Model Number N/A |
Device Problem
Separation Failure (2547)
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Patient Problem
Osteolysis (2377)
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Event Date 09/28/2018 |
Event Type
Injury
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Manufacturer Narrative
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This report is being submitted to report (b)(4).Concomitant medical products: osseotite® tapered certain® prevail® implant 5/4 x 8.5mm, item #: xiitp5485, lot #: 2016120172.The following information is unknown at the time of this report: product code: unknown.Device manufacture date? unknown.The device has been received for evaluation.Investigation has not yet begun.Once the investigation has been completed, a follow up medwatch will be submitted.
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Event Description
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It was reported that the driver does not release from the implant.The patient was given a graft and will return for a new implant.Bone loss was reported.
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Manufacturer Narrative
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This report is being submitted to relay corrected information.Additional information has been received from the customer.The driver that was received with the implant was from the implant removal kit to remove the implant, there was no malfunction with the unknown driver.The reported unknown driver no longer meets the requirements to submit a medwatch report.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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Additional information has been received from the customer.The driver that was received with the implant was from the implant removal kit that they used to remove the implant, there was no malfunction with it.The implant was only being removed due to bone loss.
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Search Alerts/Recalls
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