Model Number N/A |
Device Problems
Off-Label Use (1494); Device Dislodged or Dislocated (2923)
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Patient Problems
Failure of Implant (1924); Joint Dislocation (2374)
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Event Date 10/13/2023 |
Event Type
Injury
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Manufacturer Narrative
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(b)(4).D10: cat# 01.29.242a.Lot# 2304662.Mectacer biolox taper.Cat# 01.29.232h.Lot# 2106000.Mectacer ceramic head.G2: foreign ¿ australia.Multiple mdr reports were filed for this event, please see associated reports: 0001825034 - 2023 - 02573.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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Event Description
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It was reported that the patient underwent a revision surgery approximately four months post implantation due to a dislocation after poor positioning of the implanted cup that was used with competitor product.A new liner was placed to compensate for the cups poor positioning.Attempts have been made and no further information has been provided.
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Event Description
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No further information is available at the time of this report.
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Manufacturer Narrative
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(b)(4).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.A review of the device history records identified no deviations or anomalies during manufacturing.Medical records/radiographs were reviewed by a health care professional and identified findings of the reported issues.Impressions: anatomic alignment of the right hip arthroplasty.A definitive root cause cannot be determined, however there was a competitor head used with a zimmer biomet liner.It¿s unknown if this caused or contributed to the reported event.The event is not confirmed.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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Search Alerts/Recalls
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