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

Model Number	880-307/11
Medical Device Problem Code	Component Misassembled (4004)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/14/2022
Type of Reportable Event	Malfunction
Event or Problem Description
Screws that attach augment to fem component were put into augments backwards.Screws should be fed from prox to distal.There were fed through the augment from distal to proximal thus causing the surgeon to have to remove them and reinsert them.The patient in no way was affected and the surgery proceeded as planned.Dr.S.Does not want or need any follow up.Has specifically asked to just inform link so they can correct the problem moving forward.Customer.
Additional Manufacturer Narrative
Recall class ii as per information of (b)(6) 2023 and therewith classified as reportable.

• Brand Name: LINKSYMPHOKNEE SYSTEM
• Common Device Name: DISTAL FEMORAL AUGMENT MEDIAL-RIGHT/LATERAL-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: 17446078
• Report Number: 3004371426-2023-00067
• Device Sequence Number: 2710561
• Product Code: HRY
• UDI-Device Identifier: 04026575257379
• UDI-Public: 04026575257379
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: K211768
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• 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): 12/20/2022

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: 880-307/11
• Device Catalogue Number: 880-307/11
• Device Lot Number: 2123225
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/20/2022
• 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 Sex: Unknown