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Model Number N/A |
Device Problems
Corroded (1131); Unstable (1667)
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Patient Problems
Necrosis (1971); Pain (1994); Local Reaction (2035); Reaction (2414); Limited Mobility Of The Implanted Joint (2671)
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Event Date 07/26/2017 |
Event Type
Injury
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Manufacturer Narrative
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(b)(4).Customer has indicated that the product will not be returned to zimmer biomet for investigation, as the device location is unknown.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Concomitant medical products: item # unk, hip-versys-unknown-head, lot # unk.Item # unk, unk m/l kinectiv neck, lot # unk.Item # unk, hip-m / l taper-stems-unk, lot # unk.Item # unk, hip-trilogy-unknown-cups, lot # unk.Multiple reports have been submitted for this event.Please see associated reports: 0001822565-2018-05665, 0001822565-2018-05555, 0002648920-2018-00722.
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Event Description
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It was reported that a patient underwent a revision surgery approximately 7 years post implantation due to allegations of metallosis, pain, instability, altr, trunnionosis, necrosis, and limited rom.Medical findings listed in legal document as follows: adverse local tissue reaction, left hip (cobalt metal reaction); alval (aseptic lymphocyte dominated vasculitis-associated lesion); trunnionosis with necrotic ¿dead¿ periarticular muscle; metal disease; corrosion found at trunnion of 36 mm femoral head with titanium dual modular neck; and, abnormal colored tissue with avascularity.Attempts have been made, and no further information has been provided.
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Manufacturer Narrative
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Upon receipt of additional information, it has been determined that this device was originally reported under an incorrect manufacturing facility.The initial report was forwarded in error and should be voided.This device has been correctly reported under 0002648920 - 2018 - 00828.
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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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