MAUDE Adverse Event Report: WALDEMAR LINK GMBH & CO. KG LINK ENDO-MODEL EVO; MODULAR JOINT COMPONENT, FEMORAL COMPONENT, UNCEMENTED, CONDYLAR REPLACEMENT

Model Number	15-8541/10
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	12/18/2025
Type of Reportable Event	Serious Injury
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.
Event or Problem Description
Notified by representative (b)(6) that a surgery was performed on (b)(6) 2025 using an endo evo w with an optistem adaptor, and it became disassociated a few weeks later and had to be revised.The representative stated that when the revision of the components took place, they noticed that the set screw was not used in the femoral component and optistem adaptor junction.A revision occurred on (b)(6) 2025 without any issues when the set screw was used.[customer].
Event or Problem Description
Notified by representative (b)(6) that a surgery was performed on (b)(6) 2025 using an endo evo w with an optistem adaptor, and it became disassociated a few weeks later and had to be revised.The representative stated that when the revision of the components took place, they noticed that the set screw was not used in the femoral component and optistem adaptor junction.A revision occurred on (b)(6) 2025 without any issues when the set screw was used.[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.

• Brand Name: LINK ENDO-MODEL EVO
• Common Device Name: MODULAR JOINT COMPONENT, FEMORAL COMPONENT, UNCEMENTED, CONDYLAR REPLACEMENT
• Manufacturer (Section D): WALDEMAR LINK GMBH & CO. KG; barkhausenweg 10; hamburg, 22339 ; GM 22339
• Manufacturer Contact: lisa effe ; barkhausenweg 10; hamburg, 22339 ; GM 22339
• MDR Report Key: 24289896
• Report Number: 3004371426-2026-00008
• Device Sequence Number: 9426509
• Product Code: KRO
• UDI-Device Identifier: 04026575223657
• UDI-Public: 04026575223657
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: K220628
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Device Explanted Year: 2025
• 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): 01/14/2026

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: 15-8541/10
• Device Catalogue Number: 15-8541/10
• 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: 01/14/2026
• Supplement Date Received by Manufacturer: 01/14/2026
• Initial Report FDA Received Date: 02/09/2026
• Supplement Report FDA Received Date: 02/27/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/01/2025
• 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: 48 YR
• Patient Sex: Male