SMITH & NEPHEW, INC. R3 0 DEG XLPE ACET LNR 36MM X MM56; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED
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Model Number 71332756 |
Device Problem
Fitting Problem (2183)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 02/18/2021 |
Event Type
malfunction
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Manufacturer Narrative
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Internal complaint reference number: case (b)(4).
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Event Description
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It was reported that, during a thr the r3 0 deg xlpe acet lnr 36mm x mm56 cannot be anchored in the cup.Look 2-3mm out of the cup.The procedure was completed without delay using a smith-nephew back-up device.No patient injury or other complications were reported.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.
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Manufacturer Narrative
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H3, h6: the device, used in treatment, was not returned for evaluation.Therefore, product analysis could not be performed at this time.So the reported event could not be confirmed.A review of complaint history did not reveal additional complaints for the listed batch for the same failure mode.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 have no reason to suspect that the products failed to meet any product specifications at the time of manufacture.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.Without the actual products involved and/or device information, our investigation cannot proceed.If these devices or new information is received in the future, this complaint can be re-opened.No further actions are being taken at this time.We consider this investigation closed.
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Manufacturer Narrative
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The associated device was returned and evaluated.The contribution of the device to the reported event could not be corroborated.A visual inspection of the returned device did not confirm the stated failure mode.A dimensional evaluation of the returned device could not confirm the stated failure mode.The device was found to be within tolerance.A review of complaint history did not reveal similar events for the listed device.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 revealed this failure mode was previously identified.The anticipated risk level is still adequate.Assessment of historical escalated cases concluded that there are no prior actions related to this device and failure mode.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 future complaints and investigate as necessary.We consider this investigation closed.
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