Catalog Number 112852110 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Pain (1994); Unspecified Tissue Injury (4559)
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Event Date 04/05/2024 |
Event Type
Injury
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Event Description
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Revision global advantage hemi arthroplasty.Patient presented to surgeon with pain.Global advantage stem and head removed and revision to djo reverse total shoulder arthroplasty performed.Doi: (b)(6) 2004; doe: (b)(6) 2024.
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Manufacturer Narrative
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Product complaint # (b)(4).This report is being submitted pursuant to the provisions of 21 cfr, part 803 (and/or part 4, as applicable).This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by depuy synthes, or its employees that the report constitutes an admission that the product, 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 report, a follow-up report will be filed as appropriate.
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Event Description
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Additional information received: a.Was there any surgical delay related to the event? if yes, what is the duration of the delay? ¿ no delay related to this event b.Was there any patient consequence related to the event? -the revision surgery was due to rotator cuff deficiency.C.Please specify if there were other clinical findings: (e.G.Non-union, infection, allergic reaction, broken devices, etc.) -no clinical findings found in relation to the implants.D.Was other medical intervention required? if yes, please specify details.No other intervention was required.E.Was the surgery completed successfully? (yes or no)? yes.
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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 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 records evaluation (mre) was not performed.As part of our company quality system process, all devices are manufactured, inspected, and distributed to approved specifications.Additional complaint information monitoring for potential safety signals will be conducted through complaint trending as part of the post-market surveillance.If additional information is made available, the investigation will be updated as applicable.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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