SMITH & NEPHEW, INC. JOURNEY DCF AP FEM CUT BLK 7; PROSTHESIS,KNEE,FEMOROTIBIAL,SEMICONSTRAINED,CEMENTED,METALPOLYMER
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Model Number 74012417 |
Device Problem
Corroded (1131)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 04/15/2022 |
Event Type
malfunction
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Manufacturer Narrative
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Smith & nephew is submitting this report pursuant to the provisions of 21 c.F.R.Part 803.This report may be based upon information which smith & nephew has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, smith & nephew, or its employees, that the report constitutes an admission that the device, smith & nephew or its employees caused or contributed to the potential event described in this report.
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Event Description
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It was reported that the journey dcf ap fem cut blk 4, journey dcf ap fem cut blk 7 and journey dcf ap fem cut blk 8 were corroded.As this was noticed upon field inspection, there was not patient involvement.
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Event Description
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It was reported that the journey dcf ap fem cut blk 7 was corroded.As this was noticed upon field inspection, there was not patient involvement.
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Manufacturer Narrative
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H3, h6: the associated device was returned and evaluated.A visual inspection of the returned device did not confirm the stated failure mode.There is no sign of corrosion.The device shows signs of extensive use.A review of complaint history for the part number over the past 12 months and for the batch number based on historical data of the device 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.The contribution of the device to the reported event could not be corroborated.This device is a reusable instrument that can be exposed to numerous surgeries.Damage from prolonged use, misuse or rough handling are 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.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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