SMITH & NEPHEW, INC. GII MIS DCF DISTAL CUT BLK; PROSTHESIS, KNEE, FEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, METAL
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Model Number 71441147 |
Device Problem
Corroded (1131)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 11/18/2020 |
Event Type
malfunction
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Manufacturer Narrative
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Case reference: (b)(4).
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Event Description
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It was reported that, a genesis ii mis dcf distal cut blk was starting to rust.No case reported; therefore, there was no patient involvement.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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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 the complaint history for the listed part revealed no prior complaints for the listed failure mode with the same batch number.A review of the manufacturing records did not reveal any manufacturing or material abnormalities that could have caused or contributed to the reported incident this device is a reusable instrument that can be exposed to numerous surgeries; damage from repeated use can occur.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.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.Based on this investigation, the need for corrective action is not indicated.Without the actual product involved and/or device information, our investigation cannot proceed.If the device or new information is received in the future, this complaint can be re-opened.No further investigation warranted for these complaints; however, we will continue to monitor for future complaints and investigate as necessary.
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