MAUDE Adverse Event Report: ZIMMER MANUFACTURING B.V. ALL POLY PATELLA CEMENTED 35 MM DIAMETER; PROSTHESIS, KNEE

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- 3007963827-2020-00301.42512100511 articular surface medial congruent left 11 mm lot# 64781367.Mdr- 3007963827-2020-00302.

Event Description

It was reported that a patient had an initial left unilateral tka.Subsequently, the patient experienced a left posterior tibial calf dvt and 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

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.

• Brand Name: ALL POLY PATELLA CEMENTED 35 MM DIAMETER
• Type of Device: PROSTHESIS, KNEE
• Manufacturer (Section D): ZIMMER MANUFACTURING B.V.; turpeaux industrial park; route #1 km 123.4 bldg #1; mercedita PR 00715
• MDR Report Key: 10813455
• MDR Text Key: 215483392
• Report Number: 0002648920-2020-00494
• Device Sequence Number: 1
• Product Code: JWH
• Combination Product (y/n): N
• PMA/PMN Number: K172524
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 12/03/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 42540000035
• Device Lot Number: 64775300
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 10/29/2020
• Initial Date FDA Received: 11/09/2020
• Supplement Dates Manufacturer Received: 11/25/2020
• Supplement Dates FDA Received: 12/04/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Treatment: SEE H10 NARRATIVE.
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Weight: 92