MAUDE Adverse Event Report: WALDEMAR LINK GMBH & CO. KG ENDO-MODEL SL; CONNECTION COMPONENTS, ROTATING HINGE

Model Number 16-2840/05

Device Problems Unstable (1667); Detachment of Device or Device Component (2907)

Patient Problem Failure of Implant (1924)

Event Date 04/26/2023

Event Type  Injury  

Event Description

A revision surgery was performed by (b)(6) on (b)(6) 2023 because of a loose bushing and connection component.The rep reported that the components were still intact/associated but the knee was very unstable.The explanted components were discarded.Originally implanted on (b)(6) 2020.Connection component and bushings were replaced.Surgery was successful.

Manufacturer Narrative

The review of the device history record showed no deviations.The product complies with the specifications valid at the time of manufacture.This is the final supplemental report, the complaint is closed.

Event Description

A revision surgery was performed by dr.L.On (b)(6) 2023 because of a loose bushing and connection component.The rep reported that the components were still intact/associated but the knee was very unstable.The explanted components were discarded.Originally implanted on (b)(6) 2020.Connection component and bushings were replaced.Surgery was successful.

• Brand Name: ENDO-MODEL SL
• Type of Device: CONNECTION COMPONENTS, ROTATING HINGE
• Manufacturer (Section D): WALDEMAR LINK GMBH & CO. KG; barkhausenweg 10; hamburg, 22339 ; GM 22339
• Manufacturer Contact: lisa effe ; barkhausenweg 10; hamburg, 22339 ; GM 22339
• MDR Report Key: 16972144
• MDR Text Key: 315680253
• Report Number: 3004371426-2023-00025
• 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,Followup
• Report Date: 04/27/2023

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: 16-2840/05
• Device Catalogue Number: 16-2840/05
• Device Lot Number: 170119/0021
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 04/27/2023
• Initial Date FDA Received: 05/22/2023
• Supplement Dates Manufacturer Received: 04/27/2023
• Supplement Dates FDA Received: 01/19/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/01/2019
• 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: 42 YR
• Patient Sex: Male