• 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 (PS) RIGHT 11 MM HEIGHT 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 (PS) RIGHT 11 MM HEIGHT PROSTHESIS, KNEE Back to Search Results
Model Number N/A
Device Problems Material Erosion (1214); Naturally Worn (2988)
Patient Problem No Information (3190)
Event Date 04/07/2020
Event Type  Injury  
Manufacturer Narrative

(b)(4). Foreign report source: (b)(6). Customer has indicated that the product will not be returned to zimmer biomet for investigation as it has been discarded. The investigation is in process. Once the investigation has been completed, a follow-up mdr will be submitted.

 
Event Description

It was reported that a patient was revised approximately one-month post implantation due to implant wear. Debridement was performed and the surface was replaced. The surgeon found scaly wear on the explanted surface. There is no additional information available at this time.

 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameARTICULAR SURFACE FIXED BEARING POSTERIOR STABILIZED (PS) RIGHT 11 MM HEIGHT
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 Key10001525
MDR Text Key191604778
Report Number3007963827-2020-00123
Device Sequence Number1
Product Code MBH
Combination Product (Y/N)N
Reporter Country CodeJA
PMA/PMN NumberK121771
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,DISTRI
Reporter Occupation
Type of Report Initial,Followup
Report Date 07/02/2020
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received04/27/2020
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberN/A
Device Catalogue Number42522400711
Device LOT Number64472779
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 Received07/01/2020
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured12/12/2019
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

Patient TREATMENT DATA
Date Received: 04/27/2020 Patient Sequence Number: 1
-
-