• 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. PERSONA STEMMED CEMENTED TIBAL COMPONENT 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. PERSONA STEMMED CEMENTED TIBAL COMPONENT PROSTHESIS, KNEE Back to Search Results
Catalog Number 42532006702
Device Problem Scratched Material (3020)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 03/06/2019
Event Type  Malfunction  
Manufacturer Narrative

(b)(4). Product has been received by zimmer biomet and the investigation is in process. Once the investigation has been completed, a follow-up mdr will be submitted.

 
Event Description

It was reported upon opening the tibial component, there were scratch marks and an unpolished appearance. A new implant was used to complete the procedure. No adverse events have been reported as a result of the malfunction. Attempts have been made, and no further information has been provided.

 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NamePERSONA STEMMED CEMENTED TIBAL COMPONENT
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 Key8482186
MDR Text Key140894672
Report Number0001822565-2019-01302
Device Sequence Number1
Product Code MBH
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberK172524
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type DISTRIBUTOR,HEALTH PROFESSION
Reporter Occupation
Type of Report Initial,Followup
Report Date 11/15/2019
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received04/04/2019
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device Catalogue Number42532006702
Device LOT Number63775479
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer03/12/2019
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received11/13/2019
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured09/27/2017
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

-
-