MAUDE Adverse Event Report: UNKNOWN METAL KNEECAP IMPLANT; PROSTHESIS, KNEE, HINGED (METAL-METAL)

Patient Problems Bone Fracture(s) (1870); Pain (1994); Joint Dislocation (2374)

Event Type  Injury  

Event Description

It was reported that the patient had been having so many problems for the last 6 to 7 months and it was understood that these issues were related to the patient breaking their femur and dislocating their metal kneecap implant.The patient was in the hospital for emergency medical surgery on jan 16th (stayed in the hospital for 2 months), and said their "back is going crazy." pt (patient) said they broke their femur sideways and their kneecap turned to gravel.Pt had 3 surgeries on their leg, and is back walking and driving now.This report reflects information received by fda in the form of a notification per 803.22 (b)(2).

• Brand Name: METAL KNEECAP IMPLANT
• Type of Device: PROSTHESIS, KNEE, HINGED (METAL-METAL)
• Manufacturer (Section D): UNKNOWN
• MDR Report Key: 17397352
• MDR Text Key: 319963642
• Report Number: MW5120089
• Device Sequence Number: 1
• Product Code: HRZ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 07/21/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/24/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Patient Sequence Number: 1