Model Number 130710100 |
Device Problems
Adverse Event Without Identified Device or Use Problem (2993); No Apparent Adverse Event (3189)
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Patient Problems
Unspecified Infection (1930); Pain (1994)
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Event Date 12/02/2022 |
Event Type
Injury
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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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Event Description
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Patient was revised due to chronic infection, pain, health issues and multiple falls, the implant were removed.No other information.No surgical delay was there.Doi: (b)(6) 2018.Dor: (b)(6) 2022, affected side: left shoulder.
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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.H6 (device code).
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Search Alerts/Recalls
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