MAUDE Adverse Event Report: WALDEMAR LINK GMBH & CO. KG ENDO-MODEL - M, ROTATIONAL KNEE PROSTHESIS; KNEE-JOINT PROSTHESIS LEFT, SMALL, COCRMO/TINBN, WITH PATELLAR FLANGE

Model Number 15-3816/12#02

Device Problem Loosening of Implant Not Related to Bone-Ingrowth (4002)

Patient Problems Hypersensitivity/Allergic reaction (1907); Failure of Implant (1924); Bone Shedding Debris (4557)

Event Date 01/04/2023

Event Type  Injury  

Event Description

Patient, who had link hinge knee porex with custom-coated porex femoral and tibial augments underwent revision surgery for femoral loosening.[customer].

Manufacturer Narrative

The review of the device history record showed no deviations.The product complies with the specifications valid at the time of manufacture.

Event Description

Patient, who had link hinge knee with custom-coated porex femoral and tibial augments underwent revision surgery for femoral loosening.[customer].

Manufacturer Narrative

The review of the device history record showed no deviations.The product complies with the specifications valid at the time of manufacture.

• Brand Name: ENDO-MODEL - M, ROTATIONAL KNEE PROSTHESIS
• Type of Device: KNEE-JOINT PROSTHESIS LEFT, SMALL, COCRMO/TINBN, WITH PATELLAR FLANGE
• Manufacturer (Section D): WALDEMAR LINK GMBH & CO. KG; barkhausenweg 10; hamburg, 22339 ; GM 22339
• Manufacturer Contact: tizia hucklenbroch ; barkhausenweg 10; hamburg, 22339 ; GM 22339
• MDR Report Key: 17280073
• MDR Text Key: 318647996
• Report Number: 3004371426-2023-00051
• Device Sequence Number: 1
• Product Code: KRO
• UDI-Device Identifier: 04026575034758
• UDI-Public: 04026575034758
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K212742
• 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: 06/09/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/07/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 15-3816/12#02
• Device Catalogue Number: 15-3816/12#02
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/09/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/01/2021
• 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: 64 YR
• Patient Sex: Female
• Patient Weight: 69 KG