MAUDE Adverse Event Report: ZIMMER GMBH NCB®, PERIPROSTHETIC FEMUR PLATE, PROXIMAL, LEFT, 15 HOLES, 324 MM; TRAUMA, PLATE

Model Number	N/A
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	10/08/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).G2: report source sweeden.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 patient underwent revision approximately 1 month post implantation due to the ncb pp plate breaking off in the body.Attempts have been made and additional information on the reported event is unavailable at this time.
Event or Problem Description
No further event information available at the time of this report.
Additional Manufacturer Narrative
(b)(4).This follow-up report is being submitted to relay additional information.The following sections were updated: b4, d9, d10, g3, g6, h2, h3, h6, h11.D10: item # 0202263301, ncb pp troch plate lt narrow, lot # 3186612.The ncb periprosthetic proximal femur plates was returned for investigation together with a periprosthetic trochanter plate.The periprosthetic trochanter plate have two connection screws inserted, both of which have stripped threads in their threaded areas.The plate fracture can be confirmed as the periprosthetic proximal femur plate is fractured into two parts through a screw hole.The surface of the plate that does not face the bone exhibits some scratches but is otherwise inconspicuous.The bone-facing side of the plate has some polished area.The fracture surfaces exhibit signs of damage, likely resulting from reciprocal contact after the fracture occurred; however, the undamaged areas display features that indicate a fatigue fracture.A review of the device manufacturing records confirmed no abnormalities or deviations.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.Based on the analysis of the retrievals, a fracture of the ncb periprosthetic proximal femur plate can be confirmed and is most likely attributed to fatigue.Review of the manufacturing records confirm that the product was manufactured according to specification; therefore, it is not expected that the manufacturing process contributed to the reported issue.In conclusion, since the cause may be multifactorial, consisting of patient- and procedure-related factors, a definitive root cause could not be identified.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.

• Brand Name: NCB®, PERIPROSTHETIC FEMUR PLATE, PROXIMAL, LEFT, 15 HOLES, 324 MM
• Common Device Name: TRAUMA, PLATE
• 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: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 20566767
• Report Number: 0009613350-2024-00517
• Device Sequence Number: 7987948
• Product Code: HRS
• UDI-Device Identifier: 00889024292765
• UDI-Public: (01)00889024292765(17)340618(10)3203548
• Combination Product (Y/N): N
• Initial Reporter Country: SW
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2024
• 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): 01/15/2025

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 Model Number: N/A
• Device Catalogue Number: 0202263115
• Device Lot Number: 3203548
• 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: 10/08/2024
• Supplement Date Received by Manufacturer: 01/14/2025
• Initial Report FDA Received Date: 10/30/2024
• Supplement Report FDA Received Date: 01/15/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/18/2024
• 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: Hospitalization; Required Intervention
• Patient Sex: Unknown