MAUDE Adverse Event Report: WALDEMAR LINK GMBH & CO. KG MEGASYSTEM-C; STEM SEGMENT TILASTAN, L 30, Ø 28

Model Number	15-8522/02
Medical Device Problem Codes	Fracture (1260); Separation Failure (2547)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	04/18/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
Cold fusion between stem and stem segment.
Event or Problem Description
Cone fracture and cold fusion between stem and stem segment.
Additional Manufacturer Narrative
The review of the device history record was not possible due to the missing lot number.This is the final supplemental report, the complaint is closed.

• Brand Name: MEGASYSTEM-C
• Common Device Name: STEM SEGMENT TILASTAN, L 30, Ø 28
• Manufacturer (Section D): WALDEMAR LINK GMBH & CO. KG; barkhausenweg 10; hamburg, 22339 ; GM 22339
• Manufacturer Contact: annerike tizia hucklenbroch ; barkhausenweg 10; hamburg, 22339 ; GM 22339
• MDR Report Key: 17076880
• Report Number: 3004371426-2023-00049
• Device Sequence Number: 14000308
• Product Code: KRO
• UDI-Device Identifier: 04026575383535
• UDI-Public: 04026575383535
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: K151008
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/25/2023

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
• Operator of Device: Health Professional
• Device Model Number: 15-8522/02
• Device Catalogue Number: 15-8522/02
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/25/2023
• Supplement Date Received by Manufacturer: 05/25/2023
• Initial Report FDA Received Date: 06/07/2023
• Supplement Report FDA Received Date: 03/20/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 65 YR
• Patient Sex: Unknown