MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US SIGMA FEM ADAPTER 5 DEGREE; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL

Catalog Number	960781
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Limb Fracture (4518); Bone Notching (4890)
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.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.H11: additional narrative: d2: full common name: prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer.D4: udi: as the catalog/model number was not provided, the (01) gtin is not available.
Event or Problem Description
It was reported there was a fracture in the left knee.A revision procedure took place on (b)(6) 2025.It was noted the bone behind the femoral component was in a very bad condition, there was no bony support for the metal component.
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 that 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 recon described in this report.H11 additional narrative: added: a1, a3a, h6.Health effect - clinical code.If information that was not available for the initial report is obtained, a follow-up report will be filed as appropriate.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary: according to the information received, "hcp is reporing a fracture in the left knee-tep.See x-rays.Revision is planned".The product was not returned to depuy synthes; however, an x-ray and photos were provided for review.(b)(4) implant passport and (b)(4) x-rays.Review of the available evidence determined that the knee femoral adaptor does not exhibit any damage or signs of a device non conformance that could have contributed to the reported event.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 unk knee femoral adaptor would not have 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 depuy synthes 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: the device lot number is unknown; therefore a device history review could not be performed.If the lot/serial number becomes available, the record will be re-assessed.Added: d10 (concomitant).
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.H11 additional narrative: added: b5, d4 (lot, expiration date), d9, g4 pma/ 510(k).Corrected: d1, d2b, d4 (catalog, primary udi number).The device was received, the investigation is in progress, no conclusion could be drawn at the time of filing 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: a.The examination of the x-ray shows that the femur adapter pin is broken.Can you please explain the reason for the revision? the femoral adapter bolt between the femoral component and the sleeve was broken, there is no possibility to place a new femoral component on the sleeve, therefore a complete femoral change including the sleeve + stem was necessary, the tibial component appeared natviradiologically and also intraoperatively solid.B.Was the bolt broken or was there a fracture of the femoral bone or both? there were both.Ultimately, it was no trauma, the pat.A traumatic femoral fracture cannot have been the cause of this.Rather, the femoral fracture was the result of the coupling fracture with dislocation of the femoral component.Another factor that could have played a part was certainly the osteolysis of the distal femur in stress shielding by the well-fixed femoral sleeve, thereby the distal femur and the bony guidance was weakened, an increased translational load on the coupling mechanism could have played a role here.C.Have a femur sleeve and a femur adapter also been revised? unfortunately, there is no way to put a new femoral tuber on the sleeve and stem.Therefore, both components are changed additionally.Otherwise, they would have liked to leave these fixed components in place.

• Brand Name: SIGMA FEM ADAPTER 5 DEGREE
• Common Device Name: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 -098
• Manufacturer (Section G): JTE WARSAW MFG SITE; 700 orthopaedic drive; warsaw IN 46582
• Manufacturer Contact: elba bello ; 700 orthopaedic dr.; warsaw, IN 46581 ; 9083863534
• MDR Report Key: 23717631
• Report Number: 1818910-2025-21224
• Device Sequence Number: 10298337
• Product Code: JWH
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K060515
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2025
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,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: 02/15/2022
• Device Catalogue Number: 960781
• Device Lot Number: 200702
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 11/17/2025
• Supplement Date Received by Manufacturer: 12/16/2025; 02/12/2026; 05/13/2026; 07/27/2026; 10/01/2026
• Initial Report FDA Received Date: 12/04/2025
• Supplement Report FDA Received Date: 12/26/2025; 02/13/2026; 05/19/2026; 07/28/2026; 10/02/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/15/2012
• 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 REVISION CEM TIB TRAY SZ 4; PFC*SIGMA TC3 FEM LEFT SZ4; SIG FEM ADAP +2/-2 OFFSET BOLT; UNIVERSAL STEM 115X16MM FLUTED; UNIVERSAL STEM 115X16MM FLUTED; UNK KNEE FEMORAL SLEEVE; UNKNOWN KNEE TIBIAL INSERT
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Female
• Patient Weight: 264 LB