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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY RAYNHAM ATTUNE CR FB INSRT SZ 6 5MM TIBIAL KNEE INSERT

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DEPUY RAYNHAM ATTUNE CR FB INSRT SZ 6 5MM TIBIAL KNEE INSERT Back to Search Results
Catalog Number 151620605
Event Date 05/07/2012
Event Type  Injury  
Manufacturer Narrative

The product associated with this reported event was not returned for examination. A search of the complaint database did not show any additional reports against the product lot code. The investigation could not draw any conclusions about the reported patient knee infection. No evidence was found suggesting product error was a contributing factor and the need for corrective action is not indicated. Depuy considers the investigation closed at this time. Should the product and/or additional information be received, the investigation will be re-opened.

 
Manufacturer Narrative

The revision surgery operative notes were provided and reviewed. The investigation could not draw any conclusions regarding the reported event with the information available. Based on the inability to identify a root cause, the need for corrective action was not indicated. Depuy considers the investigation closed at this time. Should any additional information be received to change the outcome of the performed investigation, the complaint will be re-opened.

 
Event Description

Clinical report states that patient was revised to address infection.

 
Manufacturer Narrative

This complaint is still under investigation. Depuy will notify the fda of the results of this investigation once it has been completed.

 
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Brand NameATTUNE CR FB INSRT SZ 6 5MM
Type of DeviceTIBIAL KNEE INSERT
Manufacturer (Section D)
DEPUY RAYNHAM
325 paramount dr.
raynham MA 02767
Manufacturer (Section G)
DEPUY RAYNHAM
325 paramount dr.
raynham MA 02767
Manufacturer Contact
donald dion jr.
700 orthopaedic drive
warsaw , IN 46581-0988
MDR Report Key2598233
Report Number1818910-2012-14223
Device Sequence Number1
Product CodeJWH
Report Source Manufacturer
Source Type Study,Health Professional
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 05/15/2012
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received06/05/2012
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device Catalogue Number151620605
Device LOT Number194627
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Date Manufacturer Received05/15/2012
Was Device Evaluated By Manufacturer? No
Date Device Manufactured02/15/2012
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: 06/05/2012 Patient Sequence Number: 1
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