STRYKER ORTHOPAEDICS-MAHWAH V40 COCR LFIT HEAD 40MM/+4; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED
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Catalog Number 6260-9-240 |
Device Problem
Insufficient Information (3190)
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Patient Problems
Inflammation (1932); Injury (2348); Reaction (2414)
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Event Date 08/02/2016 |
Event Type
Injury
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Manufacturer Narrative
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Device history review: device history review indicated the devices accepted into final stock from the reported lot were free from discrepancies complaint history review: there has been no other event for the lot referenced.The other device listed in this report is catalog number 623-00-40f, trident 0 deg insert 40mm, lot code mhrj7d.At this time, it cannot be determined if this device may have caused or contributed to the patient¿s experience.Additional information has been requested, should additional information become available it will be reported in a supplemental report.Not returned to manufacturer.
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Event Description
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Revision surgery due to adverse tissue reaction.Doctor removed two components: 623-00-40f, lot#:nhrj70 and 6260-9-240,lot#nhn9mh.
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Manufacturer Narrative
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An event regarding altr involving an lfit v40 cocr head was reported.The event was not confirmed.Conclusions: the subject device has been identified to be within scope of ra 2016-028.Lot specific voluntary recall ra 2016-028 was initiated for the lfit v40 cocr head.The investigation revealed that only specific catalog numbers and specific lots are impacted by the regulatory action and that the affected lots were manufactured on or before march 4, 2011.The root cause analyses identified a process related anomaly as to the affected sizes and lots.The affected product has all been implanted and/or expired.No further investigation is required.
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Event Description
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Revision surgery due to adverse tissue reaction.Doctor removed two components: 623-00-40f, lot#:nhrj70 and 6260-9-240,lot#nhn9mh.
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Search Alerts/Recalls
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