MAUDE Adverse Event Report: WALDEMAR LINK GMBH & CO. KG LINKSYMPHOKNEE; POSTERIOR FEMORAL AUGMENT MEDIAL-RIGHT/LATERAL-LEFT, SZ. 3-4 TILASTAN, CEMENTED

Model Number	880-313/11
Medical Device Problem Codes	Separation Failure (2547); Positioning Problem (3009)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/27/2024
Type of Reportable Event	Malfunction
Event or Problem Description
During the assembly phase, was not possibile to fix the screw of posterior femoral augment with the femoral component.After some try to fix, was opened another similar augment and was changed the screw.With the "new" screw, the augments was assembled with success.[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
During the assembly phase, was not possible to fix the screw of posterior femoral augment with the femoral component.After some try to fix, was opened another similar augment and was changed the screw.With the "new" screw, the augments was assembled with success.[customer].

• Brand Name: LINKSYMPHOKNEE
• Common Device Name: POSTERIOR FEMORAL AUGMENT MEDIAL-RIGHT/LATERAL-LEFT, SZ. 3-4 TILASTAN, CEMENTED
• Manufacturer (Section D): WALDEMAR LINK GMBH & CO. KG; barkhausenweg 10; barkhausenweg 10; hamburg, hamburg 22339 ; GM 22339
• Manufacturer Contact: lisa effe ; barkhausenweg 10; barkhausenweg 10; hamburg, hamburg 22339 ; GM 22339
• MDR Report Key: 18948606
• Report Number: 3004371426-2024-00027
• Device Sequence Number: 7078251
• Product Code: HRY
• UDI-Device Identifier: 04026575257621
• UDI-Public: 04026575257621
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• 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
• Report Date (Section B): 03/06/2024

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
• Device Model Number: 880-313/11
• Device Catalogue Number: 880-313/11
• Device Lot Number: 2227176
• 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: Not provided
• Supplement Date Received by Manufacturer: 03/06/2024
• Initial Report FDA Received Date: 03/21/2024
• Supplement Report FDA Received Date: 06/12/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/01/2022
• 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: 71 YR
• Patient Sex: Female