Model Number 130720101 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Fall (1848); Bone Fracture(s) (1870)
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Event Date 12/15/2020 |
Event Type
Injury
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Manufacturer Narrative
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Product complaint #: (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 due to fall and loosening of the humeral stem at the bone to implant interface.The patient had a delta extend reverse shoulder implanted years ago.The humeral components were revised and the metaglene, screws and glenosphere were left implanted.An 8mm unite revision stem, size 1 centered epi, 2 spacers and a 42mm + 3 poly were implanted.Doi: (b)(6) 2017, dor: (b)(6) 2020, left shoulder.
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Event Description
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1.It was indicated in the der that the loosening interface is bone to cement, however, the products involved (stem and epiphysis) are porocoat/cementless products.Please verify and provide the correct loosening interface.Answer: the sales rep responded over the phone, the surgeon did not like the fixation of the humeral stem and therefore elected to cement the stem in place to achieve additional fixation.The cement manufacturer is still unknown.
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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 lot code was provided, a manufacturing records evaluation (mre) was not performed h10 additional narrative: added: b5.
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Search Alerts/Recalls
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