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 LINKSYMPHOKNEE
  • 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 LINKSYMPHOKNEE Back to Search Results
Model Number 880-201/10
Medical Device Problem Code Insufficient Device Problem Information (3190)
Health Effect - Clinical Code Medical device site infection (4845)
Date of Event 07/30/2023
Type of Reportable Event Serious Injury
Event or Problem Description
Linkbio complaints was notified on (b)(6) 2023 about a surgery performed on (b)(6) 2023 to replace an lsk plateau because of infection.Original surgery was performed (b)(6) 2022 by (b)(6).
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
LINKSYMPHOKNEE
Common Device Name
LINKSYMPHOKNEE
Manufacturer (Section D)
WALDEMAR LINK GMBH & CO. KG
barkhausenweg 10
hamburg, 22339
GM  22339
MDR Report Key17606922
Report Number3006721341-2023-00021
Device Sequence Number6206199
Product Code KRO
UDI-Device Identifier04026575245291
UDI-Public(01)04026575245291(17)261031(10)2038116
Combination Product (Y/N)N
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2022
Device Explanted Year2023
Serviced by Third Party (Y/N)N
Reporter Type Importer
Initial Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date (Section B) 08/23/2023
Report Date (Section F) 08/07/2023
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? Yes
Device Expiration Date05/31/2023
Device Model Number880-201/10
Device Catalogue Number880-201/10
Device Lot Number2038116
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Distributor Facility Aware Date07/30/2023
Device Age2 YR
Event Location Hospital
Date Report to Manufacturer08/07/2023
Initial Date Received by Manufacturer Not provided
Initial Report FDA Received Date08/23/2023
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
Outcome Attributed to Adverse Event Required Intervention;
Patient Age51 YR
Patient SexFemale
-
-