MAUDE Adverse Event Report: WALDEMAR LINK GMBH & CO.KG MEGASYSTEM-C TUMOR- AND REVISION SYSTEM; COUPLING FOR DIA-PHYSEAL SPACER,LINK® MEGASYSTEM-C,,TILASTAN

Model Number	15-8522/65
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Codes	Failure of Implant (1924); Insufficient Information (4580)
Date of Event	12/19/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
Ultimately, according to the diagnostic report, the cone of the proximal stem with the femoral shaft diaphyseal partial replacement on the right broke on december 8, 2023 without external influence and should be sent to you for examination.On (b)(6) 2023 my right thigh was fitted with the following prosthesis model from your company link.Stem element 100mm and coupling proximal femur long 30mm and body 126° xxl 65mm with 20mm recess ring and 61mm expansion screw as well as l-head 22mm ceramic and cup bi mobile 56mm.[excerpt from patient letter].
Additional Manufacturer Narrative
Article number was only available for a combined article, but not for the affected article.This is the final supplemental report, the complaint is closed.
Event or Problem Description
Ultimately, according to the diagnostic report, the cone of the proximal stem with the femoral shaft diaphyseal partial replacement on the right broke on (b)(6) 2023 without external influence and should be sent to you for examination.On (b)(6) 2023 my right thigh was fitted with the following prosthesis model from your company link.Stem element 100mm and coupling proximal femur long 30mm and body 126° xxl 65mm with 20mm recess ring and 61mm expansion screw as well as l-head 22mm ceramic and cup bi mobile 56mm.[excerpt from patient letter].

• Brand Name: MEGASYSTEM-C TUMOR- AND REVISION SYSTEM
• Common Device Name: COUPLING FOR DIA-PHYSEAL SPACER,LINK® MEGASYSTEM-C,,TILASTAN
• 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: 19259021
• Report Number: 3004371426-2024-00039
• Device Sequence Number: 14124564
• Product Code: KRO
• UDI-Device Identifier: 04026575384068
• UDI-Public: 04026575384068
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K151008
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/18/2024

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: 15-8522/65
• Device Catalogue Number: 15-8522/65
• Device Lot Number: 2248002
• 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: 04/18/2024
• Supplement Date Received by Manufacturer: 04/18/2024
• Initial Report FDA Received Date: 05/07/2024
• Supplement Report FDA Received Date: 09/26/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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 Sex: Male