DEPUY ORTHOPAEDICS, INC. 1818910 PIN TRIAL SHELL 52 STD PROFILE; HIP INSTRUMENTS : ACETABULAR TRIALS
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Catalog Number 221701052 |
Device Problems
Corroded (1131); Contamination /Decontamination Problem (2895); Device Contamination with Chemical or Other Material (2944)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 01/01/2019 |
Event Type
malfunction
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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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Event Description
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After surgery within multiple hospital, in 4 orthokits we have found out that the xxx are have oxidated around the incaved letters and numbers when did the device problem occur? after using the orthokits for surgery.Some has rust, some has not.
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Manufacturer Narrative
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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.Product complaint # (b)(4).Investigation summary : no products were returned for investigation.Without further information the cause of the rusting to these products cannot be confirmed and so the complaint will be closed to an undetermined conclusion.Device history lot : null.Device history batch : null.Device history review : null.If information is obtained that was not available for the initial medwatch, a follow-up medwatch, a follow-up medwatch will be filed as appropriate.
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Manufacturer Narrative
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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.Product complaint # (b)(4).Investigation summary = > no products were returned for investigation.Without further information the cause of the rusting to these products cannot be confirmed and so the complaint will be closed to an undetermined conclusion.If information is obtained that was not available for the initial medwatch, a follow-up medwatch, a follow-up medwatch will be filed as appropriate.
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Search Alerts/Recalls
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