Model Number 47-2484-050-60 |
Device Problem
Loosening of Implant Not Related to Bone-Ingrowth (4002)
|
Patient Problem
No Information (3190)
|
Event Date 01/21/2021 |
Event Type
Injury
|
Manufacturer Narrative
|
(b)(4).5.0 mm diameter cortical screw cat: 47248404050 lot: 64677063.5.0 mm diameter cortical screw cat: 47248404550 lot: 64581106.Greater trochanter femoral nail cat: 47249232011 lot: 62451700.Foreign: (b)(6).Product has been received by zimmer biomet and the investigation is in process.Once the investigation has been completed, a follow-up report will be submitted.
|
|
Event Description
|
It was reported that approximately 8 months post implantation, the patient experienced a fracture and the implanted nail had also fractured and become loose.The patient was revised.No further information has been provided.
|
|
Event Description
|
No further event information available at the time of this report.
|
|
Manufacturer Narrative
|
This follow-up report is being submitted to relay additional information.Visual examination of the returned products identified the screws were scratched and gouged.The nail had heavy scratches and gouges and was fractured.The nail was submitted for further analysis.Analysis determined the fracture was due to fatigue.The material is consistent with specifications.Radiographs were provided and reviewed by a health care professional.Review of the available records identified the following: the x-ray dated (b)(6) 2020 showed an intramedullary rod with 2 screws and 3 cerclage wires.Faint linear lucency was noted along the anterior cortex of the mid diaphysis of the femur extending proximally from the most proximal cerclage wire.The x-ray dated (b)(6) 2020 showed an intramedullary rod with 1 proximal and 2 distal screws for an oblique fracture of the distal diaphysis medical cortex, along with 3 cerclage wires.X-rays on (b)(6) 2021 showed a comminuted fracture of the distal diaphysis of the femur with radiolucency surrounding the intramedullary rod and the distal screws as well as the cerclage wires consistent with bony fracture and hardware loosening.There is fracture of the distal intramedullary rod.Device history record was reviewed and no discrepancies were found.Root cause was unable to be determined.A summary of the investigation has been sent to the complainant.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.
|
|
Search Alerts/Recalls
|