ZIMMER BIOMET, INC. MINI HUMERAL TRAY STANDARD THICKNESS +6 MM TAPER OFFSET 40 MM DIAMETER; SHOULDER PROSTHESIS, REVERSE CONFIGURATION/EXTREMITIES
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Model Number 110031405 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Hematoma (1884); Hemorrhage/Bleeding (1888)
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Event Date 02/07/2023 |
Event Type
Injury
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Manufacturer Narrative
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(b)(4).Multiple mdr reports were filed for this event, please see associated reports: 0001822565-2023-00543 and 0001822565-2023-00545.: concomitant medical products: item#: 110030777, glenosphere +3 mm lateral offset 40 mm diameter; lot#: 65369821.Item#: 110031428, bearing +3 mm thickness 40 mm diameter; lot#: 65592546.Customer has indicated that the product will not be returned to zimmer biomet for investigation, product was requested from hospital but not released by the hospital.The investigation is in process.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 a right shoulder arthroplasty.Subsequently, the patient underwent a revision surgery approximately two (2) and a half months later due to post operative drainage, a hematoma, and bleeding in the shoulder joint.There were no signs of an infection as the patient's white blood cell count was not found intraoperative.
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Manufacturer Narrative
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(b)(4).This follow-up report is being submitted to relay additional information.Multiple mdr reports were filed for this event, please see associated reports: 0001822565-2023-00543-1, 0001822565-2023-00545-1.A hematoma is a mass of clotted blood that forms in a tissue, organ, or body space.A hematoma can be associated with pain, swelling, ecchymosis, serosanguinous or bloody drainage after a recent surgical procedure or trauma and can predispose the patient to infection.The development of a postoperative hematoma can be correlated with the surgical procedure and perioperative anticoagulation therapy prescribed to prevent thrombus formation.Most hematomas resolve on their own, without surgical intervention, while some do not.Larger hematomas may need to be surgically evacuated in order to resolve.As timeframes of onset differ due to individual contributing factors, a specific timeframe of expected occurrence cannot be established.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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