• 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. PARTIAL ARTICULAR SURFACE LEFT MEDIAL 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. PARTIAL ARTICULAR SURFACE LEFT MEDIAL PROSTHESIS, KNEE Back to Search Results
Model Number N/A
Device Problem Difficult to Insert (1316)
Patient Problem No Information (3190)
Event Date 12/24/2018
Event Type  Malfunction  
Manufacturer Narrative

(b)(4). (b)(6). Customer has indicated that the product will be returned to zimmer biomet for investigation. The investigation is in process. Once the investigation has been completed, a follow-up mdr will be submitted.

 
Event Description

It was reported that articular surface could not be inserted into tibia plate. There is no additional information at this time.

 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NamePARTIAL ARTICULAR SURFACE LEFT MEDIAL
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 Key8263974
MDR Text Key133767028
Report Number0001822565-2019-00239
Device Sequence Number1
Product Code HSX
Combination Product (Y/N)N
Reporter Country CodeJA
PMA/PMN NumberK161592
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,FOREIG
Reporter Occupation
Type of Report Initial,Followup
Report Date 09/25/2019
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received01/21/2019
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberN/A
Device Catalogue Number42518200409
Device LOT Number63730435
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer02/15/2019
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received09/20/2019
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured08/03/2017
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

-
-