MAUDE Adverse Event Report: ZIMMER SWITZERLAND MANUFACTURING GMBH ZNN, CMN FEMORAL NAIL, CCD 130, RIGHT, 11.5 MM, 38 CM; HIP INTERNAL FIXATION SYSTEM

Model Number	N/A
Medical Device Problem Codes	Fracture (1260); Patient Device Interaction Problem (4001)
Health Effect - Clinical Codes	Failure of Implant (1924); Discomfort (2330)
Date of Event	10/14/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Concomitant medical products: znnâ¿¢, cmn, lag screw extraction instrument item# 00249009012 lot# unknown.Report source: foreign - (b)(6).Investigation of this incident is currently ongoing.Once the investigation is completed, a supplemental medwatch 3500a will be submitted.Multiple mdr reports were filed for this event, please see associated reports: 0009613350 - 2022 - 00355.
Event or Problem Description
It was reported that the patient was scheduled to be revised for ablation of right femoral centromedullary material due to indications of discomfort approximately 2.5 years after the implantation.During removal of the cephalic screw, fracture of the wings occurred making the removal impossible, which resulted in leaving the nail and the cephalic screw in place.The revision surgery was rescheduled.No further patient outcome provided.Due diligence is in progress for this complaint; to date no additional information or product has been received.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional and corrected information.The following sections were updated: b4, b5, d10, g3, g6, h1, h2, h6, h10 d10 - medical devices: unknown lag screw; item# unknown; lot# unknown no product was returned or pictures provided; visual and dimensional evaluations could not be performed.The device manufacturing quality records indicate that the released components met all requirements to perform as intended.Devices are 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
It was reported that the patient was implanted with a femoral nail and screw.Around 2.5 years later, the bone had consolidated and the patient was feeling discomfort so a revision surgery took place.During this revision surgery, while removing the lag screw, fracture of the wings made the removal of both implants impossible.The revision surgery had to be rescheduled.The second revision surgery took place 49 days later, in this surgery the screw and nail were removed without difficulty (reported under 0009613350-2022-00353).

• Brand Name: ZNN, CMN FEMORAL NAIL, CCD 130, RIGHT, 11.5 MM, 38 CM
• Common Device Name: HIP INTERNAL FIXATION SYSTEM
• Manufacturer (Section D): ZIMMER SWITZERLAND MANUFACTURING GMBH; sulzer allee 8; sulzer industrie park; winterthur 8404 ; SZ 8404
• 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: 14869519
• Report Number: 0009613350-2022-00354
• Device Sequence Number: 20118581
• Product Code: HSB
• UDI-Device Identifier: 00889024299863
• UDI-Public: (01)00889024299863(17)250930(10)2820901
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K091566
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2021
• 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
• Report Date (Section B): 09/06/2022

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 Expiration Date: 09/30/2025
• Device Model Number: N/A
• Device Catalogue Number: 47-2493-382-11
• Device Lot Number: 2820901
• 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: 06/03/2022
• Supplement Date Received by Manufacturer: 08/31/2022
• Initial Report FDA Received Date: 06/30/2022
• Supplement Report FDA Received Date: 09/15/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/07/2015
• 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
• Concomitant Medical Products and Therapy/Usage Dates: SEE H10 NARRATIVE; SEE H10 NARRATIVE
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Sex: Unknown