MAUDE Adverse Event Report: WALDEMAR LINK GMBH & CO. KG ENDO-MODEL ROTATIONAL KNEE PROSTHESIS, MODULAR; FEMORAL SEGMENT, RIGHT, LARGE, TI6AL4V H 80, W 75

Model Number	15-2979/02
Medical Device Problem Code	Difficult or Delayed Positioning (1157)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/14/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
New classification as recall class ii as per information of 30 june 2023 and therewith classified as reportable.In 2021 it was recorded and performed under recall class iii.
Event or Problem Description
Difficult or delayed positioning of femoral segment [customer].

• Brand Name: ENDO-MODEL ROTATIONAL KNEE PROSTHESIS, MODULAR
• Common Device Name: FEMORAL SEGMENT, RIGHT, LARGE, TI6AL4V H 80, W 75
• Manufacturer (Section D): WALDEMAR LINK GMBH & CO. KG; barkhausenweg 10; hamburg, 22339 ; GM 22339
• Manufacturer Contact: annerike-tizia hucklenbroch ; barkhausenweg 10; hamburg, 22339 ; GM 22339
• MDR Report Key: 17413429
• Report Number: 3004371426-2023-00065
• Device Sequence Number: 17937545
• Product Code: KRO
• UDI-Device Identifier: 04026575328109
• UDI-Public: 04026575328109
• Combination Product (Y/N): N
• Initial Reporter Country: AU
• PMA/510(K) Number: K143179
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Other
• Remedial Action: Recall
• Type of Report: Initial
• Report Date (Section B): 09/14/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 07/31/2025
• Device Model Number: 15-2979/02
• Device Catalogue Number: 15-2979/02
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/14/2020
• Initial Report FDA Received Date: 07/28/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/01/2020
• 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
• Patient Sex: Male