MAUDE Adverse Event Report: WALDEMAR LINK GMBH & CO. KG LINKSYMPHOKNEE; ARTICULATING SURFACE, SYMMETRIC, SZ. 5-6, UHMWPE CCK, FIXED, H= 10

Model Number	880-235/10
Medical Device Problem Code	Positioning Failure (1158)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/13/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The plateau could not be secured.Another plateau had to be opened to complete the surgery.
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
The plateau could not be secured.Another plateau had to be opened to complete the surgery.
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.
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.Update 09/18/2025: according to our initial information, the complaint sample was discarded and the case was closed based on the available information.After the complaint was closed, we were informed that the complaint sample was returned, which is why the case was reopened to examine the sample.This is the final supplemental report, the complaint is closed.
Event or Problem Description
The plateau could not be secured.Another plateau had to be opened to complete the surgery.

• Brand Name: LINKSYMPHOKNEE
• Common Device Name: ARTICULATING SURFACE, SYMMETRIC, SZ. 5-6, UHMWPE CCK, FIXED, H= 10
• 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: 22465740
• Report Number: 3004371426-2025-00032
• Device Sequence Number: 8112852
• Product Code: HRY
• UDI-Device Identifier: 04026575254514
• UDI-Public: 04026575254514
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K202924
• 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,Followup
• Report Date (Section B): 06/24/2025

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 Model Number: 880-235/10
• Device Catalogue Number: 880-235/10
• Device Lot Number: 2136161
• 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: 06/24/2025
• Supplement Date Received by Manufacturer: 06/24/2025; 06/24/2025
• Initial Report FDA Received Date: 07/10/2025
• Supplement Report FDA Received Date: 07/31/2025; 09/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/01/2022
• 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
• Patient Age: 61 YR
• Patient Sex: Male