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Model Number N/A |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Tissue Damage (2104); Blood Loss (2597); Osteopenia/ Osteoporosis (2651); Patient Problem/Medical Problem (2688)
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Event Date 03/30/2017 |
Event Type
Injury
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Manufacturer Narrative
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Concomitant medical products: item #: unknown unknown head lot #: unknown, 00786201350 lot 07886766 stem 13 eo.Customer has indicated that the product will not 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: 0001822565 - 2019 - 04512stem, 0001822565 - 2019 - 04514head.
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Event Description
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It was reported that an initial right total hip arthroplasty performed and subsequently underwent revision of the head and liner due to complications from trunnionosis seven years later.The patient then underwent a second revision due to pain, wound complications, and radiolucency with apparent acetabular screw fracture on x-ray.After the second revision, the patient fell due to unknown reasons and suffered an acetabular protrusion.A third revision was performed a month after the second revision during which all components were removed and a girdlestone procedure was performed.Attempts were made to obtain additional information; however, none was available.
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Manufacturer Narrative
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(b)(4).This follow-up report is being submitted to relay additional information.D11: multiple mdr reports were filed for this event, please see associated reports: 0001822565-2020-00517 liner.Reported event was confirmed by review of medical records.Device history record (dhr) review was unable to be performed as the lot number of the device involved in the event is unknown.Root cause was unable to be determined.Medical records identified zimmer biomet components were implanted without complications.The patient underwent a revision procedure due to trunnionosis.The patient underwent a second revision procedure due to pain, wound complications and radiolucency.Following second revision, the patient fell and suffered acetabular protrusion, and underwent another revision surgery.During the procedure, a protrusion was noted to be putting pressure on the iliac artery graft causing mild kinking but no compromise to the circulation in the lower extremity.Cultures were negative for infection.The superior arch appeared to be intact, but anterior and posterior walls were rather weak and the whole of the medial wall was completely blown out with a bipolar component protruding into the pelvis.All zimmer biomet components were removed and a girdlestone procedure was performed.Blood loss of 800ml, prbcs transfused.No other findings related to the reported event were noted.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 event information available at the time of this report.
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Search Alerts/Recalls
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