MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US PFC SIGMARP CV TB/IN S3 15.0; SIGMA KNEE PRIMARY : KNEE TIBIAL INSERT

Model Number	96-2033
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Pain (1994); Osteolysis (2377); Joint Laxity (4526); Physical Asymmetry (4573); Swelling/ Edema (4577)
Date of Event	07/18/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Product complaint # (b)(4).Update: medical records received ad 27 jul 2022 were reviewed on 03 aug 2022 by a clinician to identify patient harms/product issues.Office notes (b)(6) 2022 indicate the patient is experiencing pain, popping, swelling, instability, and a slight leg length discrepancy in the right knee.Xray reveals bone pitting / osteolysis on the femoral bone.Revision operative notes were not provided within this set of medical records.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.
Event or Problem Description
Clinical adverse event received for instability and increased pain.Event is serious and is considered moderate.Event is possibly related to both device and procedure.Date of implant: (b)(6) 2014, date of event: (b)(6) 2022, (right knee).Treatment: revision; insert was removed.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary : device associated with this report was not received for examination.All available x-rays and photographs were reviewed and found no evidence of device issue.Depuy synthese 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.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
Office notes (b)(6 2022 indicate the patient is experiencing pain, popping, swelling, instability, and a slight leg length discrepancy in the right knee.Xray reveals bone pitting / osteolysis on the femoral bone.Revision operative notes were not provided within this set of medical records.

• Brand Name: PFC SIGMARP CV TB/IN S3 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: 15163408
• Report Number: 1818910-2022-15013
• Device Sequence Number: 17792081
• Product Code: NJL
• UDI-Device Identifier: 10603295240761
• UDI-Public: 10603295240761
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: P830055
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• 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): 08/04/2022

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?: No
• Operator of Device: Health Professional
• Device Model Number: 96-2033
• Device Catalogue Number: 962033
• Device Lot Number: 6050332
• 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: 07/27/2022
• Supplement Date Received by Manufacturer: 07/27/2022; 09/15/2022
• Initial Report FDA Received Date: 08/04/2022
• Supplement Report FDA Received Date: 08/11/2022; 09/16/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/26/2013
• 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 CMW 1 40G; MBT CEM KEEL TIB TRAY SZ4; PFC SIGMARP CV TB/IN S3 15.0; PFC*SIGMA C/R NPOR FEM RT SZ 3; PFC*SIGMA/OV/DOME PAT 3PEG,38
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 74 YR
• Patient Sex: Male
• Patient Weight: 82 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White