SMITH & NEPHEW, INC. R3 0 DEG XLPE ACET LNR 32MM X 48MM; PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL/POLYMER, POROUS
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Catalog Number 71339548 |
Device Problem
Insufficient Information (3190)
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Patient Problem
Joint Dislocation (2374)
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Event Date 11/03/2017 |
Event Type
Injury
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Event Description
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It was reported that a surgical intervention was performed due to dislocation, all parts were removed.
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Manufacturer Narrative
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The associated complaint device was not returned.A clinical analysis indicated that it was reported this patient returned to the hospital due to dislocations.All parts were removed and a liner was cemented in.However, no clinically supporting documentation has been provided for inclusion in this investigation.Without the explant, or the requested clinical information the root cause of the dislocation cannot be determined.The impact to the patient beyond the dislocations cannot be concluded.No further clinical/medical assessment is warranted at this time.Without the actual product involved and/or device information, our investigation cannot proceed.If the device or new information is received in the future, this complaint can be re-opened.No further actions are being taken at this time.We consider this investigation closed.
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