Catalog Number 4845-4-106 |
Device Problem
Insufficient Information (3190)
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Patient Problems
Bone Fracture(s) (1870); Reaction (2414)
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Event Date 02/11/2010 |
Event Type
Injury
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Manufacturer Narrative
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An evaluation of the device cannot be performed as the device was not returned to the manufacturer.Should additional information become available, the evaluation summary will be submitted in a supplemental report.Not returned.
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Event Description
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We have received a compensation claim for a patient subjected on (b)(6) 2017 to cementless arthroplasty of the right hip abgii mod, after femoral fracture.Subsequently, the values of cobalt chrome in the blood were consistently higher than normal.
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Manufacturer Narrative
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An event regarding "femur fracture and abnormal ion level" involving an abgii modular stem was reported.The event was not confirmed.Conclusions: the reported femur fracture could not be confirmed nor the root cause determined as sufficient information was not provided.Further information such as return of device, operative reports, x-rays, histapathology reports, patient history & follow-up notes are needed to investigate this event further.However, voluntary recall ra 2012-067 was initiated for abgii and rejuvenate modular stems and necks due to the potential risks associated with these devices.The reported revision due to abnormal ion level is considered to be under the scope of this recall.No further investigation is possible at this time.If additional information and/or device become available, this investigation will be reopened.
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Event Description
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We have received a compensation claim for a patient subjected on (b)(6) 2017 to cementless arthroplasty of the right hip abgii mod, after femoral fracture.Subsequently, the values of cobalt chrome in the blood were consistently higher than normal.
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Search Alerts/Recalls
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