MAUDE Adverse Event Report: WALDEMAR LINK GMBH & CO.KG LINK SLED PROSTHESIS; LINK SLED, TIBIAL PLATEAU ANATOMICAL, UHMWPE, COCRMO CEMENTED, METAL-BACKED

Model Number	15-2030/13
Medical Device Problem Codes	Degraded (1153); Naturally Worn (2988)
Health Effect - Clinical Codes	Failure of Implant (1924); Pain (1994)
Date of Event	02/27/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
Our client had a cemented sled prosthesis inserted on the right we enclose the surgical report and the x-rays.We enclose a copy of the implant id.Postoperatively; our client experienced pain in her right knee after some time.However, due to the pandemic, an arthroscopy of the right knee joint was not performed until (b)(6) 2023 to clarify the cause of the complaints.This revealed the indication for a prosthesis change due to prosthesis failure.
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
Our client had a cemented sled prosthesis inserted on the right we enclose the surgical report and the x-rays.We enclose a copy of the implant id.Postoperatively, our client experienced pain in her right knee after some time.However, due to the pandemic, an arthroscopy of the right knee joint was not performed until february 27, 2023 to clarify the cause of the complaints.This revealed the indication for a prosthesis change due to prosthesis failure.[customer].

• Brand Name: LINK SLED PROSTHESIS
• Common Device Name: LINK SLED, TIBIAL PLATEAU ANATOMICAL, UHMWPE, COCRMO CEMENTED, METAL-BACKED
• Manufacturer (Section D): WALDEMAR LINK GMBH & CO.KG; barkhausenweg 10; hamburg, hamburg 22339 ; GM 22339
• Manufacturer Contact: annerike-tizia hucklenbroch ; barkhausenweg 10; hamburg, hamburg 22339 ; GM 22339
• MDR Report Key: 20743413
• Report Number: 3004371426-2024-00075
• Device Sequence Number: 21021608
• Product Code: HSX
• UDI-Device Identifier: 04026575436705
• UDI-Public: 04026575436705
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K954186
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2024
• 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): 10/22/2024

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: 01/31/2020
• Device Model Number: 15-2030/13
• Device Catalogue Number: 15-2030/13
• 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: 10/22/2024
• Supplement Date Received by Manufacturer: 10/22/2024
• Initial Report FDA Received Date: 11/21/2024
• Supplement Report FDA Received Date: 05/06/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/01/2015
• 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: 75 YR
• Patient Sex: Female