MAUDE Adverse Event Report: ZIMMER GMBH NCB®, PERIPROSTHETIC FEMUR PLATE, PROXIMAL, RIGHT, 15 HOLES, 324 MM; TRAUMA, PLATE

Catalog Number	0203263015
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	11/27/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).G2: report source france.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 3500a will be submitted.
Event or Problem Description
It was reported patient underwent revision approximately 2 and a half months post implantation due to fractured plate.Attempts have been made and additional information on the reported event is unavailable at this time.
Event or Problem Description
No further event information available at the time of this report.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were updated: b4, d9, g3, g6, h2, h3, h6, h11.The reported ncb pp plate was returned and was examined by the product surveillance team.The plate was found to have fractured through the central hole of a three-hole pattern.Macroscopically, scratches were visible, primarily on the non-bone-facing surface.On the bone-facing surface, abrasion marks were observed close to the fracture site.It is not known whether cables were used to stabilize the fracture.Polished areas were identified on both fracture surfaces.These are most likely post-fracture features caused by repeated contact between the two fractured fragments.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.The patient presented with a broken peri-prosthetic plate, which had been initially implanted and subsequently after 2 and a half months post implantation was explanted.Visual inspection confirmed a plate fracture extending through the central hole of a three-hole pattern.Polished regions observed on the fracture surfaces suggest contact between the parts following the fracture event.Abrasion marks and scratches were observed on the bone-facing side of the plate near the fracture site.With the available information and performed investigation, a definitive root cause for the plate fracture cannot be established.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.

• Brand Name: NCB®, PERIPROSTHETIC FEMUR PLATE, PROXIMAL, RIGHT, 15 HOLES, 324 MM
• Common Device Name: TRAUMA, PLATE
• 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: 22541306
• Report Number: 0009613350-2025-00610
• Device Sequence Number: 6975168
• Product Code: HRS
• UDI-Device Identifier: 00889024297470
• UDI-Public: (01)00889024297470(10)3156627
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K100111
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/23/2025

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: 0203263015
• Device Lot Number: 3156627
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• 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: 06/25/2025
• Supplement Date Received by Manufacturer: 10/24/2025
• Initial Report FDA Received Date: 07/18/2025
• Supplement Report FDA Received Date: 10/24/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/05/2023
• 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: Hospitalization; Required Intervention
• Patient Sex: Female