Model Number 1504-10-207 |
Device Problem
Loss of or Failure to Bond (1068)
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Patient Problems
Adhesion(s) (1695); Low Blood Pressure/ Hypotension (1914); Ischemia (1942); Pain (1994); Ambulation Difficulties (2544); Confusion/ Disorientation (2553); Swelling/ Edema (4577)
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Event Date 03/17/2020 |
Event Type
Death
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Event Description
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Patient received a right primary attune to treat severe end-stage arthritis.The patella was resurfaced and depuy cement x 2 was utilized.The surgeon notes that the patient had a preexisting left bka that was performed to treat a clotting issue.The procedure was completed without complications.Patient received a right knee revision to treat pain, swelling, and inability to walk secondary to aseptic loosening.The patient has extensive comorbidities.Because of this, he was given dialysis and extensive treatments for his preexisting clotting disorder before being approved for the revision and cleared for the procedure.Upon entering the joint, scar tissue was debrided from the joint.The tibial tray was grossly loose and debonded at the cement to implant interface and easily removed.The femoral component and patella were both loose at an unknown interface and revised.There was no reported product problem with the revised tibial insert.The patient was revised with competitor products.The procedure was completed without complications.Hours after the revision.The patient had an episode of hypotension and confusion and was transferred to the icu.Dialysis was attempted but was discontinued as the hypotension returned.Ct scan revealed significant ischemic and dead bowel.The family and physicians conversed, and corrective surgery was declined.Patient was given comfort measures and expired on the second post-operative day.There is insufficient information provided to determine the root cause of the death and the depuy synthes products cased or contributed to the reported death two days after the revision.Doi: (b)(6) 2016, dor: (b)(6) 2020, dod: (b)(6) 2020, right knee.
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Manufacturer Narrative
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(b)(4).Initial reporter occupation: lawyer.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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Manufacturer Narrative
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Product complaint # (b)(4).Investigation summary an analysis of the product could not be performed since a physical sample was not received for evaluation.As part of our company quality system process, all devices are manufactured, inspected, and distributed to approved specifications.Additional complaint information monitoring for potential safety signals will be conducted through complaint trending as part of the post-market surveillance.However, if the product is received at a later date, the investigation will be updated as applicable.
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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.The information received will be retained for potential series investigations if triggered by trend analysis, post market surveillance, or other events within the quality system.Depuy considers the investigation closed.Should additional information be received, the information will be reviewed and the investigation will 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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Search Alerts/Recalls
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