Model Number 1365-51-000 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Arrhythmia (1721); Foreign Body Reaction (1868); Headache (1880); Pyrosis/Heartburn (1883); Itching Sensation (1943); Pain (1994); Rash (2033); Synovitis (2094); Tinnitus (2103); Discomfort (2330); Ambulation Difficulties (2544); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
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Event Type
Injury
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Manufacturer Narrative
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(b)(4).Initial reporter occupation: lawyer.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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It was reported by the patient that " i had my right hip & knee replaced (b)(6) 2006 and my left hip replaced (b)(6) 2007.I began having left hip problems in 2016.I went to the original operating doctor to have it checked.At that time he did not find a solution for my discomfort.He did, however take a cobalt test at that time.It came back at 7.2.This year he took another cobalt test on (b)(6) 2020 and the results were 16.4.After review of medical record patient was revised to address metallosis.Revision notes stated that an inflammatory fluid in the joint and staining of the synovium and synovitis was encountered.Burnishing on the femoral components was noted.Head and liner were removed.Added patient's medical history, laboratory data, dor, revision hospital, and patient's dob.Corrected patient's initials and surgeon.Doi: (b)(6) 2006 - dor: (b)(6) 2020 (right 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.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.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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