MAUDE Adverse Event Report: WALDEMAR LINK GMBH & CO. KG MEGASYSTEM C; DISTAL FEMUR REPLACEMENT COMPONENT

Model Number 16-2855/21

Device Problems Fracture (1260); Unstable (1667); Detachment of Device or Device Component (2907)

Patient Problem Failure of Implant (1924)

Event Date 02/21/2023

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.On (b)(6) 2023 we recognized that the day of awareness of the german sales represantive was (b)(6) 2023 instead of (b)(6) 2023 this explains the delay.

Event Description

Axis components in soft tissues.

Manufacturer Narrative

The review of the device history record showed no deviations.The product complies with the specifications valid at the time of manufacture.This is the final supplemental report, the complaint is closed.

Event Description

Axis components in soft tissues.

• Brand Name: MEGASYSTEM C
• Type of Device: DISTAL FEMUR REPLACEMENT COMPONENT
• Manufacturer (Section D): WALDEMAR LINK GMBH & CO. KG; barkhausenweg 10; hamburg, 22339 ; GM 22339
• Manufacturer Contact: andreas brandt ; barkhausenweg 10; hamburg, 22339 ; GM 22339
• MDR Report Key: 16683153
• MDR Text Key: 312709016
• Report Number: 3004371426-2023-00022
• Device Sequence Number: 1
• Product Code: KRO
• UDI-Device Identifier: 04026575383320
• UDI-Public: 04026575383320
• 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: 02/27/2023

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 Expiration Date: 04/30/2020
• Device Model Number: 16-2855/21
• Device Catalogue Number: 16-2855/21
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 02/27/2023
• Initial Date FDA Received: 04/05/2023
• Supplement Dates Manufacturer Received: 02/27/2023
• Supplement Dates FDA Received: 01/29/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/01/2015
• 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
• Patient Age: 76 YR
• Patient Sex: Male