MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US PFC KEEL TIB TRAY CEM SZ3; SIGMA KNEE PRIMARY : KNEE TIBIAL TRAY

Model Number	86-4181
Medical Device Problem Code	Loss of or Failure to Bond (1068)
Health Effect - Clinical Codes	Joint Laxity (4526); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	02/04/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).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
Revision total knee replacement for loosening and instability.Pfc sigma ps fb tkr.No implant details are available due to records be unavailable due to timeframe.The entire tibial component was affected, not one particular side.The knee was 20 years old it was hard to determine what interface was involved.This was associated with bone subsidence and collateral ligament instability.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary : no device associated with this report was received for examination.A worldwide complaint database search found no other related reported incidents against the provided product code/lot number combination since 01-jan-2015.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.Device history lot : product code 864181 work order (b)(4) was manufactured on 27-jun-2001.(b)(4) parts were manufactured per specification and all raw materials met specification.There are no scrap parts associated with lot 928503.The cmm reports were reviewed as parts of this dhr review.All parts at the machining step in the process are 100 percent inspected on a cmm and all parts passed the cmm inspection therefore there is no correlation to the failure mode described.Deviation 1067 found associated with lot 928503.This was opened to document a change for mps0555 to correct overlabel part therefore there is no correlation between dev.1067 and the complaint failure mode.

• Brand Name: PFC KEEL TIB TRAY CEM SZ3
• Common Device Name: SIGMA KNEE PRIMARY : KNEE TIBIAL TRAY
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 11358122
• Report Number: 1818910-2021-03511
• Device Sequence Number: 3415700
• Product Code: JWH
• UDI-Device Identifier: 10603295216438
• UDI-Public: 10603295216438
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K830927
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2001
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/04/2021

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: 86-4181
• Device Catalogue Number: 864181
• Device Lot Number: 928503
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/04/2021
• Supplement Date Received by Manufacturer: 04/29/2021
• Initial Report FDA Received Date: 02/22/2021
• Supplement Report FDA Received Date: 04/29/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: PFC SIGMA STAB INS SZ3 15MM; PFC*SIGMA C/S NPOR FEM RT SZ 3; PFC*SIGMA/OV/DOME PAT 3PEG,38
• Outcome Attributed to Adverse Event: Required Intervention