MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US PFC*SIGMA/RD/DOME PAT 3PEG,38; SIGMA KNEE PRIMARY : KNEE PATELLA

Model Number	96-0112
Medical Device Problem Code	Naturally Worn (2988)
Health Effect - Clinical Codes	Pain (1994); Synovitis (2094); Insufficient Information (4580)
Date of Event	02/16/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
Clinical notification received for revision of left knee to address polyethylene wear.Date of implantation: (b)(6) 2002, date of revision: (b)(6) 2022, (left knee).Treatment: revision of tibial insert and patella components.
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.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary: an analysis of the product could not be performed since a physical sample was not received for evaluation.As part of our company quality system process, all devices are manufactured, inspected, and distributed to approved specifications.Additional complaint information monitoring for potential safety signals will be conducted through complaint trending as part of the post-market surveillance.However, if the product is received at a later date, the investigation will be updated as applicable.
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
Medical records and operative notes reviewed indicating that "on (b)(6) 2022, patient's left knee was revised to address pain.The knee had been in place for ~twenty years.The surgeon found evidence of foreign body synovitis, as a consequence of polyethylene wear debris.The tibial insert was found to be very worn posterior medially and posterior laterally, with marked delamination.The patella component also was found to have delamination wear, primarily centrally worn.It was well-fixed though, as was the tibial tray and femur components.The patella was revised, as was the tibial insert--femur and tibial tray were retained.Multiple pulsatile lavages were performed on the soft tissues, to remove the polyethylene debris.No surgical complications were identified.".
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary : no device associated with this report was received for examination.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.Depuy considers the investigation closed.Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.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.

• Common Device Name: SIGMA KNEE PRIMARY : KNEE PATELLA
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• Manufacturer (Section G): DEPUY IRELAND 9616671; loughbeg, ringaskiddy co.; cork ; EI
• Manufacturer Contact: amy hendrickson ; 700 orthopaedic dr.; warsaw, IN 46581-0988 ; 5743674841
• MDR Report Key: 13950463
• Report Number: 1818910-2022-05789
• Device Sequence Number: 19925434
• Product Code: JWH
• UDI-Device Identifier: 10603295232681
• UDI-Public: 10603295232681
• Combination Product (Y/N): N
• Initial Reporter State: CT
• Initial Reporter Country: US
• PMA/510(K) Number: P830055
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2002
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Study,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 03/30/2022

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: 96-0112
• Device Catalogue Number: 960112
• Device Lot Number: 1031311
• 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: 03/15/2022
• Supplement Date Received by Manufacturer: 03/23/2022; 04/11/2022; 04/20/2022
• Initial Report FDA Received Date: 03/30/2022
• Supplement Report FDA Received Date: 04/08/2022; 04/12/2022; 04/21/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/22/2008
• 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: ENDURANCE BONE CEMENT 40G; ENDURANCE BONE CEMENT 40G; MBT POROCOAT KEEL SZ 3; PFC SIGMARP STB TB IN 3 15.0; PFC*SIGMA C/S NPOR FEM LT SZ 3; PFC*SIGMA/RD/DOME PAT 3PEG,38
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 83 YR
• Patient Sex: Female
• Patient Weight: 118 KG
• Patient Race: White