MAUDE Adverse Event Report: WALDEMAR LINK GMBH & CO. KG ENDO-MODEL ROTATIONAL KNEE PROSTHESIS SL; ENDO-MODEL ROTATIONAL KNEE PROSTHESIS SL, FEMORAL COMPONENT LEFT, LARGE (4)

Model Number 16-2825/22

Device Problems Detachment of Device or Device Component (2907); Loosening of Implant Not Related to Bone-Ingrowth (4002)

Patient Problem Failure of Implant (1924)

Event Date 09/19/2022

Event Type  Injury  

Event Description

Loosening of the cone connection.

Event Description

Loosening of the cone connection.

Manufacturer Narrative

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

• Brand Name: ENDO-MODEL ROTATIONAL KNEE PROSTHESIS SL
• Type of Device: ENDO-MODEL ROTATIONAL KNEE PROSTHESIS SL, FEMORAL COMPONENT LEFT, LARGE (4)
• Manufacturer (Section D): WALDEMAR LINK GMBH & CO. KG; barkhausenweg 10; hamburg, 22339 ; GM 22339
• Manufacturer Contact: tizia hucklenbroch ; barkhausenweg 10; hamburg, 22339 ; GM 22339
• MDR Report Key: 16408609
• MDR Text Key: 309895323
• Report Number: 3004371426-2023-00008
• Device Sequence Number: 1
• Product Code: KRO
• UDI-Device Identifier: 04026575392285
• UDI-Public: 04026575392285
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K151008
• 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: 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?: No
• Device Operator: Health Professional
• Device Model Number: 16-2825/22
• Device Catalogue Number: 16-2825/22
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 02/06/2023
• Initial Date FDA Received: 02/21/2023
• Supplement Dates Manufacturer Received: 02/06/2023
• Supplement Dates FDA Received: 10/20/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/01/2021
• 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: 60 YR
• Patient Sex: Male
• Patient Weight: 113 KG