The patient was revised to address instability of knee joint and loosening of the patella at the cement to implant interface, cement manufacturer is competitor.It also stated that a thicker implant is needed for stability, and fractured patella probably from falling event.Doi: (b)(6) 2016; dor: (b)(6) 2017; right knee.
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(b)(4).Investigation summary: no device associated with this report was received for examination.Depuy considers the investigation closed at this time.Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.Device history lot: product code 151810038, lot number 8325797.Device history review: product code 15180038, work order (b)(4) was manufactured on 01 july 2016.30 parts were manufactured per specification and all raw materials met specification.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate. .
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