MAUDE Adverse Event Report: ZIMMER GMBH NCB PP PR FEM PLT R15H L324MM; Plate, Fixation, Bone

Catalog Number	02.02263.015
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Periprosthetic fracture (4902)
Date of Event	04/18/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient experienced ncb plate breakage associated with a femoral refracture and underwent revision approximately 14 weeks post-implantation.Attempts have been made and no further information has been provided.
Additional Manufacturer Narrative
(b)(4).G2: foreign - event occurred in australia.D10: concomitant medical products.Desc: unk screw; item: unknown; lot: unknown.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
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: a3a, b4, b5, d4, g3, g6, h2, h3, h6, h11.No product was returned or pictures provided; a product evaluation could not be performed.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 surgeon reported that an inadequate working length may have contributed to poor healing and subsequent implant breakage; however, this potential contributing factor could not be verified.As no device, photographs, radiographs, or medical records were available for evaluation, and the manufacturing record review identified no abnormalities or deviations, 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 PP PR FEM PLT R15H L324MM
• 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 ; SZ 8404
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 24979502
• Report Number: 0009613350-2026-00220
• Device Sequence Number: 9642756
• Product Code: HRS
• UDI-Device Identifier: 00889024292703
• UDI-Public: (01)00889024292703(17)350910(10)3249978
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K100111
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2026
• Device Explanted Year: 2026
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/25/2026

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
• Device Catalogue Number: 02.02263.015
• Device Lot Number: 3249978
• Was Device Available for Evaluation?: No
• 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: 04/18/2026
• Supplement Date Received by Manufacturer: 08/25/2026
• Initial Report FDA Received Date: 04/24/2026
• Supplement Report FDA Received Date: 08/25/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/10/2025
• 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: Female