MAUDE Adverse Event Report: WALDEMAR LINK GMBH & CO. KG ENDO-MODEL SADDLE PROSTHESIS

Model Number	99-8007/13
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Joint Laxity (4526)
Type of Reportable Event	Serious Injury
Event or Problem Description
Notified by (b)(6).That a saddle prothesis implanted in 2019 by dr (b)(6).Will require a revision using a compassionate use part (2026-0241), with dr.(b)(6).Dr.(b)(6) believes the part is disassociated.

• Brand Name: ENDO-MODEL SADDLE PROSTHESIS
• Common Device Name: ENDO-MODEL SADDLE PROSTHESIS
• Manufacturer (Section D): WALDEMAR LINK GMBH & CO. KG; barkhausenweg 10; hamburg, 22339 ; GM 22339
• MDR Report Key: 25725437
• Report Number: 3006721341-2026-00014
• Device Sequence Number: 5675688
• Product Code: KWL
• UDI-Device Identifier: 04026575401482
• UDI-Public: 04026575401482
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Serviced by Third Party (Y/N): N
• Reporter Type: Importer
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 07/06/2026
• Report Date (Section F): 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?: Yes
• Device Model Number: 99-8007/13
• Device Catalogue Number: 99-8007/13
• Device Lot Number: 130820
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 06/11/2026
• Device Age: 7 YR
• Event Location: Hospital
• Date Report to Manufacturer: 06/12/2026
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/06/2026
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 36 YR
• Patient Sex: Female
• Patient Weight: 75 KG