Model Number 130714000 |
Device Problem
Osseointegration Problem (3003)
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Patient Problems
Bone Fracture(s) (1870); Inadequate Osseointegration (2646)
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Event Date 04/16/2021 |
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 humeral fracture and loosening of the stem at the bone to implant interface.The stem/body was replaced with new components.There were no deficiencies noted with the implants.The implants are unavailable for return.Doi: unknown, dor: (b)(6) 2021, unknown affected side.
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Manufacturer Narrative
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Product complaint # (b)(4).Investigation summary : no device associated with this report was received for examination.Depuy synthes considers the investigation closed.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 product and lot code was provided, a manufacturing records evaluation (mre) was not performed.
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Search Alerts/Recalls
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