(b)(4).Customer has indicated that the product will not be returned to zimmer biomet for investigation, as it remains implanted.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Additional associated products and mdrs.42502006401 femur cemented cruciate retaining narrow left size 8 lot# 64756099.Mdr-3007963827-2020-00300.42512100511 articular surface medial congruent left 11 mm lot# 64781367.Mdr- 3007963827-2020-00302.42540000035 all poly patella cemented 35 mm diameter lot# 64775300.Mdr- 0002648920-2020-00494.
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This follow-up report is being submitted to relay additional information.It was reported that 68 year old caucasian female, with known bmi of 35.8 is participating in a clinical study and underwent primary left tka and subsequently developed dvt in left lower extremity approximately 7 days post procedure.Procedural related complications are influenced by the 'type of surgery, patients pre-existing comorbid state, and perioperative management.' deep vein thrombosis, or dvt, occurs when a blood clot forms in one of the deep veins of the body.This can happen if a vein becomes damaged or if the blood flow within a vein slows down or stops.Total joint patients are typically placed on medication post-operative for a period of time to prevent the development of dvt/blood clot.Even with the administration of preventive medication, dvt/blood clots can still develop.Patient was placed on aspirin at discharge as preventive measure for dvt.Patient is also noted to have increase risk for developing a dvt as patient has elevated bmi.Clinical study reports medical intervention was provided to treat the dvt and remains implanted to date.
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