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

Model Number 16-2853/21

Device Problem Detachment of Device or Device Component (2907)

Patient Problem Hyperextension (4523)

Event Date 10/26/2022

Event Type  Injury  

Event Description

As notified by t.A.To complaints on (b)(6) 2022, surgery on (b)(6) 2022, a revision of sl hinge dfr disassociated out of femur.Through text, information as follows: patient fell and twisted knee badly.No fault of implant.X-ray shows femur was in a great deal of hyper extension.

• 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: 15779735
• MDR Text Key: 303552056
• Report Number: 3006721341-2022-00010
• 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
• Type of Report: Initial
• Report Date: 10/28/2022,11/11/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/11/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Expiration Date: 04/30/2022
• Device Model Number: 16-2853/21
• Device Catalogue Number: 16-2853/21
• Device Lot Number: 161010
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 10/21/2022
• Event Location: Hospital
• Date Report to Manufacturer: 10/28/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 71 YR
• Patient Sex: Female