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Model Number N/A |
Device Problem
Insufficient Information (3190)
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Patient Problem
Death (1802)
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Event Date 01/30/2018 |
Event Type
Death
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Manufacturer Narrative
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(b)(4).Multiple mdr's were filed for this event.Please see associated report(s): 0001825034 - 2019 - 02617, 0001825034 - 2019 - 02619, 0001825034 - 2019 - 02620, 0001825034 - 2019 - 02621, 0001825034 - 2019 - 02622, 0001825034 - 2019 - 02623, 0001825034 - 2019 - 02624, 0001825034 - 2019 - 02625, 0001825034 - 2019 - 02626, 0001825034- 2019 - 02627.Concomitant medical products: product lot or serial description primary di# 815355070 lot unknown 5.5mm polyaxial screw ft 70mm (01) 00887868041853, 815355080 lot unknown 5.5mm polyaxial screw ft 80mm (01) 00887868041877, 815355060 lot unknown 5.5mm polyaxial screw ft 60mm (01) 00887868041839, 815355025 lot unknown 5.5mm polyaxial screw ft 25mm (01) 00887868041662, 815308075 lot unknown 8.0mm cann locking ft 75mm (01) 00887868041211, 815045540 lot unknown 4.5 locking shaft screw 40mm (01) 00887868040894, 815045536 lot unknown 4.5 locking shaft screw 36mm (01) 00887868040870, 815045514 lot unknown 4.5 locking shaft screw 14mm (01) 00887868040764, 815745036 lot unknown 4.5 x 36mm cortical screw ft (01) 00887868042416, 814131106 lot 666670 femoral plate 6 hole left (01) 00887868036934. the investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Not returned to manufacturer.
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Event Description
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It was reported the patient expired; however, cause of death was not listed.There are no allegations of device involvement.No further information is available at the time of this reporting.
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Manufacturer Narrative
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This follow-up report is being submitted to relay additional information.No product was returned or pictures provided; visual and dimensional evaluations could not be performed.Review of the device history record for pn 814131106 ln 666670 identified no deviations or anomalies during manufacturing related to the reported event.Lot identification is necessary for review of device history records, lot identification was not provided for the remaining devices.A definitive root cause cannot be determined.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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No further information is available at the time of this reporting.
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Manufacturer Narrative
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Upon reassessment of the reported event based on the additional information received, it was determined that the cause of death was due to anorexia, poor po intake ¿ patient was not eating or drinking enough to support/sustain life and was not due to the medical devices.Hence the initial report needs to be voided.
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Event Description
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It was further reported upon review the patient expired due to natural causes, and the devices were not alleged to have contributed, according to the medical documentation.Cause of death was: anorexia, poor po intake ¿ patient was not eating or drinking enough to support/sustain life.Significant conditions contributing to but not causing death: hyponatremia, gerd, copd, anxiety.
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Search Alerts/Recalls
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