MAUDE Adverse Event Report: WALDEMAR LINK GMBH & CO. KG LINK OPTISTEM; LINK OPTISTEM, ADAPTER, FOR ENDO-MODEL SL/ LINK ENDO-MODEL EVO-W, COCRMO, SHORT,

Model Number	17-1000/05
Medical Device Problem Code	Unintended Movement (3026)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	02/24/2026
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 that a revision took place with dr.(b)(6).On (b)(6) 2026, for products implanted on (b)(6) 2025 as the femur was externally rotated.The representative stated that during the on (b)(6) 2026 revision the femur was indeed found to be externally rotated.During the revision, the screws were removed from each side of the femur and the adapter started spinning once the femur was separated.[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 that a revision took place with dr.(b)(6) on (b)(6) 2026 for products implanted on (b)(6) 2025 as the femur was externally rotated.The representative stated that during the (b)(6) 2026 revision the femur was indeed found to be externally rotated.During the revision, the screws were removed from each side of the femur and the adapter started spinning once the femur was separated.[customer].

• Brand Name: LINK OPTISTEM
• Common Device Name: LINK OPTISTEM, ADAPTER, FOR ENDO-MODEL SL/ LINK ENDO-MODEL EVO-W, COCRMO, SHORT,
• Manufacturer (Section D): WALDEMAR LINK GMBH & CO. KG; barkhausenweg 10; hamburg, 22339 ; GM 22339
• Manufacturer Contact: tizia hucklenbroch ; barkhausenweg 10; hamburg, 22339 ; GM 22339
• MDR Report Key: 24659615
• Report Number: 3004371426-2026-00019
• Device Sequence Number: 12041513
• Product Code: KRO
• UDI-Device Identifier: 04026575284566
• UDI-Public: 04026575284566
• 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: 2026
• 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): 02/24/2026

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: 17-1000/05
• Device Catalogue Number: 17-1000/05
• Device Lot Number: 2502313
• 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: 02/24/2026
• Supplement Date Received by Manufacturer: 02/24/2026
• Initial Report FDA Received Date: 03/23/2026
• Supplement Report FDA Received Date: 03/30/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/01/2025
• 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: 57 YR
• Patient Sex: Male