MAUDE Adverse Event Report: ZIMMER GMBH NCB®, PERIPROSTHETIC FEMUR PLATE, DISTAL, RIGHT, 18 HOLES, 355 MM; PROSTHESIS, HIP

Model Number	N/A
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Codes	Hematoma (1884); Failure of Implant (1924)
Date of Event	10/18/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).G2: report source france 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 a patient presented after a fall in the bathroom with difficult mobilization and thigh hematoma approximately 3 months post implantation of a femoral plate.X-rays showed a plate fracture, and the patient underwent a surgery for cure of iterative pseudoarthrosis and plate osteosynthesis.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: b4, d6a, d9, g3, g6, h2, h3, h6, h11.The product was returned for investigation, and the issue can be confirmed: the 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 dents near the fracture line.The features of the fracture surface indicate a force (ductile) fracture.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 found no additional related complaints for this item and the reported part and lot combination.Radiographs were provide and reviewed by a radiologist.Ap imaging of the right femur shows a right total knee arthroplasty, along with a lateral side plate and screw fixation device.Mild radiolucency is noted between the plate and the proximal femoral diaphysis.A single screw is visible near what appears to be an oblique fracture of the distal femoral diaphysis.Subsequent ap imaging of the right femur reveals a fracture of the lateral plate and screw fixation device at the level of the patient¿s distal femoral diaphysis fracture, with a single screw remaining within the femur.The evaluation is otherwise limited.The fit and alignment of the implants appear appropriate.However, the lateral plate and screw fixation device eventually fractured at the site of the distal femoral diaphysis fracture.Follow-up imaging confirms the hardware fracture in this region, likely due to trauma and instability at the fracture site.Based on the available information, the reported event can be confirmed and most likely attributed to the fall of the patient.However, due to lack of available data, it is not possible to determine a sequence of event between the fall and the fracture.With the available information, a definitive root cause cannot be established.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®, PERIPROSTHETIC FEMUR PLATE, DISTAL, RIGHT, 18 HOLES, 355 MM
• Common Device Name: PROSTHESIS, HIP
• 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: 20772322
• Report Number: 0009613350-2024-00545
• Device Sequence Number: 8137416
• Product Code: HRS
• UDI-Device Identifier: 00889024297586
• UDI-Public: (01)00889024297586(10)3140720
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K100111
• 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): 12/20/2024

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: 0203264018
• Device Lot Number: 3140720
• 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: 10/30/2024
• Supplement Date Received by Manufacturer: 12/17/2024
• Initial Report FDA Received Date: 11/25/2024
• Supplement Report FDA Received Date: 12/20/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/07/2023
• 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
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Age: 73 YR
• Patient Sex: Male
• Patient Weight: 120 KG