IN 46581 0988
Manufacturer Contact
kara ditty-bovard
700 orthopaedic drive
warsaw, IN 46581-0988
6107428552
MDR Report Key10080663
MDR Text Key192146514
Report Number1818910-2020-12466
Device Sequence Number1
Product Code JWJ
Combination Product (y/n)N
Reporter Country CodeNL
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer,foreign,health profe
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup,Followup,Followup
Report Date 05/11/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received05/21/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number115604000
Device Lot NumberT5WD51006
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 Received07/22/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

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