Model Number N/A |
Device Problems
Unstable (1667); Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Damage to Ligament(s) (1952); Joint Laxity (4526)
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Event Date 07/07/2023 |
Event Type
Injury
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Event Description
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It was reported patient underwent a revision procedure twenty months post implantation due to instability in knee.Attempts to obtain additional information have been made; however, no more is available at this time.
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Manufacturer Narrative
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(b)(4).D10 - medical product: bmt 360 7.5mm offset adapter catalog # 185212 lot # 391690.Bmt 360 tib tray 63mm catalog # 185201 lot # 737090.Bmt 360 tib aug 63x10mm catalog # 185231 lot # 138590.Bmt 360 tib sm cruciate wing catalog # 185650 lot # 547810.Bmt splined knee stm v2 17x80 catalog # 148307 lot # 698780.Vngd ps open intl fem rt 60 catalog # 183104 lot # j3862188.H3: customer has indicated that the product will not be returned because product location is unknown.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.
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Event Description
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Upon receipt of information received and reassessment of the reported event, it was determined to be not reportable.No problem found with zimmer biomet device.The initial report was forwarded in error and should be voided.
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Manufacturer Narrative
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Upon receipt of information received and reassessment of the reported event, it was determined to be not reportable.No problem found with zimmer biomet device.The initial report was forwarded in error and should be voided.
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Search Alerts/Recalls
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