Legal claim received.Update rec'd 11/26/2014- litigation papers received.Litigation alleges pain, discomfort, soreness, malaise, swelling, loss of energy, immobilization and both acute localized damage to tissue and/or bone surrounding the acetabulum and systemic injuries, and elevated metal ion levels.The stem and sleeve are being added to the complaint.The existing mdr decision has been reversed and the cup and head are being reported.The complaint was updated on: 12/18/2014.
|
Additional narrative: if information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.The asr platform was voluntarily recalled from the market in august 2010, and the asr product codes are now considered inactive.Further investigation of this individual incident will not be undertaken, as there is an ongoing investigation regarding the root cause(s) and/or corrective actions.(b)(4).Depuy considers the investigation closed at this time.Should the product and/or additional information be received, the investigation will be re-opened.Udi: unavailable.This complaint is the subject of litigation or a legal claim and currently complete product detail is not available at this time.A follow-up medwatch will be filed as appropriate.
|