MAUDE Adverse Event Report: WALDEMAR LINK GMBH & CO. KG ENDO-MODEL - M; ROTATING HINGE, CEMENTED, LINK POREX, PRODUCT CODE: KRO

Model Number	15-3818/11
Medical Device Problem Codes	Inaccurate Delivery (2339); Device Handling Problem (3265)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	04/12/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
During a procedure on (b)(6) 2023, the incorrect prosthesis was supplied, and the intended nickelfree link rotating hinge prosthesis was not available in the operating room.Consequently, the surgeon had to use a temporary prosthesis and close the surgical site.On (b)(6) 2023, the patient had to undergo surgery again to place the correct prosthesis.[customer] (legal case).
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.
Event or Problem Description
During a procedure on (b)(6) 2023, the incorrect prosthesis was supplied, and the intended nickelfree link rotating hinge prosthesis was not available in the operating room.Consequently, the surgeon had to use a temporary prosthesis and close the surgical site.The patient then required a follow-up surgery on (b)(6) 2023, performed by dr.(b)(6) to place the correct prosthesis.[transmission smith & nephew] it was confirmed on (b)(6) 2024, that an incorrect side knee was ordered by the sales rep (right instead of left) for an (b)(6) 2023 surgery.(2 right-side parts were ordered and sent as ordered, see pn / lots above).It was only realized during the surgery, after the procedure had been started, that the incorrect implants had been ordered, and the procedure could not continue.Subsequent to this incomplete surgery, the correct parts were then ordered by the sales rep and the new order was sent.The patient had to return for the second surgery, where the correct left-side device was implanted on (b)(6) 2023.[customer].

• Brand Name: ENDO-MODEL - M
• Common Device Name: ROTATING HINGE, CEMENTED, LINK POREX, PRODUCT CODE: KRO
• Manufacturer (Section D): WALDEMAR LINK GMBH & CO. KG; barkhausenweg 10; hamburg, 22339 ; GM 22339
• Manufacturer Contact: andreas brandt ; barkhausenweg 10; hamburg, 22339 ; GM 22339
• MDR Report Key: 20210437
• Report Number: 3004371426-2024-00068
• Device Sequence Number: 7494136
• Product Code: KRO
• UDI-Device Identifier: 04026575164028
• UDI-Public: 04026575164028
• 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: Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/16/2024

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: 06/01/2022
• Device Model Number: 15-3818/11
• Device Catalogue Number: 15-3818/11
• 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: 08/16/2024
• Supplement Date Received by Manufacturer: 08/16/2024
• Initial Report FDA Received Date: 09/13/2024
• Supplement Report FDA Received Date: 03/26/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/01/2022
• 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: Male