MAUDE Adverse Event Report: WALDEMAR LINK GMBH & CO. KG ENDO-MODEL SADDLE PROSTHESIS; ENDO-MODEL SLED PROSTHESIS, SADDLE SEGMENT, WITH SUTURE HOLE, UHMWPE, COCRMO,

Model Number	99-8007/13
Medical Device Problem Code	Unintended Movement (3026)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	06/11/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The production records have been inspected and reviewed.Additional steps have been taken to release the product.
Event or Problem Description
"notifed by (b)(6) that a saddle prothesis implanted in 2019 by dr.(b)(6), will require a revision using a compassionate use part, with dr.(b)(6).Dr.(b)(6) provided some information on (b)(6) 2026 as to whether he believed the device caused the need for a revision.He believes the part is disassociated." [customer].

• Brand Name: ENDO-MODEL SADDLE PROSTHESIS
• Common Device Name: ENDO-MODEL SLED PROSTHESIS, SADDLE SEGMENT, WITH SUTURE HOLE, UHMWPE, COCRMO,
• 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: 25758418
• Report Number: 3004371426-2026-00056
• Device Sequence Number: 13379946
• Product Code: KWL
• UDI-Device Identifier: 04026575401482
• UDI-Public: 04026575401482
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: K951355
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 06/12/2026

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 Expiration Date: 02/28/2022
• Device Model Number: 99-8007/13
• Device Catalogue Number: 99-8007/13
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/12/2026
• Initial Report FDA Received Date: 07/09/2026
• Date Device Manufactured: 02/01/2017
• 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: 36 YR
• Patient Sex: Female