MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US SIG RP AOX CRV INS SZ2.5 12.5; SIGMA KNEE PRIMARY : KNEE TIBIAL INSERT

Model Number	1961-92-022
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Adhesion(s) (1695); Muscular Rigidity (1968); Pain (1994); Joint Laxity (4526); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/04/2021
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 instability and pain/stiffness date of implantation: (b)(6) 2017 date of revision: (b)(6) 2021 (left knee) on (b)(6) 2017, patient received bilateral pfc sigma cemented posterior crutiate retaining, rotating platform total knee replacements to address significant pain & discomfort, dysfunction, and bone-on-bone arthritis and chondrosis.Patellas were resurfaced in both cases.There were no reported complications for either knee.Patient was seen in the physicians office for clinical follow-up on (b)(6) 2021.She presented with a painful, unstable left knee.Her diagnosis is global instability of the left, with plan to revise following the raising of covid 19 restrictions.On (b)(6) 2021, patient's left knee was revised to address moderate global instability with significant scarring/arthrofibrosis.Tibial insert was revised, and an extensive scar resection/synovectomy was performed.There were no complications reported.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.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
On (b)(6) 2021, patient's left knee was revised to address moderate global instability with significant scarring/arthrofibrosis.Tibial insert was revised, and an extensive scar resection/synovectomy was performed.There were no complications reported.
Additional Manufacturer Narrative
Product complaint # (b)(4).Mfr# 1818910-2021-10967 is being retracted since it was found to be a duplicate of mrf# 1818910-2021-10468.Mfr# 1818910-2021-10468 will be kept for investigation purposes.

• Brand Name: SIG RP AOX CRV INS SZ2.5 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: kara ditty-bovard ; 700 orthopaedic dr.; warsaw, IN 46581-0988 ; 6107428552
• MDR Report Key: 11870018
• Report Number: 1818910-2021-10967
• Device Sequence Number: 19062904
• Product Code: NJL
• UDI-Device Identifier: 10603295076131
• UDI-Public: 10603295076131
• 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: 2017
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Study,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/11/2021

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?: No
• Operator of Device: Health Professional
• Device Model Number: 1961-92-022
• Device Catalogue Number: 196192022
• Device Lot Number: 8528945
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Received by Manufacturer: 05/11/2021
• Supplement Date Received by Manufacturer: 05/19/2021; 05/30/2022
• Initial Report FDA Received Date: 05/24/2021
• Supplement Report FDA Received Date: 06/04/2021; 06/14/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/04/2017
• 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.; DEPUY CMW 3 40G.; MBT CEM KEEL TIB TRAY SZ2.5.; PFC*SIGMA C/R NPOR FEM LTSZ2.5.; PFC*SIGMA/OV/DOME PAT 3PEG,35.; SIG RP AOX CRV INS SZ2.5 12.5.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 58 YR
• Patient Sex: Female
• Patient Weight: 73 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White