Catalog Number 121881754 |
Device Problems
Fracture (1260); Noise, Audible (3273)
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Patient Problem
Insufficient Information (4580)
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Event Date 08/28/2018 |
Event Type
Injury
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Event Description
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Patient of (b)(4) (= 2nd revision) was revised before.This complaint ((b)(4)) covers the first revision: revision of inlay and hip head because of noises of coc pairing right side.During revision the ceramic inlay fractured.
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Manufacturer Narrative
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Product complaint # (b)(4).Additional event information: on (b)(6) 2014 right cement-free hip arthroplasty occurred.The patient developed pronounced noise of the ceramic-ceramic sliding combination used.Revision took place (b)(6) 2018 ((b)(4)) during the (b)(6) 2018 revision a rupture of the ceramic inlay occurred.The patient dislocated twice in 2018 with a closed reduction in each case.There was no surgical delay.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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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 that 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 was received: a surgical delay was not reported.
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Search Alerts/Recalls
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