MAUDE Adverse Event Report: WALDEMAR LINK GMBH & CO. KG ENDO MODEL; TOTAL HINGE KNEE TIBIAL COMPONENT, NEUTRAL, MEDIUM COCRMO, WITH GROOVES

Model Number	15-2834/03
Medical Device Problem Codes	Component Missing (2306); Positioning Problem (3009)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/11/2024
Type of Reportable Event	Malfunction
Event or Problem Description
The femoral implant stop made of pe was missing.Another implant had to be opened.Issue was noticed before implantation.The implant was therefore not used.[customer].
Event or Problem Description
The femoral implant stop made of pe was missing.Another implant had to be opened.Issue was noticed before implantation.The implant was therefore not used.[customer].
Additional Manufacturer Narrative
The review of the histrory record showed no deviations.This is the final supplemental report.The complaint is closed.

• Brand Name: ENDO MODEL
• Common Device Name: TOTAL HINGE KNEE TIBIAL COMPONENT, NEUTRAL, MEDIUM COCRMO, WITH GROOVES
• Manufacturer (Section D): WALDEMAR LINK GMBH & CO. KG; barkhausenweg 10; barkhausenweg 10; hamburg, hamburg 22339 ; GM 22339
• Manufacturer Contact: tizia hucklenbroch ; barkhausenweg 10; barkhausenweg 10; hamburg, hamburg 22339 ; GM 22339
• MDR Report Key: 21394793
• Report Number: 3004371426-2025-00008
• Device Sequence Number: 12821619
• Product Code: KRO
• UDI-Device Identifier: 04026575316755
• UDI-Public: 04026575316755
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K143179
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• 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): 01/25/2025

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: 15-2834/03
• Device Catalogue Number: 15-2834/03
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/30/2025
• Supplement Date Received by Manufacturer: 01/30/2025
• Initial Report FDA Received Date: 02/18/2025
• Supplement Report FDA Received Date: 08/14/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/01/2022
• 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 Sex: Unknown