MAUDE Adverse Event Report: ZIMMER SWITZERLAND MANUFACTURING GMBH CMN FEMORAL NAIL, CCD 125, LEFT, 10 MM, 21.5 CM; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Model Number	N/A
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Codes	Bone Fracture(s) (1870); Failure of Implant (1924); Pain (1994)
Date of Event	09/15/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient underwent a surgery for fixation of a pertrochanteric fracture of the left femur, and approximately 2 months later the implant was found to be fractured in the bone.Due diligence is in progress for this complaint; to date no additional information or product has been received.
Additional Manufacturer Narrative
(b)(4).Report source - foreign: italy.Investigation of this incident is currently ongoing.Once the investigation is completed, a supplemental medwatch 3500a will be submitted.
Additional Manufacturer Narrative
(b)(4).This follow-up report is being submitted to relay additional information.No product was returned or pictures provided; visual and dimensional evaluations could not be performed.Review of the device history record identified no deviations or anomalies during manufacturing.Device is used for treatment.Medical records were not provided.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
No further event information available at the time of this report.
Event or Problem Description
It was reported that a patient sustained a fall at home resulting in a severely displaced and comminuted left subtrochanteric femoral neck fracture, a reduction with im nail internal fixation was performed without complications.The patient did well and showed signs of fracture consolidation in follow up x-rays.Approximately 5 months postop, the patient presented to the emergency department due to severe pain after discontinuing ambulating with assistance a few days prior.Ct showed multiple subtrochanteric fractures of the left femur with detachment of the lesser trochanter and angulation of the proximal portion of the nail.The patient was revised revision post implantation; during which, the nail was found broken above the cephalic screw.Poor bone quality was noted with absence of osteoreparative callus at the site of the previous fracture with consequent hypermobility of the fracture stumps.The nail and screws were removed, and a competitor total hip arthroplasty was placed.Due diligence is in progress for this complaint; to date no additional information or product has been received.
Additional Manufacturer Narrative
(b)(4).This follow-up report is being submitted to relay additional information.The following sections were updated: a2, a3, b3, b4, b5, b7, d6b, g3, g6, h2, h6, h11.If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly.Zimmer biomet will continue to monitor for trends.
Event or Problem Description
No further event information available at the time of this report.
Additional Manufacturer Narrative
(b)(4).This follow-up report is being submitted to relay additional information.The following sections were updated: b4, d10, g3, g6, h2, h3, h6, h11.D10: item # 47248403050, 5.0 mm diameter cortical screw - red fixed angle 3.5 mm hex head, lot # 65267042.Item # 47248510510, znnâ¿¢, cmn lag screw, 10.5 mm, 105 mm including set screw, lot # 3038603.No product was returned or pictures provided; visual and dimensional evaluations could not be performed.Review of the device history record identified no deviations or anomalies during manufacturing.Review of the complaint history identified additional similar complaints for the reported item and no additional similar complaints for the reported part and lot combination.Medical records for the implantation were provided and reviewed by a health care professional.The review identified the patient sustaining a closed subtrochanteric fracture of the left femur after an accidental fall at home.Im nail and anti-rotational screw placed successfully with no intraoperative or postoperative complications.Medical records for and leading up to the revision dated were provided and reviewed by a health care professional.The review identified that the patient with poor bone quality initially showed good fracture consolidation and mobility but later developed complications leading to revision surgery.Indication for revision surgery was given due to subtrochanteric fracture and nail breakage, with the nail found being broken above the cephalic screw.Competitor tha placed.Based on the available information, the reported event can be confirmed.The medical records indicate that the patient had poor bone quality, which may have contributed to the reported issue.However, based on the available information and investigation results, a definitive root cause cannot be determined.If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly.Zimmer biomet will continue to monitor for trends.

• Brand Name: CMN FEMORAL NAIL, CCD 125, LEFT, 10 MM, 21.5 CM
• Common Device Name: ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
• Manufacturer (Section D): ZIMMER SWITZERLAND MANUFACTURING GMBH; sulzer allee 8; sulzer industrie park; winterthur
• Manufacturer (Section G): ZIMMER SWITZERLAND MANUFACTURING GMBH; sulzer allee 8; sulzer industrie park; winterthur 8404 ; SZ 8404
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 15575124
• Report Number: 0009613350-2022-00520
• Device Sequence Number: 2797037
• Product Code: HSB
• UDI-Device Identifier: 00889024298873
• UDI-Public: (01)00889024298873(17)300131(10)3023876
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: K091566
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 04/16/2025

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 Model Number: N/A
• Device Catalogue Number: 47249321110
• Device Lot Number: 3023876
• Was Device Available for Evaluation?: No
• 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: 09/16/2022
• Supplement Date Received by Manufacturer: 11/14/2022; 10/30/2024; 04/04/2025
• Initial Report FDA Received Date: 10/11/2022
• Supplement Report FDA Received Date: 11/15/2022; 11/25/2024; 04/16/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/16/2020
• 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
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: N/A
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Age: 77 YR
• Patient Sex: Female