STRYKER GMBH UNKNOWN RSA REUNION PERIPHERAL SCREW; PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED
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Catalog Number UNK_SEL |
Device Problems
Device Appears to Trigger Rejection (1524); Naturally Worn (2988)
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Patient Problems
Unspecified Infection (1930); Loss of Range of Motion (2032); Metal Related Pathology (4530); Implant Pain (4561)
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Event Date 01/28/2022 |
Event Type
Injury
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Event Description
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As reported; "surgeon had a patient come in 2 weeks ago that had a reverse total shoulder reunion done at a different facility.The patient presented with shoulder stiffness and a lot of pain.X-rays showed aseptic loosening and surgeon suspected deep infection.During the surgery the surgeon noticed extreme metallosis on the glenoid side of the implant and he cleaned it all out by hand without instrumentation where the 2 peripheral screws stayed inside the glenoid and did not come out of the baseplate.Took all the implants out.After the case, upon close inspection of the glenoid baseplate he noticed that the peripheral screws where they lock into the baseplate through the threads had worn away due to aseptic loosening and infection.This had worn all the way through and the screws had pulled all the way through the baseplate.All implants were removed from the shoulder and a cement antibiotic spacer was put in.Surgeon reported that the patient is very happy with the outcomes.Implants were discarded by the hospital.No additional information is available.".
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Manufacturer Narrative
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The device will not be returned.If additional information becomes available, it will be provided in a supplemental report.Disposed by hospital.
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