MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US SIG RP AOX CRV INS SZ4 12.5; SIGMA KNEE PRIMARY : KNEE TIBIAL INSERT

Model Number	1961-92-042
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Fever (1858); Unspecified Infection (1930); Pain (1994); Swelling/ Edema (4577)
Date of Event	11/05/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
Clinical adverse event received for deep infection.Event is serious and is considered moderate.Event is possibly related to both device and procedure.Date of implant: (b)(6) 2016.Date of revision: (b)(6) 2022.Date of event: (b)(6) 2022.(right knee) treatment: revision and i&d; insert was 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 : the device associated with this report was not returned to depuy synthes for evaluation.All available x-rays were reviewed, and no evidence of implant fracture, disassociation, or anything indicative of a device nonconformance was found.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post-market safety surveillance activities.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.
Event or Problem Description
Medical records received indicate that on dor: (b)(6)2022: 54 yo- female patient right knee i&d and revision of tibial insert to treat pain, swelling, and fever secondary to infection.The surgeon notes the infection was confirmed after aspiration and testing of the synovial fluid.Upon entering the joint, purulent pus and swelling were evacuated and the right knee was thoroughly debrided and washed.There was no reported product problem with the revised tibial insert.The surgeon inserted a drain and a picc line for iv antibiotic prophylaxis.The procedure was completed without complications.Clinic note dated 15 november 2022: patient is healing well.The surgeon removed the staples and drain.Clinic note dated 14 december 2022: patient healing is progressing as expected.Rom is excellent and radiographic images identify a well-fixed right tka.
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.

• Brand Name: SIG RP AOX CRV INS SZ4 12.5
• 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 orthpaedic dr.; warsaw, IN 46581 ; 3035526892
• MDR Report Key: 16095300
• Report Number: 1818910-2023-00338
• Device Sequence Number: 15116304
• Product Code: NJL
• UDI-Device Identifier: 10603295076216
• UDI-Public: 10603295076216
• 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: 2016
• 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): 01/04/2023

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: 1961-92-042
• Device Catalogue Number: 196192042
• Device Lot Number: 8284783
• 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: 12/14/2022
• Supplement Date Received by Manufacturer: 01/03/2023; 02/03/2023
• Initial Report FDA Received Date: 01/04/2023
• Supplement Report FDA Received Date: 01/18/2023; 02/06/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/27/2016
• 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 3 40G; MBT CEM KEEL TIB TRAY SZ3; PFC SIG CR NPOR FEM RT SZ 4N; PFC*SIGMA/OV/DOME PAT 3PEG,38
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 54 YR
• Patient Sex: Female
• Patient Weight: 146 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White