18 may 2018 medical records received.After review of the medical records for mdr reportability, the patient had an i and d with poly exchange to address wound dehiscence with cellulitis, right knee, status post total knee arthroplasty with communication into the joint.Infection was noted to be mainly superficial with a section of purulence noted deep to the fascia.Only the insert was revised.Doi: (b)(6) 2017 (insert) dor: (b)(6) 2018 (right knee).Patient was previously revised to address overstuffing of the patella on (b)(6) 2017, which is captured on another complaint.
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Product complaint # = > pc-(b)(4).Investigation summary = > no device associated with this report was received for examination.Depuy synthes considers the investigation closed.Should additional information be received, the information will be reviewed and the investigation may be re-opened as necessary.If information is obtained that was not available for the initial medwatch , a follow-up medwatch, a follow-up medwatch will be filed as appropriate. .
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