• 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. BMET REGENX PRI TIB TRAY 75MM 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. BMET REGENX PRI TIB TRAY 75MM PROSTHESIS, KNEE Back to Search Results
Model Number N/A
Device Problem Fracture (1260)
Patient Problems Failure of Implant (1924); Necrosis (1971); Pain (1994); Reaction (2414); Metal Related Pathology (4530)
Event Date 06/29/2020
Event Type  Injury  
Manufacturer Narrative
(b)(4). Concomitant medical products: 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, catalog #: ep-183740, e1 vngd ps+ tib brg 71/75x10, lot # 403580. Customer has indicated that the product will not be returned to zimmer biomet for investigation, as the device is still implanted. The investigation is in process. Once the investigation has been completed, a follow-up mdr will be submitted. 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. Remains implanted.
 
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. No plans for a revision as of yet.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameBMET REGENX PRI TIB TRAY 75MM
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 Key8565472
MDR Text Key143571896
Report Number0001825034-2019-01920
Device Sequence Number1
Product Code OIY
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K171054
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional,other
Reporter Occupation
Remedial Action Recall
Type of Report Initial,Followup,Followup,Followup
Report Date 04/21/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/30/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberN/A
Device Catalogue Number141274
Device Lot Number504580
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 Manufactured02/05/2016
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Invalid Data
Removal/Correction NumberZ-2068-2017

Patient Treatment Data
Date Received: 04/30/2019 Patient Sequence Number: 1
-
-