If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Device was used for treatment, not diagnosis.
510k: this report is for an unknown device/unknown lot.
Part and lot number are unknown; udi number is unknown.
(b)(4).
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Pinnacle mom litigation records received.
Litigation alleges popping, pain, injuries, lack of mobility, emotional distress, anxiety, depression, disability and elevated metal ion levels.
However, lab result shows metal ion levels were below 7ppb.
It was also stated that the patient was revised to address mechanical complications and bearing surface wear resulting to metallosis.
Revision note reported some grayish staining within the trochanter bursa region and some bone type tissue forming between the metal liner and shell.
Doi: (b)(6) 2007; dor: (b)(6) 2017; right hip.
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