ZIMMER BIOMET, INC. 3 PEG MONO GLEN SZ 4; PROSTHESIS, SHOULDER, SEMI CONSTRAINED, METAL/POLYMER CEMENTED
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Catalog Number SAGL2024 |
Device Problem
Detachment of Device or Device Component (2907)
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Patient Problems
Hematoma (1884); Pain (1994); Fluid Discharge (2686); Subluxation (4525)
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Event Date 10/09/2023 |
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: 0001822565-2024-00499, 0001822565-2024-00500, 0001822565-2024-00501, 0001822565-2024-00502.D10: medical products: item#: sahh4516, humeral head 45x16; lot#: 65488726.Item#: sahs1111, humeral stem standard size 11; lot#: 65628117.Item#: sahha001, hum head adapter identity; lot#: 66023931.Item#: sahaf135, hum stem adapter 135 deg; lot#: 66074660.H3: customer has indicated that the product will not be returned to zimmer biomet for investigation, as the product remains implanted in the patient.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 an initial total shoulder arthroplasty approximately four (4) and a half months ago.Subsequently, the patient was seen approximately two (2) and a half weeks after the surgery and was complaining of wound drainage and increased pain following a sudden grab of their pants as they were falling down a few days prior to the appointment.On evaluation a hematoma was present, and the patient was prescribed antibiotics.It was noted on x-ray that there was evidence of the implants subluxing.At the patient's six weeks appointment the hematoma had resolved, and the patient reported no further complications.
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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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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: 0001822565-2024-00499-1, 0001822565-2024-00500-1, 0001822565-2024-00501-1, 0001822565-2024-00502-1.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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