MAUDE Adverse Event Report: WALDEMAR LINK GMBH & CO.KG ENDO-MODEL ROTATIONAL KNEE PROSTHESIS; ENDO-MODEL ROTATIONAL KNEE PROSTHESIS, MODULAR, MODULAR STEM TI6AL4V, CEMENTLES

Model Number	15-2951/21
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Codes	Failure of Implant (1924); Unspecified Infection (1930)
Date of Event	06/27/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
Fracture of the cone of the tibial cementless stem.
Additional Manufacturer Narrative
The review of the device history record could not be conducted yet.
Additional Manufacturer Narrative
The review of the device history record could not be conducted yet.Update: the review of the device history record showed no deviations.The product complies with the specifications valid at the time of manufacture.This is the final supplemental report, the complaint is closed.
Event or Problem Description
Fracture of the cone of the tibial cementless stem.

• Brand Name: ENDO-MODEL ROTATIONAL KNEE PROSTHESIS
• Common Device Name: ENDO-MODEL ROTATIONAL KNEE PROSTHESIS, MODULAR, MODULAR STEM TI6AL4V, CEMENTLES
• 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: 18630300
• Report Number: 3004371426-2024-00010
• Device Sequence Number: 15426112
• Product Code: KRO
• UDI-Device Identifier: 04026575325993
• UDI-Public: 04026575325993
• 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 Explanted Year: 2023
• 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): 01/11/2024

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: 15-2951/21
• Device Catalogue Number: 15-2951/21
• Device Lot Number: 1511234
• 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: 01/11/2024
• Supplement Date Received by Manufacturer: 01/11/2024
• Initial Report FDA Received Date: 02/02/2024
• Supplement Report FDA Received Date: 10/25/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: 61 YR
• Patient Sex: Male