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Catalog Number 180550 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Pain (1994); Swelling (2091); Thrombus (2101)
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Event Date 07/06/2016 |
Event Type
Injury
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Manufacturer Narrative
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(b)(4).Concomitant medical products: ti-115313 comp vrsdl glnspr 36mm +3 ti 465130, 010000589 comp rvrs 25mm bsplt ha+adptr 790090, 115395 comp rvs cntrl 6.5x25mm st/rst 515010, 180551 comp lk scr 3.5hex 4.75x20 st ni, 180551 comp lk scr 3.5hex 4.75x20 st 005100, 180552 comp lk scr 3.5hex 4.75x25 st ni, 00434901213 humeral stem 12 mm stem diameter 130 mm stem length 632573459.Multiple mdr reports were filed for this event, please see associated reports: 0001825034 - 2020 - 01385.0001825034 - 2020 - 01386.0001825034 - 2020 - 01387.0001825034 - 2020 - 01388.0001825034 - 2020 - 01389.0001825034 - 2020 - 01391.Customer has indicated that the product will not be returned to zimmer biomet for investigation, as the product remains implanted.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.If any further information which would change or alter any conclusions or information, a supplemental report will be filed accordingly.Zimmer biomet will continue to monitor for trends.
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Event Description
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It has been reported patient underwent a primary right reverse total shoulder arthroplasty.Subsequently, one week post-implantation, patient was doing pt at home when she felt her arm tighten up and start to swell.Patient then had an er visit complaining of arm pain, redness and swelling above the elbow.Ultrasound revealed superficial thrombus is cephalic vein.Treated with warm compressed and discharged home without admission.No device revision or removal.Attempts have been made and no further information has been provided.
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Manufacturer Narrative
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This follow-up report is being submitted to relay additional information.The following sections were updated/corrected: b4, b5, g4, g7, h1, h2, h3, h6.Dhr was not reviewed, because the issue was found to not be device-related.Procedural related complications are influenced by the type of surgery, patients pre-existing comorbid state, and perioperative management.Deep vein thrombosis, or dvt, occurs when a blood clot forms in one of the deep veins of the body.Blood clots can also occur in superficial veins, or veins closer to the surface of the skin.This can happen if a vein becomes damaged or if the blood flow within a vein slows down or stops.Total joint patients are typically placed on medication post-operative for a period of time to prevent the development of dvt/blood clot.Even with the administration of preventive medication, dvt/blood clots can still develop.As the complaint indicated, a post-operative complication developed and a visit to the emergency room was required to treat the complication.Therefore, our complaint category medical procedure related would be appropriate.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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