Catalog Number 00434903811 |
Device Problems
Material Erosion (1214); Malposition of Device (2616); Loosening of Implant Not Related to Bone-Ingrowth (4002)
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Patient Problem
Failure of Implant (1924)
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Event Date 08/17/2021 |
Event Type
Injury
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Manufacturer Narrative
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(b)(4).Report source: foreign: (b)(6).Glenosphere 36 mm diameter cat: 00434903611 lot: 60741589.Humeral stem spacer size 9 cat: 00434903909 lot: 60544935.Humeral stem 14 mm stem diameter 130 mm stem length cat: 00434901413 lot: unknown.Customer has indicated that the product will not be returned to zimmer biomet for investigation.The investigation is in process.Once the investigation has been completed, a follow-up report will be submitted.Product not returned.
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Event Description
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It was reported that the patient was revised due to superior malpositioning of the glenoid component that led to wear of the humeral component.It was further stated that the patient was noncompliant.
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Manufacturer Narrative
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This follow-up report is being submitted to relay additional information.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 the patient was revised due to aseptic loosening of the glenoid component.It was further stated that the patient was noncompliant.No additional patient consequences were reported.Attempts have been made and additional information on the reported event is unavailable.
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Manufacturer Narrative
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This follow-up report is being submitted to relay additional information.Visual examination of the provided pictures identified the explanted glenosphere and baseplate, both showing signs of wear and damage from extensive use.Device history record was reviewed and no discrepancies were found.It is alleged that the patient was a very active patient and the glenoid component was placed quite superiorly on the glenoid face with superior inclination, rather than inferiorly with inferior inclination.The effects of this were twofold.The superior position increased the risk of scapula notching, which would have explained the wear observed on the polyethelene where the poly had butted against the lateral border of the scapula.The superior inclination created a sheer force at the glenoid/implant interface rather than a compressive force, which would have predisposed the implant to micro-motion and compromised secondary fixation.Root cause was unable to be determined as the necessary information to adequately investigate the reported event was not provided.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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