Catalog Number 3051-0508 |
Device Problems
Degraded (1153); Device Slipped (1584); Material Integrity Problem (2978); Naturally Worn (2988)
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Patient Problems
Tissue Damage (2104); Injury (2348); No Code Available (3191)
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Event Date 05/14/2014 |
Event Type
Injury
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Event Description
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It was reported that the insert which was implanted for left knee and replaced 12 years after implanted.The implant was implanted in (b)(6) 1993.Soft tissue loosening was confirmed, so it (8mm) was changed to 15mm insert.
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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 joint instability involving a scorpio insert was reported.The event was confirmed.Method & results: -device evaluation and results: a visual inspection found no material or manufacturing defects.A visual inspection showed evidence of delamination and pitting.These are fatigue wear mechanisms are consistent with commonly identified damage modes in uhmwpe inserts.-medical records received and evaluation: not performed as no patient information was provided for review.-device history review: all devices accepted into final stock conformed to specification.-complaint history review: there have been no similar previous reported events for this lot id.Conclusions: the exact cause of the event could not be determined because insufficient patient medical records were provided for review.No further investigation for this event is possible at this time.If additional information becomes available, this investigation will be reopened.
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Event Description
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It was reported that the insert which was implanted for left knee and replaced 12 years after implanted.The implant was implanted in (b)(6)1993.Soft tissue loosening was confirmed, so it (8mm) was changed to 15mm insert.
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Search Alerts/Recalls
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