MAUDE Adverse Event Report: WALDEMAR LINK GMBH & CO. KG LINKSYMPHONKNEE; LINKSYMPHOKNEE SYSTEM, ARTICULATING SURFACE, SYMMETRIC, SZ. 3-4, UHMWPE PS

Model Number 880-213/14

Device Problem Positioning Failure (1158)

Patient Problems Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/11/2022

Event Type  Injury  

Manufacturer Narrative

The review of the device history record showed no deviations.The product complies with the specifications valid at the time of manufacture.

Event Description

The poly seemed to disassociate from the tibial based off radiograph taken on approx.(b)(6) 2022.Patient is scheduled for revision surgery on (b)(6) 2022.

Manufacturer Narrative

The review of the device history record showed no deviations.The product complies with the specifications valid at the time of manufacture.The complained polyethylene ps plateau was returned for investigation.The visual inspection of the plateau revealed wear marks and deformations at the distal surface, medial/lateral snap, central rail and the anterior edge.The medial/lateral locking mechanism shows marks of the tibial tray and was bent proximally.It is assumed that the anterior locking mechanism was not engaged correctly leaving the plateau lie obliquely on the tibial tray after the surgery was finished.The plateau stayed inside the body for 5 weeks, as a result bent under constant load leading to deformation and wear effects.Based on the surgical technique, it is important to ensure the correct assembly of the plateau into the tibial tray before impaction.One of the reason could be assumed that the tibial or the femoral rotation may have caused the post/box mechanism and/or the condyles to guide the snap mechanism incorrectly.As a measure, an intensive exchange of training material is underway with the users in order to clarify the correct assembly of the pe plateau to the tibial component.Additionally, an engineering change request is initiated to provide a more detailed surgical technique.The dimensions of the entire lot were measured 100% during production and no deviations were found.Based on the above information no product problem is assumed.

Event Description

The poly seemed to disassociate from the tibial based off radiograph taken on approx.(b)(6) 2022.Patient is scheduled for revision surgery on (b)(6) 2022.

• Brand Name: LINKSYMPHONKNEE
• Type of Device: LINKSYMPHOKNEE SYSTEM, ARTICULATING SURFACE, SYMMETRIC, SZ. 3-4, UHMWPE PS
• Manufacturer (Section D): WALDEMAR LINK GMBH & CO. KG; barkhausenweg 10; hamburg, 22339 ; GM 22339
• Manufacturer Contact: sagar shetty ; barkhausenweg 10; hamburg, ; GM
• MDR Report Key: 14432628
• MDR Text Key: 292023275
• Report Number: 3004371426-2022-00009
• Device Sequence Number: 1
• Product Code: HRY
• 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
• Type of Report: Initial,Followup
• Report Date: 06/05/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 880-213/14
• Device Catalogue Number: 880-213/14
• Device Lot Number: 2014065
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 06/05/2022
• Initial Date FDA Received: 05/18/2022
• Supplement Dates Manufacturer Received: 06/05/2022
• Supplement Dates FDA Received: 09/23/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/01/2021
• 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