Model Number N/A |
Device Problem
Migration or Expulsion of Device (1395)
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Patient Problems
Pain (1994); Swelling (2091); Synovitis (2094); Ambulation Difficulties (2544); No Code Available (3191)
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Event Date 01/09/2017 |
Event Type
Injury
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Manufacturer Narrative
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Current information is insufficient to permit a conclusion as to the cause of the event.Date of event - ni.Device product code - ni.Expiration date - ni.Unique identifier (udi) # - ni.Date implanted - ni.Date explanted - ni.Manufacture date ¿ ni.
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Event Description
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Patient alleged experiencing left knee loosening, swelling and ambulation difficulties.A revision has been indicated; however, no revision has been reported to date.
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Manufacturer Narrative
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This follow-up report is being filed to report additional information.Concomitant products: femur trabelcular metal cr 42502206201 lot 62600169, articular surface fixed bearing 42512200413 lot 62470512.(b)(4).
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Event Description
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Patient has been indicated for a left knee revision approximately 2 years post-implantation due to loosening of the tibial tray, swelling and ambulation difficulties; however, no revision has been reported to date.This report is based on allegations set forth in patient's complaint, and the allegations contained therein are unverified.Additional information received in patient's medical records note pain and tenderness of the left knee, calf and tibia.Further noted is loosening of tibial component and possible synovitis, a hard knot over the posterior medial aspect, tibial tenderness and thrombophlebitis.
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Manufacturer Narrative
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This follow-up report is being filled to relay additional information, which was unknown at the time of the initial medwatch.
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Event Description
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Additional information received in patient's medical records indicate that the patient had bony overgrowth.A piece of the posterior medial tibia fractured while trying to remove the tibia, tightness in flexion was noted as well.
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Manufacturer Narrative
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This follow-up report is being submitted to relay corrected and additional information.Complaint could not be confirmed.Investigation results determined that this device has been the subject of a recall due to a design issue that can lead to loosening.This device was implanted prior to the recall and medical records indicate there was no evidence of loosening of the tibial component during the revision procedure.Dhr was reviewed and no discrepancies were found relevant to the reported event.A summary of the investigation has been sent to the complainant.If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly.Zimmer biomet will continue to monitor for trends.
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Event Description
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Additional information received in patient's medical records indicates the patient's left knee was revised 3 years post-implantation due to pain and possible loosening.Revision operative report noted the femoral and patellar components were well-fixed and there was no indication of loosening of the tibial tray.The tibial bearing and tibial tray were removed during the procedure.The tibial tray had to be removed with saws and osteotomes.A small piece of the posterior medial tibia was inadvertently removed during extraction of the tibial tray; however, the surgeon noted that it would not affect stability.The tibial tray and bearing were replaced.
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Search Alerts/Recalls
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