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Adverse Event Report

DEPUY ORTHOPAEDICS DEPUY (JOHNSON & JOHNSON) RIGHT PATELLA COMPONENT OF TOTAL KNEE   back to search results
Catalog Number 960121
Device Problems Fragmentation; Implant, removal of
Event Date 05/06/2003
Patient Outcome  Required Intervention;
Event Description

Pt admitted to hosp for removal of patella component status post right total knee arthroplasty (1999) secondary to fragmentation of the patella and failure of the implant.

 
Event Description

Add'l info rec'd from mfr 10/24/03: the catalog number listed in the medical device report is 960121. This is a 28mm pfc sigma patella component. The manufacturing lot number listed in the medical device report is 161315. Depuy submitted an initial mdr for this event on august 28, 2003. The mdr number assigned to this report is 1818910-2003-00576.

 
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Brand NameDEPUY (JOHNSON & JOHNSON)
Type of DeviceRIGHT PATELLA COMPONENT OF TOTAL KNEE
Baseline Device 510(K) Number
Baseline Device PMA Number
Manufacturer (Section F)
DEPUY ORTHOPAEDICS
700 orthopaedic dr
warsaw IN 46581
Manufacturer (Section D)
DEPUY ORTHOPAEDICS
700 orthopaedic dr
warsaw IN 46581
Device Event Key465691
MDR Report Key476887
Event Key451975
Report Number476887
Device Sequence Number1
Product CodeJWH
Report Source User Facility
Reporter Occupation RISK MANAGER
Type of Report Initial,Followup
Report Date 08/01/2003
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received08/04/2003
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number960121
Device LOT Number161315
OTHER Device ID Number28MM
Was Device Available For Evaluation? Yes
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA? No
Distributor Facility Aware Date07/28/2003
Device Age4 yr
Event Location Hospital
Is this a Reprocessed and Reused Single-Use Device? No
Is the Device an Implant? Yes
Is this an Explanted Device?

Patient TREATMENT DATA
Date Received: 10/24/2003 Patient Sequence Number: 1
#TreatmentTreatment Date
1,NONE,

Database last updated on February 28, 2009

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