MAUDE Adverse Event Report: ZIMMER GMBH NCB, PERIPROSTHETIC FEMUR PLATE, DISTAL, RIGHT, 15 HOLES, 317 MM; PLATE, FIXATION, BONE

Catalog Number	0203264015
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Periprosthetic fracture (4902)
Date of Event	03/17/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4) g2: foreign - event occurred in germany.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
It was reported that the patient had a right distal femur fracture, orif performed with 9-hole ncb plate placed.Subsequently plate fracture occurred, with removal of plate and new 15-hole ncb plate placed approximately 8 months post implantation.Due diligence is in process and no further information on the reported event has been provided.
Event or Problem Description
Diligence is completed and no further information on the reported event has been provided.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were updated: b4, d1, d4, g3, g6, h2, h4, h11.

• Brand Name: NCB, PERIPROSTHETIC FEMUR PLATE, DISTAL, RIGHT, 15 HOLES, 317 MM
• Common Device Name: PLATE, FIXATION, BONE
• Manufacturer (Section D): ZIMMER GMBH; sulzer allee 8; sulzer industrie park; winterthur
• 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: 25216974
• Report Number: 0009613350-2026-00252
• Device Sequence Number: 21350505
• Product Code: HRS
• UDI-Device Identifier: 00889024297579
• UDI-Public: (01)00889024297579(10)3199525
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K100111
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Device Explanted Year: 2026
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/16/2026

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: 0203264015
• Device Lot Number: 3199525
• 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: 04/22/2026
• Supplement Date Received by Manufacturer: 05/21/2026
• Initial Report FDA Received Date: 05/19/2026
• Supplement Report FDA Received Date: 06/16/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/06/2024
• 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
• Concomitant Medical Products and Therapy/Usage Dates: SEE H11 NARRATIVE.
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 83 YR
• Patient Sex: Unknown