MAUDE Adverse Event Report: ZIMMER GMBH NCB PLATE FOR FEMUR RIGHT 13H; Plate, Fixation, Bone

Catalog Number	02.03260.013
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	08/04/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient underwent removal of a plate and screws approximately five months post-implantation.Photographs confirm that the plate had fractured.Attempts have been made and no further information has been provided.
Additional Manufacturer Narrative
(b)(4).D4: primary unique device identification (udi) number is not applicable as the lot number of the device is unknown.D10: concomitant medical products: desc: cortical screws 3.5mm; item: unknown; lot: unknown; qty: x1 desc: cortical screws 3.5mm; item: unknown; lot: unknown; qty: x1 desc: unk screw; item: unknown; lot: unknown; qty: x5 desc: unk screw; item: unknown; lot: unknown; qty: x6 desc: ncb locking cap; item: 02.03150.300; lot: unknown; qty: x11.G2: foreign - event occurred in switzerland.The customer has indicated that the product is in process of being returned to zimmer biomet for investigation.Once the investigation has been completed, a follow-up mdr will be submitted.
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, b5, g3, g6, h2, h6, h11.The product involved in the reported event was not returned for investigation; however, pictures were provided and review identified a ncb plate fractured in two pieces, at the level of a screw hole, in the middle portion of the plate.A review of the device manufacturing records could not be performed due to missing lot number.Review of the complaint history identified additional similar complaints for the reported item.However, due to the lack of the lot number, an additional lot search could not be performed.Complaints are monitored per complaint trending process in order to identify potential adverse trends.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 report will be filed accordingly.Zimmer biomet will continue to monitor for trends.

• Brand Name: NCB PLATE FOR FEMUR RIGHT 13H
• Common Device Name: Plate, Fixation, Bone
• 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
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 24108604
• Report Number: 0009613350-2026-00019
• Device Sequence Number: 5816467
• Product Code: HRS
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K192217
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Device Explanted Year: 2025
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/30/2026

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: 02.03260.013
• Device Lot Number: 3175888
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 01/23/2026
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/12/2026
• Supplement Date Received by Manufacturer: 07/03/2026; 07/30/2026
• Initial Report FDA Received Date: 01/19/2026
• Supplement Report FDA Received Date: 07/07/2026; 07/30/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/02/2023
• 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
• Concomitant Medical Products and Therapy/Usage Dates: SEE H11 NARRATIVE.
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Sex: Unknown