MAUDE Adverse Event Report: DEPUY INTERNATIONAL LTD - 8010379 PFC SIG RPF INS SZ 4 10MM; PFC SIGMA RP-F : KNEE TIBIAL INSERT

Model Number	95-1040
Medical Device Problem Codes	Naturally Worn (2988); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Joint Laxity (4526)
Date of Event	11/29/2021
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
Patient was revised due to unstable knee.Doi: unknown dor: (b)(6) 2021 left knee.Additional information was received on (b)(6) 2021 at 4:05 pm stating - questions: with regard to this, please confirm if any of the following information is available: date of implantation.Was instability related to polyethylene wear? was there any reported malposition of components that led to the instability? were any components undersized on the primary surgery that led to the instability? was the femur or tibia excessively resected/joint line raised during the primary surgery that led to the instability? answers: we do not know the date of implantation.The instability was due to wear over time.Knee had been in at least 15 years.No malposition of implants.No implants were undersized.Joint line was not raised.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary = > no device associated with this report was received for examination.The information received will be retained for potential series investigations if triggered by trend analysis, post market surveillance, or other events within the quality system.Depuy considers the investigation closed.Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.Device history lot = > a manufacturing record evaluation (mre), was not possible because the required lot code was not provided.H10 additional narrative: added: g1.
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 the instability was due to wear over time.Knee had been in at least 15 years.No malposition of implants and no implants were undersized.Joint line was not raised.

• Brand Name: PFC SIG RPF INS SZ 4 10MM
• Common Device Name: PFC SIGMA RP-F : KNEE TIBIAL INSERT
• Manufacturer (Section D): DEPUY INTERNATIONAL LTD - 8010379; st. anthony's road; leeds LS11 8DT; UK LS11 8DT
• Manufacturer (Section G): DEPUY ORTHOPAEDICS, INC. 1818910; 700 orthopaedic dr.; warsaw IN 46581 0988
• Manufacturer Contact: kara ditty-bovard ; 700 orthopedics drive; warsaw, IN 19380 ; 6107428552
• MDR Report Key: 12967738
• Report Number: 1818910-2021-27590
• Device Sequence Number: 4451884
• Product Code: JWH
• UDI-Device Identifier: 10603295230410
• UDI-Public: 10603295230410
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Consumer,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/29/2021

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: Health Professional
• Device Model Number: 95-1040
• Device Catalogue Number: 951040
• 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: 11/29/2021
• Supplement Date Received by Manufacturer: 12/06/2021; 12/21/2021
• Initial Report FDA Received Date: 12/09/2021
• Supplement Report FDA Received Date: 12/14/2021; 12/31/2021
• 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): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: PFC SIG RPF INS SZ 4 10MM
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 77 YR
• Patient Sex: Male