SMITH & NEPHEW, INC. UNKN ORTHOPAEDIC RECONSTRUCTION DEV; PROSTHESIS, HIP, SEMI-CONSTRAINED
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Catalog Number UNKNOWN |
Device Problem
Device-Device Incompatibility (2919)
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Patient Problem
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
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Event Date 10/21/2020 |
Event Type
Injury
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Manufacturer Narrative
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Case (b)(4).
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Event Description
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It was reported that, during a thr, surgeon implanted a 32mm diameter head in a 36mm diameter liner and the two devices are not compatible.Patient will need revision surgery to swap out the head and the liner for a compatible pair.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.
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Manufacturer Narrative
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After further assessment of the information gathered by the manufacturer, it was identified that this event should be re-evaluated for mdr reporting.The original information stated that a compatibility issue was noticed.However after further clarification and information received, it was determined that the issue had already been previously reported (under our reference number (b)(4) and report number 1020279-2020-07552).Therefore, it was determined that this case will be covered under the first report sent (1020279-2020-07552).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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