Catalog Number 6260-9-236 |
Device Problems
Material Separation (1562); Device Dislodged or Dislocated (2923)
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Patient Problem
Injury (2348)
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Event Date 04/24/2019 |
Event Type
Injury
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Manufacturer Narrative
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Review of the device history records indicate devices were manufactured and accepted into final stock with no relevant reported discrepancies.There have been no other similar events for the lot referenced.It was noted that the device is not available for evaluation.Should additional information become available, it will be provided in a supplemental report upon completion of the investigation.Lot specific voluntary recall was initiated for the lfit v40 cocr heads within scope of a capa.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 analysis identified a process related anomaly as to the affected sizes and lots.The affected product has all been implanted and/or expired.Device not returned.
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Event Description
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Patient called stating he had a right hip revision done on (b)(6) 2019 due to disassociation.Patient would like to know if his implants were involved in a recall.
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Manufacturer Narrative
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An event regarding disassociation involving a metal head was reported.The event was confirmed as the device was identified to be part of the metal head recall relating to disassociation.Method & results: device evaluation and results: not performed as product was not returned.Clinician review: no medical records were received for review with a clinical consultant.Device history review: all devices were manufactured and accepted into final stock with no relevant reported discrepancies.Complaint history review: there have been no other similar events for the reported lot.Conclusions the subject device has been identified to be within scope of nc and capa.Lot specific voluntary recall pfa 1757583 was initiated for the lfit v40 cocr heads within scope of nc and capa.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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Patient called stating he had a right hip revision done on (b)(6)2019 due to disassociation.Patient would like to know if his implants were involved in a recall.
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Search Alerts/Recalls
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