MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US SIG RP AOX CRV INS SZ3 12.5; SIGMA KNEE PRIMARY : KNEE TIBIAL INSERT

Model Number	1961-92-032
Medical Device Problem Codes	Naturally Worn (2988); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Pain (1994); Discomfort (2330); Joint Laxity (4526); Unspecified Tissue Injury (4559); Swelling/ Edema (4577); Insufficient Information (4580)
Date of Event	06/09/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
Clinical adverse event received for poly failure and tibial fracture.Event is serious and is considered severe.Event is possibly related to device.Event is not related to procedure.Date of implant: (b)(6) 2021.Date of revision: unk.Date of event: (b)(6) 2023 (left knee).Treatment: revision; tibial base 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 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: added: b5, h6 (clinical code, medical device problem code) 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 were received and stated that on (b)(6) 2021, the patient received bilateral total knee replacements utilizing j&j depuy sigma, with press-fit femurs and cemented tibial tray and patella implants.Inserts were curved cruciate retaining devices.There were no reported complications.On (b)(6) 2023, the patient was seen in the clinic for a preop evaluation.There was a gross failure of the rotating-platform knee insert with significant medial varus laxity and flexion instability.The patient was scheduled for revision.On (b)(6) 2023, the patient's left total knee was revised to address gross instability, with revision of tibial insert and synovectomy.This appears to be related to an injury sustained during tennis, where the patient had a sudden onset of pain, discomfort, soft tissue deformity, and swelling.All other products besides the insert were found to be well-fixed and positioned and were retained.

• Brand Name: SIG RP AOX CRV INS SZ3 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 ORTHOPAEDICS, INC. 1818910; 700 orthopaedic dr.; warsaw IN 46581 0988
• Manufacturer Contact: kate karberg ; 700 orthopaedic dr.; warsaw, IN 46581-0988 ; 3035526892
• MDR Report Key: 17208090
• Report Number: 1818910-2023-13075
• Device Sequence Number: 6741770
• Product Code: NJL
• UDI-Device Identifier: 10603295076179
• UDI-Public: 10603295076179
• 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: 2021
• 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): 06/27/2023

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: 1961-92-032
• Device Catalogue Number: 196192032
• Device Lot Number: 9715897
• 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: 06/15/2023
• Supplement Date Received by Manufacturer: 07/05/2023; 08/10/2023
• Initial Report FDA Received Date: 06/27/2023
• Supplement Report FDA Received Date: 07/14/2023; 08/11/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/22/2021
• 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 2 20G; MBT CEM KEEL TIB TRAY SZ3; PFC*SIGMA/OV/DOME PAT 3PEG,38; SIG C/R POROCOAT FEM LT SZ 3
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 57 YR
• Patient Sex: Female
• Patient Weight: 86 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White