SMITH & NEPHEW, INC. R3 3 HOLE HA CTD ACET SHELL 52MM; PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL/POLYMER, POROUS
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Catalog Number 71331952 |
Device Problem
Unstable (1667)
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Patient Problems
Failure of Implant (1924); No Code Available (3191)
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Event Date 07/22/2018 |
Event Type
Injury
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Event Description
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It was reported that the reason for revision was instability, the surgeon doesn't blame the implant, x-rays were unavailable.The 36 mm head and 52 mm od /36 mmi id liner were removed and replaced with the r3 52 mm od /22 mm id constrained liner and 22 mm head.
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Manufacturer Narrative
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The associated oxinium femoral head and r2 3 hole acetabular shell were not returned for evaluation.Our investigation including a review of complaint history for the listed parts revealed no prior complaints for the listed failure mode with the same batch number.A review of the manufacturing records for the listed batches did not reveal any deviation from the standard manufacturing processes.A clinical evaluation noted that no clinical supporting documentation has been provided for inclusion in this investigation.Without the requested clinical information, a thorough clinical/medical investigation cannot be rendered.Therefore, the patient's current status nor the future impact to the patient as a result of the reported infection can be concluded.No further clinical/medical investigation is warranted at the time.Without the return of the actual product involved, our investigation of this report is inconclusive.No further investigation warranted for this complaint; however we will continue to monitor for future complaints and investigate as necessary.We recommend that all re-usable instruments be routinely inspected for wear/damage and replaced as necessary.Should additional information be received, the complaint will be reopened.
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Search Alerts/Recalls
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