• 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. FEMORAL COMPONENT POROUS SIZE F RIGHT 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. FEMORAL COMPONENT POROUS SIZE F RIGHT PROSTHESIS, KNEE Back to Search Results
Model Number N/A
Device Problem Insufficient Information (3190)
Patient Problems Muscle Weakness (1967); Burning Sensation (2146)
Event Type  Injury  
Manufacturer Narrative

(b)(4). Concomitant medical products: patella reamer blade with pilot hole, catalog #: 00597909535, lot #: 54067300, trabecular metal ps tibial, catalog #: 00588605614, lot #: 6037644, nexgen tm standard patella, catalog #: 00587806535, lot #: 60448090. Customer has indicated product will not be returned to zimmer biomet for investigation as the product remains implanted. The investigation is in process. When the investigation is complete, a follow-up report 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. Device remains implanted in patient.

 
Event Description

It was reported patient underwent right total knee arthroplasty. Subsequently, patient experienced a burning in his knee since 9 months post-op. Patient also reports loosening of the muscles, causing knee to be loose. There is a continuous burning that affects of the leg muscles, going up into buttocks and now affecting the patient's chest and arm.

 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameFEMORAL COMPONENT POROUS SIZE F RIGHT
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 Key8152120
MDR Text Key129951896
Report Number0001822565-2018-06844
Device Sequence Number1
Product Code MBH
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberK031061
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 09/03/2019
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received12/11/2018
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date02/29/2016
Device MODEL NumberN/A
Device Catalogue Number00599201602
Device LOT Number60407124
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 Received08/29/2019
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured02/20/2006
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage
Removal/Correction NumberN/A

Patient TREATMENT DATA
Date Received: 12/11/2018 Patient Sequence Number: 1
-
-