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 05/15/2023

Event Type  malfunction  

Manufacturer Narrative

Recall class ii as per information of (b)(6) 2023 and therewith classified as reportable.

Event 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
• 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: 17441407
• MDR Text Key: 320254836
• Report Number: 3004371426-2023-00063
• 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: 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
• Report Date: 05/17/2023

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: 05/17/2023
• 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
• Patient Age: 70 YR
• Patient Sex: Male