MAUDE Adverse Event Report: ZIMMER GMBH CMN FEMORAL NAIL, CCD 130°, RIGHT, ø 10 MM, 21.5 CM; IMPLANT, TRAUMA

Catalog Number	47249321210
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Codes	Nonunion/Delayed-union Bone Fracture (2369); Insufficient Information (4580)
Date of Event	01/22/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).G2.Report source: germany.Customer has indicated that the product is in process of being returned to zimmer biomet for investigation.Once the investigation has been completed, a follow-up mdr will be submitted.
Event or Problem Description
It was reported that an intramedullary nail broke post operatively.Revision was performed with iliac graft.Due diligence is in progress for this complaint; to date no additional information or product has been received.
Event or Problem Description
The patient sustained a femoral fracture occurring around unknown total knee prosthesis.Subsequently, required multiple fixation procedures, the most recent involving a proximal femoral nail (zimmer) combined with ready cable cerclage.Imaging showed a fracture of the proximal femoral nail as well as weak, incomplete healing of the proximal femur.Due to non-union and broken nail, the patient was revised approximately 2 years post implantation to remove the broken nail and perform a new fixation.Diligence is completed and no further information on the reported event has been provided.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were updated: a1, b4, b5, b7, d6a, d9, d10, g3, g6, h2, h6, h11.D10.Cerclage cable with crimp 1.8 mm dia.Cable 22 in.(559 mm) length item# 00223200118, lot# 65593102.Cerclage cable with crimp 1.8 mm dia.Cable 22 in.(559 mm) length item# 00223200118, lot# 65601087.Cerclage cable with crimp 1.8 mm dia.Cable 22 in.(559 mm) length item# 00223200118, lot# 65800487.Znnâ, cmn lag screw, 㸠10.5 mm, 105 mm including set screw item# 47248510510, lot# 3166565.5.0 mm diameter cortical screw - red fixed angle 3.5 mm hex head item# 47248403550, lot# 66216653.Product has been received by zimmer biomet and the investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were updated: a3, b4, g3, g6, h2, h3, h6, h11.Complaint sample was evaluated, and the reported event was confirmed.The nail has fractured toward the distal end of the device around one of the distal holes.Visual examination of the returned product identified sign of use and wear and tear on the nail.There are scratches and gouges on the body of the nail.The femoral nail surface displayed fracture features in the observed regions that suggest a primary fatigue mode of fracture.The initiation site was likely located at the tips of the surface.The analysis of the nail surface revealed ti, al, and v, suggesting that the elemental composition is consistent with ti-6al-4v, titanium alloy.The eds analysis also displayed presence of c, o, p, and ca which may correlate to surface contamination.The device history record was reviewed and no discrepancies relevant to the reported event were found.A definitive root cause cannot be determined.If any further information is found which would change or alter any conclusions or information, a supplemental report will be filed accordingly.Zimmer biomet will continue to monitor for trends.
Event or Problem Description
Diligence is completed and no further information on the reported event has been provided.

• Brand Name: CMN FEMORAL NAIL, CCD 130°, RIGHT, ø 10 MM, 21.5 CM
• Common Device Name: IMPLANT, TRAUMA
• Manufacturer (Section D): ZIMMER GMBH; sulzer allee 8; sulzer industrie park; winterthur
• Manufacturer (Section G): ZIMMER GMBH; sulzer allee 8; sulzer industrie park; winterthur
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 24428925
• Report Number: 0009613350-2026-00096
• Device Sequence Number: 21395855
• Product Code: HSB
• UDI-Device Identifier: 00889024298910
• UDI-Public: (01)00889024298910(17)330720(10)3163486
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2026
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/15/2026

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: Lay User/Patient
• Device Catalogue Number: 47249321210
• Device Lot Number: 3163486
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/28/2026
• Supplement Date Received by Manufacturer: 02/27/2026; 04/13/2026
• Initial Report FDA Received Date: 02/24/2026
• Supplement Report FDA Received Date: 03/19/2026; 04/15/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/20/2023
• 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: SEE H11 NARRATIVE.
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 81 YR
• Patient Sex: Female
• Patient Weight: 69 KG