Catalog Number UNK_JR |
Device Problems
Device-Device Incompatibility (2919); Insufficient Information (3190)
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Patient Problems
Failure of Implant (1924); Pain (1994); Ambulation Difficulties (2544)
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Event Date 09/13/2010 |
Event Type
Injury
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Manufacturer Narrative
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An event regarding pain involving an unknown rejuvenate modular device was reported.The event was confirmed.Method & results: device evaluation and results: device evaluation was not performed as no devices were received.Device history review: review of device history records could not be performed as the reported device was not properly identified.Complaint history review: a search of the complaint databases could not be performed as the reported device was not properly identified.Similar events have occurred for the rejuvenate modular product family.These events were determined to be associated with ra 2012-067.Conclusions: 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 pain is considered to be under the scope of this recall.No further investigation is required.Not returned.
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Event Description
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It was reported that the patients right leg is shorter than his left.Patient also experiences pain in right leg at times and has difficulty sleeping on the right side.Additional information received from legal: the plaintiff alleges that the right rejuvenate modular hip stem implanted on (b)(6) 2010 failed.Revision not yet scheduled.
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Event Description
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It was reported that the patients right leg is shorter than his left.Patient also experiences pain in right leg at times and has difficulty sleeping on the right side.Additional information received from legal: the plaintiff alleges that the right rejuvenate modular hip stem implanted on (b)(6) 2010 failed.Revision not yet scheduled.
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Manufacturer Narrative
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Reported event: an event regarding pain, limb length discrepancy and implant failure involving an unknown rejuvenate modular device was reported.The event was confirmed for pain and implant failure.Method & results: device evaluation and results: device evaluation was not performed as no devices were received.Device history review: review of device history records could not be performed as the reported device was not properly identified.Complaint history review: a search of the complaint databases could not be performed as the reported device was not properly identified.Similar events have occurred for the rejuvenate modular product family.These events were determined to be associated with ra 2012 067.Conclusions: 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 pain, implant failure is considered to be under the scope of this recall.No further investigation is required.H3 other text : device not returned.
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Search Alerts/Recalls
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