Model Number N/A |
Device Problem
Insufficient Information (3190)
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Patient Problems
Unspecified Infection (1930); Pain (1994); Swelling (2091); Synovitis (2094)
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Event Date 12/29/2015 |
Event Type
Injury
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Manufacturer Narrative
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(b)(4).Customer has not yet indicated if the product will be returned to zimmer biomet for investigation.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:0001825034-2017-00590/ 0001825034-2017-00591/ 0001825034-2017-02519/ 0001825034-2017-02524/ 0001825034-2017-02525.
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Event Description
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It is reported that the patient initially underwent arthroscopically assisted anterior cruciate ligament reconstruction in her right knee.Subsequently, the patient underwent a synovectomy procedure approximately seven (7) months post-operatively due to pain and swelling.Revision operative notes provided noted hypertrophic synovial tissue and a "cyclops" lesion.The excess tissue was removed.
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Manufacturer Narrative
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(b)(4).Reported event was confirmed through receipt of medical records and operative notes.The notes cover the procedure to remove a "hypertrophic synovial lesion, anterior aspect, right knee" and a "cyclops lesion".The report also notes that "there was no significant degenerative changes" and that the "anterior cruciate ligament graft is in good position." no devices were received; therefore the visual inspection was not performed.Device history record (dhr) was reviewed and no discrepancies were found.Review of the complaint history determined that no further action is required.This product is in scope of previous corrective action, however, root cause was unable to be confirmed for this event.No corrective actions, preventive actions, or field actions resulted after investigation of this event.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 is reported that the patient initially underwent athroscopically assisted anterior cruciate ligament reconstruction in her right knee.Subsequently, the patient underwent a synovectomy procedure approximately seven (7) months post-operatively due to pain and swelling.Revision operative notes provided noted hypertrophic synovial tissue and a "cyclops" lesion.The excess tissue was removed.The surgeon later expressed the possibility of potential infection, however this was not confirmed.
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Search Alerts/Recalls
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