SMITH & NEPHEW, INC. JRNY II BCS XLPE ART ISRT SZ 7-8 LT 10MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL
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Model Number 74027282 |
Device Problem
Connection Problem (2900)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 05/11/2021 |
Event Type
Injury
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Event Description
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It was reported that, during a tka, surgeon could not get a jrny ii bcs xlpe art isrt sz 7-8 lt 10mm to seat into tibia base, so was opened another identical insert and this also could not be seated into tibial base, finally was opened a constrained insert of same size and insert seated perfectly.Device outside the patient.The procedure was completed without delay with a change in surgical technique.Patient was not harmed.
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Manufacturer Narrative
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H6: the device, used in treatment, was returned for evaluation.A visual inspection of the returned device confirms damage to the lock detail, more than likely due to trying to force the insert to lock into the base-plate.A review of complaint history did not reveal additional complaints for the listed batch.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 and instructions for use document for this failure mode was conducted and concluded this failure mode has been identified.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 warranted for this complaint, 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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