MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS, INC. 1818910 PFC*SIGMA C/S NPOR FE RT SZ2.5; KNEE FEMORAL

Catalog Number	960058
Medical Device Problem Code	Loss of or Failure to Bond (1068)
Health Effect - Clinical Code	Pain (1994)
Date of Event	11/01/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Product complaint #(b)(4).
Event or Problem Description
Der states that patient was claiming of pain and the surgeon was concerned with bone growth around patella as well as possible loosening of femoral component.During surgery both tibial and femoral components were loose.Cement was found both on implants and bone.Patella was also resurfaced and implant replaced.
Additional Manufacturer Narrative
Pc-(b)(4).The device associated with this report was not returned for examination.Depuy synthes considers the investigation closed at this time.Should additional information be received, the information will be reviewed and the investigation may be re-opened as necessary.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Common Device Name: KNEE FEMORAL
• Manufacturer (Section D): DEPUY ORTHOPAEDICS, INC. 1818910; 700 orthopaedic drive; warsaw IN 46582 0988
• MDR Report Key: 7072603
• Report Number: 1818910-2017-50472
• Device Sequence Number: 16433937
• Product Code: JWH
• UDI-Device Identifier: 10603295232445
• UDI-Public: 10603295232445
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: K950010
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2006
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/01/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Catalogue Number: 960058
• Device Lot Number: 366058AB
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/01/2017
• Supplement Date Received by Manufacturer: 09/05/2018
• Initial Report FDA Received Date: 11/30/2017
• Supplement Report FDA Received Date: 09/07/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 68 YR