Model Number N/A |
Device Problems
Material Erosion (1214); Migration or Expulsion of Device (1395)
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Patient Problem
Pain (1994)
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Event Date 05/09/2018 |
Event Type
Injury
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Manufacturer Narrative
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(b)(4).Unknown head, pn unknown, ln unknown.Multiple mdr reports were filed for this event.Please see reports: 0001825034-2018-09555.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.
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Event Description
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It was reported a patient underwent a revision procedure approximately nine years post implantation due to pain, loosening, and metallosis.Surgeon noted some serous brown fluid in the joint.He also indicated that the acetabular component was mechanically loose and showed no evidence of ingrowth on the back side with soft bone and loss of bone within the acetabulum.Attempts have been made and additional information on the reported event is unavailable at this time.No further information is available.
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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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(b)(4).This report is being submitted to relay additional information.Reported event was unable to be confirmed due to limited information provided by customer.Device history record (dhr) was unable to be reviewed as lot numbers were not provided.A definitive root cause cannot be determined with the information provided.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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Manufacturer Narrative
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Upon receipt of additional information within medical records, it has been determined a zimmer biomet device did not cause or contribute to the reported event.The initial and final reports were forwarded in error and should be voided.
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Event Description
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Upon receipt of additional information within medical records, it has been determined a zimmer biomet device did not cause or contribute to the reported event.The initial and final reports were forwarded in error and should be voided.
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Manufacturer Narrative
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Upon receipt of additional information, it has been determined that this device did not cause or contribute to the reported event.The initial report was forwarded in error and should be voided.
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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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