Clinical adverse event received for ligament ruptured mcl - intraoperative.Event is serious and is considered moderate.Event is possibly related to device and definitely related to procedure.Date of implant:(b)(6) 2021; date of event: (b)(6) 2021; (right knee).Treatment: intraoperative change in plan once knee had been prepared for primary components (but not yet implanted) revision components were used instead in order to substitute for the ruptured mcl.Depuy components used in procedure.Catalog id: 151710314, lot id: 8956761, component type: insert.Description: attune revision crs rotating platform insert size 3 14 mm.Catalog id: 152303001, lot id: j5231r, component type: acc.Description: attune revision tibial augment universal size 3/4 5 mm.Catalog id: 150660003, lot id: 9716082, component type: tibial, description: attune revision tibial base rotating platform size 3 cemented.Catalog id: 150440203, lot id: j46j50, component type: femoral, description: attune revision.Crs femoral size 3 right cemented.Catalog id: 151214050, lot id: j97a41, component type: stem, description: attune revision cemented stem 14 mm x 50 mm.Catalog id: 151820035, lot id: 9772632, component type: patellar.Description: attune medial dome pat 35mm.
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Product complaint (b)(4).Investigation summary: the device associated with this report was not returned, thus the reported event could not be confirmed.The investigation could not verify or identify any product contribution to the reported event with the information provided.Depuy synthes considers the investigation closed at this time.Should additional information be received, the information will be reviewed and the investigation may be re-opened as necessary.Device history lot: the product investigation found no evidence suspecting an error in the manufacturing or material that would be a contributing factor in the reported allegation(s).A manufacturing records evaluation (mre) was not performed.
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