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

Device Problem Separation Failure (2547)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/27/2024

Event Type  malfunction  

Event 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].

• Brand Name: LINKSYMPHOKNEE
• Type of Device: POSTERIOR FEMORAL AUGMENT MEDIAL-RIGHT/LATERAL-LEFT, SZ. 3-4 TILASTAN, CEMENTED
• Manufacturer (Section D): WALDEMAR LINK GMBH & CO.KG; barkhausenweg 10; hamburg, hamburg 22339 ; GM 22339
• Manufacturer Contact: andreas brandt ; barkhausenweg 10; hamburg, hamburg 22339 ; GM 22339
• MDR Report Key: 18948606
• MDR Text Key: 339094695
• Report Number: 3004371426-2024-00027
• Device Sequence Number: 1
• Product Code: HRY
• UDI-Device Identifier: 04026575257621
• UDI-Public: 04026575257621
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: K202924
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/06/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/21/2024
• 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?: No
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 71 YR
• Patient Sex: Female