Catalog Number 6942-7-060 |
Device Problems
Mechanical Problem (1384); Fitting Problem (2183)
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Patient Problems
Bone Fracture(s) (1870); No Consequences Or Impact To Patient (2199)
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Event Date 04/12/2017 |
Event Type
malfunction
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Manufacturer Narrative
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A supplemental report will be submitted upon completion of the investigation.
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Event Description
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It was reported by the sales representative via phone that during a primary surgery for a fractured hip, that the taper head would not lock onto the stem.The physician tried 3 times.The physician used a bipolar head the same size and it worked.
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Manufacturer Narrative
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An event regarding alleged "seating/locking issues" involving a unitrax c-taper sleeve was reported.The event was not confirmed.Method & results: device evaluation and results: the device was returned in used condition.Review of the device with a material analysis engineer indicated "damage consistent with in-service use was observed on the sleeve.In-service use can potentially affect the dimensions of the product." a dimensional inspection was performed on the returned device and found the device to be within specifications.Medical records received and evaluation: no medical records or x-rays were made available for evaluation.Device history review: review of the device history records indicates that all devices were manufactured and accepted into final stock with no reported discrepancies.Complaint history review: there have been no other events for this lot.Conclusions: the event could not be confirmed nor the root cause could be determined.Review of the device with a material analysis engineer indicated "damage consistent with in-service use was observed on the sleeve.In-service use can potentially affect the dimensions of the product." however, a dimensional inspection was performed on the returned device and found the device to be within specifications.
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Event Description
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It was reported by the sales representative via phone that during a primary surgery for a fractured hip, that the taper head would not lock onto the stem.The physician tried 3 times.The physician used a bipolar head the same size and it worked.
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Search Alerts/Recalls
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