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Catalog Number NOT COMMUNICATED |
Device Problem
Device Dislodged or Dislocated (2923)
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Patient Problem
Failure of Implant (1924)
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Event Date 06/10/2018 |
Event Type
Injury
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Manufacturer Narrative
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(b)(4).Report source, foreign - event occurred in (b)(6).The investigation is in process.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 reported revision surgeries in the journal article "minimally invasive oxford unicompartmental knee arthroplasty ensures excellent functional outcome and high survivorship in the long term": the revisions were due to a progression of arthritis in 5 patients, associated to a persistence of pain in 3 patients, infection or wound dehiscence in 3 patients, aseptic loosening in 2 patients, bearing dislocation in 2 patients, and breakage of the bearing in 1 patient.The current complaint is related to a revision due to the breakage of the bearing for one patient.Journal article: tilman walker, pit hetto, thomas bruckner, tobias gotterbarm, christian merle, benjamin panzram moritz m.Innmann, babak moradi,(2018) minimally invasive oxford unicompartmental knee arthroplasty ensures excellent functional outcome and high survivorship in the long term.Knee surgery, sports traumatology, arthroscopy https://doi.Org/10.1007/s00167-018-5299-2.
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Manufacturer Narrative
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(b)(4).This follow-up report is being submitted to relay additional information.The following sections were updated: b5, g4, h2, h6, h10.The product was not returned so the event could not be confirmed.The product analysis can't be performed as the product was not returned.The review of the device manufacturing quality can't be performed as the product batch number was not communicated.10 similar complaints (including the current complaint) have been recorded regarding a "revision" on refobacin bone cement r-1 (all references) products since one year.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 reported revision surgeries in the journal article "minimally invasive oxford unicompartmental knee arthroplasty ensures excellent functional outcome and high survivorship in the long term" : the revisions were due to a progression of arthritis in 5 patients, associated to a persistence of pain in 3 patients, infection or wound dehiscence in 3 patients, aseptic looseneing in 2 patients, bearing dislocation in 2 patients, and breakage of the bearing in 1 patient.The current complaint is related to revisions due to bearing dislocations in two patients.Journal article: tilman walker, pit hetto, thomas bruckner, tobias gotterbarm, christian merle, benjamin panzram moritz m.Innmann, babak moradi,(2018) minimally invasive oxford unicompartmental knee arthroplasty ensures excellent functional outcome and high survivorship in the long term.Knee surgery, sports traumatology, arthroscopy https://doi.Org/10.1007/s00167-018-5299-2.
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Search Alerts/Recalls
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