SMITH & NEPHEW, INC. R3 20 DEG XLPE ACET LNR 28MM X 46MM; PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL/POLYMER, POROUS
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Model Number 71334946 |
Device Problem
Fitting Problem (2183)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 02/12/2021 |
Event Type
malfunction
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Event Description
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It was reported that, during a tha procedure, after implanting the shell, the liner could not lock into the shell.More than 30 minutes delay.No further complications reported.Procedure was completed with the same devices.
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Manufacturer Narrative
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The device, used in treatment, was not returned for evaluation.Therefore, the product analysis and the reported event could not be confirmed 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 the complaint history on the listed part revealed no prior complaints for the listed failure mode with the same batch number.Factors and/or potential causes that could contribute to the reported event could include alignment or surgical technique.This case reports a delay of greater than 30 minutes while attempting to lock the liner into the shell during a tha surgery.Per complaint details, the procedure was completed with same liner, and no patient injury was reported.Therefore, no further clinical assessment is warranted.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.A relationship, if any, between the device and the reported incident could not be corroborated.Based on this investigation, the need for corrective action is not indicated.Should additional information be received, the complaints will be reopened.No further investigation is warranted for these complaints; however, we will continue to monitor for future complaints and investigate as necessary.We consider this investigation closed.
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Search Alerts/Recalls
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