Catalog Number 6264-8-026R |
Device Problems
Break (1069); Fracture (1260); Material Integrity Problem (2978)
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Patient Problems
No Patient Involvement (2645); No Code Available (3191)
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Event Date 02/13/2014 |
Event Type
malfunction
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Event Description
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The v40 trial head was broken at the time of the trial reduction.Because these were placed in the stem by striking with a hammer when the v40 trial head and bipolar trial head was combined,.
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Manufacturer Narrative
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When completed, the investigation results will be submitted in a supplemental report.
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Manufacturer Narrative
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An event regarding a fractured trial head involving a partnership trial head was reported.The event was confirmed.Method & results: device evaluation and results: visual inspection confirmed the reported event.Material analysis was performed on the reported device, which concluded that the head trial broke from multiple overload conditions.In addition, no material or manufacturing defects were observed.Medical records received and evaluation: not performed as medical records were not provided for evaluation.Device history review: review of device history records indicates the lot was manufactured and accepted into final stock free of discrepancies.Complaint history review: there have been no other events for the lot referenced.Conclusions: the investigation concluded that the reported fracture was caused by multiple overload conditions.No manufacturing defects were observed.
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Event Description
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The v40 trial head was broken at the time of the trial reduction.Because these were placed in the stem by striking with a hammer when the v40 trial head and bipolar trial head was combined,.
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Search Alerts/Recalls
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