MAUDE Adverse Event Report: WALDEMAR LINK GMBH & CO. KG MEGASYSTEM C; MEGASYSTEM-C, MODULAR STEM TILASTAN, CEMENTLESS, STEM-L. 130 Ø 23

Model Number 15-8523/61

Device Problem Fracture (1260)

Patient Problem Failure of Implant (1924)

Event Date 08/02/2022

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.

Event Description

Taper fracture of the mega c stem.

Manufacturer Narrative

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

Event Description

Taper fracture of the mega c stem.

• Brand Name: MEGASYSTEM C
• Type of Device: MEGASYSTEM-C, MODULAR STEM TILASTAN, CEMENTLESS, STEM-L. 130 Ø 23
• 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: 15346824
• MDR Text Key: 299142909
• Report Number: 3004371426-2022-00035
• Device Sequence Number: 1
• Product Code: KRO
• UDI-Device Identifier: 04026575384204
• UDI-Public: 04026575384204
• 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,User Facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 08/11/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/02/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2024
• Device Model Number: 15-8523/61
• Device Catalogue Number: 15-8523/61
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/11/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/01/2019
• 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