Model Number 6260-9-140 |
Device Problems
Degraded (1153); Material Erosion (1214)
|
Patient Problems
Foreign Body Reaction (1868); Metal Related Pathology (4530)
|
Event Date 07/11/2022 |
Event Type
Injury
|
Manufacturer Narrative
|
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.
|
|
Event Description
|
Sales rep reported: "i got a phone call from dr., he reports that one of these patients with an abg ii prosthesis has abnormal iron levels in the blood.It would appear that the patient has liver cancer which may be related to the prosthesis.I don't have any more information at this time.".
|
|
Event Description
|
Sales rep reported: "i got a phone call from dr., he reports that one of these patients with an abg ii prosthesis has abnormal iron levels in the blood.It would appear that the patient has liver cancer which may be related to the prosthesis.I don't have any more information at this time.".
|
|
Manufacturer Narrative
|
Reported event: an event regarding abnormal ion level involving a metal head was reported.The event was not confirmed.Method & results: product evaluation and results: material analysis, visual, functional and dimensional inspections could not be performed as the device was not returned.Clinician review: no medical records were received for review with a clinical consultant.Product history review: review of the device history records indicate the 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 lot referenced.Conclusions: 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.
|
|
Search Alerts/Recalls
|