MAUDE Adverse Event Report: ZIMMER BIOMET, INC. UNKNOWN TIBIAL ARTICULATING SURFACE; 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; lps allpoly tib sz 7 blu 10 catalog # 00599600710 lot # 63843447; nexgen all poly patella catalog # 00597206638 lot # 64441878.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, 0001822565-2020-03860, 0001822565-2020-03861.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.

Event Description

Upon receipt of additional information, it was determined that the initial report was submitted in error and should be voided.This component is not listed in medical records.

Manufacturer Narrative

Upon receipt of additional information, it was determined that the initial report was submitted in error and should be voided.This component is not listed in medical records.

• Brand Name: UNKNOWN TIBIAL ARTICULATING SURFACE
• Type of Device: PROSTHESIS, KNEE
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 10853333
• MDR Text Key: 216669471
• Report Number: 0001822565-2020-03862
• Device Sequence Number: 1
• Product Code: JWH
• Combination Product (y/n): N
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,health profession
• Type of Report: Initial,Followup
• Report Date: 11/20/2020

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
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 10/30/2020
• Initial Date FDA Received: 11/17/2020
• Supplement Dates Manufacturer Received: 11/17/2020
• Supplement Dates FDA Received: 11/20/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Weight: 96