ZIMMER, INC. PERSONA VIVACIT-E ARTICLUAR SURFACE POSTERIOR STABILIZED; PROSTHESIS, KNEE
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Catalog Number 42512401010 |
Device Problems
Migration or Expulsion of Device (1395); Noise, Audible (3273)
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Patient Problems
Pain (1994); Swelling (2091)
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Event Date 06/15/2015 |
Event Type
Injury
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Manufacturer Narrative
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(b)(4).Concomitant medical products:- unknown tibial tray, catalog # unknown, lot # unknown.Unknown femoral, catalog # unknown, lot # unknown.Customer has indicated that the product will not be returned to zimmer biomet for investigation due to the device remains implant.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: 0001822565-2017-04717, 0001822565-2017-04722.
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Event Description
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It was reported following a left knee arthroplasty, the patient underwent a manipulation.The patient is experiencing loosening, swelling, popping and snapping.No additional patient consequences were reported.
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Manufacturer Narrative
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(b)(4) the following report is submitted to relay additional information femur cemented posterior stabilized (ps) standard left size 10 lot#62747654 item#42500606801,psn tib stm 5 deg sz g l lot#62954439 item#42532007901 , all-poly patella, ve 38mm x 9.5mm lot#62916598 item#42540200038, headless trocar drill pin 75mm lot#62899977 item#00590102000, 48mm headed screw lot#62916537 item#00579104100, 48mm headed screw lot#62916538 item#00579104100, psn asf ps 12mm ve l 10-12 gh lot#62679125 item#42512401012 the reported event could not be confirmed based on limited information received.No products were returned; therefore, the visual and dimensional inspections were not performed.Device history record (dhr) was reviewed and no discrepancies relevant to the reported event were found.Review of the complaint history determined that no further action is required.The components were reviewed for compatibility with no issues noted.A definitive root cause cannot be determined with the information provided.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.Multiple mdr reports were filed for this event, please see associated reports: 3007963827-2018-00004, 0002648920-2018-00015.
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