Catalog Number UNK SHOULDER NON-LOCKING SCREW |
Device Problems
Adverse Event Without Identified Device or Use Problem (2993); Osseointegration Problem (3003)
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Patient Problems
Unspecified Infection (1930); Inadequate Osseointegration (2646); Joint Laxity (4526)
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Event Date 03/23/2022 |
Event Type
Injury
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Event Description
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Revision of a delta xtend due to infection and dislocation.All components were removed and a cemented spacer was implanted.4x screws were also removed.The infection impacted the soft tissues causing the them to become lax and this resulted in a dislocation.Components were also loose as a result of the infection.Poly wear observed, which have been caused by the dislocation.
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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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Manufacturer Narrative
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Product complaint # (b)(4).This report is being submitted pursuant to the provisions of 21 cfr, part 803.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 joint reconstruction, or its employees that the report constitutes an admission that the product, depuy synthes joint reconstruction, 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: 1.Was infection confirmed? yes.2.Can you confirm the primary surgery date or the original implantation date? i¿m unsure sorry.The patient was previously operated on at (b)(6).The patients¿ notes were unavailable which i why i unable to get any further information.3.If known, please also advise the primary surgeon/hospital.The previous surgery was done in 2018 at (b)(6).4.It was indicated that there was loosening.What components were loose? on what interface did the loosening occur? all components were loose.The stem was the only cemented implant, and this was loose at the implant-cement interface.5.Was the stem retained? please verify.The stem was removed.6.Did any of the previous revisions mentioned involve depuy products? unfortunately i am unable to confirm exactly what was done previously as the patient notes weren¿t available in theatre.7.Was there a surgical delay? if yes, what is the duration of the delay? no delay reported.
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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.All available photographs were reviewed.Complaint is not confirmed.In order to confirm the loosening allegation, a series of x-ray images is required.Visual examination of the photographic evidence did not identify any indication it contributed to the reported event.Nothing indicative of a product problem is identified.Depuy synthes considers the investigation closed at this time.Should additional information be received, the information will be reviewed, and the investigation may be re-opened as necessary.Device history lot: a manufacturing records evaluation (mre) was not performed as no lot number was provided for this device.
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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.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 joint reconstruction, or its employees that the report constitutes an admission that the product, depuy synthes joint reconstruction, 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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Search Alerts/Recalls
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