MAUDE Adverse Event Report: WALDEMAR LINK GMBH CO. KG LINK ENDO-MODEL UNICONDYLAR SLED PROSTHESIS; LINK UNKCONDYLAR SLED PROSTHESIS

Model Number 15-2030/10

Device Problems Patient-Device Incompatibility (2682); Device Dislodged or Dislocated (2923)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 07/08/2014

Event Type  malfunction  

Event Description

A wire dislocated from the tibial component, approximately 6 years after the implantation of the prosthesis.

Manufacturer Narrative

We have requested for more information regarding this case so that the investigation can be initiated.Momentarily a root cause analysis for the failure cannot be accomplished.We will provide further information when the investigation is complete.This event occurred outside of the u.S.And involve a product that was manufactured outside of the u.S.However, because the affected product is also marketed in the u.S., waldemar link (b)(4) is submitting this mdr to ensure full compliance with 21 cfr part 803.(b)(4).

• Brand Name: LINK ENDO-MODEL UNICONDYLAR SLED PROSTHESIS
• Type of Device: LINK UNKCONDYLAR SLED PROSTHESIS
• Manufacturer (Section D): WALDEMAR LINK GMBH CO. KG; hamburg ; GM
• Manufacturer Contact: philipp kottman ; barkhausenweg 10; hamburg ; GM ; 053575432
• MDR Report Key: 4392164
• MDR Text Key: 5120513
• Report Number: 3004371426-2014-00012
• Device Sequence Number: 1
• Product Code: HSX
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K954186
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 09/25/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/16/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 15-2030/10
• Device Catalogue Number: 15-2030/10
• Other Device ID Number: GMDN: 48068
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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): Hospitalization; Required Intervention
• Patient Age: 58 YR
• Patient Weight: 95