MAUDE Adverse Event Report: ZIMMER SWITZERLAND MANUFACTURING GMBH NCB PERIPROSTHETIC FEMUR PLATE, PROXIMAL, RIGHT, 15 HOLES, 324 MM; NCB PERIPROSTHETIC FEMUR POLYAXIAL LOCKING PLATE SYSTEM

Model Number	N/A
Medical Device Problem Codes	Fracture (1260); Material Integrity Problem (2978)
Health Effect - Clinical Codes	Failure of Implant (1924); Pain (1994)
Date of Event	10/15/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Therapy date: (b)(6) 2021.Surgical reports were received and will be reviewed as part of ongoing investigation.The manufacturer did not receive the device for investigation.As no lot number was provided, the device history records could not be reviewed.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.Zimmer biomet¿s reference number of this file is (b)(4).
Event or Problem Description
It was reported that there was a revision due to implant fracture and pain.
Additional Manufacturer Narrative
This report is being filed to relay additional information, which was unknown at the time of the previous submitted report.Investigation of this incident is currently ongoing.A followup/ final report will be submitted when additional information becomes available.Zimmer biomet¿s reference (b)(4).
Event or Problem Description
Investigation of this incident is currently ongoing.This report is being filed to relay additional information, which was unknown at the time of the previous submitted report.
Additional Manufacturer Narrative
(b)(4).As no product was returned, visual and dimensional evaluations could not be performed.Review of the device history records identified no deviations or anomalies during manufacturing.The raw material certificate was reviewed with no anomalies noted.Therefore, the investigation did not identify a nonconformance or a complaint out of box (coob).The device is used for treatment.A definitive root cause cannot be determined, as no products were returned for evaluation.However, it is likely that the incomplete bone healing/union of the femur under partial-weight bearing and the subsequent shift to a full-weight bearing as per rehabilitation protocol led the fracture of the ncb plate and a re-fracturing of the femur.Potential patient-related contributing conditions in regards to the reported event might be related to age, bmi, leg length discrepancy and morbidities such as osteoporosis.Potential procedure-related contributing conditions in regards to the reported event might be related to the placement of the ncb plate, where contrary to the recommended ncb plate insertion and positioning as per surgical technique, it appears that not the widest part of the plate was placed on the fracture site and it appears that there is an incomplete contact of the distal part of the plate with the bone.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 further event information available at the time of this report.

• Brand Name: NCB PERIPROSTHETIC FEMUR PLATE, PROXIMAL, RIGHT, 15 HOLES, 324 MM
• Common Device Name: NCB PERIPROSTHETIC FEMUR POLYAXIAL LOCKING PLATE SYSTEM
• Manufacturer (Section D): ZIMMER SWITZERLAND MANUFACTURING GMBH; sulzer allee 8; sulzer industrie park; winterthur 8404 ; SZ 8404
• Manufacturer (Section G): ZIMMER SWITZERLAND MANUFACTURING 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: 13858494
• Report Number: 0009613350-2022-00166
• Device Sequence Number: 1401584
• Product Code: HRS
• UDI-Device Identifier: 00889024292703
• UDI-Public: (01)00889024292703(17)291031(10)3016274
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K100111
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/23/2022

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: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 02.02263.015
• Device Lot Number: 3016274
• Was Device Available for Evaluation?: No
• 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: 02/21/2022
• Supplement Date Received by Manufacturer: 03/23/2022; 07/27/2022
• Initial Report FDA Received Date: 03/23/2022
• Supplement Report FDA Received Date: 04/20/2022; 08/23/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/30/2019
• 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: Hospitalization; Required Intervention
• Patient Age: 85 YR
• Patient Sex: Female
• Patient Weight: 75 KG