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Model Number N/A |
Device Problem
Detachment Of Device Component (1104)
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Patient Problem
No Information (3190)
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Event Type
Injury
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Manufacturer Narrative
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(b)(4).Concomitant medical products: tm reverse glenosphere, pn00-4349-036-11, ln62655524; tm reverse stem, pn00-4349-012-13, ln62658795; poly liner plus, pn00-4349-036-00, ln62438564.Customer has indicated that the product will not be returned to zimmer biomet for investigation, as it remains implanted in the patient.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 reverse shoulder arthroplasty.At the follow-up two months later, the surgeon noticed the glenosphere was floating up from the base-plate.Subsequently, at the follow-up one year later, the glenosphere was dissociated from the base-plate.Revision surgery was performed on an unknown date, one year and six months following the initial surgery.During the revision surgery, the surgeon noted that the glenosphere and base plate had no damage, so the implants were reused.At the follow-up five months after the revision, no issues with the patient were reported.
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Manufacturer Narrative
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Revision surgery date -(b)(6) 2016.Report source: (b)(6).Review of the radiographic images by the surgeon confirmed the event.Device history record was reviewed and no discrepancies relevant to the reported event were found.Review of the complaint history determined that no further action is required as no trends were identified.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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