Catalog Number 113708 |
Device Problem
Insufficient Information (3190)
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Patient Problems
Patient Problem/Medical Problem (2688); No Code Available (3191)
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Event Date 12/07/2018 |
Event Type
Injury
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Manufacturer Narrative
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(b)(4).Concomitant medical product - not sdr hm hd 48x20 o/st without pin, item: 106516, lot: 589855.Therapy date - remains implanted.Report source, foreign - event occurred in the (b)(6).The investigation is in process.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: 3002806535-2018-01166.
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Event Description
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It was reported that a patient underwent an initial left shoulder arthroplasty.Subsequently, a revision procedure is being planned due to patient's native glenoid cavity wear.
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Manufacturer Narrative
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(b)(4).
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Event Description
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It was reported that a patient underwent an initial left shoulder arthroplasty.Subsequently, a revision procedure was performed due to patient's native glenoid cavity wear.
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Event Description
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It was reported that a patient underwent an initial left shoulder arthroplasty.Subsequently, a revision procedure is being planned due to patient's naitive glenoid cavity wear.
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Manufacturer Narrative
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(b)(4).Device history record (dhr) was reviewed and no discrepancies were found.In order to investigate the matter thoroughly access is needed to certain hospital notes, x-rays and retrievals.Due to insufficient information provided by the hospital, the definite root cause cannot be determined, however information provided from the sales rep suggests that the reported event was due to patient condition.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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