MAUDE Adverse Event Report: WALDEMAR LINK GMBH & CO. KG ENDO-MODEL SL KNEE PROSTHESIS SYSTEM; CONNECTION COMPONENT, HINGE

Model Number UNKNOWN

Device Problems Degraded (1153); Detachment of Device or Device Component (2907)

Patient Problem Failure of Implant (1924)

Event Date 07/13/2022

Event Type  Injury  

Event Description

Revision due to defect of the coupling mechanism.

Manufacturer Narrative

It was not possible to check the production records, as the article, lot and serial numbers of the complaint sample are not available.The complaint sample was discarded.Based on the available information, it is assumed that insufficient securing of the of the axle from the screw could be the most likely cause of the coupling failure.

Event Description

Revision due to defect of the coupling mechanism.

• Brand Name: ENDO-MODEL SL KNEE PROSTHESIS SYSTEM
• Type of Device: CONNECTION COMPONENT, HINGE
• Manufacturer (Section D): WALDEMAR LINK GMBH & CO. KG; barkhausenweg 10; hamburg, 22339 ; GM 22339
• Manufacturer Contact: sagar shetty ; barkhausenweg 10; hamburg, 22339 ; GM 22339
• MDR Report Key: 15273438
• MDR Text Key: 298388393
• Report Number: 3004371426-2022-00031
• Device Sequence Number: 1
• Product Code: KRO
• Combination Product (y/n): N
• Reporter Country Code: GM
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 08/02/2022

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?: No
• Device Model Number: UNKNOWN
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 08/02/2022
• Initial Date FDA Received: 08/23/2022
• Supplement Dates Manufacturer Received: 08/02/2022
• Supplement Dates FDA Received: 10/05/2022
• 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): Required Intervention
• Patient Age: 84 YR
• Patient Sex: Female
• Patient Weight: 65 KG