Model Number N/A |
Device Problem
Detachment of Device or Device Component (2907)
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Patient Problem
Osteopenia/ Osteoporosis (2651)
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Event Date 03/01/2024 |
Event Type
Injury
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Event Description
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It was reported that approximately three days post-implantation, the patient was revised because the head came off the trunnion.Attempts have been made and no further information has been provided.
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Manufacturer Narrative
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(b)(4).G2: foreign ¿ australia.Multiple mdr reports were filed for this event, please see associated reports: 0001822565 - 2024 - 00974.The customer has indicated that the product will not be returned to zimmer biomet for investigation as its location is unknown.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.
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Manufacturer Narrative
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Upon receipt of additional information, it was determined this product should not have been reported under this mfr number.This report should be voided and a corrected report will be filed under mfr number (b)(4).
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Event Description
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Upon receipt of additional information, it was determined this product should not have been reported under this mfr number.This report should be voided and a corrected report will be filed under mfr number (b)(4).
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Search Alerts/Recalls
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