DEPUY ORTHOPAEDICS, INC. 1818910 ALTRX +4 10D 32IDX50OD; PINNACLE HIP SYSTEM : HIP POLY ACETABULAR LINERS
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Catalog Number 122132150 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Necrosis (1971); Tissue Damage (2104); Injury (2348); Not Applicable (3189); No Code Available (3191)
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Event Date 06/22/2018 |
Event Type
Injury
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Manufacturer Narrative
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(b)(4).Initial reporter occupation: lawyer.(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 review of medical records, the patient was revised to address a large fluid collection and metal-on-metal trunnion reaction.Revision note reported an extensive amount of joint fluid, damaged anterior aspect of the abductor muscle, necrotic-appearing bone and tissue, and an 8mm ring of black trunnion wear at the base of the head.An extended trochanteric osteotomy was done to remove the stem; however, a distal portion broke off as it was very well fixed to the femoral component.A cable was placed distal to the osteotomy to avoid further fracture.The extensive damage from the mom reaction required an extended operating time of 6 hours.Doi: (b)(6) 2013; dor: (b)(6) 2018; right hip.
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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 device associated with this report was received for examination.A worldwide complaint database search found no other related reported incidents against the provided product code/lot number combination since release for distribution.The information received will be retained for potential series investigations if triggered by trend analysis, post market surveillance, or other events within the quality system.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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Search Alerts/Recalls
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