It was reported that a patient underwent subchondroplasty on their tibia prior to an initial total knee replacement procedure.The surgeon has reported that when the cut was made on the tibia for the knee replacement, it was noticed that the bone had avascular necrosis.The surgeon believes the avn is related to the scp.The initial date of the scp procedure and the lot number of the device in questions are unknown; the device cannot be returned for investigation since it was implanted.As additional information about the event is reported, a supplemental report will be submitted with any additional findings.
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The patient underwent an scp procedure into patient¿s subcondylar tibia bone an unknown date and then sequentially underwent a tka on an unknown date.The event was reported on (b)(6) 2019.The complaint engineer contacted the sales representative regarding the case.The sales representative reported that the surgeon has not reported any clinical issues for the patient post conversion to tka.The sales representative requested additional information regarding the conversion to tka; however, the request had been blocked by the clinic where the tka was performed.The hospital was unwilling to release any radiographic information to the rep regarding the case.With no further clinical information, we are unable to further review this case.This complaint is being closed due lack of information.It will be reopened if further information becomes available.The dhr was unable to be reviewed, as the lot number for the device related to the event was unable to be confirmed.The product was not returned for the investigation, as it remains implanted in the patient.
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