Model Number N/A |
Device Problems
Migration or Expulsion of Device (1395); Unstable (1667); Failure to Osseointegrate (1863); Noise, Audible (3273)
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Patient Problems
Pain (1994); Swelling (2091); Weakness (2145); Numbness (2415); Limited Mobility Of The Implanted Joint (2671); No Information (3190)
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Event Date 01/30/2018 |
Event Type
Injury
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Manufacturer Narrative
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(b)(4).Concomitant medical products: articular surface fixed bearing posterior stabilized (ps) left 14 mm height catalog # 42512401014 lot # 62199213, femur cemented posterior stabilized (ps) standard left size 11 catalog # 42500607001 lot # 62629231.Product will not be returning to zimmer biomet for investigation because surgeon did not approve for implant return.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Surgeon didn't approve for return.
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Event Description
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It was reported that the patient underwent an initial left knee arthroplasty.Subsequently, the patient was revised due to loosening.
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Event Description
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It was further reported during the revision procedure, the surgeon noted lack of bony ingrowth and subsidence of the tibial component.
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Manufacturer Narrative
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Concomitant medical products: persona all polyethylene patella, catalog #: 42540000038, lot #: 62113096.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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Manufacturer Narrative
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Concomitant medical products: palacos bone cement, catalog #: 00111314001, lot #: 77884368.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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It was further noted that patient had mild swelling approximately eight weeks post-initial implantation and continued to have one year post-initial implantation with effusion noted.The patient was also noted to have felt "like he pulled something and feels fluid behind the knee" approximately one year post-implantation.Finally, one year post-implantation the patient also noted sharp pain in the morning.Approximately three years post-implantation, the patient was noted to have moderate to severe pain which is aggravated by physical activity, twisting, stairs and prolonged walking and standing.The symptoms are associated with muscle calf weakness, hyper extension, painful range of motion, difficulty arising from a chair and vehicle, and using stairs.The patient is noted to have varus thrust with walking and mild varus upon exam.It was further reported the revision procedure was performed as patient also had pain, swelling, instability, painless popping and clicking, locking, catching, numbness, and dysfunction.
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Manufacturer Narrative
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This follow-up report is being submitted to relay updated and additional information.Complaint sample was evaluated and the reported event was confirmed.Visual evaluation of two-peg trabecular metal tibia, from the picture provided exhibits sign of being implanted with one peg was covered with soft tissues than other peg.Primary surgical notes was provided and found no complication noted.The x-ray was provided and review was performed by third party hcp.The review states loosening and radiolucency along tibia plate.Dhr was reviewed and no discrepancies relevant to the reported event were found.Investigation results concluded that the reported event was due to design deficiency.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.Multiple mdr reports were filed for this event, please see associated reports: 0001822565 - 2018 - 01302 - 3 0001822565 - 2018 - 02467 - 1 0001822565 - 2019 - 01316 - 1 3007963827 - 2019 - 00086 - 1 0002648920 - 2019 - 00240 - 1.
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Event Description
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No further event information available at the time of this report.
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Search Alerts/Recalls
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