The reported event could be confirmed, on the basis of the medical expert opinion.The device inspection revealed the following: the visual inspection of the returned device indicates the scuffed area which is a result of mechanical impingement and/or subluxation/dislocation and are coherent with the described event of dislocation.The hole in the center is left after the screw insertion is made to pull out the polyethylene inlay during the revision surgery.The device history record could not be reviewed because the lot number was not communicated.Indications of material, manufacturing, or design related problems were unable to be identified as the lot number was not communicated.A review of the labeling did not indicate any abnormalities.Based on investigation, the root cause was attributed to most likely a patient related issue.The failure was most likely due to insufficient soft-tissue tension.If any further information is provided, the complaint report will be updated.
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