(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 code(s) was not provided.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.(b)(4).Occupation: attorney.
|
Litigation alleges pain, discomfort and limited mobility.Update ad 25 jul 2018: receipt of ppf and implant records.In addition to what were previously alleged, ppf alleges elevated metal ions and loosening of stem.Added dor, revision surgeon, and revision hospital.
|