MAUDE Adverse Event Report: ZIMMER GMBH NCB®, PERIPROSTHETIC FEMUR PLATE, PROXIMAL, RIGHT, 12 HOLES, 285 MM; IMPLANT, TRAUMA

Catalog Number	0202263012
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Codes	Failure of Implant (1924); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/23/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).G2.Report source: new zealand.The device will not be returned for analysis; however, an investigation of the reported event is in progress.Once the investigation is completed, a supplemental medwatch will be submitted.
Event or Problem Description
It was reported that the patient had an initial surgery with ncb plate on unknown date and subsequently underwent a revision surgery due to plate fracture.Diligence is completed and no further information on the reported event has been provided.
Event or Problem Description
It was reported that during a procedure, the plate was fractured prior to being implanted in the patient, this plate was discarded, and another ncb plate was used for the operation.No harm to the patient.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: b1, b4, b5, d6b, g3, g6, h1, h2, h6, h11.Corrected: e1 (address - line 1) d6b.Explant date should be removed; it was confirmed that the product was never implanted.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were updated: b4, g3, g6, h2, h3, h6, h11.The reported product was not returned to the product surveillance team as it was discarded.However, one image was provided upon complaint receipt showing the ncb plate.The image shows the plate in the operating theater, as it is covered in blood and bio-debris.Of note, the plate appears to show several damages in the form of scratches and notches.Additionally, there is an incomplete fracture going from the side of the plate to a screw hole.Further, cracks can be identified at another screw hole.A review of the device manufacturing records confirmed no abnormalities or deviations.Review of the complaint history found no additional related complaints for this item and the reported part and lot combination.Per surgical technique it is stated that "if additional contouring is required, use the bending press inserts and the corresponding bending press.Be aware that bending the plate may decrease its fatigue strength.Furthermore, the locking mechanism of the ncb hole may be damaged and, therefore, may no longer function.Do not use a hole that has been altered by contouring for locking." based on the available information, the reported event can be confirmed.However, with the available information, 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.
Event or Problem Description
Diligence is completed and no further information on the reported event has been provided.

• Brand Name: NCB®, PERIPROSTHETIC FEMUR PLATE, PROXIMAL, RIGHT, 12 HOLES, 285 MM
• 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 8404 ; SZ 8404
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 21401366
• Report Number: 0009613350-2025-00067
• Device Sequence Number: 9455990
• Product Code: HRS
• UDI-Device Identifier: 00889024292697
• UDI-Public: (01)00889024292697(17)340201(10)3186491
• Combination Product (Y/N): N
• Initial Reporter Country: NZ
• PMA/510(K) Number: K100111
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2025
• 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): 05/21/2025

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 Catalogue Number: 0202263012
• Device Lot Number: 3186491
• 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: 01/23/2025
• Supplement Date Received by Manufacturer: 04/02/2025; 05/16/2025
• Initial Report FDA Received Date: 02/18/2025
• Supplement Report FDA Received Date: 04/23/2025; 05/21/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/01/2024
• 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: 78 YR
• Patient Sex: Unknown
• Patient Weight: 110 KG