MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS, INC. UNKNOWN DEPUY SZ 3 CS PFC FEMORAL COMPONENT; KNEE FEMORAL COMPONENT

Catalog Number UNK-KNEE

Device Problem Loss of or Failure to Bond (1068)

Patient Problem Pain (1994)

Event Date 03/19/2014

Event Type  Injury  

Event Description

Patient was revised to address osteolysis, poly wear and femoral/tibial loosening at the cement/implant interface.The cement manufacturer is unknown.Pain was also reported.

Manufacturer Narrative

This complaint is still under investigation.Depuy will notify the fda of the results of this investigation once it has been completed.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.Depuy synthes has been informed that the catalog number and lot number is not available.

Manufacturer 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 code(s).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.Corrective action was not indicated.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.

• Brand Name: UNKNOWN DEPUY SZ 3 CS PFC FEMORAL COMPONENT
• Type of Device: KNEE FEMORAL COMPONENT
• 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: steve dowell ; 700 orthopaedic drive; warsaw, IN 46581 ; 5743714918
• MDR Report Key: 4286426
• MDR Text Key: 5295646
• Report Number: 1818910-2014-32854
• Device Sequence Number: 1
• Product Code: HTG
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Distributor,distributor,health prof
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/19/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/01/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNK-KNEE
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/20/2015
• 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 Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 74 YR
• Patient Weight: 83