MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 SIGMA STAB GVF INS 3 15MM; KNEE TIBIAL INSERT

Catalog Number	158123015
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Osteolysis (2377)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Product complaint #(b)(4).This report is being submitted pursuant to the provisions of 21 cfr, part 803 (and/or part 4, as applicable).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, or its employees that the report constitutes an admission that the product, 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 report, a follow-up report will be filed as appropriate.Additional narrative: d4: udi: as the catalog/model number was not provided, the (01) gtin is not available.
Event or Problem Description
It was reported that a patient was implanted with a sigma pfc tray approximately 14 months ago.Patient was revised to total knee replacement due to tibio train loosening.This was because of lysis under the cement mantle.Surgeon did not notice lysis between the implant and the cement, but he noticed light between the cement and the bone.Per surgeon it is not an implant related issue.The date of implantation is unknown and the implant was not retained after the case.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary : an analysis of the product could not be performed since a physical sample was not received for evaluation.As part of our company quality system process, all devices are manufactured, inspected, and distributed to approved specifications.Additional complaint information monitoring for potential safety signals will be conducted through complaint trending as part of the post-market surveillance.However, if the product is received at a later date, the investigation will be updated as applicable.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary : no device associated with this report was received for examination.A manufacturing record evaluation were performed for the finished device dhr 158123015/ d18110804, it was manufactured on 02-nov-2018.48 parts were manufactured per specification and all raw materials met specification, and no non-conformances were identified.As part of our company quality system process, all devices are manufactured, inspected, and distributed to approved specifications.Additional complaint information monitoring for potential safety signals will be conducted through complaint trending as part of the post-market surveillance.If additional information is made available, the investigation will be updated as applicable.Device history lot : a manufacturing record evaluation were performed for the finished device dhr 158123015/ d18110804, it was manufactured on 02-nov-2018.48 parts were manufactured per specification and all raw materials met specification, and no non-conformances were identified.

• Brand Name: SIGMA STAB GVF INS 3 15MM
• Common Device Name: KNEE TIBIAL INSERT
• Manufacturer (Section D): DEPUY IRELAND - 9616671; loughbeg ringaskiddy co.; cork ; EI
• Manufacturer (Section G): JTE WARSAW MFG SITE; 700 orthopaedic drive; warsaw IN 46582
• Manufacturer Contact: kate karberg ; 700 orthpaedic dr.; warsaw, IN 46581 ; 3035526892
• MDR Report Key: 20411325
• Report Number: 1818910-2024-21242
• Device Sequence Number: 18115979
• Product Code: JWH
• UDI-Device Identifier: 10603295064275
• UDI-Public: (01)10603295064275(17)231031(10)D18110804
• Combination Product (Y/N): N
• Initial Reporter Country: EI
• PMA/510(K) Number: K033272
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup

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 Expiration Date: 10/31/2023
• Device Catalogue Number: 158123015
• Device Lot Number: D18110804
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 10/03/2024
• Supplement Date Received by Manufacturer: 10/12/2024; 11/14/2024
• Initial Report FDA Received Date: 10/09/2024
• Supplement Report FDA Received Date: 10/15/2024; 11/15/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/09/2018
• 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: PFC SIGMA TIB TRAY CEM SZ3; PFC*SIGMA/OV/DOME PAT 3PEG,35; UNK KNEE TIBIAL TRAY SIGMA
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown