Catalog Number 11-300812 |
Device Problems
Loss of or Failure to Bond (1068); Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Bone Fracture(s) (1870); Unspecified Infection (1930); Malunion of Bone (4529)
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Event Date 08/05/2021 |
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 product location is unknown.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Report source: (b)(6).
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Event Description
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It was reported a patient underwent hip revision surgery approximately 2.5 years post implantation due to infection, periprosthetic fracture, malunion and loosening.Attempts have been made and additional information on the reported event is unavailable at this time.
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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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Manufacturer Narrative
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D10: catalog#: 11-301300 arcos con sz a std 50mm lot#: 981060.Medical records/radiographs were provided and reviewed by a health care professional.A review of the available records identified findings of the reported issues mmi:impressions: moderate-sized periprosthetic zone of lucency in the right femoral component located at the trochanteric and subtrochanteric region suggests loosening and/or infection.Device history record (dhr) was reviewed and no discrepancies were found.Root cause was unable to 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.
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Search Alerts/Recalls
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