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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY IRELAND 9616671 ATTUNE FB TIB BASE SZ 5 CEM KNEE TIBIAL TRAY

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DEPUY IRELAND 9616671 ATTUNE FB TIB BASE SZ 5 CEM KNEE TIBIAL TRAY Back to Search Results
Catalog Number 150600005
Device Problem Loss of or Failure to Bond
Event Date 08/03/2017
Event Type  Injury  
Manufacturer Narrative

If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

 
Event Description

Patient was revised to address aseptic loosening of the tibial component at the cement to implant interface. Unknown cement was used. It was noted that the tibial component had debonded from the cement mantle.

 
Manufacturer Narrative

The device associated with this report was not received for examination\ 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.

 
Manufacturer Narrative

Product complaint #: (b)(4). Investigation summary: no device associated with this report was received for examination. Depuy synthes considers the investigation closed. Should additional information be received, the information will be reviewed and the investigation may 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 FB TIB BASE SZ 5 CEM
Type of DeviceKNEE TIBIAL TRAY
Manufacturer (Section D)
DEPUY IRELAND 9616671
loughbeg, ringaskiddy co.
cork
EI 
Manufacturer (Section G)
DEPUY IRELAND 9616671
loughbeg, ringaskiddy co.
cork
EI 
Manufacturer Contact
kara ditty-bovard
1210 ward avenue
west chester , IN 19380
6103142063
MDR Report Key6837195
Report Number1818910-2017-23912
Device Sequence Number1
Product CodeJWH
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,HEALTH
Reporter Occupation HEALTH PROFESSIONAL
Type of Report Initial
Report Date 08/03/2017
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received08/31/2017
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device Catalogue Number150600005
Device LOT Number3616666
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 Received12/27/2018
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured05/03/2013
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: 08/31/2017 Patient Sequence Number: 1
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