MAUDE Adverse Event Report: ZIMMER SWITZERLAND MANUFACTURING GMBH NCB, FEMUR PLATE, RIGHT, 9 HOLES, 246 MM; NCB PLATING SYSTEM

Model Number	N/A
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Codes	Failure of Implant (1924); Insufficient Information (4580)
Date of Event	01/19/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The manufacturer received x-rays and other source documents for review.The manufacturer did not receive the device for investigation.The device history records were reviewed and found to be conforming.A cause for this specific event cannot be ascertained from the information provided.As soon as supplemental information becomes available an updated report will be submitted.(b)(4).
Event or Problem Description
Patient was implanted on right side and underwent revision surgery due to implant fracture.
Additional Manufacturer Narrative
Investigation results were made available.Event description: it was reported that the patient had an ncb plate implanted on the right side on (b)(6) 2020.Subsequently, the patient suffered an implant fracture, after which the fractured plate was revised on an unknown date.Review of received data: due diligence: no further due diligence required as all required information to support the conclusion is available or was already requested.X-rays: one undated view of the right femur before plate implantation was received, as well as two views of the right femur dated (b)(6) 2020, and two undated views of the right femur after plate implantation.The following radiographic review was performed by a radiologist.The image taken prior to plate implantation shows a spiral fracture of the distal right femur.The two views of the right femur dated (b)(6) 2020 demonstrate recent placement of a lateral plate and screw fixation of the distal femur with right total knee arthroplasty.Surgical skin staples are present.There is a comminuted fracture of the distal mid to distal diocese of the right femur.Soft tissue calcifications within the right lateral thigh.Follow-up imaging shows a fracture of the lateral plate through the 6th screw hole from proximal, which is not occupied by a screw.Images: two images were received showing the removed ncb plate on a surgical table.One image shows the complete ncb plate with a fracture running through the 6th screw hole from proximal and perpendicular to the longitudinal axis of the ncb plate.The other image shows the proximal end of the plate with the reference number and the two screw holes adjacent to the fracture site of the other fracture part.Patient data: (b)(6), female, born (b)(6) 1943.Product evaluation: the product was not returned by the patient; therefore, visual and dimensional evaluation could not be performed.Review of product documentation: device purpose: this device is intended for treatment.Product compatibility: the compatibility check could not be performed as only the complained product is known, while the screws are unknown.Dhr review: review of the device history records identified no deviations or anomalies during manufacturing.Conclusion: it was reported that the patient had an ncb plate implanted on the right side on (b)(6) 2020.Subsequently, the patient suffered an implant fracture, after which the fractured plate was revised on an unknown date.Based on the received images and radiographs, the reported plate fracture can be confirmed.The ncb plate fractured through the unoccupied 6th screw hole from proximal.However, as the ncb plate was not returned, a product investigation could not be performed.The quality records show that all specified characteristics of the ncb plate have met the specifications valid at the time of production.Therefore, the investigation did not identify a nonconformance or a complaint out of box (coob).Based on the provided data a specific root cause could not be found.The need for corrective measures is not indicated and zimmer switzerland manufacturing gmbh considers this case as closed.Zimmer biomet's reference number of this file is (b)(4).
Event or Problem Description
Investigation has been completed.

• Brand Name: NCB, FEMUR PLATE, RIGHT, 9 HOLES, 246 MM
• Common Device Name: NCB PLATING SYSTEM
• Manufacturer (Section D): ZIMMER SWITZERLAND MANUFACTURING GMBH; sulzer allee 8; sulzer industrie park; winterthur 8404 ; SZ 8404
• MDR Report Key: 11402970
• Report Number: 0009613350-2021-00116
• Device Sequence Number: 14521725
• Product Code: HRS
• UDI-Device Identifier: 00889024297371
• UDI-Public: 00889024297371
• Combination Product (Y/N): N
• Initial Reporter Country: EG
• PMA/510(K) Number: K042695
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/19/2021

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: 02.03260.009
• Device Lot Number: 2981196
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 02/01/2021
• Supplement Date Received by Manufacturer: 08/18/2021
• Initial Report FDA Received Date: 03/03/2021
• Supplement Report FDA Received Date: 08/19/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• 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: Hospitalization; Required Intervention
• Patient Age: 78 YR
• Patient Weight: 110