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U.S. Department of Health and Human Services

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

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DEPUY ORTHOPAEDICS, INC. 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 05/04/2017
Event Type  Injury  
Manufacturer Narrative

This complaint is under investigation. Depuy will notify the fda of the results of the investigation once it has been completed. (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 loosening of the tibial component at the cement to implant interface, competitor cement was used.

 
Manufacturer Narrative

No device associated with this report was received for examination. A worldwide lot specific complaint database search, or device history record (dhr) review was not possible because the required lot code(s) was not provided. 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 the 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 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 Key6600626
Report Number1818910-2017-18834
Device Sequence Number1
Product CodeJWH
Report Source Manufacturer
Source Type DISTRIBUTOR,HEALTH PROFESSION
Reporter Occupation HEALTH PROFESSIONAL
Type of Report Initial,Followup
Report Date 05/04/2017
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received05/31/2017
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device Catalogue Number150600005
Device LOT 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 Received06/21/2017
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: 05/31/2017 Patient Sequence Number: 1
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