MAUDE Adverse Event Report: ZIMMER GMBH NCB PP DIS FEM PLT R9H L238MM; IMPLANT, TRAUMA

Catalog Number	02.03264.009
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Bone Fracture(s) (1870)
Date of Event	10/03/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was that a patient was admitted for a subsequent femoral fracture, previously treated with an ncb pp distal femoral plate.Both the femur and the distal plate were fractured.The plate was removed, and a new one was inserted.The fractured plate will be sent for examination.Attempts have been made and additional information on the reported event is unavailable at this time.
Additional Manufacturer Narrative
(b)(4).G2: country report source: poland.Attempts have been made to gather all product identification information and no further information has been provided.An investigation of the reported event is in progress.Once the investigation is completed, a supplemental medwatch 3500a will be submitted.
Additional Manufacturer Narrative
(b)(4).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
No additional event information.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were updated: b4, b5, d2, g1, g3, g6, h1, h2, h3, h6.The cmp was confirmed.Visual examination of the returned product identified signs of use with some gouges on the edge of the plate, discoloration on the top side near the screw and on the bottom side of the plate near the fracture as well.There are also scratches on the top side and edge of the plate.The plate has fractured at the 14th hole location.There is also a blue screw inserted in hole 31 of the plate.Optical images of the device fracture surface exhibited faint beach marks and river lines, suggesting that the fracture was suspected to have initiated due to fatigue, although not clearly evident, and transitioned into overload mode of failure.A review of the device manufacturing records confirmed no abnormalities or deviations that could be related to the reported event.Due to insufficient product information, the compatibility of the involved products could not be verified.Review of the complaint history identified additional similar complaints for the reported item and no additional similar complaints for the reported part and lot combination.Complaints are monitored per complaint trending process in order to identify potential adverse trends.Medical records were not provided.A definitive root cause 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.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
No further information is available at the time of this report.

• Brand Name: NCB PP DIS FEM PLT R9H L238MM
• 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: 23394443
• Report Number: 0009613350-2025-00805
• Device Sequence Number: 18645688
• Product Code: HRS
• UDI-Device Identifier: 00889024297555
• UDI-Public: (01)00889024297555(11)241008(10)3213089
• Combination Product (Y/N): N
• Initial Reporter Country: PL
• 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): 03/31/2026

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: 02.03264.009
• Device Lot Number: 3213089
• 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: 10/06/2025
• Supplement Date Received by Manufacturer: 12/23/2025; 03/30/2026
• Initial Report FDA Received Date: 10/27/2025
• Supplement Report FDA Received Date: 01/13/2026; 03/31/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/08/2024
• 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 Sex: Unknown