Model Number AE-QAS-H546-32 |
Device Problem
Material Integrity Problem (2978)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Type
malfunction
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Manufacturer Narrative
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(b)(4).Manufacturing site evaluation: evaluation on-going.
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Event Description
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Country of complaint: (b)(6).It was reported that there is a possible metallosis in patient.All med watch submissions related to this report are: 9610612-2018-00319; 9610612-2018-00320.
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Manufacturer Narrative
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Investigation: no product is at hand.Conclusion and root cause: based on the information available, the root cause is most probably usage related.Rational: according to the provided information it came to mix and match during the primary surgery.Aesculap components were combined with competitor components.This is not allowed according to our ifu.The combination between the competitor ball head with the metha neck adapter may have led to a high leverage effect.This combination is not tested and approved by aesculap.A high leverage effect can contribute to a higher ion release.There are no indication of a product or material deviation.No capa is necessary.
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Search Alerts/Recalls
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