MAUDE Adverse Event Report: ZIMMER SWITZERLAND MANUFACTURING GMBH NCB PERIPROSTHETIC DISTAL FEMUR PLATE, RIGHT, 9 HOLES, L. 238 MM; PLATE, FIXATION, BONE

Model Number	N/A
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Codes	Bone Fracture(s) (1870); Failure of Implant (1924)
Date of Event	05/26/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Source foreign: (b)(6).Investigation of this incident is currently ongoing.Once the investigation is completed, a supplemental medwatch 3500a will be submitted.
Event or Problem Description
It was reported that a femoral plate had been implanted and approximately 6 months later, due to an accidental fall of the patient, the plate broke together with a transverse bone fracture, and revision surgery was required.Due diligence is in progress for this complaint; to date, no additional information or product has been received.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The complained ncb plate was returned for examination.No screws or other concomitant implants were received.The plate has fractured around half way of its length and through a screw hole.There are multiple scratches seen on both sides of the plate.No clear signs of beach lines can be seen when observing the fracture site of both the proximal and distal part of the ncb plate.Review of the device history records identified no deviations or anomalies during manufacturing.Therefore, the investigation did not identify a nonconformance or a complaint out of box (coob).Device is used for treatment.Medical records were not provided.No beach lines are seen on the fracture site of both the proximal and distal part of the ncb plate.Therefore, it is likely that a forced fracture occurred due to the fall event that the patient sustained.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 DISTAL FEMUR PLATE, RIGHT, 9 HOLES, L. 238 MM
• Common Device Name: PLATE, FIXATION, BONE
• 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: 14873262
• Report Number: 0009613350-2022-00348
• Device Sequence Number: 7050287
• Product Code: HWC
• UDI-Device Identifier: 00889024297555
• UDI-Public: (01)00889024297555(11)210831(10)3083036
• 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: 2021
• Device Explanted Year: 2022
• 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): 10/20/2022

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: Lay User/Patient
• Device Model Number: N/A
• Device Catalogue Number: 0203264009
• Device Lot Number: 3083036
• 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: 06/09/2022
• Supplement Date Received by Manufacturer: 10/14/2022
• Initial Report FDA Received Date: 06/30/2022
• Supplement Report FDA Received Date: 10/20/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/30/2021
• 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
• 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 Sex: Unknown