Litigation papers allege pain, discomfort, swelling, elevated metal ion levels, immobilization, acute localized damage to tissue and/or bone surrounding the acetabulum, and elevated metal ion levels.
Update rec¿d (b)(6) 2014 - plaintiff¿s preliminary disclosure form was received, which identified dob information.
Part/lot was identified from patient sticker sheet.
The complaint and associated mdrs were updated.
There was no new information that would change the outcome of the investigation.
The complaint was updated on: (b)(6) 2014.
Update ad (b)(6) 2021: (b)(4) has been reopened under due to the receipt of medical record.
Revision notes stated that scarred bursal layer was removed.
The cup was grossly loose and was removed.
Upon removal there was a defect in the medial wall.
Patient had a preoperative leg length discrepancy and previously sustained a fall with periprosthetic fracture of femur, stem had subsided.
Stem and sleeve were added due to elevated metal ion.
Doi: (b)(6) 2007 - dor: (b)(6) 2020 (right hip).
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