MAUDE Adverse Event Report: WALDEMAR LINK GMBH & CO. KG MEGASYSTEM-C; MEGASYSTEM-C, MODULAR STEM TILASTAN, CEMENTLESS, STEM-L. 160 Ø 22

Model Number 15-8522/60

Device Problem Detachment of Device or Device Component (2907)

Patient Problems Bone Fracture(s) (1870); Failure of Implant (1924)

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.

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.

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: MEGASYSTEM-C
• Type of Device: MEGASYSTEM-C, MODULAR STEM TILASTAN, CEMENTLESS, STEM-L. 160 Ø 22
• Manufacturer (Section D): WALDEMAR LINK GMBH & CO. KG; barkhausenweg 10; hamburg, 22339 ; GM 22339
• Manufacturer Contact: lisa effe ; barkhausenweg 10; hamburg, 22339 ; GM 22339
• MDR Report Key: 16471495
• MDR Text Key: 310548913
• Report Number: 3004371426-2023-00010
• Device Sequence Number: 1
• Product Code: KRO
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K151008
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Distributor
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 02/01/2023

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: 15-8522/60
• Device Catalogue Number: 15-8522/60
• Device Lot Number: 1950034
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 02/01/2023
• Initial Date FDA Received: 03/02/2023
• Supplement Dates Manufacturer Received: 02/01/2023
• Supplement Dates FDA Received: 06/02/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/01/2020
• 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: 48 YR
• Patient Sex: Male