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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS, INC. ATTUNE RP TIB BASE SZ 5 CEM KNEE TIBIAL TRAY

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DEPUY ORTHOPAEDICS, INC. ATTUNE RP TIB BASE SZ 5 CEM KNEE TIBIAL TRAY Back to Search Results
Catalog Number 150610005
Device Problem Loss of or Failure to Bond
Event Date 04/10/2017
Event Type  Injury  
Manufacturer Narrative

Complete product detail has not been received at this time. If further information is received a follow-up medwatch will be filed as appropriate. This complaint is still under investigation. Depuy will notify the fda of the results of this investigation once it has been completed.

 
Event Description

Patient was revised to address tibial tray loosening at the cement/implant interface. Competitor cement was used.

 
Manufacturer Narrative

The device associated with this report was not returned. Depuy considers the investigation closed. Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary. If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

 
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Brand NameATTUNE RP TIB BASE SZ 5 CEM
Type of DeviceKNEE TIBIAL TRAY
Manufacturer (Section D)
DEPUY ORTHOPAEDICS, INC.
700 orthopaedic drive
warsaw IN 46582
Manufacturer (Section G)
DEPUY ORTHOPAEDICS, INC.
700 orthopaedic drive
warsaw IN 46582
Manufacturer Contact
chad gibson
700 orthopaedic drive
warsaw , IN 46581
5743725905
MDR Report Key6530106
Report Number1818910-2017-17184
Device Sequence Number1
Product CodeJWH
Report Source Manufacturer
Source Type DISTRIBUTOR,HEALTH PROFESSION
Reporter Occupation
Type of Report Initial,Followup
Report Date 04/10/2017
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received04/28/2017
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device Catalogue Number150610005
Device LOT NumberUNKNOWN
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 Received06/06/2017
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: 04/28/2017 Patient Sequence Number: 1
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