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 CONNECTION COMPONENT ROTATIONAL VERSION; 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 CONNECTION COMPONENT ROTATIONAL VERSION; ROTATING HINGED TOTAL KNEE PROSTHESIS Back to Search Results
Catalog Number 16-2840/02
Device Problems Degraded (1153); Mechanical Problem (1384); Connection Problem (2900); Device Dislodged or Dislocated (2923)
Patient Problems Failure of Implant (1924); Metal Related Pathology (4530)
Event Date 06/26/2021
Event Type  Injury  
Event Description
It was reported that a revision surgery took place to address a dislocation of a failed connection component.This report concerns the same patient as report 3004371426-2017-00002 and 3004371426-2020-00017.
 
Event Description
It was reported that a revision surgery took place to address a dislocation of a failed connection component.This report concerns the same patient as report 3004371426-2017-00002 and 3004371426-2020-00017.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
CONNECTION COMPONENT ROTATIONAL VERSION
Type of Device
ROTATING HINGED TOTAL KNEE PROSTHESIS
Manufacturer (Section D)
WALDEMAR LINK GMBH & CO. KG
barkhausenweg 10
hamburg, 22339
GM  22339
MDR Report Key12115193
MDR Text Key259989540
Report Number3004371426-2021-00018
Device Sequence Number1
Product Code KRO
Combination Product (y/n)N
PMA/PMN Number
K151008
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor
Type of Report Initial,Followup
Report Date 06/29/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/05/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Catalogue Number16-2840/02
Was Device Available for Evaluation? No
Date Manufacturer Received06/29/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Age67 YR
-
-