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Model Number HUMERAL HEAD SHORT, 50MM (BETA) |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problem
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
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Event Date 02/16/2023 |
Event Type
Injury
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Manufacturer Narrative
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Concomitant medical products: 300-21-00 - 0mm fixed angled kit 7195549.304-21-13 - 12.5mm platform fx stem left 6715604.Additional information, including the product investigation, will be submitted within 30 days of receipt.
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Event Description
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It was reported that a 51 year-old male patient who had an initial left shoulder arthroplasty on (b)(6) 2022, was revised on (b)(6) 2023, approximately 10 months post the initial procedure.The revision procedure was for failed rotator cuff in l) hemi-arthroplasty, performed for proximal humeral fracture in 2022.All components were revised and converted to a reverse total shoulder replacement using equinoxe system.No surgical delays reported.Patient was last known to be in stable condition following the event.No device returns anticipated.The implants were required for collection of infected materials and were sent to hospital pathology.No further information.
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Manufacturer Narrative
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H6: upon review of the available information, there is no evidence that this is a device related problem and there is no allegation against the device.Implantation of a total joint could result pain, infection, or instability of total joint hardware.The most likely cause of the reported event is the patient¿s activity and the surgeon¿s choice of initial implant.
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Search Alerts/Recalls
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