Model Number 130720101 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Foreign Body Reaction (1868); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
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Event Date 12/18/2020 |
Event Type
Injury
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Manufacturer Narrative
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(b)(4).If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
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Event Description
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The patient was revised to address infection of spinal hardware/shoulder implants.Surgeon removed all shoulder implants and out in an antibiotic spacer.Upon opening the joint he found traces of metaloasis, surgeon was unsure what caused it.The glenosphere was loose and pulled out with a ronguer.The metaglene baseplate and screws all came out with the glenosphere.The inferior locking screw was broken midway on the screw.No further patient information is available at this time.Doi: (b)(6) 2017, dor: (b)(6) 2020, right shoulder.
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Manufacturer Narrative
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Product complaint # (b)(4).Investigation summary the device associated with this report was not received for examination.Depuy synthes considers the investigation closed at this time.Should additional information be received, the information will be reviewed and the investigation may be re-opened as necessary.Device history lot the product investigation found no evidence suspecting an error in the manufacturing or material that would be a contributing factor in the reported allegation(s).Where the lot code was provided, a manufacturing records evaluation (mre) was not performed.
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Search Alerts/Recalls
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