MAUDE Adverse Event Report: ZIMMER GMBH NCB PP PR FEM PLT L15H L324MM; TRAUMA, PLATE.

Catalog Number	0202263115
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	03/11/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).G2: report source australia.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 due to an ncb plate fracture an unknown amount of time after implantation.Attempts have been made and additional information on the reported event is unavailable at this time.
Event or Problem Description
It was reported patient underwent revision due to an ncb plate fracture approximately 10 months post-implantation.Attempts have been made and additional information on the reported event is unavailable at this time.
Additional Manufacturer Narrative
(b)(4): this follow-up report is being submitted to relay additional information.The following sections were updated: a1, a2, b4, d1, d4, d6a, d10, g3, g6, h2, h4, h11.D10: item # 00223200418, cable cerclage cable with crimp 1.8 mm dia.635 mm length, lot # 66254304 item # 0202151020, unicortical screw 5.0 mm diameter 20 mm length warning: this device is not approved for screw attachment or fixation, lot # 64297298.Item # 0202150032, ncbâ®, cortical screw, 5.0 mm, 32 mm, lot # 3072785 item # 0202151016, unicortical screw 5.0 mm diameter 16 mm length warning: this device is not approved for screw attachment or fixation, lot # 63970835 item # 0202151018, unicortical screw 5.0 mm diameter 18 mm length warning: this device is not approved for screw attachment or fixation, lot # 63970833 item # 0202150300, ncbâ®, locking cap, lot # 3166991.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.
Additional Manufacturer Narrative
(b)(4): this follow-up report is being submitted to relay additional information.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 that could be related to the reported event.Review of the complaint history identified additional similar complaints for the reported item and the part and lot combination.Complaints are monitored per complaint trending process in order to identify potential adverse trends.A complaint trend was detected during the mctr and issue evaluation (b)(4) has been initiated for ncb pp femur plate fractures.Based on the available information, the reported event cannot be confirmed 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.
Event or Problem Description
No further event information available at the time of this report.

• Brand Name: NCB PP PR FEM PLT L15H L324MM
• 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 8404 ; SZ 8404
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 21762826
• Report Number: 0009613350-2025-00216
• Device Sequence Number: 12877582
• Product Code: HRS
• UDI-Device Identifier: 00889024292765
• UDI-Public: (01)00889024292765(17)330522(10)3156506
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• 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): 06/11/2025

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: 0202263115
• Device Lot Number: 3156506
• 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: 03/11/2025
• Supplement Date Received by Manufacturer: 05/04/2025; 06/05/2025
• Initial Report FDA Received Date: 04/03/2025
• Supplement Report FDA Received Date: 05/29/2025; 06/11/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/22/2023
• 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