MAUDE Adverse Event Report: WALDEMAR LINK GMBH & CO. KG LINKSYMPHOKNEE; TIBIAL COMPONENT, MODULAR, SYMMETRIC, SZ. 3, COCRMO/TINBN, CEMENTED, FIXED

Model Number	880-100/30
Medical Device Problem Code	Positioning Failure (1158)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/28/2025
Type of Reportable Event	Malfunction
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
As described by (b)(6) on (b)(6) 2025, during a revision knee case on (b)(6) 2025, the surgeon was assembling the implants and the press fit stem would not seat into the modular tibia taper.The cone adapter appeared fully seated, so the surgeon thought it might be the stem that had the issue.Another stem was retrieved, which caused only a slight delay, but that part also had the seating issue.The surgeon thought then that the issue may be the cone adapter on the tibia, so he broke it off and impacted the stem onto the tibial taper.Both were then implanted into the patient with no issue.[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.Update 12/08/2025: based on the available information and the surgeon's opinion, the cone adapter is suspected to be the cause of the problem.The main medical device has been changed from the modular stem to the tibial component.
Event or Problem Description
As described by f.K.On 11/3/25, during a revision knee case on (b)(6) 2025, the surgeon was assembling the implants and the press fit stem would not seat into the modular tibia taper.The cone adapter appeared fully seated so the surgeon thought it might be the stem that had the issue.Another stem was retrieved, which caused only a slight delay, but that part also had the seating issue.The surgeon thought then that the issue may be the cone adapter on the tibia, so he broke it off and impacted the stem onto the tibial taper.Both were then implanted into the patient with no issue.[customer].

• Brand Name: LINKSYMPHOKNEE
• Common Device Name: TIBIAL COMPONENT, MODULAR, SYMMETRIC, SZ. 3, COCRMO/TINBN, CEMENTED, FIXED
• 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: 23702269
• Report Number: 3004371426-2025-00056
• Device Sequence Number: 13410535
• Product Code: HRY
• UDI-Device Identifier: 04026575251254
• UDI-Public: 04026575251254
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• 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: Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/03/2025

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: 880-100/30
• Device Catalogue Number: 880-100/30
• Device Lot Number: 2004297
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/14/2025
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/03/2025
• Supplement Date Received by Manufacturer: 11/03/2025
• Initial Report FDA Received Date: 12/03/2025
• Supplement Report FDA Received Date: 12/15/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/01/2021
• 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: 85 YR
• Patient Sex: Female