MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US PFC SIGMA MOD TIB TRAY CEM SZ4; KNEE TIBIAL TRAY

Catalog Number	866024
Medical Device Problem Code	Loss of or Failure to Bond (1068)
Health Effect - Clinical Codes	Osteolysis (2377); Ambulation or Postural Difficulties (2544)
Date of Event	10/22/2014
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Event or Problem Description
In 2003 the patient received bilateral depuy sigma total knee replacements.(b)(6) 2014 the patient was advised by his surgeon that the pfc sigma total knee replacement system was ¿cementing.¿ on (b)(6) 2014 the patient had a revision surgery.At this time, it is unclear what the reason for revision or patient harm is.It is also unclear if both total knees have been revised.If additional information becomes available, this will be re-addressed.Update dec 12, 2017 and dec 18, 2017 medical records reviewed.Revision notes on (b)(6) 2014 for the right knee indicated the presence of severe, grade iii retrofemoral osteolysis involving the distal femur beneath the femoral component.Additionally, it was identified that the tibia component was loose at the implant to cement interface.It was noted that the patella component was well-fixed and not revised.Tibia, insert, and patella components added and reported.Complaint updated on: jan 10, 2018.
Additional Manufacturer Narrative
Product complaint #: (b)(4).Investigation summary: no device associated with this report was received 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.

• Brand Name: PFC SIGMA MOD TIB TRAY CEM SZ4
• Common Device Name: KNEE TIBIAL TRAY
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; munster; warsaw IN 46582 0988
• MDR Report Key: 7179795
• Report Number: 1818910-2018-10034
• Device Sequence Number: 956404
• Product Code: JWH
• UDI-Device Identifier: 10603295216797
• UDI-Public: 10603295216797
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K884796
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2014
• Reporter Type: Manufacturer
• Report Source: company representative,consum
• Initial Reporter Occupation: Attorney
• Type of Report: Initial,Followup
• Report Date (Section B): 12/18/2017

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
• Operator of Device: Health Professional
• Device Catalogue Number: 866024
• Device Lot Number: 1065137
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/18/2017
• Supplement Date Received by Manufacturer: 09/25/2018
• Initial Report FDA Received Date: 01/10/2018
• Supplement Report FDA Received Date: 10/03/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention