SMITH & NEPHEW, INC. R3 0 HOLE ACET SHELL 50MM; PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL/POLYMER, POROUS
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Model Number 71331850 |
Device Problems
Inadequacy of Device Shape and/or Size (1583); Patient Device Interaction Problem (4001)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 10/22/2020 |
Event Type
Injury
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Event Description
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It was reported that, during a thr, the cup would not properly seat into acetabulum.Surgeon decided to use a 3 hole cup instead and that one seated fine.No surgical delay reported.The patient was not injured.
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Manufacturer Narrative
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Additional information: d4, h4.H3, h6: the associated device, used in treatment, was returned and evaluated.A visual inspection of the returned device does not confirm the stated failure mode.The device has scratches and burrs.The device shows signs of extensive use.The dimensional analysis was completed on the returned r3 acetabular shell device for all features critical to acetabular seating.No deviations were noted during dimensional evaluation.See attached for details.The failure mode cannot be confirmed via dimensional analysis.A review of complaint history did not reveal additional complaints for the listed batch.A review of the manufacturing records did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.At this time, we do not have reason to suspect that the product failed to meet any product specifications at the time of manufacture.A review of the risk management file and instructions for use documents revealed this failure mode and potential harm was previously identified.Some potential probable causes for this event could include a fit/ sizing issue or poor insertion technique.Based on this investigation, the need for corrective action is not indicated.Should additional information be received, the complaint will be reopened.No further investigation is warranted for this complaint; however, we will continue to monitor for future complaints and investigate as necessary.We consider this investigation closed.
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