MAUDE Adverse Event Report: ZIMMER BIOMET, INC. LPS ALLPOLY TIB SZ 7 BLU 10; PROSTHESIS, KNEE

Model Number N/A

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Thrombosis (2100)

Event Date 12/17/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).Medical products: nexgen lps femoral component catalog # 00599601852 lot # 64480322; nexgen all poly patella catalog # 00597206638 lot # 64441878; unknown tibial articulating surface catalog # unknown lot # unknown.Customer has indicated that the product will not be returned because it remains implanted.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Multiple mdr reports were filled for this event: 0001822565-2020-03856, 0001822565-2020-03861, 0001822565-2020-03862.Remains implanted.

Event Description

It was reported that the patient underwent a knee arthroplasty.Subsequently, the patient was diagnosed with a deep vein thrombosis.No revision procedure or further intervention has been reported to date.Attempt for further information has been made, but no further information has been provided.

Manufacturer Narrative

D11 medical records: depuy smart set hv bone cement catalog # unknown lot # unknown.

Event Description

Patient was placed on dvt prophy of compression devices through hospital stay.Further, patient was given 325mg ec asa which was started on post op day 1 for home dvt prophy.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.It was reported the patient developed a dvt approximately 6 days post op.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.It was noted that the patient was placed on dvt prevention post op, with use of compression devices during hospital stay, as well as it was ordered for patient to start taking 325mg asa on pod1 for home dvt prevention.It is recorded that patient had elevated bmi of 30.75 increase the risk for post operative dvt development.If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly.Zimmer biomet will continue to monitor for trends.

Event Description

No further event information available at the time of this report.

• Brand Name: LPS ALLPOLY TIB SZ 7 BLU 10
• Type of Device: PROSTHESIS, KNEE
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 10853202
• MDR Text Key: 216655029
• Report Number: 0001822565-2020-03860
• Device Sequence Number: 1
• Product Code: JWH
• Combination Product (y/n): N
• PMA/PMN Number: K173057
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup,Followup
• Report Date: 11/24/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/17/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2023
• Device Model Number: N/A
• Device Catalogue Number: 00599600710
• Device Lot Number: 63843447
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/20/2020
• 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): Other
• Patient Weight: 96