Catalog Number 00840004510 |
Device Problem
Loosening of Implant Not Related to Bone-Ingrowth (4002)
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Patient Problems
Fall (1848); Bone Fracture(s) (1870); Failure of Implant (1924); Osteopenia/ Osteoporosis (2651)
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Event Date 08/12/2021 |
Event Type
Injury
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Manufacturer Narrative
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(b)(4).Multiple mdr reports were filed for this event, please see associated reports: 0001822565-2021-03018.Concomitant medical products: item# 00840009000; lot# 63909416, item# 00840001507; lot# 63670155, and item# 00840009500; lot# 63930799.Full establishment name - (b)(6).Foreign - event occurred in uk.Customer has indicated that the product will not be returned to zimmer biomet for investigation, as the product remains implanted.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.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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Event Description
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It was reported that the patient underwent a total elbow arthroplasty in a clinical study approximately two (2) years and five (5) months ago.Subsequently, patient had fallen post-implantation and experienced a peri-prosthetic fracture on an unknown date.Patient was treated with a splint.Approximately two (2) months ago during the patient's two (2) year follow-up appointment, it was noted in the x-rays that the humeral component was loose at the site of the previous peri-prosthetic fracture.There is currently no plan to revise the patient or do further intervention.Attempts have been made and no further information has been provided.
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Manufacturer Narrative
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This follow-up report is being submitted to relay additional information.If any further information which would change or alter any conclusions or information, a supplemental report will be filed accordingly.Zimmer biomet will continue to monitor for trends.
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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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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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This follow-up report is being submitted to relay additional information.Upon reassessment of the reported event, it was determined to be not reportable.The initial report was forwarded in error and should be voided.It is further noted that the patient has osteoporotic bone and rheumatoid arthritis with autoimmune therapies for treatment.Bone quality (density, strength & weakness of a bone) is influenced by many internal and external factors.The root cause of the reported issue is attributed to human factor issue and is not device-related.If any further information which would change or alter any conclusions or information, a supplemental report will be filed accordingly.Zimmer biomet will continue to monitor for trends.
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Search Alerts/Recalls
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