Model Number 314-02-14 |
Device Problem
Loosening of Implant Not Related to Bone-Ingrowth (4002)
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Patient Problem
Failure of Implant (1924)
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Event Date 10/26/2021 |
Event Type
Injury
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Manufacturer Narrative
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Concomitant medical products: 300-10-15, (b)(4) - eq replicator plate 1.5mm o/s; 300-20-02, (b)(4) - eq square torque screw kit; 310-01-50, (b)(4) - eq humeral head short 50mm beta.
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Event Description
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As reported, this (b)(6) y/o male patient had a right primary total done on (b)(6) 2012.Glenoid became loose and a large central defect formed.Glenoid was removed and the defect was filled with bone autograft from clavicle.Glenoid was reamed and a hemi was performed.Patient is expected to do well and left or stable.Patient was last known to be in stable condition following the event.Devices not returning due to facility policy.
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Manufacturer Narrative
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Concomitant medical products: 300-10-15, (b)(4) - eq replicator plate 1.5mm o/s; 300-20-02, (b)(4) - eq square torque screw kit; 310-01-50, (b)(4) - eq humeral head short 50mm beta.
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Event Description
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As reported, this (b)(6) y/o male patient had a right primary total done on (b)(6) 2012.Glenoid became loose and a large central defect formed.Glenoid was removed and the defect was filled with bone autograft from clavicle.Glenoid was reamed and a hemi was performed.Patient is expected to do well and left operating room stable.Patient was last known to be in stable condition following the event.Devices not returning due to facility policy.
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Manufacturer Narrative
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(h3) the revision reported was likely the result of both patient-related conditions and a degradation of the bond between the glenoid component and the bone, which led to aseptic (non-infected) glenoid loosening.However, this cannot be confirmed as the devices were not available for evaluation and pre-revision x-rays were not provided.
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Search Alerts/Recalls
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