MAUDE Adverse Event Report: WALDEMAR LINK GMBH&CO.KG LINKSYMPHOKNEE SYSTEM; DISTAL FEMORAL AUGMENT LATERAL-RIGHT/MEDIAL-LEFT, SZ. 7-8 TILASTAN, CEMENTED

Model Number	880-307/21
Medical Device Problem Code	Component Misassembled (4004)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/15/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Recall class ii as per information of (b)(6) 2023 and therewith classified as reportable.
Event or Problem Description
Dr.(b)(6) was in a surgery on (b)(6) 2023 and had augments that were packaged with the screws assembled from the incorrect side.Screws were removed and put into other side and augments were implanted.No consequence to the patient.[customer].

• Brand Name: LINKSYMPHOKNEE SYSTEM
• Common Device Name: DISTAL FEMORAL AUGMENT LATERAL-RIGHT/MEDIAL-LEFT, SZ. 7-8 TILASTAN, CEMENTED
• Manufacturer (Section D): WALDEMAR LINK GMBH&CO.KG; barkhausenweg 10; hamburg, hamburg 22339 ; GM 22339
• Manufacturer Contact: annerike-tizia hucklenbroch ; barkhausenweg 10; hamburg, hamburg 22339 ; GM 22339
• MDR Report Key: 17441407
• Report Number: 3004371426-2023-00063
• Device Sequence Number: 2735856
• Product Code: HRY
• UDI-Device Identifier: 04026575257393
• UDI-Public: 04026575257393
• 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: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Other
• Remedial Action: Recall
• Type of Report: Initial
• Report Date (Section B): 05/17/2023

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 Expiration Date: 09/30/2026
• Device Model Number: 880-307/21
• Device Catalogue Number: 880-307/21
• Device Lot Number: 2123233
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/17/2023
• Initial Report FDA Received Date: 08/02/2023
• Date Device Manufactured: 10/01/2021
• 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: 70 YR
• Patient Sex: Male