MAUDE Adverse Event Report: WALDEMAR LINK GMBH & CO. KG ENDO-MODEL SL KNEE PROTHESIS SYSTEM

Model Number 16-2840/05

Device Problem Unstable (1667)

Patient Problem Joint Laxity (4526)

Event Date 04/26/2023

Event Type  Injury  

Event Description

A revision surgery was performed by dr.(b)(6) on (b)(6) 2023 because of a loose bushing and connection component.It was reported that the components were still intact/associated but the knee was very unstable.Originally implanted on (b)(6) 2020.

• Brand Name: ENDO-MODEL SL KNEE PROTHESIS SYSTEM
• Type of Device: ENDO-MODEL SL KNEE PROTHESIS SYSTEM
• Manufacturer (Section D): WALDEMAR LINK GMBH & CO. KG; barkhausenweg 10; hamburg, 22339 ; GM 22339
• MDR Report Key: 16896741
• MDR Text Key: 314848754
• Report Number: 3006721341-2023-00010
• Device Sequence Number: 1
• Product Code: KRO
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 04/27/2023,05/09/2023

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?: Yes
• Device Model Number: 16-2840/05
• Device Catalogue Number: 16-2840/05
• Device Lot Number: 170119
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 04/27/2023
• Device Age: 4 YR
• Event Location: Hospital
• Date Report to Manufacturer: 04/27/2023
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 05/09/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 42 YR
• Patient Sex: Male