Model Number 1365-32-710 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Fall (1848); Unspecified Infection (1930); Pain (1994); Loss of Range of Motion (2032); Physical Asymmetry (4573)
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Event Date 02/27/2023 |
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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Failed subsided corail stem.Suspected failure due to prior infection.Removed stem and replaced with a reclaim stem.Attached is dictation, xray, & original implant log from (b)(6) 2018.Doi: (b)(6) 2018, dor: (b)(6) 2023, left hip.
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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 x-rays were reviewed, and no evidence of implant fracture, disassociation, or anything indicative of a device nonconformance was found.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 = > 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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Event Description
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Medical records received indicate that on (b)(6)2018: the patient underwent a left tha with depuy implants placed.It was reported the patient fell several years later and has experienced pain with progressive loosening.(b)(6)2023: patient underwent a left tha revision for pain, 3cm limb discrepancy, decreased rom, potential infection, and femoral stem loosening and subsidence.Bmi-27.98 height: 5'4".
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Manufacturer Narrative
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Product complaint # = > pc-(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: b5, b7 and h6 (clinical codes) 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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