MAUDE Adverse Event Report: ZIMMER GMBH NCB PLATE FOR FEMUR LEFT 9H; IMPLANT, TRAUMA

Model Number	N/A
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	09/18/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).D10.Unknown screws item# unknown lot# unknown.G2.Report source: germany.Product has been received by zimmer biomet and the investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.
Event or Problem Description
It was reported that a patient had an initial left total knee on an unknown date with unknown implants.Subsequently, the patient sustained a periprosthetic femur fracture and underwent an orif with ncb plate implanted.Approximately 3 months later, the patient was revised due to an ncb plate fracture.During the revision it was noted that no infection was present, and the reduction had improved.Patient ncb plate was revised without complications.Diligence is completed and to date no additional information on the reported event has been provided.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The reported ncb plate was returned and examined by the product surveillance team.The plate was found to have fractured through a screw hole into two fragments.Macroscopically, it showed scratches, primarily on the non-bone-facing side.Two parallel horizontal abrasion marks were also noted proximal to the fracture, likely from contact with cerclage wires.Beach marks, indicating fatigue fracture, were visible on the fracture surface of the proximal fragment, with the fracture originating at the chamfer on the non-bone-facing side.Polished areas and scratches on the fracture surfaces suggest contact between the parts after the fracture occurred.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.Surgical notes for the implantation surgery were provided and reviewed by a health care professional with the following findings: the patient presented with a periprosthetic distal femur fracture following a fall event.An open reduction of the multi-fragment femur fracture was performed, followed by osteosynthesis.Significant offset was noted in the distal femur, and a plate was implanted under x-ray guidance.There was no loss of reduction during the procedure.Cerclage wires were placed to aid in stabilization, and the osteosynthesis was confirmed to be stable on the final x-ray.No intraoperative complications.Surgical notes for the revision surgery were provided and reviewed by a health care professional with the following findings: the patient was diagnosed with a multifragmentary extra-articular distal femur fracture, accompanied by a plate fracture with a short swivel distance.Scar tissue and clear callus formation were noted at the fracture site.The plate screws were easily removed, and there were no signs of infection.Reduction of the fracture was improved during the procedure.A 10-hole ncb plate was implanted and secured to the old panel bearing under x-ray guidance.Eight cortical screws were placed proximal to the fracture, allowing for a longer pivot point.The osteosynthesis was adjusted to permit micromovements.No intraoperative complications were reported.Radiographs were provided to the product surveillance team and reviewed by a radiologist.The review identified: - two views of the left knee show a left total knee arthroplasty with a comminuted fracture of the distal femoral diaphysis.- a single lateral view of the left knee demonstrates a left total knee arthroplasty with a new distal femoral plate and screw fixation device, accompanied by cerclage wires.The plate is fractured, with a lucent fracture line noted.Vascular calcifications are present.- a single ap view of the left knee and distal femur demonstrates a left total knee arthroplasty with lateral plate and screw fixation of the distal femur, stabilized with cerclage wires for a comminuted distal femoral diaphysis fracture.The plate appears intact.A vascular stent graft is in place.- a single ap view of the left knee and distal femur demonstrates lateral plate and screw fixation of the distal femur with a comminuted fracture of the distal diaphysis.Screw tracks indicate prior hardware.Surgical skin staples are noted, along with vascular calcifications and a vascular stent graft.Based on the available information, the reported event can be confirmed the visual inspection of the plate reveals a fatigue fracture, with horizontal abrasion marks on the bone facing side, close to the fracture site.These were likely caused by the cerclage wire placed between bone and plate for fracture reduction.In the surgical technique it is stated that ncb bone spacers may be used if the fracture has been reduced using a cable, to avoid contact between the plate and the cable wire.If and to what extend the omission of these spacers may have contributed to the fracture remains unknown.Additionally, fatigue fractures might be a result of cyclic overloading, which may be contributed by patient related factors such as improper patient behavior or an inadequately healed bone.Therefore, based on the available information and the investigation conducted, the exact cause of the plate fracture 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
Diligence is completed and to date no additional information on the reported event has been provided.

• Brand Name: NCB PLATE FOR FEMUR LEFT 9H
• Common Device Name: IMPLANT, TRAUMA
• 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: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 20475801
• Report Number: 0009613350-2024-00490
• Device Sequence Number: 12630462
• Product Code: HRS
• UDI-Device Identifier: 00889024297401
• UDI-Public: (01)00889024297401(10)3091091
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K192217
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/19/2025

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: 02.03260.109
• Device Lot Number: 3091091
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/16/2024
• 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: 09/25/2024
• Supplement Date Received by Manufacturer: 02/14/2025
• Initial Report FDA Received Date: 10/17/2024
• Supplement Report FDA Received Date: 02/19/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/05/2021
• 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 Age: 81 YR
• Patient Sex: Female