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

Model Number 15-8523/44

Device Problem Detachment of Device or Device Component (2907)

Patient Problem Joint Laxity (4526)

Event Date 07/11/2023

Event Type  Injury  

Event Description

As reported by representative t.A., on 2023-07-12, after a surgery performed on (b)(6) 2023 with dr.(b)(6), the stem disassociated from the femur, after being cemented when patient was moved from or to recovery, approximately 45 minutes after surgery.

• Brand Name: ENDO-MODEL SL KNEE PROSTHESIS SYSTEM
• Type of Device: ENDO-MODEL SL KNEE PROSTHESIS SYSTEM
• Manufacturer (Section D): WALDEMAR LINK GMBH & CO. KG; barkhausenweg 10; hamburg, 22339 ; GM 22339
• MDR Report Key: 17390839
• MDR Text Key: 319744004
• Report Number: 3006721341-2023-00017
• Device Sequence Number: 1
• Product Code: KRO
• UDI-Device Identifier: 04026575384242
• UDI-Public: (01)04026575384242(17)271031(10)22224077
• Combination Product (y/n): N
• Reporter Country Code: US
• 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: 07/12/2023,07/25/2023

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 Operator: Health Professional
• Device Model Number: 15-8523/44
• Device Catalogue Number: 15-8523/44
• Device Lot Number: 2224077
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 07/12/2023
• Event Location: Hospital
• Date Report to Manufacturer: 07/12/2023
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 07/25/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 86 YR
• Patient Sex: Male