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Model Number N/A |
Device Problem
Material Fragmentation (1261)
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Patient Problems
Fall (1848); Pain (1994)
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Event Date 08/01/2018 |
Event Type
Injury
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Manufacturer Narrative
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(b)(4).Concomitant medical products: 00432605200, trabecular metal glenoid component, 62863158.The 00430001113, offset modular humeral stem, 62867066.Foreign country: (b)(6).Customer has indicated that the product is in process of being returned to zimmer biomet for investigation.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: 0001822565-2018- 04899.Not yet returned.
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Event Description
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It was reported that patient had initial total shoulder arthroplasty.Subsequently, patient was revised approximately three (3) years post initial surgery due to pain and loosening.Patient had a fall one (1) year post initial surgery.Upon x-ray review post fall, glenoid loosening and lucency with intra-articular metal debris was observed.No additional patient consequences were reported.
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Manufacturer Narrative
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(b)(4).Reported event was confirmed by review of the product return and x-rays.As per the visual inspection of the product, there are some scratches on the articulation surface of the head, possibly happened during explantation.The humeral stem exhibits a shiny spot on the glass bead finish.Dimensions taken are within specifications.As per the x-ray review, extensive abnormal radiolucency along the glenoid and humeral components of the left shoulder arthroplasty consistent with component loosening.Dhr was reviewed and no discrepancies were found.Investigation results concluded that the reported event was due to human factor.It is reported that, patient sustained a work-related fall (b)(6) 2016.Patient returned to surgeon 10 months post fall.Upon xray review, surgeon noted lucency of the glenoid without clinical complications.Details of the fall are unknown.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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No further event information available at the time of this report.
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Search Alerts/Recalls
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