Model Number N/A |
Device Problems
Fracture (1260); Noise, Audible (3273)
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Patient Problems
Failure of Implant (1924); Osteopenia/ Osteoporosis (2651)
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Event Date 06/27/2022 |
Event Type
Injury
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Manufacturer Narrative
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(b)(4).Concomitant medical products: 178538 046990 compress centering sleeve.178710 698200 locking cap and screw.150483 275220 diaphysial stacking adaptor.178366 151420 short anti rotation spindle.Foreign country: (b)(6).The device will not be returned for analysis, as the device location is unknown; however, an investigation of the reported event is in progress.Once the investigation is completed, a supplemental medwatch 3500a will be submitted.
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Event Description
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It was reported the implant of oss compress system fractured.Patient noticed a cracking noise when walking.The patient was revised.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: d4; h2; h3; h4; h6.No product was returned or pictures provided; visual and dimensional evaluations could not be performed.X-ray reviewed confirms fracture of proximal femoral implant is confirmed with varus alignment noted.No implant loosening seen, bone quality is osteopenic.No other concerns or abnormalities.Review of device history records identified no deviations or anomalies during manufacturing.A definitive root cause cannot 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 further event information available at the time of this report.
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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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Manufacturer Narrative
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This follow-up report is being submitted to relay additional information.H6: type of investigation - device not returned is n/a which was reported on initial report.Complaint sample was evaluated and the reported event was confirmed.Visual evaluation of the returned device shows the shaft is fractured off.Further evaluation of device states that the device fractured due to fatigue and semi-quantitative elemental analysis of the sample showed that the composition was consistent with ti-6al-4v alloy.Device history record (dhr) was reviewed and no discrepancies relevant to the reported event were found.Root cause cannot 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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Search Alerts/Recalls
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