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

Model Number	N/A
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Codes	Failure of Implant (1924); Insufficient Information (4580)
Date of Event	11/14/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that patient had a revision surgery due to a broken ncb pp proximal left plate after 6 months of implantation.Attempts have been made and no further information has been provided.
Additional Manufacturer Narrative
(b)(4).G2: foreign: united kingdom 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 will be submitted.
Additional Manufacturer Narrative
(b)(4).This follow-up report is being submitted to relay additional information.No product was returned, but one photograph has been provided, which shows a left 15-hole ncb periprosthetic proximal femur plate.The depicted plate is fractured.The fracture runs through the middle hole of the most distal 3-hole pattern.The plate has blood and tissue remains and does not show the fracture surfaces; therefore, a more detailed assessment could not be performed.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.Complaints are monitored per complaint trending process in order to identify potential adverse trends.With the available information, 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.
Event or Problem Description
No additional information at this time.
Event or Problem Description
No additional event information.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The fractured plate was returned for investigation.The fracture line is located through a screw hole.On the fracture surfaces, both on proximal and distal parts, beach lines are visible which point to a possible fatigue fracture failure.The fracture surfaces show also small, polished areas and some scratches, most probably due to contact between the parts after the fracture.Some scratches are visible on the surface of the non-bone-facing side of the plate, most probably due to contact with some cerclage; however, no x-ray was received to confirm this hypothesis.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.Complaints are monitored per complaint trending process in order to identify potential adverse trends.The new available information do not change the outcome of the investigation.With the available information, 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®, PERIPROSTHETIC FEMUR PLATE, PROXIMAL, LEFT, 15 HOLES, 324 MM
• Common Device Name: TRAUMA IMPLANT
• 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: 18301034
• Report Number: 0009613350-2023-00650
• Device Sequence Number: 3225272
• Product Code: HRS
• UDI-Device Identifier: 00889024292765
• UDI-Public: (01)00889024292765(17)301130(10)3057628
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K100111
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2023
• 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,Followup
• Report Date (Section B): 06/19/2024

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: 3057628
• 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: 11/15/2023
• Supplement Date Received by Manufacturer: 02/05/2024; 06/06/2024
• Initial Report FDA Received Date: 12/11/2023
• Supplement Report FDA Received Date: 02/08/2024; 06/19/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/14/2020
• 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
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: N/A
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Sex: Unknown