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Model Number N/A |
Device Problems
Migration or Expulsion of Device (1395); Loosening of Implant Not Related to Bone-Ingrowth (4002); Migration (4003)
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Patient Problems
Failure of Implant (1924); Insufficient Information (4580)
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Event Date 11/20/2023 |
Event Type
Injury
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Event Description
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It was reported that three days after a right hip revision surgery, the patient required a second revision due to a screw pulling through the acetabular shell with subsequent loosening of the acetabular shell.The surgeon removed the shell and re-implanted a new shell.It was reported that there was no patient injury, no surgical complications, and no foreign body was retained.It is not known whether the patient's condition or anatomy contributed to the event.No additional information.
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Manufacturer Narrative
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(b)(4).D10: cat# 31-323230 lot# 66103691 3.2mmx30mm rnglc+ acet drl bit, cat# 00625006550 lot# 64179977 bone scr 6.5x50 self-tap , cat# 00625006520 lot# j7442427 bone scr 6.5x20 self-tap, cat# 00625006515 lot# j7583487 bone scr 6.5x15 self-tap , cat# 30124006 lot# 65875468 g7 vit e high wall lnr 40mm f, cat# 110010266 lot# 65698426 g7 osseoti multihole 56mm f.The customer was unable to determine which bone screw pulled through the shell.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: 0001822565-2023-03587, 0001822565-2023-03590, 0001822565-2023-03591.
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Manufacturer Narrative
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This follow-up report is being submitted to relay additional and corrected information.No product was returned, or pictures provided; visual and dimensional evaluation could not be performed.Medical records were not provided.The reported products were reviewed for compatibility with no issues noted.The reported issue cannot be confirmed.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.Multiple mdr reports were filed for this event, please see associated report: 0002648920-2024-00084.
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Event Description
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No further event information is available at the time of this report.
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Search Alerts/Recalls
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