Model Number 1217-22-052 |
Device Problem
Difficult to Remove (1528)
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Patient Problem
Insufficient Information (4580)
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Event Date 10/09/2022 |
Event Type
malfunction
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Event Description
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Liner breakage intra-op.Patient underwent total hip arthroplasty on (b)(6) 2022.A ceramic liner was placed and the rim was smashed.In addition, the liner could not be taken out only.Therefore, the pinnacle sector cup was removed out together with the ceramic liner.The surgery was completed with a larger size of cup and liner, which caused the surgery prolonged by approximately 1 hour.The patient was in stable condition now.
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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).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.H10 additional narrative: added: d9.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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Manufacturer Narrative
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Product complaint (b)(4).Investigation summary: the device associated with this report was received for examination.Review of the photographic evidence along with physical examination of the device did not confirm, the allegation.Ceramic insert and cup were received separated.Fracture of the insert's rim caused the disengaging of mating devices.No malfunction or failure conditions were observed, related to cup.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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