Model Number N/A |
Device Problem
Fracture (1260)
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Patient Problems
Bone Fracture(s) (1870); Failure of Implant (1924)
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Event Date 12/10/2020 |
Event Type
Injury
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Manufacturer Narrative
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(b)(4).Year of birth: (b)(6).Concomitant medical devices: nexel humeral component.Foreign country: (b)(6).Customer has indicated that the product will not be returned to zimmer biomet for investigation, due to the location of the device is unknown.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.
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Event Description
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Patient underwent initial left total elbow arthroplasty.Subsequently, the patient underwent an additional procedure approximately 6 month post implantation.The patient then sustained a fall and was revised approximately one year later due to implant and periprosthetic fracture.The patient has been indicated for revision when a custom ulnar component is available.Attempts have been made and additional information on the reported event is unavailable at this time.
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Manufacturer Narrative
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Reported event was confirmed by review of photographs and medical records received.Visual examination of the provided pictures identified the explanted product.The stem is fractured and bone cement still appears attached.No other conclusions can be made regarding the implant.Review of the available medical records identified the failure of ulna or fracture of ulna.Removal and bony rehabilitation.Humerus is left in place.Extremity not functional until reimplantation.New special ulna is required.The device history record (dhr) was reviewed and no discrepancies were found.A definitive root cause cannot be determined.A fall/high stress was noted, however, this could not be confirmed as the reason for fracture/loosening.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.
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Event Description
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No further event information available at the time of this report.
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Search Alerts/Recalls
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