MAUDE Adverse Event Report: WALDEMAR LINK GMBH & CO. KG MEGA C MODULAR STEM - CEMENTLESS

Model Number 15-8522/60

Device Problem Detachment of Device or Device Component (2907)

Patient Problem Limb Fracture (4518)

Event Date 01/18/2023

Event Type  Injury  

Event Description

Patient presented with the femoral stem disassociated from the femoral component.There is a fracture in the distal femur.It is unknown if this occurred prior to (or after) the stem disassociating from the femoral component.

• Brand Name: MEGA C MODULAR STEM - CEMENTLESS
• Type of Device: MEGA C MODULAR STEM - CEMENTLESS
• Manufacturer (Section D): WALDEMAR LINK GMBH & CO. KG; barkhausenweg 10; hamburg, 22339 ; GM 22339
• MDR Report Key: 16409761
• MDR Text Key: 309889695
• Report Number: 3006721341-2023-00003
• Device Sequence Number: 1
• Product Code: KRO
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/01/2023,02/21/2023

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?: Yes
• Device Operator: Health Professional
• Device Model Number: 15-8522/60
• Device Catalogue Number: 15-8522/60
• Device Lot Number: 1950034
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 01/26/2023
• Device Age: 11 MO
• Event Location: Hospital
• Date Report to Manufacturer: 02/01/2023
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/21/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 47 YR
• Patient Sex: Male