Model Number 30MM CENTRAL SCREW, MODULAR |
Device Problems
Loose or Intermittent Connection (1371); Appropriate Term/Code Not Available (3191)
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Patient Problem
Insufficient Information (4580)
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Event Date 09/16/2020 |
Event Type
Injury
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Manufacturer Narrative
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The contribution of the device to the reported event could not be determined as the device was not returned for evaluation.The root cause of the event could not be determined from the information available and without device evaluation.
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Event Description
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It was reported through the surgical outcome system that a issue possibly related to an arthrex product took place.Upon further investigation the following was discovered: a patient had undergone a reverse total shoulder arthroplasty (b)(6) 2019.It was diagnosed via x-ray and ct scan (b)(6) 2020 that the patient was experiencing loosening of the implant glenoid side.A revision of glenoid and humeral components with allograft surgery was performed (b)(6) 2020 during which time the following original arthrex implants were explanted: arthrex univers revers mgs peripheral screw nl 4.5x24 mm; lot #170182004; catalog # ar-9562-24nl.Arthrex univers revers mgs peripheral screw 4.5x32 mm; lot #2018001455; catalog # ar-9562-32nl; qty 2.Arthrex central screw modular 30 mm; lot #5652; catalog # ar-9561-30s.Arthrex glenosphere 39 +4 lat/24; lot #18.00656; catalog # ar-9564-2439-lat.Arthrex cup univers revs suture 39mm ntrl +2 left; lot #170074105; catalog # ar-9502f-39lcpc.Arthrex baseplate 24 m modular; lot #5362; catalog # ar-9560-24.After removal of the above devices the surgeon performed a conversion to hemiarthroplasty with glenoid bone graft.
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Manufacturer Narrative
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Complaint not confirmed, no abnormality was observed on the device that may have contributed to the event.This submission contains additional information which has been added to section b5.
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Event Description
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Additional information 11/16/20: when the explanted products were returned for evaluation the original humeral insert m/39 +6 to fit in 39 cup, ar-9503m-06 (lot 18.00568) was also returned.It was not included in the original list of explanted products provided.
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Search Alerts/Recalls
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