MAUDE Adverse Event Report: UNKNOWN TITANIUM STEM; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/POLYMER, CEMENTED OR NON-POROUS

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 06/21/2023

Event Type  Injury  

Event Description

X-rays showed a complete break in my titanium stem about 3 inches below the top of my femur.Corrective surgery was done in (b)(6) of this year it was invasive beyond measure, and i am still trying to recover.

• Brand Name: TITANIUM STEM
• Type of Device: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/POLYMER, CEMENTED OR NON-POROUS
• Manufacturer (Section D): UNKNOWN
• MDR Report Key: 18327538
• MDR Text Key: 330599081
• Report Number: MW5149259
• Device Sequence Number: 1
• Product Code: LZO
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 12/09/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/13/2023
• Patient Sequence Number: 1
• Treatment: FARXIGA.; OZEMPIC.
• Patient Outcome(s): Hospitalization; Required Intervention; Other; Disability
• Patient Age: 69 YR
• Patient Sex: Male
• Patient Weight: 91 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White