SMITH & NEPHEW, INC. R3 3 HOLE HA CTD ACET SHELL 52MM; PROSTHESIS, HIP, HEMI-, TRUNNION-BEARING, FEMORAL, METAL/POLYACETAL
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Catalog Number 71331952 |
Device Problem
Loose or Intermittent Connection (1371)
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Patient Problem
Joint Dislocation (2374)
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Event Date 01/19/2018 |
Event Type
Injury
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Event Description
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Patient positioned and hip dislocated.Liner and screws removed cup was loose.Removed cup reamed acetabulum and implanted a 52mm multihole cup and three screws.A constrained liner inserted and checked to be locked in the cup.Hip reduced using a 22mm stryker head.Hip stable.
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Manufacturer Narrative
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The associated complaint device was not returned for evaluation.The associated r3 3hole acetabular shell, r3 acetabular liner, head screws and hole cover were not returned for evaluation.A review of complaint history on the listed parts revealed no additional complaints for this issue with the same batch number.Our investigation included a review of the manufacturing records which did not reveal any manufacturing or material abnormalities that could have caused or contributed to the reported incident.A clinical evaluation noted that based on the available information, the root cause of the ¿cup loosening¿ cannot be concluded.It is unknown if the post-primary surgery fall contributed to the ¿loosening¿ but that explanation cannot be excluded.Without the return of the actual product involved, our investigation is inconclusive.No further investigation is warranted for this complaint; however we will continue to monitor for future complaints and investigate as necessary.Should the device or additional information be received, the complaint will be reopened.
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