MAUDE Adverse Event Report: WALDEMAR LINK GMBH & CO. KG ENDO-MODEL - M; ROTATIONAL KNEE PROSTHESIS, KNEE-JOINT PROSTHESIS LEFT, SMALL, COCRMO/TINBN

Model Number	15-3816/12
Medical Device Problem Codes	Unstable (1667); Malposition of Device (2616)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	10/03/2023
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
(b)(6) was notified that (b)(6) that a revision surgery occurred on (b)(6) 2023 with dr.(b)(6) because there seemed to be too much internal rotation of the femoral component.[customer].
Event or Problem Description
L.B was notified that j.B.That a revision surgery occurred on (b)(6) 2023 with dr.D.L.Because there seemed to be too much internal rotation of the femoral component.[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.

• Brand Name: ENDO-MODEL - M
• Common Device Name: ROTATIONAL KNEE PROSTHESIS, KNEE-JOINT PROSTHESIS LEFT, SMALL, COCRMO/TINBN
• Manufacturer (Section D): WALDEMAR LINK GMBH & CO. KG; barkhausenweg 10; hamburg, hamburg 22339 ; GM 22339
• Manufacturer Contact: andreas brandt ; barkhausenweg 10; hamburg, hamburg 22339 ; GM 22339
• MDR Report Key: 18064119
• Report Number: 3004371426-2023-00104
• Device Sequence Number: 17998943
• Product Code: KRO
• UDI-Device Identifier: 04026575034758
• UDI-Public: 04026575034758
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: K212742
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/04/2023

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
• Device Model Number: 15-3816/12
• Device Catalogue Number: 15-3816/12
• 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: 10/04/2023
• Supplement Date Received by Manufacturer: 10/04/2023
• Initial Report FDA Received Date: 11/03/2023
• Supplement Report FDA Received Date: 03/15/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/01/2023
• 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: 59 YR
• Patient Sex: Female