MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US SIG RP AOX CRV INS SZ5 15; SIGMA KNEE PRIMARY : KNEE TIBIAL INSERT

Model Number	1961-92-053
Medical Device Problem Codes	Unintended Movement (3026); Noise, Audible (3273)
Health Effect - Clinical Codes	Hematoma (1884); Pain (1994); Joint Laxity (4526); Insufficient Information (4580)
Date of Event	04/23/2021
Type of Reportable Event	Serious Injury
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.
Event or Problem Description
Clinical notification received for revision of left total knee to address bearing spin out date of implantation: (b)(6) 2021; date of revision: (b)(6) 2021; (left knee).Treatment: revision of tibial insert.
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 and h6 (device code).If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.Corrected: h6 (clinical codes).
Event or Problem Description
Medical records received and were reviewed: on (b)(6) 2021, the patient underwent a primary left knee arthroplasty to address osteoarthritis.Depuy products and cement were used.There were no indicated intra-operative complications.On (b)(6) 2021, the patient presented for a left knee evaluation due to multiple occurrences of clunking in his knee with mild pain.On examination, the physician noted with deep flexion past 130 degrees there was a tendency for the poly tibial insert to spin out.When palpated, there was an audible clunk with subluxation and an audible clunk when it subluxed back into the joint.It was noted this can be reproduced with flexion past 130.The physician indicated at that point the patient was experiencing poly subluxation, but had not formerly spun out.Plan for revision with poly swap as well as pcl release.On (b)(6) 2021, the patient underwent a left knee revision to address poly tibial insert subluxation/spinout.The surgeon noted findings as increased flexion gap posterolaterally with increased femoral rollback posterolaterally.The patient was experiencing pain and instability.There was a bit of a coagulant from resolving hematoma.The tibial insert was the only product revised.There were no indicated intra-operative complications.

• Brand Name: SIG RP AOX CRV INS SZ5 15
• Common Device Name: SIGMA KNEE PRIMARY : KNEE TIBIAL INSERT
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 11841009
• Report Number: 1818910-2021-10526
• Device Sequence Number: 3142425
• Product Code: NJL
• UDI-Device Identifier: 10603295076261
• UDI-Public: 10603295076261
• 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
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: health professional,study
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/05/2021

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: No Information
• Device Model Number: 1961-92-053
• Device Catalogue Number: 196192053
• Device Lot Number: 9356858
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/05/2021
• Supplement Date Received by Manufacturer: 05/13/2021; 06/18/2021
• Initial Report FDA Received Date: 05/18/2021
• Supplement Report FDA Received Date: 05/28/2021; 06/22/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: DEPUY CMW 1 40G; DEPUY CMW 1 40G; DEPUY CMW 2 20G; MBT CEM KEEL TIB TRAY SZ5; PFC*SIGMA C/R NPOR FEM LT SZ5; PFC*SIGMA/OV/DOME PAT 3PEG,41; SIG RP AOX CRV INS SZ5 15; DEPUY CMW 1 40G; DEPUY CMW 1 40G; DEPUY CMW 2 20G; MBT CEM KEEL TIB TRAY SZ5; PFC*SIGMA C/R NPOR FEM LT SZ5; PFC*SIGMA/OV/DOME PAT 3PEG,41; SIG RP AOX CRV INS SZ5 15
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 76 YR
• Patient Weight: 92