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

Model Number	15-8521/14
Medical Device Problem Code	Device Damaged Prior to Use (2284)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	02/16/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
Notification by a representative on 2021-02-21, that a femoral component, endo dfr product, had a punctured internal sterile packaging.The box itself did not appear to be damaged.The packaging issue was noticed during a surgery, after the corresponding component was opened, which extended the surgery approximately 20 minutes, because there was not an additional large size implant available so the decision was to downsize to a medium size implant.

• Brand Name: ENDO-MODEL MODULAR KNEE PROSTHESIS SYSTEM
• Common Device Name: ENDO-MODEL MODULAR KNEE PROSTHESIS SYSTEM
• Manufacturer (Section D): WALDEMAR LINK GMBH & CO. KG; barkhausenweg 10; hamburg, 22339 ; GM 22339
• MDR Report Key: 18881704
• Report Number: 3006721341-2024-00004
• Device Sequence Number: 21116114
• Product Code: KRO
• UDI-Device Identifier: 04026575383252
• UDI-Public: 04026575383252
• Combination Product (Y/N): N
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Importer
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 03/11/2024
• Report Date (Section F): 02/21/2024

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
• Operator of Device: Health Professional
• Device Model Number: 15-8521/14
• Device Catalogue Number: 15-8521/14
• Device Lot Number: 200224
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/04/2024
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 02/16/2024
• Event Location: Hospital
• Date Report to Manufacturer: 02/21/2024
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/11/2024
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Female