MAUDE Adverse Event Report: WALDEMAR LINK GMBH&CO.KG LINKSYMPHOKNEE; ARTICULATING SURFACE PS

Model Number 880-215/10

Device Problems Positioning Failure (1158); Device Dislodged or Dislocated (2923)

Patient Problem Failure of Implant (1924)

Event Date 01/04/2023

Event Type  Injury  

Manufacturer Narrative

The review of the device history record showed no deviations.The product complies with the specifications valid at the time of manufacture.

Event Description

Poly disassociated from tibial plauteau.

Manufacturer Narrative

The review of the device history record showed no deviations.The product complies with the specifications valid at the time of manufacture.

Event Description

Poly disassociated from tibial plauteau.

• Brand Name: LINKSYMPHOKNEE
• Type of Device: ARTICULATING SURFACE PS
• Manufacturer (Section D): WALDEMAR LINK GMBH&CO.KG; barkhausenweg 10; hamburg, hamburg 22339 ; GM 22339
• Manufacturer Contact: lisa effe ; barkhausenweg 10; hamburg, hamburg 22339 ; GM 22339
• MDR Report Key: 16435634
• MDR Text Key: 310145749
• Report Number: 3004371426-2023-00009
• Device Sequence Number: 1
• Product Code: HRY
• UDI-Device Identifier: 04026575253159
• UDI-Public: 04026575253159
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K202924
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Distributor
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 02/03/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/24/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 880-215/10
• Device Catalogue Number: 880-215/10
• Device Lot Number: 2138134
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/14/2023
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/03/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/01/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 57 YR
• Patient Sex: Female