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Model Number N/A |
Device Problems
Migration or Expulsion of Device (1395); Noise, Audible (3273)
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Patient Problems
Pain (1994); Swelling (2091); Weakness (2145); Numbness (2415); Limited Mobility Of The Implanted Joint (2671)
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Event Date 01/30/2018 |
Event Type
Injury
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Manufacturer Narrative
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Zimmer biomet complaint number (b)(4).Concomitant medical product: persona fixed bearing articular surface; p/n: 42512401014, l/n: 62199213; persona posterior stabilized femoral; p/n: 42500607001, l/n: 62629231; persona all polyethylene patella; p/n: 42540000038, l/n: 62113096.Customer has indicated that the product will not be returned to zimmer biomet for investigation, as product location is unknown.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Multiple mdr reports were filed for this event, please see associated reports: 3007963827 - 2019 - 00086, 0002648920 - 2019 - 00240.Product location is unknown.
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Event Description
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It was reported that the patient underwent a revision procedure four years post-implantation due to loosening.During the revision procedure, the surgeon noted lack of bony ingrowth and subsidence of the tibial component and bone cement present on device.
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Manufacturer Narrative
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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, 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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