MAUDE Adverse Event Report: ZIMMER SWITZERLAND MANUFACTURING GMBH NCB, PERIPROSTHETIC FEMUR PLATE, PROXIMAL, RIGHT, 18 HOLES, 363 MM; PLATE, FIXATION, BONE

Model Number	N/A
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	09/01/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).D10/d11: concomitant medical products ¿ unknown screw; item# unknown, lot# unknown.G2 ¿ foreign ¿ switzerland.H3 ¿ other: device evaluation could not be performed as part# and lot# are unknown.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 the proximal femoral plate, placed over a hip prosthesis, broke in a patient diagnosed with diaphyseal tumor approximately nine months post implantation.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.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.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were updated: the reported ncb pp femur plate as well as the ncb screws with nail caps, screwdriver shaft, and femoral stem with an assembled ceramic femoral head were returned to the post market surveillance team for examination.A visual examination was performed, and the reported event of plate fracture can be confirmed.The plate has broken into two fragments.The fracture of the plate is located through two screw holes.Beach marks, indicative of a fatigue fracture, are visible on both fracture surfaces.The fracture origin is located at the beginning of the chamfer on the non-bone-facing side of the plate.Additionally, on the fracture surfaces there are some polished areas to be seen, most probably due to contact between the parts after the fracture.Both sides of the plate are covered in fine scratches, which are inconspicuous.The returned ncb screws show some occasional signs of damage but are inconspicuous.The femoral components of unknown competitor were also returned but are not related to the reported event.A review of the device manufacturing records confirmed no abnormalities or deviations that could be related to the reported event.Device is used for treatment.Reported event is not related to a combination of products; therefore, a compatibility review is not applicable.Review of the complaint history found no additional related complaints for this item and the reported part and lot combination.Medical records were not provided.Based on the received devices, the reported event can be confirmed.Examination of the fracture surfaces of the ncb plate identified beach lines, indicative of a fatigue fracture.If the reported patient condition of diaphyseal bone tumor potentially contributed to the reported event cannot be determined based on the available information and no medical records being provided.If and to what extend other factors may have played a role in the sequence of events leading to the revision surgery cannot be determined.Therefore, with the information provided, we are unable to provide further analysis of the complaint reported or draw any definitive conclusions as to the root cause of the reported issue no corrective, preventive or field action was taken following the investigation of this event.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, PROXIMAL, RIGHT, 18 HOLES, 363 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: 17823017
• Report Number: 0009613350-2023-00536
• Device Sequence Number: 2342692
• Product Code: HRS
• UDI-Device Identifier: 00889024297487
• UDI-Public: (01)00889024297487(11)190925(10)3010958
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: N/A
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2023
• 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,Followup
• Report Date (Section B): 02/09/2024

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: 02.03263.018
• Device Lot Number: 3010958
• 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: 09/01/2023
• Supplement Date Received by Manufacturer: 10/04/2023; 01/29/2024
• Initial Report FDA Received Date: 09/27/2023
• Supplement Report FDA Received Date: 10/30/2023; 02/09/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/25/2019
• 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
• Concomitant Medical Products and Therapy/Usage Dates: SEE H10 NARRATIVE
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Sex: Prefer Not To Disclose
• Patient Weight: 80 KG