Model Number N/A |
Device Problems
Migration or Expulsion of Device (1395); Misassembly by Users (3133)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 03/06/2017 |
Event Type
Injury
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Manufacturer Narrative
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(b)(4).Concomitant medical products: catalog no: 00434903611, lot no: 63399742, description: trabecular metal glenosphere 36 mm diameter.Customer has indicated that the product will not be returned to zimmer biomet for investigation as it remains implanted.The investigation is in process.Once the investigation has been completed, a follow-up report will be submitted.Multiple mdr reports were filed for this event, please see associated report: 1822565-2017-02133.
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Event Description
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It was reported that patient underwent reverse total shoulder arthroplasty, and that the glenosphere was not fully seated on the baseplate during the procedure.No patient consequences were reported as a result of the malfunction at this time.
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Manufacturer Narrative
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This follow-up report is being submitted to report additional information.Upon reassessment of the reported event, it was determined to be not reportable, as the malfunction was corrected during surgery and would not lead to harm or injury to the patient.
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Manufacturer Narrative
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This follow-up report is being submitted to relay additional information.Reported event was confirmed by review of x-rays provided.X-ray reviewer stated "reverse shoulder system arthroplasty is in place.Lateral skin staples are present consistent with recent postop status.The glenosphere is not fully seated, and is angled asymmetrically on the base plate." device history record (dhr) was reviewed and no discrepancies were found.Review of the complaint history determined that no further action(s) is/are required.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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Event Description
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It was reported that patient underwent reverse total shoulder arthroplasty, and that the glenosphere was not fully seated on the baseplate during the procedure.No patient consequences were reported as a result of the malfunction at this time.The surgeon claims to have corrected the issue during the procedure and does not plan to revise the patient.
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Search Alerts/Recalls
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