MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS, INC. PFC C/R FEM CEM RT SZ3; KNEE FEMORAL COMPONENT

Catalog Number 864162

Device Problem Insufficient Information (3190)

Patient Problem Pain (1994)

Event Date 05/05/2014

Event Type  Injury  

Event Description

Patient was revised to address poly wear of the insert and pain.

Manufacturer Narrative

\ the investigation is ongoing.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

The device associated with this report was not returned.Requests for additional investigational inputs were made in accordance with wi-7915 appendix a.No additional information was obtained.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.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: PFC C/R FEM CEM RT SZ3
• 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: stacey trick ; 700 orthopaedic drive; warsaw, IN 46581 ; 5743714554
• MDR Report Key: 3838865
• MDR Text Key: 15326242
• Report Number: 1818910-2014-19719
• Device Sequence Number: 1
• Product Code: HSA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK833118
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Distributor
• Reporter Occupation: Physician
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 05/05/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/29/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 864162
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/16/2014
• 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: 58 YR