MAUDE Adverse Event Report: WALDEMAR LINK GMBH & CO. KG ENDO MODEL SL; MODULAR STEM, OVAL SZ. 4, TILASTAN , CEMENTLESS, L= 100 MM, W= 32 MM

Model Number	17-1100/04
Medical Device Problem Codes	Detachment of Device or Device Component (2907); Osseointegration Problem (3003)
Health Effect - Clinical Code	Pain (1994)
Date of Event	03/18/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The review of the history record showed no deviations.The product complies with the specifications valid at the time of manufacture.
Event or Problem Description
Intracondylar detachment of the femur from the optistem stem cone.[customer].
Event or Problem Description
Intracondylar detachment of the femur from the optistem stem cone.[customer].
Additional Manufacturer Narrative
The review of the 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.

• Brand Name: ENDO MODEL SL
• Common Device Name: MODULAR STEM, OVAL SZ. 4, TILASTAN , CEMENTLESS, L= 100 MM, W= 32 MM
• Manufacturer (Section D): WALDEMAR LINK GMBH & CO. KG; barkhausenweg 10; hamburg, hamburg 22339 ; GM 22339
• Manufacturer Contact: andreas brandt ; barkhausenweg 10; hamburg, hamburg 22339 ; GM 22339
• MDR Report Key: 21812000
• Report Number: 3004371426-2025-00017
• Device Sequence Number: 21034667
• Product Code: KRO
• UDI-Device Identifier: 04026575282944
• UDI-Public: 04026575282944
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K220628
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2025
• 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): 03/19/2025

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
• Device Expiration Date: 06/30/2026
• Device Model Number: 17-1100/04
• Device Catalogue Number: 17-1100/04
• Device Lot Number: 2031169
• 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: 03/19/2025
• Supplement Date Received by Manufacturer: 03/19/2025
• Initial Report FDA Received Date: 04/10/2025
• Supplement Report FDA Received Date: 07/29/2025
• Date Device Manufactured: 07/01/2021
• 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: 67 YR
• Patient Sex: Male