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

Model Number	86-4182
Medical Device Problem Code	Loss of or Failure to Bond (1068)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	03/09/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Product complaint # (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 completed due to loose tibial component, osteolysis, and polyethylene wear.Tibial component was also revised.
Additional Manufacturer Narrative
Product complaint # (b)(4).This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by depuy synthes joint reconstruction, or its employees that the report constitutes an admission that the product, depuy synthes joint reconstruction, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.
Event or Problem Description
Revision right knee.
Additional Manufacturer Narrative
Product complaint # (b)(4).This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by depuy synthes joint reconstruction, or its employees that the report constitutes an admission that the product, depuy synthes joint reconstruction, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.
Event or Problem Description
Additional information was received stated the following: 1.It was indicated that there was tibial loosening.On what interface did the loosening occur? there was significant loosening and osteolysis of the tibia and the failed interface could not be determined.2.Was/were the bone cement/s used depuy manufactured? if yes, please provide the quantity, product and lot numbers.Unknown and if known would have been stated in the original report, not believed to be depuy synthes cement.3.Please specify which poly was worn.Was it the insert or the patella or both? both.4.Was there an allegation against the revised femoral component? if this is the case i think it is the femur was not revised and would have been marked as still implanted.This case is several weeks ago now and i do many cases and many cst reports.Please understand all information available at the time is included however after several weeks as is the case here it can be very difficult to recall one single case.5.Was surgery time extended? if yes, what is the duration of the delay? no delay.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary: no device associated with this report was received for examination.A worldwide lot specific complaint database search, or manufacturing record evaluation, was not possible as the required lot number was not provided.The information received will be retained for trend analysis, post market surveillance, or other events within the quality system.Device history lot: the product investigation found no evidence suspecting an error in the manufacturing or material that would be a contributing factor in the reported allegation(s).A manufacturing records evaluation (mre) was not performed.

• Brand Name: PFC KEEL TIB TRAY CEM SZ4
• Common Device Name: SIGMA KNEE PRIMARY : KNEE TIBIAL TRAY
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• Manufacturer (Section G): DEPUY ORTHOPAEDICS, INC. 1818910; 700 orthopaedic dr.; warsaw IN 46581 0988
• Manufacturer Contact: kara ditty-bovard ; 700 orthopaedic dr.; warsaw, IN 46581-0988 ; 6107428552
• MDR Report Key: 13889661
• Report Number: 1818910-2022-05307
• Device Sequence Number: 19273507
• Product Code: JWH
• UDI-Device Identifier: 10603295216445
• UDI-Public: 10603295216445
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K961685
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2008
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 03/24/2022
• 2 Devices were Involved in the Event: 1 2

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: 86-4182
• Device Catalogue Number: 864182
• Device Lot Number: 2643709
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/08/2022
• Supplement Date Received by Manufacturer: 04/04/2022; 04/08/2022; 04/20/2022
• Initial Report FDA Received Date: 03/24/2022
• Supplement Report FDA Received Date: 04/07/2022; 04/12/2022; 04/21/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/21/2008
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: COMPETITOR CEMENT.; COMPETITOR CEMENT.; PFC KEEL TIB TRAY CEM SZ4.; PFC SIGMA CRVD INS SZ4 12.5MM.; PFC*SIGMA/OV/DOME PAT 3PEG,41.; SIG C/R POROCOAT FEM RT SZ 5.; UNK KNEE FEMORAL SIGMA.; UNK KNEE PATELLA SIGMA.; UNK KNEE TIBIAL INSERT SIGMA.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 79 YR
• Patient Sex: Male