|
Catalog Number UNK HIP FEMORAL STEM |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
|
Patient Problems
Pain (1994); Injury (2348); Deformity/ Disfigurement (2360); Test Result (2695); No Code Available (3191)
|
Event Date 09/18/2018 |
Event Type
Injury
|
Manufacturer Narrative
|
If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.Device was used for treatment, not diagnosis.This report is for an unknown device/unknown lot.Part and lot number are unknown; udi number is unknown.(b)(4).
|
|
Event Description
|
Pinnacle mom litigation records received alleging pain, difficulty walking, difficulty sleeping, elevated blood cobalt and chromium, injury, emotional distress, disability and disfigurement.Doi: (b)(6) 2006 - dor: (b)(6) 2018 (right hip).Patient is bilateral.
|
|
Manufacturer Narrative
|
Product complaint # (b)(4).Investigation summary = > no device associated with this report was received for examination.A worldwide lot specific complaint database search, or device history record (dhr) review, was not possible because the required lot number was not provided.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.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.
|
|
Search Alerts/Recalls
|
|
|