Model Number N/A |
Device Problem
Positioning Failure (1158)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 06/04/2020 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4) report source: (b)(6).Reported event was unable to be confirmed due to limited information provided by the customer.The dhr was unable to be reviewed as the lot number for the device is unavailable.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.Multiple mdr reports were filed for this event, please see associated reports: 0001822565 - 2020 - 02285.
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Event Description
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It was reported that during an initial total hip arthroplasty, the surgeon broached the femur with a size 6.5 partially and attempted to insert a size 6 stem.The stem was loose so it was removed and the surgeon attempted to broach again with the size 6.5.The surgeon then attempted to insert a size 6.5 stem and it sat lower than the broach.The surgeon is questioning if the stems are within spec of the hybrid broach.There was no reported harm or injury to that patient.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.Reported event was unable to be confirmed due to limited information provided by the customer.Dhr was unable to be reviewed as the lot number for the device is unknown.It was reported that a size 6.5 broach was used and a size 6 stem was tried to be implanted.This would be considered off label usage.Per the avenir complete surgical technique, "the definitive implant must correspond to the last rasp used".Therefore, the inability to seat the size 6 stem after broaching to size 6.5 can be attributed to user error.However, the root cause for not being able to seat the sz 6.5 stem is unknown.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 further event information available at the time of this report.
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Search Alerts/Recalls
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