MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US SIG RP AOX CRV INS SZ4 10; SIGMA KNEE PRIMARY : KNEE TIBIAL INSERT

Model Number	1961-92-041
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Pain (1994); Loss of Range of Motion (2032); Joint Laxity (4526); Unspecified Tissue Injury (4559)
Date of Event	12/15/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
Clinical adverse event received for instability and increase pain.Event is serious and is considered severe.Event is possibly related to both device and procedure.Date of implant: (b)(6) 2021; date of revision: unk; date of event: (b)(6) 2022.(right knee).Treatment: revision; 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: no device associated with this report was received for examination.Through follow up it is now understood there is no allegation associated against a product malfunction.Review of the x-ray evidence found nothing indicative of a device nonconformance.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post-market safety surveillance activities.Device history lot : a search of the depuy nonconformance (nc) quality system found no nc¿s associated with this product/lot combination.Based on the inability to find any nc¿s against the provided product code/lot code combination, it is reasonable to conclude that there are no anomalies with regard to manufacturing or inspection contained in the device history records that would contribute to the reported event.
Event or Problem Description
Medical records received.Doi: (b)(6)2021: patient received a right sigma tka to treat severe valgus arthrosis, tibial bone loss, a severe patellofemoral disease with osteophyte formation, and cystic femoral changes with tapering of the bone.The surgeon notes that the natural pcl was atrophic and required the removal of osteophytes.The tibial bone loss was treated with a cut below the defect and required the use of an mbt tibial tray and bone grafting.The cystic femoral formation was excised and filled in with bone cement before cementing the femoral component.There was approximately 1 mm of varus/valgus laxity after final implantation, which the surgeon deemed appropriate.The procedure was completed without complications.Clinic note dated (b)(6)2022: patient presents with new onset pain, instability, and hyperextension of the right knee.She has 4-5 mm varus/valgus laxity and 10 degrees of hyperextension.X-rays reveal a well-fixed right tka with a little lucency around the anterior femoral component.The patient is referred for revision of the insert and placed into a knee brace in the interim.There were no revision operative notes provided.
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 10
• 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: 16095709
• Report Number: 1818910-2023-00375
• Device Sequence Number: 6529334
• Product Code: NJL
• UDI-Device Identifier: 10603295076209
• UDI-Public: 10603295076209
• 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): 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: 1961-92-041
• Device Catalogue Number: 196192041
• Device Lot Number: 9799515
• 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: 12/15/2022
• Supplement Date Received by Manufacturer: 01/03/2023; 02/02/2023
• Initial Report FDA Received Date: 01/04/2023
• Supplement Report FDA Received Date: 01/18/2023; 02/02/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/10/2021
• 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 1 40G; DEPUY CMW 1 40G; MBT CEM KEEL TIB TRAY SZ4; PFC*SIGMA C/R NPOR FEM RT SZ 4; PFC*SIGMA/OV/DOME PAT 3PEG,38
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 58 YR
• Patient Sex: Female
• Patient Weight: 59 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White