Model Number 1218-87-352 |
Device Problem
Noise, Audible (3273)
|
Patient Problems
Arrhythmia (1721); Headache (1880); Pyrosis/Heartburn (1883); Itching Sensation (1943); Pain (1994); Loss of Range of Motion (2032); Rash (2033); Tinnitus (2103); Discomfort (2330); Ambulation Difficulties (2544); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
|
Event Date 06/01/2020 |
Event Type
Injury
|
Manufacturer Narrative
|
(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.
|
|
Event Description
|
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 records, it was determined that the patient experienced limited mobility accompanied by sensation that hip ball has come out of the socket and went back in.In 2016 patient felt/heard an audible pop.Revision notes stated that a scar tissue was removed.Head and liner were revised.Doi: (b)(6) 2007; dor: (b)(6) 2020; (left hip).
|
|
Manufacturer Narrative
|
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 : a manufacturing record evaluation (mre) will not be performed since mom systems are obsolete.
|
|
Search Alerts/Recalls
|