• 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 ROTATIONAL KNEE JOINT PROSTHESIS ENDO-MODEL®, TIBIAL COMPONENT; ROTATING HINGED TOTAL KNEE PROSTHESIS

  • 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 ROTATIONAL KNEE JOINT PROSTHESIS ENDO-MODEL®, TIBIAL COMPONENT; ROTATING HINGED TOTAL KNEE PROSTHESIS Back to Search Results
Model Number 15-8030/11
Device Problem Break (1069)
Patient Problem Failure of Implant (1924)
Event Date 01/15/2015
Event Type  Injury  
Manufacturer Narrative
The visual inspection showed that the pe plateau showed clear pressure marks of the tibia metal component, leading to the conclusion that the pe plateau was not mounted/implanted in the correct position.This leads to micro-movements in the plateau retaining screw.These movements can lead to loosening or even fracture of the plateau screw.The report is delayed due to inconsistencies with regard to foreign event reporting to fda.After re-evaluation of the complaint we determined that it is reportable.We have addressed the inconsistency in reporting foreign events to fda through capa-(b)(4).
 
Event Description
Translation: inlay fixing screw broken on tibial component.Coupling of the tibial and femoral components was therefore not possible by simple inlay change.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
ROTATIONAL KNEE JOINT PROSTHESIS ENDO-MODEL®, TIBIAL COMPONENT
Type of Device
ROTATING HINGED TOTAL KNEE PROSTHESIS
Manufacturer (Section D)
WALDEMAR LINK GMBH & CO. KG
barkhausenweg 10
hamburg, 22339
GM  22339
Manufacturer (Section G)
WALDEMAR LINK GMBH & CO. KG
barkhausenweg 10
hamburg, 22339
GM   22339
Manufacturer Contact
omid rahmatian
barkhausenweg 10
hamburg, 22339
GM   22339
MDR Report Key8296659
MDR Text Key134724636
Report Number3004371426-2019-00006
Device Sequence Number1
Product Code KRO
Combination Product (y/n)N
Reporter Country CodeGM
PMA/PMN Number
K143179
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign
Reporter Occupation Other
Type of Report Initial
Report Date 01/19/2015
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Model Number15-8030/11
Device Catalogue Number15-8030/11
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/23/2015
Initial Date Manufacturer Received 01/23/2015
Initial Date FDA Received02/01/2019
Was Device Evaluated by Manufacturer? Yes
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Age66 YR
-
-