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Model Number 5572-2800 |
Device Problem
Separation Problem (4043)
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Patient Problems
Failure of Implant (1924); Implant Pain (4561)
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Event Date 10/26/2020 |
Event Type
Injury
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Manufacturer Narrative
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Upon completion of investigation, additional information will be provided in a supplemental report.
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Event Description
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It was reported that the patient's right reverse shoulder was revised after patient complaint of pain and x-rays showing a peripheral screw loose in the joint.Intra-operatively, it was noted that the peripheral screws had 'windshield wipered' in the joint, etching the glenosphere and passing through the baseplate into the joint.The baseplate, glenosphere and center screw came out all in one piece.
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Event Description
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It was reported that the patient's right reverse shoulder was revised after patient complaint of pain and x-rays showing a peripheral screw loose in the joint.Intra-operatively, it was noted that the peripheral screws had 'windshield wipered' in the joint, etching the glenosphere and passing through the baseplate into the joint.The baseplate, glenosphere and center screw came out all in one piece.
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Manufacturer Narrative
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The reported event could partially be confirmed, based on the state of the implants returned.The pictures provided revealed that the screw holes where the two peripheral screws were inserted have expended, in such a way that the material around it is very damaged.On one side of the baseplate, the screw hole has been damaged so severely that there is hardly any material left on one border.The deformation also makes the determination of the lot number for the baseplate impossible since the material around it disappeared.More detailed information about the complaint event such as the x-rays must be available in order to determine the root cause of the complaint event.A review of the device history was not possible because the lot number was not communicated.No corrective actions are required at this time.A review of the labeling did not indicate any abnormalities.No indications of material, manufacturing or design related problems were found during the investigation.If the device is returned or if any additional information is provided, the investigation will be reassessed.
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Search Alerts/Recalls
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