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

Device Problem Component Misassembled (4004)

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

Event Date 12/14/2022

Event Type  malfunction  

Manufacturer Narrative

Recall class ii as per information of 03 july 2023 and therewith classified as reportable.

Event 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.(b)(6) does not want or need any follow up.Has specifically asked to just inform link so they can correct the problem moving forward.[customer].

• Brand Name: LINKSYMPHOKNEE SYSTEM
• Type of Device: 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: 17441422
• MDR Text Key: 320225358
• Report Number: 3004371426-2023-00064
• Device Sequence Number: 1
• Product Code: HRY
• UDI-Device Identifier: 04026575257393
• UDI-Public: 04026575257393
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K211768
• 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
• Report Date: 12/20/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/02/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: 880-307/21
• Device Catalogue Number: 880-307/21
• Device Lot Number: 2123233
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/20/2022
• Date Device Manufactured: 10/01/2021
• 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