SMITH & NEPHEW ORTHOPAEDICS AG TRIAL FEMORAL HEAD 32 L/+8; PROSTHESIS, HIP, SEMI-CONSTRAIND, MET/CERAM/POLY, CEMNTD OR NON-POROUS, UNCEMENT
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Model Number 75100852 |
Device Problem
Deformation Due to Compressive Stress (2889)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 11/25/2020 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).
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Event Description
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It was reported that three trial femoral head 32 l/+8 were found broken.It is not known if all events are related to the same procedure.No injuries or surgical delays reported.
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Manufacturer Narrative
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It was reported that three trial femoral head 32 l/+8 (b)(4) were found broken.It is not known if all events are related to the same procedure.No injuries or surgical delays were reported.The devices, intended for use in treatment, were not returned for investigation.No product was returned for investigation and no batch number was communicated.The reported failure can therefore not be evaluated.Based on the available information, a thorough investigation cannot be conducted and the root cause of the reported issue remains undetermined.No further actions have been initiated.If the reported devices or additional information become available, this investigation will be reopened.Smith and nephew will continue to monitor the device for similar issues.This investigation is considered closed.
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Manufacturer Narrative
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Upon receipt of additional information it has been determined that this report is a duplication of mdr 9613369-2020-00267 and should therefore be disregarded.
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Search Alerts/Recalls
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