Model Number 5503-00-500 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Bone Fracture(s) (1870); Pain (1994); Discomfort (2330)
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Event Date 03/01/2023 |
Event Type
Injury
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Event Description
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It was reported that the patient is being revised due to pain and discomfort in their shoulder.Dr informed that the patient felt a pop followed by pain after lifting something above their head.Dr.¿s pa informed that there may have been a fracture of the patients glenoid.Dr removed the glenoid and humeral components and opted to revise the patient with zimmer-biomet implants.Once the implants were removed, dr told the rep that he would be going with zimmer-biomet, and that he no longer needed rep's assistance in the room.There was no surgical delay.Doi: (b)(6) 2022, dor: (b)(6) 2023, affected side: left shoulder.
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Manufacturer Narrative
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Product complaint # (b)(4).Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.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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Manufacturer Narrative
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Product complaint # (b)(4).Investigation summary : no device associated with this report was received for examination.The information received will be retained for potential series investigations if triggered by trend analysis, post market surveillance, or other events within the quality system.Depuy considers the investigation closed.Should additional information be received, the information will be reviewed and the investigation will 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).A manufacturing records evaluation (mre) was not performed.
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Search Alerts/Recalls
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