MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US SIG RP AOX CRV INS SZ2.5 17.5; SIGMA KNEE PRIMARY : KNEE TIBIAL INSERT

Model Number	1961-92-024
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Pain (1994); Ambulation or Postural Difficulties (2544); Joint Laxity (4526); Unspecified Tissue Injury (4559); Swelling/ Edema (4577)
Date of Event	11/29/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
Clinical notification received for revision due to instability.Date of implant: (b)(6) 2020; date of revision: (b)(6) 2022; (right knee).Treatment: revision; femoral component and insert were 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.
Event or Problem Description
Additional information received and stated the following: doi: (b)(6)2020: patient received a sigma rp right knee with an mbt revision tray and wedge to treat arthrosis, synovitis, and a tibial defect secondary to loosening of a competitor unicompartmental knee.The patella was resurfaced and depuy cement was utilized.The procedure was completed without complications.Clinic note dated 04 october 2022: patient reports right knee pain, instability with extreme hyperextensibility, and walking difficulty.Physical examination identifies marked effusion and 15-20 degrees of hyperextension with 4-5 mm valgus and 2-3 mm varus laxity.X-rays identify an mcl avulsion fracture with a well-fixed tka.The patient is referred for revision of the knee due to global instability.Dor: (b)(6)2022: patient received a right tka revision to treat pain, swelling, instability, and walking difficulty, and medial condyle avulsion fracture with mcl rupture.Upon entering the joint, effusion was evacuated and medial femoral epicondyle avulsion fracture with bone loss and soft tissue damage was noted.The mcl was incompetent, necessitating use of an s-rom noiles hinge system.All devices were well-fixed but revised- excluding the patella, which was retained.Depuy cement with gentamycin was utilized.The procedure was completed without complications.Doi: (b)(6)2020.Doi: (b)(6)2023.Right knee.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary the device associated with this report was not returned to depuy synthes for evaluation.Through follow up it is now understood there is no allegation associated with this product malfunction.No visible damage was found during the investigation.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.

• Brand Name: SIG RP AOX CRV INS SZ2.5 17.5
• 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 orthopaedic dr.; warsaw, IN 46581-0988 ; 3035526892
• MDR Report Key: 15966194
• Report Number: 1818910-2022-25162
• Device Sequence Number: 5573973
• Product Code: NJL
• UDI-Device Identifier: 10603295076155
• UDI-Public: 10603295076155
• 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: 2020
• 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): 12/12/2022

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: 1961-92-024
• Device Catalogue Number: 196192024
• Device Lot Number: 8238383
• 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: 11/30/2022
• Supplement Date Received by Manufacturer: 01/10/2023; 01/19/2023
• Initial Report FDA Received Date: 12/13/2022
• Supplement Report FDA Received Date: 01/11/2023; 02/09/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/19/2016
• 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 1 40G; MBT REVISION CEM TIB TRAY SZ 3; MBT STEP WEDGE SZ3 5MM; PFC*SIGMA C/R NPOR FE RT SZ2.5; PFC*SIGMA/OV/DOME PAT 3PEG,38; SIG RP AOX CRV INS SZ2.5 17.5
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 69 YR
• Patient Sex: Female
• Patient Weight: 77 KG
• Patient Race: White