MAUDE Adverse Event Report: WALDEMAR LINK GMBH & CO.KG ENDO-MODEL SL KNEE JOINT PROSTHESIS; CONNECTION COMPONENTROTATIONAL VERSION,MEDIUM

Model Number 16-2840/05

Device Problems Degraded (1153); Detachment of Device or Device Component (2907)

Patient Problem Failure of Implant (1924)

Event Date 03/01/2024

Event Type  Injury  

Event Description

Notified on 3/6/2024 by representative (b)(6), that on (b)(6) 2024, dr.(b)(6) performed a revision surgery for an endo sl that had a disassociated connection component.At review of pre-op x-rays it was still unclear as to the issue.When opened, it was clear that the components were disassociated.The representative stated that the connection components pieces were "exploded" within the patient, that they were spread out within the joint.All the pieces were removed and this extended the surgery approximately 30 minutes.The patient was revised to an endo w.[customer].

• Brand Name: ENDO-MODEL SL KNEE JOINT PROSTHESIS
• Type of Device: CONNECTION COMPONENTROTATIONAL VERSION,MEDIUM
• Manufacturer (Section D): WALDEMAR LINK GMBH & CO.KG; barkhausenweg 10; hamburg, 22339 ; GM 22339
• Manufacturer Contact: annerike tizia hucklenbroch ; barkhausenweg 10; hamburg, 22339 ; GM 22339
• MDR Report Key: 19031241
• MDR Text Key: 339223469
• Report Number: 3004371426-2024-00024
• Device Sequence Number: 1
• Product Code: KRO
• UDI-Device Identifier: 04026575359240
• UDI-Public: 04026575359240
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K151008
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/06/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/03/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 08/01/2021
• Device Model Number: 16-2840/05
• Device Catalogue Number: 16-2840/05
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/06/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 08/01/2016
• 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
• Patient Age: 76 YR
• Patient Sex: Male