Catalog Number 5573-6540 |
Device Problems
Osseointegration Problem (3003); Appropriate Term/Code Not Available (3191)
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Patient Problems
Osteolysis (2377); Inadequate Osseointegration (2646)
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Event Date 10/12/2023 |
Event Type
Injury
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Manufacturer Narrative
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Analysis results are not available at the time of this report.A follow-up report will be sent when the analysis is complete.
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Event Description
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The surgeon scheduled a revision surgery with a stryker representative.During the surgery, it was found that the baseplate/screw/glenosphere construct was loose, with two of the four screws not contained within the construct.The glenoid baseplate/glenosphere/screws and the cup/poly construct were removed.A 40mm humeral head was attached to the existing humeral stem.The indication for the primary procedure was a fracture.The revision surgery was successful.
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Event Description
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The surgeon scheduled a revision surgery with a stryker representative.During the surgery, it was found that the baseplate/screw/glenosphere construct was loose, with two of the four screws not contained within the construct.The glenoid baseplate/glenosphere/screws and the cup/poly construct were removed.A 40mm humeral head was attached to the existing humeral stem.The indication for the primary procedure was a fracture.The revision surgery was successful.
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Manufacturer Narrative
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Please note the corrections made to the d1 product long description and g1 manufacturing site for devices: this device is concomitant and did not contribute to the reported failure.Therefore, this complaint is closed without further investigation.If any additional information is provided indicating otherwise the record will be reopened and the investigation will be reworked.
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Event Description
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The surgeon scheduled a revision surgery with a stryker representative.During the surgery, it was found that the baseplate/screw/glenosphere construct was loose, with two of the four screws not contained within the construct.The glenoid baseplate/glenosphere/screws and the cup/poly construct were removed.A 40mm humeral head was attached to the existing humeral stem.The indication for the primary procedure was a fracture.The revision surgery was successful.
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Manufacturer Narrative
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Correction: h6 (results & conclusion codes).This device is concomitant and did not contribute to the reported failure.Therefore, this complaint is closed without further investigation.If any additional information is provided indicating otherwise the record will be reopened and the investigation will be reworked.
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Search Alerts/Recalls
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