(b)(4).Concomitant medical products - stem extension 00598801011, lot 62255361, tibial component 00588000300, lot 62209202, stem extension 0598801010, lot 61894690, femoral component 00588001401, lot 61885066, tibial block 00598800326, lot 61988733, tibial block 00598800426, lot 62290267.(b)(6.The complaint of revision due to pain from pseudo-tumor can be confirmed from x-ray review.However, complaint of corrosion/oxidation on the implants cannot be confirmed as neither excessive wear nor corrosion were seen on the returned devices.Dhr was reviewed and no discrepancies relevant to the reported event were found.The root cause for this event cannot be determined.There are warnings in the package insert that this type of event can occur and risks are addressed in risk documentation.If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly.Zimmer biomet will continue to monitor for trends.
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