STRYKER ORTHOPAEDICS-MAHWAH LRG TAP PRI MOD NCK 0DEG 34MM; PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL/POLYMER, NON-POROUS, CALICU
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Catalog Number NLS-340000B |
Device Problem
Degraded (1153)
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Patient Problems
Unspecified Infection (1930); Pain (1994)
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Event Date 11/16/2020 |
Event Type
Injury
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Manufacturer Narrative
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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.Review of the device history records indicate devices were manufactured and accepted into final stock with no reported discrepancies.There have been no other events for the lot referenced.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 infection 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 patient is experiencing pain when standing up from a sitting position, walking and when on legs for too long gets tired and stiff.Additional information received from sales rep on (b)(6) 2020: it was reported that the patient's hip was revised due to infection.A rejuvenate modular stem, stryker femoral head, and competitor liner and shell were removed and a spacer placed.Rep can provide an x-ray and confirmed that no further information will be released by the hospital or surgeon.This pi is for the revision of the patient's hip on (b)(6) 2020 [removal of primary implants (rejuvenate modular stem and neck) and revision1 implants].
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Search Alerts/Recalls
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