• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER BIOMET, INC. PERSONA TIBIA; PROSTHESIS KNEE

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

ZIMMER BIOMET, INC. PERSONA TIBIA; PROSTHESIS KNEE Back to Search Results
Model Number N/A
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Thrombosis/Thrombus (4440)
Event Date 04/04/2024
Event Type  Injury  
Manufacturer Narrative
(b)(4).D10 - medical product: persona femur cemented cruciate retaining (cr) catalog # 42502605802 lot # 66440727 persona articular surface medial congruent (mc) catalog # 42522100311 lot # 65929917 heraeus medical catalog # 5036963 lot # 67841256 heraeus medical catalog # 5036963 lot # 68331243 procedural related complications are influenced by the type of surgery, patients pre-existing comorbidities, and perioperative management.Deep vein thrombosis (blood clot), 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-operatively to prevent dvt formation.Even with the administration of preventive medication, dvts can still develop.As the complaint indicated, a post-operative complication occurred, and medical intervention was required for treatment.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
It was reported patient developed a deep vein thrombosis and was treated with eliquis post implantation.Attempts to obtain additional information have been made; however, no more is available.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
PERSONA TIBIA
Type of Device
PROSTHESIS KNEE
Manufacturer (Section D)
ZIMMER BIOMET, INC.
1800 w. center st.
warsaw IN 46580
Manufacturer (Section G)
ZIMMER BIOMET, INC.
1800 w. center st.
warsaw IN 46580
Manufacturer Contact
jennifer rapsavage
56 e. bell dr.
warsaw, IN 46582
5745260384
MDR Report Key19166604
MDR Text Key340860114
Report Number0001822565-2024-01376
Device Sequence Number1
Product Code JWH
UDI-Device Identifier00889024632097
UDI-Public(01)00889024632097(17)331108(10)66086971
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K221479
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Study,Health Professional,Company Representative
Reporter Occupation Physician
Type of Report Initial
Report Date 04/23/2024
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 NumberN/A
Device Catalogue Number42536006702
Device Lot Number66086971
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 04/08/2024
Initial Date FDA Received04/23/2024
Was Device Evaluated by Manufacturer? No
Date Device Manufactured08/15/2023
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Treatment
SEE H10 NARRATIVE
Patient Outcome(s) Other;
Patient SexFemale
Patient RaceBlack Or African American
-
-