Catalog Number 136506000 |
Device Problems
Material Disintegration (1177); Biocompatibility (2886)
|
Patient Problems
Inflammation (1932); Pain (1994); Discomfort (2330); Test Result (2695)
|
Event Type
Injury
|
Manufacturer Narrative
|
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.
|
|
Event Description
|
Litigation papers allege the following: after the surgery, friction and wear between the cobalt-chromium metal head and cobalt-chromium metal liner caused large amounts of toxic cobalt-chromium metal ions and particles to be released into patient's blood and tissue and bone surrounding the implant.As a result, patient has been experiencing severe pain and discomfort and inflammation in his right thigh and groin.He also experienced a popping and snapping sensation in his hip-joint when walking or moving to and from a sitting position.Doi: (b)(6) 2008 - dor: none reported (right hip).
|
|
Manufacturer Narrative
|
Product complaint # (b)(4).Investigation summary = > no device associated with this report was received for examination.Based on previous investigations this complication of joint replacement is unlikely to have been the result of a device failing to meet required specifications.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.Corrective action was not indicated.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
|
|
Search Alerts/Recalls
|