DEPUY ORTHOPAEDICS, INC. 1818910 SUMMIT POR TAPER SZ6 STD OFF; SUMMIT HIP STEM : HIP FEMORAL STEM
|
Back to Search Results |
|
Model Number 1570-01-120 |
Device Problems
Biocompatibility (2886); Adverse Event Without Identified Device or Use Problem (2993)
|
Patient Problems
Pain (1994); Tissue Damage (2104); Anxiety (2328); Limited Mobility Of The Implanted Joint (2671); 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.Device was used for treatment, not diagnosis.Initial reporter occupation: non-healthcare professional "attorney".
|
|
Event Description
|
Litigation records received.Litigation alleges defective hip have caused damage to his hip joints and body.Update in addition to what was previously alleged, pfs alleges pain, limited mobility, difficulty walking, standing, and working out, metallosis, anxiety, suffering, frustration, and diminished quality of life.Doi: (b)(6) 2012 - dor: none reported, (right hip).
|
|
Manufacturer Narrative
|
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.H10 additional narrative: corrected: h6 (device).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: 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 will be filed as appropriate.
|
|
Search Alerts/Recalls
|
|
|