Model Number 5450-50-501 |
Device Problem
Loss of or Failure to Bond (1068)
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Patient Problems
Pain (1994); Loss of Range of Motion (2032); Discomfort (2330); Joint Laxity (4526); Swelling/ Edema (4577)
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Event Date 06/17/2019 |
Event Type
Injury
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Manufacturer Narrative
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(b)(4).Initial reporter occupation: lawyer.Dmf# 13704, 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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Primary operative notes (b)(6) 2017 indicate the patient received a left total knee replacement due to end stage osteoarthritis.The patella was resurfaced, and depuy cement was utilized x2.The surgery was completed without indication of complication by the surgeon.Revision operative notes (b)(6) 2019 indicate the patient received a left total knee revision due to functional restrictions, restricted range of motion, trace laxity, trace effusion, pain and discomfort with aseptic loosening of the tibial component.Upon entering joint, polywear was present on the insert.Scratching was present on the tibial component.The tibial component was noted to be loose and the cement to implant interface.The patella component was noted to be overstuffed.There was no indication of deficiency with the femoral component.All implants were removed.Competitor products were placed.The surgery was completed without indication of complication by the surgeon.
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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 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: device history reviewed 20 september 2019.0 non-conformances on this lot number.Final micro and sterility tests passed.Total qty released: 2700.Expiry date: 31-aug-18.
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Search Alerts/Recalls
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