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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY IRELAND 9616671 ATTUNE FB TIB BASE SZ 4 CEM KNEE TIBIAL TRAY

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DEPUY IRELAND 9616671 ATTUNE FB TIB BASE SZ 4 CEM KNEE TIBIAL TRAY Back to Search Results
Catalog Number 150600004
Device Problem Loss of or Failure to Bond
Event Date 06/08/2017
Event Type  Injury  
Manufacturer Narrative

This complaint is still under investigation. Depuy will notify the fda of the results of this investigation once it has been completed. Udi: (b)(4). If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

 
Event Description

The patient was revised to address pain and loosening of the tibial component at the cement to implant interface. Depuy cement was used.

 
Manufacturer Narrative

Additional narrative: no device associated with this report was received for examination. A worldwide complaint database search found no other reported incident(s) against the provided product/lot combination(s) since release for distribution. A worldwide lot specific complaint database search, or device history record (dhr) review was not possible for the unknown lot. 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. Depuy considers the investigation closed at this time. 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 FB TIB BASE SZ 4 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
chad gibson
700 orthopaedic drive
warsaw , IN 46581
5743725905
MDR Report Key6692800
Report Number1818910-2017-20744
Device Sequence Number1
Product CodeJWH
Report Source Manufacturer
Source Type DISTRIBUTOR,HEALTH PROFESSION
Reporter Occupation HEALTH PROFESSIONAL
Type of Report Initial
Report Date 06/08/2017
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received07/07/2017
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device Catalogue Number150600004
Device LOT Number8138236
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 Received07/11/2017
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured06/22/2015
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: 07/07/2017 Patient Sequence Number: 1
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