MAUDE Adverse Event Report: WALDEMAR LINK GMBH & CO. KG LINKSYMPHOKNEE; LINKSYMPHOKNEE SYSTEM, L-SHAPED FEMORAL AUGMENT MEDIAL-RIGHT/LATERAL-LEFT,

Model Number 880-325/13

Device Problem Nonstandard Device (1420)

Patient Problems Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/18/2023

Event Type  malfunction  

Event Description

Notice from distributor - 2 parts received and opened at (b)(6) 2023 surgery, did not match the product box labeling.Samples received and being sent to manufacturer.Notice of no consequence to the patient.

Manufacturer Narrative

The production records have been inspected and reviewed.

Event Description

Notice from distributor - 2 parts received and opened at (b)(6) 2023 surgery, did not match the product box labeling.Samples received and being sent to manufacturer.Notice of no consequence to the patient.

• Brand Name: LINKSYMPHOKNEE
• Type of Device: LINKSYMPHOKNEE SYSTEM, L-SHAPED FEMORAL AUGMENT MEDIAL-RIGHT/LATERAL-LEFT,
• Manufacturer (Section D): WALDEMAR LINK GMBH & CO. KG; barkhausenweg 10; hamburg, 22339 ; GM 22339
• Manufacturer Contact: lisa effe ; barkhausenweg 10; hamburg, 22339 ; GM 22339
• MDR Report Key: 16794171
• MDR Text Key: 313813848
• Report Number: 3004371426-2023-00023
• Device Sequence Number: 1
• Product Code: HRY
• UDI-Device Identifier: 04026575258123
• UDI-Public: 04026575258123
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K202924
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Distributor
• Reporter Occupation: Other
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date: 04/19/2023

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 Operator: Health Professional
• Device Model Number: 880-325/13
• Device Catalogue Number: 880-325/13
• Device Lot Number: 1910003
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 04/19/2023
• Initial Date FDA Received: 04/24/2023
• Supplement Dates Manufacturer Received: 04/19/2023
• Supplement Dates FDA Received: 08/03/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/01/2022
• 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 Age: 78 YR
• Patient Sex: Female