SMITH & NEPHEW, INC. GII OVAL RESURFACING PAT 32MM; PROSTHESIS,KNEE,PATELLOFEMOROTIBIAL,SEMICONSTRAINED,CEMENTED,POLYMERMETALPOLYMER
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Model Number 71421032 |
Device Problem
Defective Device (2588)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 12/03/2021 |
Event Type
malfunction
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Manufacturer Narrative
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Internal complaint reference case: (b)(4).
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Event Description
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It was reported that, during a tka, surgeon had prepared everything for the genesis ii oval resurfacing patellar 32mm but due to mismatch of the final implant pegs and the prepared pegs surgeon had to prepare again for a 29 size patella and 29 size implant.Surgery was resumed, after a non-significant delay, with a back-up device.Patient was not injured as consequence of this problem.
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Manufacturer Narrative
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H3, h6: the device was not returned for evaluation and the reported event could not be confirmed.The contribution of the device to the reported event could not be corroborated.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 complaint history did not reveal similar events for the listed device.A review of the risk management file revealed this failure mode was previously identified.The anticipated risk level is still adequate.A historical review concluded that there are no prior actions related to this product and event.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.This device is a reusable instrument that can be exposed to numerous surgeries.Damage from prolonged use, misuse or rough handling are likely probable causes of the reported event.We recommend that all reusable instruments be routinely inspected for wear and damage and replaced as necessary.Based on this investigation, the need for corrective action is not indicated.Without the return of the actual product involved, our investigation could not proceed.Should the device or 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.
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