Product complaint #: (b)(4).
Initial reporter occupation: lawyer.
(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.
If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
|
Pinnacle metal on metal claim letter received.
Claim letter alleges pain, discomfort, difficulty walking and elevated metal ions.
Mri suggested bilateral foreign body reaction with osteolysis and pseudotumor formation.
Patient also suffered the following injuries but are not limited to metallosis, permanent tissue, muscle loss, limited adl and work, medical expenses, psychological and emotional injuries.
Patient is seeking compensation for all the damages that have cause him.
This is also serve as formal notice of claim and written demand.
Doi: (b)(6) 2006; dor: unknown; right hip.
|