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

Catalog Number	0202263109
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Periprosthetic fracture (4902)
Date of Event	07/30/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient underwent an initial surgery with proximal ncb.Subsequently, approximately 8 months and a half post implantation, patient fell and underwent a revision surgery due to distal femur fracture.Surgeon removed proximal ncb plate and replaced it with a distal plate to reduce and repair the new fracture.Diligence is completed and no further information on the reported event has been provided.
Additional Manufacturer Narrative
(b)(4).D10.Ncbâ®, periprosthetic trochanter plate, left, narrow item# 0202263301 lot# 3198677.Ncbâ®, locking cap (x3) item# 0202150300 lot# 31997780.Cable cerclage cable with crimp 1.8 mm dia.635 mm length item# 00223200418 lot# 66673083.Cable cerclage cable with crimp 1.8 mm dia.635 mm length (x2) item# 00223200418 lot# 66662043.Ncb cable button item# 47-2232-060-01 lot# 3139131.Ncb cable button item# 47-2232-060-01 lot# 3171212.Ncb cable button item# 47-2232-060-01 lot# 3200480.G2.Report source: australia.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.
Additional Manufacturer Narrative
The reported event could not be confirmed due to lack of product/information.No product was returned or pictures provided; visual and dimensional evaluations could not be performed.The device history record was not reviewed; a review of the device history record and complaint history review will not be completed for limited investigation complaints as the product meets the applicable acceptance criteria.Root cause has been identified as unrelated to the device.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: NCB®, PERIPROSTHETIC FEMUR PLATE, PROXIMAL, LEFT, 9 HOLES, 245 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
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 22869577
• Report Number: 0009613350-2025-00667
• Device Sequence Number: 9202988
• Product Code: HRS
• UDI-Device Identifier: 00889024292741
• UDI-Public: (01)00889024292741(17)340603(10)3203462
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K100111
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2025
• 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,Followup
• Report Date (Section B): 12/17/2025

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: 3203462
• 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: 07/30/2025
• Supplement Date Received by Manufacturer: 12/03/2025
• Initial Report FDA Received Date: 08/21/2025
• Supplement Report FDA Received Date: 12/17/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/03/2024
• 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: 87 YR
• Patient Sex: Unknown