ZIMMER ORTHOPAEDIC MFG. LTD. ARTICULAR SURFACE MEDIAL CONGRUENT (MC) LEFT 11 MM; PROSTHESIS, KNEE
|
Back to Search Results |
|
Model Number N/A |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
|
Patient Problem
Embolism (1829)
|
Event Date 10/13/2020 |
Event Type
Injury
|
Manufacturer Narrative
|
(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-3007963827-2020-00300.42532006701, tibia cemented 5 degree stemmed left size d lot# 64692975 mdr- 3007963827-2020-00301.42540000035 all poly patella cemented 35 mm diameter lot# 64775300 mdr- 0002648920-2020-00494.
|
|
Event Description
|
It was reported that a patient had an initial left unilateral tka.Subsequently, the patient experienced a left posterior tibial calf dvt, left soleal (vein), and muscular calf dvt.Medical intervention was provided.Outcome is pending.
|
|
Event Description
|
No further event information available at the time of this report.
|
|
Manufacturer Narrative
|
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.
|
|
Search Alerts/Recalls
|
|
|