MAUDE Adverse Event Report: WALDEMAR LINK GMBH & CO. KG LINK SLED PROSTHESIS; TIBIAL PLATEAU

Model Number 15-2030/14

Device Problems Detachment of Device or Device Component (2907); Device Dislodged or Dislocated (2923)

Patient Problem Failure of Implant (1924)

Event Date 03/23/2022

Event Type  Injury  

Event Description

Fixation wire of tibial plateau moved and is visible in x-ray (customer).

Manufacturer Narrative

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

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

Fixation wire of tibial plateau moved and is visible in x-ray [customer].

• Brand Name: LINK SLED PROSTHESIS
• Type of Device: TIBIAL PLATEAU
• Manufacturer (Section D): WALDEMAR LINK GMBH & CO. KG; barkhausenweg 10; hamburg, 22339 ; GM 22339
• Manufacturer Contact: annerike tizia hucklenbroch ; barkhausenweg 10; hamburg, 22339 ; GM 22339
• MDR Report Key: 14020262
• MDR Text Key: 288877936
• Report Number: 3004371426-2022-00004
• Device Sequence Number: 1
• Product Code: HSX
• UDI-Device Identifier: 04026575436712
• UDI-Public: 04026575436712
• Combination Product (y/n): N
• Reporter Country Code: SZ
• PMA/PMN Number: K954186
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/23/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/06/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2020
• Device Model Number: 15-2030/14
• Device Catalogue Number: 15-2030/14
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/23/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/01/2015
• 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