MAUDE Adverse Event Report: WALDEMAR LINK GMBH & CO. KG ENDO-MODEL M MODULAR KNEE PROSTHESIS SYSTEM, ROTATIONAL VERSION, ANTI-LUXATION

Model Number 15-3816/11

Device Problem Detachment of Device or Device Component (2907)

Patient Problems Foreign Body Reaction (1868); Implant Pain (4561)

Event Type  Injury  

Event Description

Dr.(b)(6) reported on (b)(6) 2022 that a patient returned with swollen knee and visible pseudotumors, experiencing pain and audible "clunking" of the knee.X-rays suggest polyethylene liner is displaced/destruction of locking mechanism.The patient denies any trauma.Dr.M plans to revise the patient's knee.Records indicate original surgery date was (b)(6) 2021.Surgery is scheduled for (b)(6) 2022.

• Brand Name: ENDO-MODEL M MODULAR KNEE PROSTHESIS SYSTEM, ROTATIONAL VERSION, ANTI-LUXATION
• Type of Device: ENDO-MODEL M MODULAR KNEE PROSTHESIS SYSTEM, ROTATIONAL VERSION, ANTI-LUXATION
• Manufacturer (Section D): WALDEMAR LINK GMBH & CO. KG; barkhausenweg 10; hamburg, 22339 ; GM 22339
• MDR Report Key: 15752069
• MDR Text Key: 303234750
• Report Number: 3006721341-2022-00009
• 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: 10/21/2022,11/08/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/08/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Model Number: 15-3816/11
• Device Catalogue Number: 15-3816/11
• Device Lot Number: 200511
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 10/20/2022
• Device Age: 2 YR
• Event Location: Hospital
• Date Report to Manufacturer: 10/21/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 70 YR
• Patient Sex: Male
• Patient Weight: 66 KG