Initial information received alleged patient reported symptoms related to mom implants: pinnacle mom litigation record received.Litigation alleges injury, emotional trauma, distress, worsening pain and seized metal on metal with significant inflammatory reaction.Upon revision the stem and acetabular cup were rigidly attached, well fixed and not loose.Doi: (b)(6) 2011; dor: (b)(6) 2018 (left hip).Further information received 02/05/2021: update ad 05 feb 2021: (b)(4) has been re-opened due to pinnacle pfs and medical records received.Pfs alleges severe pain and suffering, limp and mobility issues.Plaintiff is seeking claim for all the damages.After review of the medical records the patient was revised to address pain with significant inflammatory reaction, sleep disturbance, cystic changes on the proximal femur.Radiograph reported acetabulum concerning for loosening.The morbid obesity causing longer incision and difficult manipulation.Operative note reported fairly extensive fluid collection in subcutaneous tissue with fat necrosis, significant cavitary defect on the proximal femoral stem, thinning of the core tracts and cavitary lesions behind the acetabulum, significant amount of inflammatory tissue that required extensive debridement as well as diffuse punctate bleeding secondary to the significant inflammatory tissue.Tissues and scar were debrided to expose acetabulum.The shell and stem are well fixed.Intra op there was a very small crack at end of the proximal femur adjacent to the end of the stem.
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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 = > the product investigation found no evidence suspecting an error in the manufacturing or material that would be a contributing factor in the reported allegation(s).A manufacturing records evaluation (mre) was not performed.
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