MAUDE Adverse Event Report: WALDEMAR LINK GMBH & CO. KG LINK SYMPHOKNEE; LSK ARTICULATING SURFACE PS 5-6 10MM PS

Catalog Number 880-215/10

Device Problem Device Dislodged or Dislocated (2923)

Patient Problem Insufficient Information (4580)

Event Type  Injury  

Event Description

The polyethylene articulating surface disassociated from tibial plateau, requiring revision surgery to replace the articulating surface.

• Brand Name: LINK SYMPHOKNEE
• Type of Device: LSK ARTICULATING SURFACE PS 5-6 10MM PS
• Manufacturer (Section D): WALDEMAR LINK GMBH & CO. KG; barkhausenweg 10; hamburg, 22339 ; GM 22339
• MDR Report Key: 16306908
• MDR Text Key: 308882559
• Report Number: 3006721341-2023-00002
• Device Sequence Number: 1
• Product Code: KRO
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/03/2023,02/06/2023

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 Operator: Health Professional
• Device Catalogue Number: 880-215/10
• Device Lot Number: 2138133
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 01/04/2023
• Event Location: Hospital
• Date Report to Manufacturer: 02/03/2023
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/06/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 57 YR
• Patient Sex: Male