SMITH & NEPHEW, INC. REF XLPE 28 20 DEG 54-56 F; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED
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Catalog Number 71333325 |
Device Problem
Connection Problem (2900)
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Patient Problem
Injury (2348)
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Event Date 05/30/2019 |
Event Type
Injury
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Event Description
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It was reported that during surgery the liner not locked properly in to the shell.They used another liner that also not locked.They removed reflection shell 54 and used r3 shell 56 and liner.30 minutes of delay due to this incident.A backup device was available.
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Manufacturer Narrative
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Reviewing the information received by the manufacturer has identified that this event should be re-evaluated for mdr reporting.The information states that the patient suffered bone loss during the reflection shell removal and not while using the insert in the patient, 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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Manufacturer Narrative
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The associated complaint devices were not returned.The clinical/medical team concluded, without the requested clinical information, a thorough medical investigation cannot be rendered.Should any additional clinical information be provided this complaint will be re-assessed.A review of the production documentation for the corresponding products did not reveal any deviation from the standard manufacturing processes.A review of complaint history for the listed parts revealed no prior complaints for the listed batches.Without the actual device involved our investigation cannot proceed.If the device or new information is received in the future, the complaints can be re-opened.No further actions are being taken at this time.
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Search Alerts/Recalls
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