MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US PFC SIGMARP STB TB IN 5 15.0; SIGMA KNEE PRIMARY : KNEE TIBIAL INSERT

Model Number	96-2153
Medical Device Problem Codes	Fracture (1260); Naturally Worn (2988)
Health Effect - Clinical Codes	Pain (1994); Loss of Range of Motion (2032); Synovitis (2094); Joint Laxity (4526); Swelling/ Edema (4577); Insufficient Information (4580)
Date of Event	09/28/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
Clinical adverse event received for poly wear.Event is considered severe.Information is unavailable related to seriousness of event.Event is possibly related to device.Event is not related to procedure.Date of implant: (b)(6) 2002.Date of event: (b)(6) 2022.Date of revision: (b)(6) 2022.(right knee) treatment: revision; insert and patella were revised.
Additional Manufacturer Narrative
Product complaint # (b)(4).Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, 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 medwatch, a follow-up medwatch will be filed as appropriate.
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.
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.H10 additional narrative: 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
The patella and insert were revised on (b)(6) 2022 due to the patient c/o pain, limited range of motion, swelling, and marked instability.The patient is 20 years status post his original knee replacement.Intraoperatively, severe central wear was noted along with delamination of the tibial component.There were loose broken patella shards and pieces throughout the knee that were removed.There was marked foreign body synovitis.The patella was ¿easily loosened.¿ the cement was loose and removed from the patella base.There was severe wear of the post of the superior side of the tibial insert.The insert was also broken from the rotating platform post.It demonstrated ¿marked destruction, wear, delamination, pitting and discoloration with severe loss of substance posterior medially.

• Brand Name: PFC SIGMARP STB TB IN 5 15.0
• Common Device Name: SIGMA KNEE PRIMARY : KNEE TIBIAL INSERT
• 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: kate karberg ; 700 orthopaedic dr.; warsaw, IN 46581-0988 ; 3035526892
• MDR Report Key: 15673031
• Report Number: 1818910-2022-21350
• Device Sequence Number: 6368717
• Product Code: NJL
• UDI-Device Identifier: 10603295241416
• UDI-Public: 10603295241416
• Combination Product (Y/N): N
• Initial Reporter State: AL
• 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
• Report Date (Section B): 10/26/2022

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 Expiration Date: 11/30/2023
• Device Model Number: 96-2153
• Device Catalogue Number: 962153
• Device Lot Number: 8987004
• 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: 10/11/2022
• Supplement Date Received by Manufacturer: 10/28/2022; 12/07/2022
• Initial Report FDA Received Date: 10/26/2022
• Supplement Report FDA Received Date: 11/15/2022; 12/07/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/05/2018
• 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: DEPUY 3 SYRINGEABLE CEMENT 40G; MBT POR KEEL TIB TRAY SZ5; PFC SIGMARP STB TB IN 5 15.0; PFC*SIGMA C/S NPOR FEM RT SZ 5; PFC*SIGMA/OV/DOME PAT 3PEG,41
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 60 YR
• Patient Sex: Male
• Patient Weight: 91 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White