An event regarding label content discrepancy involving a mako femoral component was reported.The event was confirmed by photographs.Method & results: product evaluation and results: the device was not returned however, an image of the packaging and implant was provided.The implant noted the catalog number to be 180504 and lot number 2938001.The product label on the implant sheet noted the catalog number to be 180504 and the lot number to be 559782-m.Clinician review: not performed as medical records were not provided for review.Product history review: a device history review confirmed all devices accepted into finished goods conformed to specification.Complaint history review: no other events were reported for the lot indicated.Conclusions: the investigation concluded that the lot number on the label and implant did not match as this is part of the manufacturing process.The supplier certifications note that multiple base lots were manufactured and sterilized under the mako lot which is the "559782-m" lot number, which follows the mako procedure qip 0029, inspection of metallic implant components, section 9.3.13.2.2.The lot number noted on the part is traceable through the router which notes that this lot was indeed manufactured.No further investigation for this event is possible at this time.
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