MAUDE Adverse Event Report: 1219655 DEPUY-RAYNHAM, A DIV. OF DEPUY ORTHOPAEDIC SIGMA HP UNI TIB TRAY SZ3 LMRL; KNEE TIBIAL TRAY

Catalog Number 102451300

Device Problem Loss of or Failure to Bond (1068)

Patient Problem Pain (1994)

Event Date 05/13/2014

Event Type  Injury  

Event Description

Patient was revised because of pain and tibial loosening.Loosening was at the bone/cement and cement/implant interfaces.Cement was depuy manufactured.

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.

Manufacturer Narrative

Additional narrative: the devices associated with this report were not returned.A complaint database search finds no other reported incidents against the provided product and lot combination for the tibial tray.Review of the device history records and/or a lot specific complaint database search was not possible as the lot code required was not provided for the cement.Requests for additional investigational inputs were made in accordance with wi-7915 appendix a.No additional information was obtained.The investigation could not verify or identify any product contribution to the reported event with the information provided.Based on the inability to identify root cause, the need for corrective action was not indicated.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.

• Brand Name: SIGMA HP UNI TIB TRAY SZ3 LMRL
• Type of Device: KNEE TIBIAL TRAY
• Manufacturer (Section D): 1219655 DEPUY-RAYNHAM, A DIV. OF DEPUY ORTHOPAEDIC; 325 paramount drive; raynham MA 02767
• Manufacturer (Section G): 1219655 DEPUY-RAYNHAM, A DIV. OF DEPUY ORTHOPAEDIC; 325 paramount drive; raynham MA 02767
• Manufacturer Contact: stacey trick ; 700 orthopaedic drive; warsaw, IN 46581 ; 5743714554
• MDR Report Key: 3853276
• MDR Text Key: 4616457
• Report Number: 1818910-2014-20393
• Device Sequence Number: 1
• Product Code: HRY
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK070267
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 05/13/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 102451300
• Device Lot Number: 329047
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/25/2014
• Initial Date FDA Received: 06/06/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 07/09/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/31/2013
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 66 YR
• Patient Weight: 79