MAUDE Adverse Event Report: WALDEMAR LINK GMBH & CO. KG LINKSYMPHOKNEE; ARTICULATING SURFACE, SYMMETRIC, SZ. 3-4, UHMWPE PS, FIXED, H= 12 MM

Model Number 880-213/12

Device Problem Positioning Failure (1158)

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

Event Date 11/27/2023

Event Type  malfunction  

Event Description

During the surgery, after implanting the tibial component, the surgeon tried to insert the poly component which struggled to enter, and above all, did not fix with the classic snap.Thinking that the pe was faulty, he opened a second identical one, but the problem repeated itself.Not knowing what to do, nobody of us was in the operating room, a third component of a higher thickness as opened but again he had difficulty inserting the component and didn't hear the usual clacking.At this point, hoping that the insert was fixed and stable, but with some concern, the surgery was finished.[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.Note on exceeding the reporting deadline.Reporting deadline 29 december 2023.Reporting date 19 january 2024.This initial report is delayed due to an it 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.

Manufacturer Narrative

This is the final supplemental report.The complaint is closed.

Event Description

During the surgery, after implanting the tibial component, the surgeon tried to insert the poly component which struggled to enter, and above all, did not fix with the classic snap.Thinking that the pe was faulty, the surgeon opened a second identical one, but the problem repeated itself.Not knowing what to do, none of us was in the or, a third component of a higher thickness was opened but again, the surgeon had difficulty inserting the component and didn't hear the usual clacking.At this point, hoping that the insert was fixed and stable, but with some concern, the surgery was finished.[customer].

• Brand Name: LINKSYMPHOKNEE
• Type of Device: ARTICULATING SURFACE, SYMMETRIC, SZ. 3-4, UHMWPE PS, FIXED, H= 12 MM
• 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: 18542324
• MDR Text Key: 333228675
• Report Number: 3004371426-2024-00002
• Device Sequence Number: 1
• Product Code: HRY
• UDI-Device Identifier: 04026575252961
• UDI-Public: 04026575252961
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: K202924
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/29/2023

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: 880-213/12
• Device Catalogue Number: 880-213/12
• Device Lot Number: 2015096
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/29/2023
• Was Device Evaluated by Manufacturer?: No
• 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 Outcome(s): Required Intervention