MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US SIG FEM ADAP +2/-2 OFFSET BOLT; SIGMA REVISION IMPLANT : KNEE FEMORAL ACCESSORY

Catalog Number	960784
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Joint Laxity (4526)
Date of Event	07/07/2025
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 medwatch, a follow-up medwatch will be filed as appropriate.
Event or Problem Description
It was reported that the patient underwent the revision of left knee due to instability.Tc3/mbt in situ, tc3 removed and s-rom hinge implanted.Tc3 poly was worn and poly spine fractured.Size 5 left tc3 femoral component.No allegations against the tibial tray.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary: according to the information received, "revision of left knee due to instability.Tc3/mbt in situ, tc3 removed and s-rom hinge implanted.Tc3 poly was worn and poly spine fractured, size 5 left tc3 femoral component - product and lot number covered by cement so unable to be entered." the product was not returned to j&j medtech orthopaedics; however, photos were provided for review.The photo investigation revealed that the sig fem adap +2/-2 offset bolt is assembled and only a small part of the implant is visible.However, there is no evidence of a device non-conformance.A manufacturing record evaluation was performed for the finished device product code 960784 lot number 318797, and no non-conformances / manufacturing irregularities were identified during manufacturing.As the device was not returned, an as-received condition could not be assessed, and a dimensional inspection and document/specification review were not completed.The overall complaint was not confirmed as the observed condition of the sig fem adap +2/-2 offset bolt would have not contributed to the reported adverse event.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.There is no indication that a design or manufacturing issue has caused the reported complaint condition.As part of j&j medtech orthopaedics quality process, all devices are manufactured, inspected, and released to approved specifications.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 record evaluation was performed for the finished device product code 960784 lot number 318797, and no non-conformances / manufacturing irregularities were identified during manufacturing.Device history review: a manufacturing record evaluation was performed for the finished device product code 960784 lot number 318797, and no non-conformances / manufacturing irregularities were identified during manufacturing.Added: d10 concomitant.

• Brand Name: SIG FEM ADAP +2/-2 OFFSET BOLT
• Common Device Name: SIGMA REVISION IMPLANT : KNEE FEMORAL ACCESSORY
• 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: elba bello ; 700 orthpaedic dr.; warsaw, IN 46581 ; 9083863534
• MDR Report Key: 22580717
• Report Number: 1818910-2025-12760
• Device Sequence Number: 18158684
• Product Code: JWH
• UDI-Device Identifier: 10603295233947
• UDI-Public: (01)10603295233947(17)221231(10)318797
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K060515
• 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: Foreign,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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 12/31/2022
• Device Catalogue Number: 960784
• Device Lot Number: 318797
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/07/2025
• Supplement Date Received by Manufacturer: 09/30/2025
• Initial Report FDA Received Date: 07/23/2025
• Supplement Report FDA Received Date: 10/02/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/23/2021
• 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: TC3 RP TIBIAL INSERT S5,17.5; UNIVERSAL STEM 75X18MM FLUTED; UNK KNEE FEMORAL SIGMA; UNKNOWN BONE CEMENT
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown