• 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. E1 VNGD PS+ TIB BRG 71/75X10 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. E1 VNGD PS+ TIB BRG 71/75X10 PROSTHESIS, KNEE Back to Search Results
Model Number N/A
Device Problem Fracture (1260)
Patient Problems Failure of Implant (1924); Necrosis (1971); Pain (1994); Metal Related Pathology (4530)
Event Date 06/29/2020
Event Type  Injury  
Manufacturer Narrative
(b)(4). Medical product: catalog # 141356, regenerex 3 peg series a patella dcm arcom porous titanium lot # 561780. Catalog #: 184512, vngd ps open por fmrl rt 70, lot # 421160. Catalog #: 141316, biomet finned pri stem 80x10mm, lot # 980570. Catalog #: 141274, bmet regenx pri tib tray 75mm, lot # 504580. Customer has indicated that the product will not be returned because product location is unknown. 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: 0001825034-2019-01920.
 
Event Description
It was reported that the patient underwent an initial right knee procedure approximately two years ago. Subsequently, the patient suffered pain in the knee joints and has a fractured patella. Further it was reported that the patient was revised due pain, implant fracture, metallosis, necrotic tissue and bone.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameE1 VNGD PS+ TIB BRG 71/75X10
Type of DevicePROSTHESIS, KNEE
Manufacturer (Section D)
ZIMMER BIOMET, INC.
56 e. bell drive
warsaw IN 46582
Manufacturer (Section G)
ZIMMER BIOMET, INC.
56 e. bell drive
warsaw IN 46582
Manufacturer Contact
christina arnt
56 e. bell dr.
warsaw, IN 46582
5745273773
MDR Report Key10970258
MDR Text Key246835557
Report Number0001825034-2020-04294
Device Sequence Number1
Product Code OIY
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K113550
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer,health professional
Reporter Occupation
Type of Report Initial,Followup
Report Date 04/21/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/08/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date12/15/2020
Device Model NumberN/A
Device Catalogue NumberEP-183740
Device Lot Number403580
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received04/20/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured12/15/2015
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Removal/Correction NumberN/A

Patient Treatment Data
Date Received: 12/08/2020 Patient Sequence Number: 1
-
-