• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER ORTHOPAEDIC MFG. LTD. ARTICULAR SURFACE FIXED BEARING POSTERIOR STABILIZED 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 ORTHOPAEDIC MFG. LTD. ARTICULAR SURFACE FIXED BEARING POSTERIOR STABILIZED PROSTHESIS, KNEE Back to Search Results
Model Number N/A
Device Problem Device Contaminated During Manufacture or Shipping (2969)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 06/06/2019
Event Type  malfunction  
Manufacturer Narrative
Zimmer biomet complaint number: (b)(4). Report source: (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 during surgery the art surface had an unknown substance on it. Subsequently, the surgery was completed with a different art surface. Attempts have been made and no further information has been provided.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameARTICULAR SURFACE FIXED BEARING POSTERIOR STABILIZED
Type of DevicePROSTHESIS, KNEE
Manufacturer (Section D)
ZIMMER ORTHOPAEDIC MFG. LTD.
building no 2 east park
shannon industrial estate
shannon, county clare
EI
Manufacturer (Section G)
ZIMMER ORTHOPAEDIC MFG. LTD.
building no 2 east park
shannon industrial estate
shannon, county clare
EI
Manufacturer Contact
christina arnt
56 e. bell dr.
warsaw, IN 46582
5745273773
MDR Report Key8752666
MDR Text Key149783486
Report Number3007963827-2019-00204
Device Sequence Number1
Product Code OIY
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
K121771
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 11/08/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received07/02/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberN/A
Device Catalogue Number42522401011
Device Lot Number64162166
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/25/2019
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received11/05/2019
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured10/18/2018
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

-
-