STRYKER ORTHOPAEDICS-MAHWAH REJUVENATE STRGHT PRFIT TMZF MOD STEM SIZE 7; PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL / POLYMER, NON-POROUS, CALC
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Catalog Number SPT-070000S |
Device Problems
Material Erosion (1214); Device-Device Incompatibility (2919)
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Patient Problems
Inflammation (1932); Injury (2348); Reaction (2414)
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Event Date 05/05/2020 |
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.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 wear 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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It was reported that the patient's right hip was revised.Intra-operatively, while removing the head the modular neck came out as well with no distraction required.Trunnion wear was noted.The rejuvenate modular stem and neck, 28 +0 lfit head, and adm/ mdm insert were revised.Rep confirmed there are no allegations against the revised insert.No further information will be released by the hospital or surgeon.Update 14/may/2020 : clarification to event description (trunnion wear) provided by rep: "the wear was between the neck and the stem.".
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Manufacturer Narrative
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Updated the event description and implant date to reflect the updates received june 11,2020.Reported event: an event regarding elevated metal ion levels and wear involving a rejuvenate modular device was reported.The event was confirmed for elevated ion levels.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 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: based on event details, wear between stem and neck is also reported.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 elevated metal ion levels 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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Event Description
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It was reported that the patient's right hip was revised.Intra-operatively, while removing the head the modular neck came out as well with no distraction required.Trunnion wear was noted.The rejuvenate modular stem and neck, 28 +0 lfit head, and adm / mdm insert were revised.Rep confirmed there are no allegations against the revised insert.No further information will be released by the hospital or surgeon.Update 14/may/2020 : clarification to event description (trunnion wear) provided by rep: "the wear was between the neck and the stem." update the additional information received from legal on 06/11/2020: plaintiff was implanted with a right abg ii / rejuvenate modular hip stem on (b)(6) 2010.Its further alleged that the plaintiff had the right hip stem at issue explanted on (b)(6) 2020 due to elevated levels of cobalt and chromium in bloodwork.
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Search Alerts/Recalls
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