MAUDE Adverse Event Report: WALDEMAR LINK GMBH & CO.KG ENDO-MODEL KNEE SYSTEM / LINK ENDO-MODEL EVO KNEE; ENDO-MODEL -M, MODULAR STEMS, UNCEMENTED, TI6AL4V, CYLINDRICAL L= 280 MM, Ø=18 M

Model Number	15-2951/25
Medical Device Problem Code	Osseointegration Problem (3003)
Health Effect - Clinical Codes	Insufficient Information (4580); Aseptic loosening (4883); Periprosthetic fracture (4902)
Date of Event	10/03/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
Notified by j.C.That a patient with a fusion nail has loosening of the implant.Implanted on (b)(6) 2023.Currently, no event date known.Possible revision with a custom device.Updated 2024-10-07: event date added, as 2024-10-03, when representative received a call from dr.I.; confirmation that the femoral stem is loose in the proximal femur - product name and product combined with sections update; no other information is currently available for the patient except for the dr.Stating that the patient is obese.Waiting response on availability op report.[customer].
Additional Manufacturer Narrative
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
Notified by (b)(6).That a patient with a fusion nail has loosening of the implant.Implated on (b)(6) 2023.Currently, no event date known.Possible revision with a custom device.Updated 2024-10-07: event date added, as 2024-10-03, when representative received a call from dr.(b)(6); confirmation that the femoral stem is loose in the proximal femur - product name and product combined with sections update; no other information is currently available for the patient except for the dr.Stating that the patient is obese.Waiting response on availability op report.[customer].

• Brand Name: ENDO-MODEL KNEE SYSTEM / LINK ENDO-MODEL EVO KNEE
• Common Device Name: ENDO-MODEL -M, MODULAR STEMS, UNCEMENTED, TI6AL4V, CYLINDRICAL L= 280 MM, Ø=18 M
• Manufacturer (Section D): WALDEMAR LINK GMBH & CO.KG; barkhausenweg 10; hamburg 22339 ; GM 22339
• Manufacturer Contact: annerike-tizia hucklenbroch ; barkhausenweg 10; hamburg, hamburg 22339 ; GM 22339
• MDR Report Key: 20554255
• Report Number: 3004371426-2024-00073
• Device Sequence Number: 11569301
• Product Code: KRO
• UDI-Device Identifier: 04026575326037
• UDI-Public: 04026575326037
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: K143179
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/04/2024

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 Expiration Date: 07/31/2023
• Device Model Number: 15-2951/25
• Device Catalogue Number: 15-2951/25
• Device Lot Number: 1819048
• 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: 10/04/2024
• Supplement Date Received by Manufacturer: 10/04/2024
• Initial Report FDA Received Date: 10/29/2024
• Supplement Report FDA Received Date: 09/05/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/01/2018
• 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: 69 YR
• Patient Sex: Female