MAUDE Adverse Event Report: WALDEMAR LINK GMBH & CO. KG LINKSYMPHOKNEE; ARTICULATING SURFACE - UHMWPE - SZ. 1-2UP CCK 20MM

Model Number 880-232/20

Device Problem Positioning Failure (1158)

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

Event Date 11/30/2023

Event Type  malfunction  

Event Description

As reported by (b)(6) dr.Could not get two 20mm plateaus to snap into place.They instead used a 22mm which snapped right into place and was implanted.[customer].

Manufacturer Narrative

The review of the device history record showed no deviations.The product complies with the specifications valid at the time of manufacture.Reporting deadline 30 december 2023.Reporting date 19 january 2024.This initial report is delayed due to anti security-related incident from (b)(6) 2023.Due to the incident, we did not have access to our it systems and were temporarily unable to meet our obligation to report incidents on time.The process-relevant functions have been available again since 16 january 2024.Accordingly the reports will now be submitted retrospectively.

• Brand Name: LINKSYMPHOKNEE
• Type of Device: ARTICULATING SURFACE - UHMWPE - SZ. 1-2UP CCK 20MM
• Manufacturer (Section D): WALDEMAR LINK GMBH & CO. KG; barkhausenweg 10; hamburg, hamburg 22339 ; GM 22339
• Manufacturer Contact: lisa effe ; barkhausenweg 10; hamburg, hamburg 22339 ; GM 22339
• MDR Report Key: 18542326
• MDR Text Key: 333228683
• Report Number: 3004371426-2024-00005
• Device Sequence Number: 1
• Product Code: HRY
• UDI-Device Identifier: 04026575254293
• UDI-Public: 04026575254293
• 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: Foreign,Distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/30/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/19/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: 880-232/20
• Device Catalogue Number: 880-232/20
• Device Lot Number: 2111025
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/30/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 09/01/2021
• 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: 61 YR
• Patient Sex: Female