Model Number N/A |
Device Problems
Unstable (1667); Detachment of Device or Device Component (2907)
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Patient Problem
No Information (3190)
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Event Date 12/13/2018 |
Event Type
Injury
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Manufacturer Narrative
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(b)(4).Concomitant medical products: unknown 25mm post baseplate; unknown 40 mm glenosphere; unknown humeral stem 12 mm uncemented placed at 20 degrees retroversion.Customer has indicated that the product is in process of being returned to zimmer biomet for investigation.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 an initial shoulder arthroplasty and was revised due to disassociation of the polyethylene liner approximately two years post implantation.The patient was experiencing instability.No complication were noted.No additional information is available.
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Manufacturer Narrative
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The complaint cannot be confirmed as medical records were not provided.The device history records were reviewed and identified no deviations/ anomalies identified.A definite root cause cannot be determined with the information 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 additional information is available to report at this time.
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Search Alerts/Recalls
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