Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: WALDEMAR LINK GMBH & CO. KG ENDO-MODEL MODULAR KNEE PROSTHESIS SYSTEM
  • 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
 

WALDEMAR LINK GMBH & CO. KG ENDO-MODEL MODULAR KNEE PROSTHESIS SYSTEM Back to Search Results
Model Number 15-8521/14
Device Problem Device Damaged Prior to Use (2284)
Patient Problem Insufficient Information (4580)
Event Date 02/16/2024
Event Type  Injury  
Event Description
Notification by a representative on 2021-02-21, that a femoral component, endo dfr product, had a punctured internal sterile packaging.The box itself did not appear to be damaged.The packaging issue was noticed during a surgery, after the corresponding component was opened, which extended the surgery approximately 20 minutes, because there was not an additional large size implant available so the decision was to downsize to a medium size implant.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
ENDO-MODEL MODULAR KNEE PROSTHESIS SYSTEM
Type of Device
ENDO-MODEL MODULAR KNEE PROSTHESIS SYSTEM
Manufacturer (Section D)
WALDEMAR LINK GMBH & CO. KG
barkhausenweg 10
hamburg, 22339
GM  22339
MDR Report Key18881704
MDR Text Key337412157
Report Number3006721341-2024-00004
Device Sequence Number1
Product Code KRO
UDI-Device Identifier04026575383252
UDI-Public04026575383252
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Distributor
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 02/21/2024,03/11/2024
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/11/2024
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number15-8521/14
Device Catalogue Number15-8521/14
Device Lot Number200224
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/04/2024
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Distributor Facility Aware Date02/16/2024
Event Location Hospital
Date Report to Manufacturer02/21/2024
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient SexFemale
-
-