Model Number 110005087 |
Device Problems
Migration or Expulsion of Device (1395); Loosening of Implant Not Related to Bone-Ingrowth (4002)
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Patient Problems
Failure of Implant (1924); Unspecified Tissue Injury (4559)
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Event Date 05/19/2022 |
Event Type
Injury
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Manufacturer Narrative
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(b)(4).(b)(6).Customer has indicated that the product will not be returned to zimmer biomet for investigation, as the device location is unknown.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.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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It was reported that the surgeon fixed the tendon graft and when checking the graft fixation, he noticed that the graft was loose and the button came out and got stuck in the femoral tunnel.An osteotomy was planned to remove the button by the surgeon.
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Manufacturer Narrative
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Upon receipt of additional information, it has been determined that this device did not cause or contribute to the reported event.The button that came out and went into the femoral tunnel, was not coming out so the surgeon had to do an osteotomy and used the same tunnel for button removal.A new tunnel was not necessary as the surgeon was able to complete the procedure with the initial femoral tunnel.This event did not result in a serious injury.Furthermore, this event has not been previously reported for a serious injury.Therefore, the initial reports were forwarded in error and should be voided.
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Event Description
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Upon receipt of additional information, it has been determined that this device did not cause or contribute to the reported event.The button that came out and went into the femoral tunnel, was not coming out so the surgeon had to do an osteotomy and used the same tunnel for button removal.A new tunnel was not necessary as the surgeon was able to complete the procedure with the initial femoral tunnel.This event did not result in a serious injury.Furthermore, this event has not been previously reported for a serious injury.Therefore, the initial reports were forwarded in error and should be voided.
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Manufacturer Narrative
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This follow-up report is being submitted to relay additional information.Product has been received by zimmer biomet and the investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.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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It was reported that the surgeon fixed the tendon graft and when checking the graft fixation, he noticed that the graft was loose and the button came out and got stuck in the femoral tunnel.An osteotomy was utilized to remove the button by the surgeon.The surgeon was able to use the same tunnel to implant a second device without issue.
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Search Alerts/Recalls
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