MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US PFC SIGMARP CV TB/IN S4 10.0; SIGMA KNEE PRIMARY : KNEE TIBIAL INSERT

Model Number	96-2041
Medical Device Problem Codes	Fracture (1260); Naturally Worn (2988)
Health Effect - Clinical Codes	Foreign Body Reaction (1868); Pain (1994); Discomfort (2330); Joint Laxity (4526); Insufficient Information (4580)
Date of Event	10/12/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
Pfc sigma curved left cemented.Insert brooken on the back due to wear.Losening of tibia.Metalose.
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).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
Additional information received indicated that there was no surgical delay reported.First doi: 2004.
Event or Problem Description
Primary operative note dated (b)(6)2004: patient received a left pfc rotating platform tka to treat gonarthrosis secondary to psoriatic arthritis.There is insufficient information within the translated operative note to determine if the patella was resurfaced nor to identify the quantity and manufacturer of the cement utilized.The procedure was completed without complications.Clinic note dated (b)(6)2022: patient reports pain, instability, and a sensation of cracking in the left knee.Radiographic imaging identifies a fractured and worn through polyethylene insert resulting in metal-;on-metal articulation of the femoral component on the tibial tray causing metallosis.The patient is referred for a revision of the left knee construct.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.
Additional Manufacturer Narrative
Product complaint (b)(4).Investigation summary; the device associated with this report was not returned for analysis.Review of the x-ray evidence was not able to confirm the complaint.In order to confirm that the device has fractured and worn, a photo of the implant is required.No other defects were identified.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post-market safety surveillance activities.Device history lot; a manufacturing records evaluation (mre) was not performed as no lot number was provided for this device.

• Brand Name: PFC SIGMARP CV TB/IN S4 10.0
• 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: 15681099
• Report Number: 1818910-2022-21420
• Device Sequence Number: 20448748
• Product Code: NJL
• UDI-Device Identifier: 10603295240815
• UDI-Public: 10603295240815
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: P830055
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2004
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 10/27/2022

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: 96-2041
• Device Catalogue Number: 962041
• 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: 10/12/2022
• Supplement Date Received by Manufacturer: 11/02/2022; 11/03/2022; 01/05/2023
• Initial Report FDA Received Date: 10/27/2022
• Supplement Report FDA Received Date: 11/08/2022; 11/23/2022; 01/06/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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: MBT CEM KEEL TIB TRAY SZ5; PFC SIGMARP CV TB/IN S4 10.0; PFC*SIGMA C/R NPOR FEM LT SZ 4
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 74 YR
• Patient Sex: Male
• Patient Weight: 112 KG