Catalog Number 00434810913 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Ossification (1428); Erosion (1750); Pain (1994)
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Event Date 09/25/2020 |
Event Type
Injury
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Manufacturer Narrative
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(b)(4).Foreign- (b)(6).Customer has indicated that the product will not be returned to zimmer biomet for investigation, as the device was requested but not returned by the hospital.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: 0001822565 - 2020 - 03423.
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Event Description
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It was reported that the patient had primary hemiarthroplasty in 2012.Subsequently, the patient underwent revision due to increased pain and stiffness.The humerus is mildly superiorly subluxed and there are signs of glenoid bone erosion.No additional patient consequences were reported.
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Manufacturer Narrative
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Reported event was confirmed by review of med records/radiographs reviewed by an hcp noting all of the internal and external rotation images demonstrate loss of joint space at the glenohumeral joint with bone and metal articulation seen between the central to inferior portion of the glenoid and the medial portion of the humeral head hardware.There is heterotopic bone seen inferior to the glenohumeral joint and likely some development of heterotopic bone along the superior margin of the humeral head component.No periprosthetic lucencies are confirmed, no bone fracture.Dhr was reviewed and no discrepancies were found.The root cause is 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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No further event information available at the time of this report.
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Search Alerts/Recalls
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