STRYKER ORTHOPAEDICS-MAHWAH REJUVENATE STRGHT PRFIT TMZF MOD STEM SIZE 9; PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL / POLYMER, NON-POROUS, CALC
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Catalog Number SPT-090000S |
Device Problems
Device-Device Incompatibility (2919); Insufficient Information (3190)
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Patient Problems
Failure of Implant (1924); Injury (2348)
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Event Date 05/22/2020 |
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.The information in this report was provided by stryker orthopaedics legal affairs department.No additional information is available at this time due to the ongoing litigation.Should additional information become available, the evaluation summary will be submitted in a supplemental report.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 injury is considered to be under the scope of this recall.No further investigation is required.
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Event Description
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As reported: "removal and replacement of rejuvenate recalled modular stem, pre-op diagnosis - failed right total hip arthroplasty." spoke to rep, who provided additional patient and product information.All devices except the shell were revised to a stryker poly liner and competitor femoral devices.Rep has some additional pictures to provide, and confirmed that no further information will be released by the hospital or surgeon.
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Event Description
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As reported: "removal and replacement of rejuvenate recalled modular stem, pre-op diagnosis - failed right total hip arthroplasty." spoke to rep, who provided additional patient and product information.All devices except the shell were revised to a stryker poly liner and competitor femoral devices.Rep has some additional pictures to provide, and confirmed that no further information will be released by the hospital or surgeon.
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Manufacturer Narrative
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Reported event: an event regarding revision due to implant failure involving a 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 found the devices in the reported lot were accepted into final stock with no reported discrepancies.-complaint history review: the complaint databases show there have been no other events for the reported lot.Similar events have occurred for the catalog number and 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 revision due to 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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