MAUDE Adverse Event Report: ZIMMER GMBH NCB®, PERIPROSTHETIC FEMUR PLATE, PROXIMAL, LEFT, 9 HOLES, 245 MM; TRAUMA, PLATE

Catalog Number	0202263109
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Bone Fracture(s) (1870); Unspecified Infection (1930)
Date of Event	08/30/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4): g2: report source australia.D10: item # 0202263301, ncbâ®, periprosthetic trochanter plate, left, narrow, lot # 3179492; item # unknown, unknown screws, lot # unknown.No product was returned to the product surveillance team for examination.However, three images taken within the operating theater and showing the reported products were provided.Both sides of the plate is shown.The plate is covered is biological debris but appears mainly inconspicuous.There are several screws present in the holes of the trochanter plate.The third image shows several explanted screws within a container, also covered in biological debris.No further assessment can be performed based on the provided images.A review of the device manufacturing records confirmed no abnormalities or deviations.Review of the complaint histories found no additional related complaints for these items and the reported part and lot combinations.Surgical records were not provided.Two radiographic images of the left hip were provided.A re-fracture of the femur and detachment of the proximal portion of the plate (trochanter plate with screws) can be confirmed.A loose, free floating screw could additionally be identified.Based on the available information, the reported event can be confirmed during the investigation process a review of the sterile certifications were reviewed and found to be conforming with no applicable deviations.Devices were verified to have gone through acceptable sterilization process following iso/aami/astm & eu published guidelines.There are multiple factors that may contribute to an infection that are outside the control of zimmer biomet, such as external factors, i.E.Hospital/surgical environment, provider related risk factors, and/or patient comorbidities/risk factors.As there are no indications of a product or process issues identified affecting implant safety or effectiveness, implanted products are not identified as the source or contributing to the reported infection.As per correspondence provided, "there was an underlying infection which has caused there to be a refracture of the femur resulting in a loss screw and detachment of plate." however, based on the available information, a definitive root cause for the reported event of femur re-fracture, detachment of the plate and loosening of the screw could not 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.
Event or Problem Description
It was reported that the patient underwent revision approximately 1 month and 22 days after implantation due to infection resulting in refracture of the femur with loss of the screw and plate loosening.Attempts have been made and additional information on the reported event is unavailable at this time.

• Brand Name: NCB®, PERIPROSTHETIC FEMUR PLATE, PROXIMAL, LEFT, 9 HOLES, 245 MM
• Common Device Name: TRAUMA, PLATE
• Manufacturer (Section D): ZIMMER GMBH; sulzer allee 8; sulzer industrie park; winterthur 8404 ; SZ 8404
• Manufacturer (Section G): ZIMMER 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: 21283715
• Report Number: 0009613350-2025-00042
• Device Sequence Number: 12735458
• Product Code: HRS
• UDI-Device Identifier: 00889024292741
• UDI-Public: (01)00889024292741(17)331220(10)3179578
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 01/31/2025

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?: No
• Operator of Device: Lay User/Patient
• Device Catalogue Number: 0202263109
• Device Lot Number: 3179578
• 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: 08/30/2024
• Initial Report FDA Received Date: 01/31/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/20/2023
• 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
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Age: 70 YR
• Patient Sex: Unknown