Catalog Number 5516F801 |
Device Problems
Split (2537); Device Contaminated During Manufacture or Shipping (2969)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 01/07/2015 |
Event Type
malfunction
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Event Description
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It was reported that the implant was opened in surgery, discovering the "1st" sterile packaging was "split".The surgeon did not feel comfortable using the component, so another implant was opened to finish the case.There was "no" apparent "outside" damage to box.
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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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Manufacturer Narrative
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An event regarding packaging damage involving a triathlon femoral component was reported.The event was confirmed.Method & results: -device evaluation and results: based on the visual inspection of the returned packaging it appears that this component packaging was subjected to excessive/inappropriate handling whereby the carton may have been compressed and/or dropped from a height causing the flange to crack/fracture.-medical records received and evaluation: not performed as the event is related to a packaging issue and no adverse consequences to the patient were reported.-device history review: dhr review for the reported lot determined that the device was manufactured and packed to specification.-complaint history review: there have been no other events for the lot referenced.Conclusions: the investigation concluded that the packaging damage was most likely caused by excessive/incorrect handling prior to the opening packaging.
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Event Description
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It was reported that the implant was opened in surgery, discovering the "1st" sterile packaging was "split".The surgeon did not feel comfortable using the component so another implant was opened to finish the case.There was "no" apparent "outside" damage to box.
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Search Alerts/Recalls
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