Model Number 5450-50-501 |
Device Problem
Loss of or Failure to Bond (1068)
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Patient Problems
Adhesion(s) (1695); Muscular Rigidity (1968); Loss of Range of Motion (2032)
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Event Date 09/03/2020 |
Event Type
Injury
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Manufacturer Narrative
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Product complaint #: (b)(4).Initial reporter occupation: lawyer.Dmf# - (b)(4), trade name gentamicin sulphate, active ingredient(s) gentamicin sulphate, dosage form - powder, strength 1.0g active in our cements.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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Event Description
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Patient received a left attune total knee to treat degenerative joint disease.The patella was resurfaced and depuy cement was utilized.There were no indicated intra-operative complications.Patient received a left knee revision to address arthrofibrosis, adhesions, stiffness, deceased range of motion, and tibial tray loosening at the cement to implant interface.The tibial insert, tibial tray, and femoral component were revised.The patella component was retained.The patient was revised with competitor products and competitor cement.There were no indicated intra-operative complications.Doi: (b)(6) 2017, dor: (b)(6) 2020, left knee.
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Manufacturer Narrative
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Product complaint # (b)(4).Investigation summary : no device associated with this report was received for examination.Depuy synthes considers the investigation closed.Should additional information be received, the information will be reviewed and the investigation may be re-opened as necessary.Device history lot : a search of the depuy nonconformance (nc) quality system found no nc¿s associated with this product/lot combination.Based on the inability to find any nc¿s against the provided product code/lot code combination, it is reasonable to conclude that there are no anomalies with regard to manufacturing that would contribute to the reported event.
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Search Alerts/Recalls
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