MAUDE Adverse Event Report: ZIMMER SWITZERLAND MANUFACTURING GMBH NCB, FEMUR SHAFT PLATE, CURVED, 12 HOLES, 249 MM; PLATE, FIXATION, BONE

Model Number	N/A
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Codes	Adhesion(s) (1695); Bone Fracture(s) (1870); Failure of Implant (1924)
Date of Event	01/23/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the plate broke due to patient non-compliance with the recommendations.Event happened when patient was walking.Due diligence is in progress for this complaint; to date no additional information or product has been received.
Additional Manufacturer Narrative
(b)(4).G2 ¿ foreign ¿ poland investigation of this incident is currently ongoing.Once the investigation is completed, a supplemental medwatch 3500a will be submitted.
Additional Manufacturer Narrative
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
The following sections were updated: b4, b5, d2, g1, g3, g6, h1, h2, h6, h10.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
It was reported that the patient underwent a right total hip arthroplasty with lateral femoral plate and screw fixation device.Subsequently, the plate broke due to the patient's non-compliance with the recommendations.The event happened when the patient was walking.X-rays taken two months post-implantation demonstrated intact hardware with fracture extension to the greater trochanter with subsequent fracture of the mid aspect of the lateral femoral plate fixation device observed in an x-ray taken four months later.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional and/or corrected information.Visual examination of the returned product identified several scratches on the bone facing and especially on the non-bone facing side of the plate.The plate has fractured into two fragments, approximately halfway of the total length of the plate.The fracture of the plate is located through a screw hole.On the fracture surfaces of the plate, beach marks 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 polished areas and some scratches, most probably due to contact between the parts after the fracture.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.Radiographs were provided and reviewed by a radiologist.Two views right femur dated (b)(6) 2023 demonstrated a right total hip arthroplasty in place with radiolucent acetabular cup and comminuted fracture of the femoral diaphysis.Overall size and fit of the implants was appropriate on (b)(6) 2023, with normal alignment, however mild osteopenia appeared to be present.Lateral formal plate and screw fixation device with one proximal cerclage wire.Subcutaneous emphysema and surgical skin staples suggest recent placement.Two views right femur dated (b)(6) 2023 demonstrates intact hardware with radiolucent fracture lines along a comminuted fracture of the femoral diaphysis.A possible newly identified fracture extension into the greater trochanter was noted.Two views of the right femur from a ct scan scout dated (b)(6) demonstrate fractured lateral femoral plate and screw fixation device along its middle aspect.Right total hip arthroplasty with lateral femoral plate and screw fixation device.With the available information, a definitive root cause cannot be determined.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, FEMUR SHAFT PLATE, CURVED, 12 HOLES, 249 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: 17253793
• Report Number: 0009613350-2023-00358
• Device Sequence Number: 3480600
• Product Code: HRS
• UDI-Device Identifier: 00889024297661
• UDI-Public: (01)00889024297661(11)211026(10)3087052
• Combination Product (Y/N): N
• Initial Reporter Country: PL
• 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,Followup
• Report Date (Section B): 10/30/2023

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: 02.03265.012
• Device Lot Number: 3087052
• 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: 06/06/2023
• Supplement Date Received by Manufacturer: 07/10/2023; 07/27/2023; 10/27/2023
• Initial Report FDA Received Date: 07/04/2023
• Supplement Report FDA Received Date: 08/07/2023; 08/23/2023; 10/30/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/15/2021
• 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 Age: 88 YR
• Patient Sex: Female
• Patient Weight: 60 KG