MAUDE Adverse Event Report: ZIMMER SWITZERLAND MANUFACTURING GMBH NCB, PERIPROSTHETIC FEMUR PLATE, PROXIMAL, RIGHT, 12 HOLES, 285 MM; PLATE, FIXATION, BONE

Model Number	N/A
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Codes	Failure of Implant (1924); Pain (1994)
Date of Event	09/22/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).G2 - foreign: germany.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 plate broke when it was fully loaded.Consequently, a double plate osteosynthesis procedure was performed to address the issue, necessitating a revision surgery for the patient.Due diligence is in progress for this complaint; to date no additional information or product has been received.
Event or Problem Description
It was reported patient underwent a revision 4 months post implantation due to a plate which fractured due to fall at home while using the toilet.Consequently, a double plate osteosynthesis procedure was performed to address the issue, necessitating a revision surgery for the patient.Attempts have been made and additional information on the reported event is unavailable at this time.
Additional Manufacturer Narrative
(b)(4).
Additional Manufacturer Narrative
(b)(4): this follow-up report is being submitted to relay additional information.Visual examination of the returned product showed that the fractured ncb plate was returned for examination without any accessories such as screws and cerclage wires.The fracture of the plate is located through the center hole of the most proximal 3-hole pattern.On the fracture surfaces, beach lines are visible which point to a fatigue fracture.The fracture origins are located at the beginning of the chamfer on the non-bone-facing side.On the fracture surfaces there are small polished areas, most probably due to contact between the parts after the fracture.On the bone-facing surface of the plate, marks in the form of scratches from the cerclage wires can be seen next to the fracture and next to the second most proximal 3-hole pattern.A review of the device manufacturing records confirmed no abnormalities or deviations.Review of the complaint history identified additional similar complaints for the reported item and no additional similar complaints for the reported part and lot combination.Complaints are monitored in order to identify potential adverse trends.Medical records, consisting of the implantation report from (b)(6) 2023, the discharge letter from (b)(6) 2023, the revision report from (b)(6) 2023, the discharge report from (b)(6)2023 and radiographs (taken on (b)(6) 2023), were received.The review identified that the patient underwent an initial right total hip arthroplasty on an unknown date in 2016 with unknown products.On (b)(6) 2023, due to a fall of the patient, an open reduction with internal fixation of a periprosthetic femoral fracture was treated with an ncb plate, screws and 2 cable ready cerclage wires.On (b)(6) 2023, the patient fell on her right side while using the toilet.The patient suffered injuries to her head.X-ray examination of the right femur revealed an unchanged fracture position and material and prosthesis position.The patient was discharged on (b)(6) 2023.Subsequently, the patient presented at the emergency due to acute pain and deformity of the right thigh without significant trauma.Radiographic examination on (b)(6) 2023 revealed a plate fracture and lack of fracture consolidation.The patient underwent revision surgery on (b)(6) 2023 due to implant and femoral fracture.With the available information a definitive root cause could not be determined.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, 12 HOLES, 285 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: 17938043
• Report Number: 0009613350-2023-00584
• Device Sequence Number: 6804603
• Product Code: HRS
• UDI-Device Identifier: 00889024297463
• UDI-Public: (01)00889024297463(17)310531(10)3076689
• 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: 2023
• 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): 02/01/2024

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: 0202264012
• Device Lot Number: 3076689
• 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: 09/26/2023
• Supplement Date Received by Manufacturer: 12/14/2023; 01/19/2023
• Initial Report FDA Received Date: 10/16/2023
• Supplement Report FDA Received Date: 01/11/2024; 02/01/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/31/2021
• 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
• Concomitant Medical Products and Therapy/Usage Dates: UNK CERCLAGE WIRES.; UNK SCREWS.
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 85 YR
• Patient Sex: Female