Patient was revised to address metallosis and cup malpositioning.Examination of the reported devices was not possible as they were not returned.A search of the complaints databases finds one other report against the metal insert lot code.Per procedure, this device is exempt from dhr review.A search of the complaints databases finds no other reports against the remaining product and lot code combinations since their release to distribution.The investigation can draw no conclusion with the information provided.Based on the inability to determine root cause, the need for corrective action has not been indicated.
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