EXACTECH, INC. EQUINOXE REVERSE TRAY ADAPTER PLATE TRAY +5; PROSTHESIS, SHOULDER, NON-CONSTRAINED, METAL/POLYMER CEMENTED
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Model Number EQUINOXE REVERSE TRAY ADAPTER PLATE TRAY +5 |
Device Problems
Activation, Positioning or Separation Problem (2906); Device Dislodged or Dislocated (2923)
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Patient Problem
Failure of Implant (1924)
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Event Date 12/08/2022 |
Event Type
Injury
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Event Description
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As reported by the equinoxe shoulder study, approximately four years post initial right side tsa, the 69 y/o patient experienced disassociation of humeral plate.Patient was sitting and reaching out with sudden pain humeral tray disassociation; this was the second occurrence of tray issue.Patient had a standard reverse procedure six days later and the standard humeral stem, torque screw, humeral tray, humeral liner, glenosphere and glenosphere locking screw were removed.
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Manufacturer Narrative
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Concomitant products: equinoxe reverse 42mm humeral liner +2.5 (cat# 320-42-03 / serial# (b)(4)); rs expanded glenosphere 42mm, +4mm offset (cat# 320-02-42 / serial# (b)(4)); eq rev locking screw (cat# 320-15-05 / serial# (b)(4)); eq reverse torque defining screw kit (cat# 320-20-00 / serial# (b)(4)).Additional information, including the product investigation, will be submitted within 30 days of receipt.
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Manufacturer Narrative
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(h3) the revision reported may have been the result of not replacing the humeral stem during the first revision due to humeral tray/torque screw disassociation, which may have led to implanting a new torque defining screw into a humeral stem with damaged threads.This deformation likely did not allow for the new torque screw to be fully seated during the first revision surgery, resulting in the torque defining screw backing out of the humeral stem and subsequently the humeral tray disassociating from the humeral stem.However, this cannot be confirmed as the devices were not returned for evaluation and images/radiographs were not provided.The most probable root cause associated with the reported event of ¿disassembled / misassembled¿ is problem associated with one device causing harm to another device.
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