STRYKER GMBH GLENOSPHERE - 32MM DIA X 2MM THK CONCENTRIC; PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED
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Model Number 5573-C-3202 |
Device Problems
Material Erosion (1214); Device Damaged by Another Device (2915)
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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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Manufacturer Narrative
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The reported event could partially be confirmed, based on the state of the implants returned.The received images revealed that the glenosphere presents two black traces on the metal, caused by the peripheral screws backing out.The joint surface is smooth and does not show any major scratches or deformations.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 for the reported lot did not indicate any abnormalities.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 any further information is provided, the investigation report will be updated.
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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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