MAUDE Adverse Event Report: WALDEMAR LINK GMBH & CO. KG LINKSYMPHOKNEE; DISTAL FEMORAL AUGMENT MEDIAL-RIGHT/LATERAL-LEFT, SZ. 5-6 TILASTAN®, CEMENTED, H

Model Number	880-305/11
Medical Device Problem Codes	Positioning Failure (1158); Positioning Problem (3009)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/18/2025
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
Reported by (b)(6), that the surgeon had an issue connecting the screw of the augment.He was sure that the screw had threads, so it may have been a user issue.Under a 5 minute delay in the procedure.No patient harm.A different part (880-315/11) was used instead.The representative commented that he later used the augment on a sample femur to test it and had no issue with the screw or connection.[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.This is the final supplemental report, the complaint is closed.
Event or Problem Description
Reported by (b)(6) that the surgeon had an issue connecting the screw of the augment.He was sure that the screw had threads, so it may have been a user issue.Under a 5 minute delay in the procedure.No patient harm.A different part (880-315/11) was used instead.The representative commented that he later used the augment on a sample femur to test it and had no issue with the screw or connection.[customer].

• Brand Name: LINKSYMPHOKNEE
• Common Device Name: DISTAL FEMORAL AUGMENT MEDIAL-RIGHT/LATERAL-LEFT, SZ. 5-6 TILASTAN®, CEMENTED, H
• 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: 23263998
• Report Number: 3004371426-2025-00045
• Device Sequence Number: 21377517
• Product Code: HRY
• UDI-Device Identifier: 04026575257256
• UDI-Public: 04026575257256
• 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): 09/19/2025

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: 880-305/11
• Device Catalogue Number: 880-305/11
• Device Lot Number: 2235214
• 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: 09/19/2025
• Supplement Date Received by Manufacturer: 09/19/2025
• Initial Report FDA Received Date: 10/10/2025
• Supplement Report FDA Received Date: 11/10/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/01/2023
• 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: 88 YR
• Patient Sex: Unknown