MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US SIGMA FEMORAL TC3 CEMENTED 5 LEFT; SIGMA REVISION IMPLANT : KNEE FEMORAL

Catalog Number	960084
Medical Device Problem Code	Osseointegration Problem (3003)
Health Effect - Clinical Code	Inadequate Osseointegration (2646)
Date of Event	01/29/2025
Type of Reportable Event	Serious Injury
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 the information is unknown, not available or does not apply, the section/field of the form is left blank.H11 additional narrative: d4: specific udi number is unknown, therefore the (01) gtin is not available.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
It was reported that the patient was revised due to loosening of tc3 femur at bone to implant interface.Surgical delay is unknown.All available information has been disclosed for reporting.No further information was provided.Doi: unknown.Dor: (b)(6) 2025.Affected side: left knee.
Additional Manufacturer Narrative
Product complaint (b)(4).Investigation summary : no device associated with this report was received for examination.An evaluation of the manufacturing record could not be performed as the required product/lot number was not provided to complete the 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.If additional information is made available, the investigation will be updated as applicable.Device history lot :the device lot is unknown, therefore a¿device history review could not be performed.¿ if the lot/serial number becomes available, the record will be re-assessed.

• Brand Name: SIGMA FEMORAL TC3 CEMENTED 5 LEFT
• Common Device Name: SIGMA REVISION IMPLANT : KNEE FEMORAL
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• Manufacturer (Section G): JTE WARSAW MFG SITE; 700 orthopaedic drive; warsaw IN 46582
• Manufacturer Contact: kate karberg ; 700 orthopaedic dr.; warsaw, IN 46581 ; 3035526892
• MDR Report Key: 21346805
• Report Number: 1818910-2025-02419
• Device Sequence Number: 7853798
• Product Code: JWH
• UDI-Device Identifier: 10603295232513
• UDI-Public: (01)10603295232513
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K952830
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,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?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 960084
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/29/2025
• Supplement Date Received by Manufacturer: 02/18/2025
• Initial Report FDA Received Date: 02/10/2025
• Supplement Report FDA Received Date: 02/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 59 YR
• Patient Sex: Male