SMITH & NEPHEW, INC. R3 3 HOLE ACET SHELL MM48; PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL/POLYMER, POROUS
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Catalog Number 71335548 |
Device Problem
Appropriate Term/Code Not Available (3191)
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Patient Problem
Device Embedded In Tissue or Plaque (3165)
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Event Date 09/11/2018 |
Event Type
malfunction
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Event Description
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It was reported that during artificial hip replacement surgery, screws were used for fixation and one of the screws passed directly through the acetabulum cup, surgeon used another two screws for fixation.One of the screws was left in the patient.
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Manufacturer Narrative
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The associated complaint device was not returned.A visual examination was unable to be performed without the actual device; only the outer box was the returned.A clinical analysis indicated that the provided x-ray confirms 3 retained screws embedded in the bone with one completely through the shell.The root cause of the reported issue could be due to a procedural/user event but the screws remained implanted so were not available to be returned for testing.Since the embedded screw is comprised of bio-compatible material, migration is not likely since the screw is contained within the bone as the single image x-ray shows.The impact to the patient beyond the retained implantable screw cannot be determined.No further clinical/medical assessment is warranted at this time.A review of the manufacturing records did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.A review of complaint history for the listed part did not reveal additional complaints for the listed batch.Without the actual product involved our investigation cannot proceed.No further investigation is warranted for this complaint; however we will continue to monitor for future complaints and investigate further as necessary.If the devices are received in the future, this complaint can be re-opened.We consider this complaint closed.
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