MAUDE Adverse Event Report: WALDEMAR LINK GMBH & CO. KG LINKSYMPHOKNEE; LINKSYMPHOKNEE SYSTEM, TIBIAL COMPONENT, MODULAR, SYMMETRIC, SZ. 5, COCRMO/TINBN

Model Number	880-100/50
Medical Device Problem Code	Nonstandard Device (1420)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/18/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A recall of affected devices will be conducted under r-2025-05.
Event or Problem Description
When assembling the modular tibia, it was found that the tibial component had been delivered with two incorrect, uncoated security screws.This was detected prior to implantation, so the second unused coated screw from the femoral component was used instead.[customer].
Event or Problem Description
When assembling the modular tibia, it was found that the tibial component had been delivered with two incorrect, uncoated security screws.This was detected prior to implantation, so the second unused coated screw from the femoral component was used instead.[customer].
Additional Manufacturer Narrative
A recall of affected devices will be conducted under r-2025-05.This is the final supplemental report, the complaint is closed.

• Brand Name: LINKSYMPHOKNEE
• Common Device Name: LINKSYMPHOKNEE SYSTEM, TIBIAL COMPONENT, MODULAR, SYMMETRIC, SZ. 5, COCRMO/TINBN
• 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: 22640372
• Report Number: 3004371426-2025-00039
• Device Sequence Number: 9695467
• Product Code: HRY
• UDI-Device Identifier: 04026575251278
• UDI-Public: 04026575251278
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K202924
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• 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,Followup
• Report Date (Section B): 07/18/2025

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: 880-100/50
• Device Catalogue Number: 880-100/50
• 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: 07/18/2025
• Supplement Date Received by Manufacturer: 07/18/2025
• Initial Report FDA Received Date: 07/29/2025
• Supplement Report FDA Received Date: 08/26/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/01/2025
• 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: Unknown