SMITH & NEPHEW, INC. REF SPHER HEAD SCREW 25MM; PROSTH, HIP, SEMI-CONSTRA, UNCEMENT, METAL/POLY, NON-POROUS, CALICUM-PHOSPHATE
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Catalog Number 71332525 |
Device Problem
Fracture (1260)
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Patient Problem
Injury (2348)
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Event Date 11/29/2018 |
Event Type
Injury
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Event Description
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It was reported that revision surgery was carried out for a hip prosthesis exchange due to it broke at the shaft.
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Manufacturer Narrative
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Additional information received by the manufacturer has identified that this event should be re-evaluated for mdr reporting.The new information states that this is a duplicate of the case c-0223414, related to a nanos stem, manufactured by third party manufacturer ohst medizintechnik ag.This product is manufactured by ohst medizintechnik ag rathenow and locally distributed by smith & nephew gmbh marl.The investigation activities has been conducted by smith & nephew gmbh marl according to local procedure., therefore, it was determined that this case does not meet the threshold for reporting and is a non-reportable event.If further details are provided confirming the occurrence of a reportable event, our files will be updated accordingly and a further report submitted outlining both the event details and our investigations performed.
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Search Alerts/Recalls
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