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

Model Number	880-305/22
Medical Device Problem Codes	Nonstandard Device (1420); Positioning Problem (3009)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/24/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The review of the histrory record showed no deviations.The product complies with the specifications valid at the time of manufacture.
Event or Problem Description
In a cck procedure, the scrub tech had an issue with the screw of the size 5-6, 10mm augment that was opened to be used.They stated that they thought the screw didn't have any threads.They had trouble getting the screw out but it didn't seem normal.They instead opened a size 3-4, 10 mm to use the screw from it and proceeded on with that screw.The process of trying to get the "bad" screw out and opening another implant to use it's screw took about 20 minutes.No debris was reported or patient harm.The original augment opened was implanted with the screw from the second implant opened.[customer].
Additional Manufacturer Narrative
This is the final supplemental report.The complaint is closed.
Event or Problem Description
In a cck procedure, the scrub tech had an issue with the screw of the size 5-6, 10mm augment that was opened to be used.They stated that they thought the screw didn't have any threads.They had trouble getting the screw out but it didn't seem normal.They instead opened a size 3-4, 10 mm to use the screw from it and proceeded on with that screw.The process of trying to get the "bad" screw out and opening another implant to use it's screw took about 20 minutes.No debris was reported or patient harm.The original augment opened was implanted with the screw from the second implant opened.[customer].

• Brand Name: LINKSYMPHOKNEE
• Common Device Name: DISTAL FEMORAL AUGMENT LATERAL-RIGHT/MEDIAL-LEFT, SZ. 5-6 TILASTAN®, CEMENTED
• Manufacturer (Section D): WALDEMAR LINK GMBH & CO. KG; barkhausenweg 10; hamburg, hamburg 22339 ; GM 22339
• Manufacturer Contact: lisa effe ; barkhausenweg 10; hamburg, hamburg 22339 ; GM 22339
• MDR Report Key: 21685937
• Report Number: 3004371426-2025-00013
• Device Sequence Number: 9308703
• Product Code: HRY
• UDI-Device Identifier: 04026575257287
• UDI-Public: 04026575257287
• 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
• Device Implanted Year: 2025
• 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): 02/25/2025

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 Model Number: 880-305/22
• Device Catalogue Number: 880-305/22
• Device Lot Number: 2151248
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/05/2025
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/25/2025
• Supplement Date Received by Manufacturer: 02/25/2025
• Initial Report FDA Received Date: 03/25/2025
• Supplement Report FDA Received Date: 04/17/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/01/2022
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 42 YR
• Patient Sex: Male