• 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. ZIMMER UNI KNEE ARTICULAR SURFACE 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. ZIMMER UNI KNEE ARTICULAR SURFACE PROSTHESIS, KNEE Back to Search Results
Model Number N/A
Device Problems Difficult to Insert (1316); Difficult To Position (1467)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 03/13/2018
Event Type  Malfunction  
Manufacturer Narrative

(b)(4). (b)(6). Customer has indicated that the product is in process of being returned to zimmer biomet for investigation. 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.

 
Event Description

It was reported that the insert would not seat into the tibial tray. The insert was perceived to be defective. Another component was used to complete the case. No adverse events have been reported as a result of the malfunction.

 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameZIMMER UNI KNEE ARTICULAR SURFACE
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 Key7407375
MDR Text Key105249215
Report Number0001822565-2018-02062
Device Sequence Number1
Product Code HSX
Combination Product (Y/N)N
Reporter Country CodeIT
PMA/PMN NumberPK033363
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type FOREIGN,HEALTH PROFESSIONAL
Reporter Occupation
Type of Report Initial,Followup
Report Date 07/02/2018
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received04/09/2018
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator
Device MODEL NumberN/A
Device Catalogue Number00584202308
Device LOT Number63758099
OTHER Device ID Number(01)00889024193963
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer05/24/2018
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/28/2018
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured08/21/2017
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

-
-