Model Number N/A |
Device Problem
Separation Failure (2547)
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Patient Problem
No Information (3190)
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Event Date 12/10/2018 |
Event Type
Injury
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Manufacturer Narrative
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(b)(4).Concomitant medical devices: us157852 ¿ m2a magnum cup ¿ 959530 ; 157446 ¿ m2a magnum head ¿ 784260; 139256 ¿ m2a magnum taper ¿ 057990.Customer has indicated that the product will not be returned to zimmer biomet as the product location is unknown.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Multiple mdr reports were filed for this event, please see associated reports: 0001825034 - 2020 - 02035.
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Event Description
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It was reported that patient underwent a left hip revision approximately 10 years post implantation.During the procedure, the femoral head was found to be cold-welded to the stem and required an extended trochanteric osteotomy in order to be explanted.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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This follow-up report is being submitted to relay additional information.The following sections were updated/corrected.Updated: reported event was confirmed by review of medical records noting that a bony tamp and a mallet placed at the base of the head was used in an attempt to remove the implant.Removal was unsuccessful as the taper was found to be cold-welded to the stem.An eto was performed in order to remove the stem.Eto was secured with a trochanteric claw.Shr was reviewed and no discrepancies were found.The root cause is unable to be determined.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.
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Event Description
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No additional event information to report at this time.
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Search Alerts/Recalls
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