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
Medical Device Problem Code	Nonstandard Device (1420)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/18/2023
Type of Reportable Event	Malfunction
Event or Problem 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.
Additional Manufacturer Narrative
The production records have been inspected and reviewed.
Event or Problem 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
• Common Device Name: 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
• Report Number: 3004371426-2023-00023
• Device Sequence Number: 7516162
• Product Code: HRY
• UDI-Device Identifier: 04026575258123
• UDI-Public: 04026575258123
• 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
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date (Section B): 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
• Operator of Device: 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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/19/2023
• Supplement Date Received by Manufacturer: 04/19/2023
• Initial Report FDA Received Date: 04/24/2023
• Supplement Report FDA Received Date: 08/03/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/01/2022
• 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
• Patient Age: 78 YR
• Patient Sex: Female