MAUDE Adverse Event Report: WALDEMAR LINK GMBH & CO. KG ENDO-MODELL MODULAR; ENDO-M. MOD.ROTATIONKNEE, FEM. COMP.,W. PATELLAR FLANGE,MEDIUM, RIGHT

Model Number	15-2812/11
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Codes	Failure of Implant (1924); Pain (1994)
Date of Event	03/19/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
Femur hat sich vom schaft gelöst.Patient ist anscheinend so schon seit länger zeit rum gelaufen.Schaft war fest im zementmantel.[customer].Translation: femur has detached from the stem.
Event or Problem Description
Femur hat sich vom schaft gelöst.Patient ist anscheinend so schon seit länger zeit rum gelaufen.Schaft war fest im.Zementmantel.[customer].Translation: femur has detached from the stem.
Additional Manufacturer Narrative
The production records of ref: (b)(4) cannot be viewed and checked due to the missing serial number.This is the final supplemental report.The complaint is closed.

• Brand Name: ENDO-MODELL MODULAR
• Common Device Name: ENDO-M. MOD.ROTATIONKNEE, FEM. COMP.,W. PATELLAR FLANGE,MEDIUM, RIGHT
• Manufacturer (Section D): WALDEMAR LINK GMBH & CO. KG; barkhausenweg 10; barkhausenweg 10; hamburg, hamburg 22339 ; GM 22339
• Manufacturer Contact: andreas brandt ; barkhausenweg 10; barkhausenweg 10; hamburg, hamburg 22339 ; GM 22339
• MDR Report Key: 19077844
• Report Number: 3004371426-2024-00030
• Device Sequence Number: 17748439
• Product Code: KOR
• UDI-Device Identifier: 04026575253159
• UDI-Public: 04026575253159
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K143179
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2024
• 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): 03/20/2024

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: 15-2812/11
• Device Catalogue Number: 15-2812/11
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/27/2024
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/20/2024
• Supplement Date Received by Manufacturer: 03/20/2024
• Initial Report FDA Received Date: 04/10/2024
• Supplement Report FDA Received Date: 06/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/01/2024
• 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: 77 YR
• Patient Sex: Male