MAUDE Adverse Event Report: CORIN MEDICAL, LTD. CORIN TRIFIT AND TRINITY; PROSTHESIS, HIP, HEMI-, FEMORAL, METAL/POLYMER, CEMENTED OR UNCEMENTED

Patient Problem Insufficient Information (4580)

Event Date 10/08/2019

Event Type  Injury  

Event Description

Had a right hip replacement.Device came loose and had to have a revision surgery.Been on disability ever since.

• Brand Name: CORIN TRIFIT AND TRINITY
• Type of Device: PROSTHESIS, HIP, HEMI-, FEMORAL, METAL/POLYMER, CEMENTED OR UNCEMENTED
• Manufacturer (Section D): CORIN MEDICAL, LTD.
• MDR Report Key: 17565913
• MDR Text Key: 321521574
• Report Number: MW5144677
• Device Sequence Number: 1
• Product Code: KWY
• 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: 08/14/2023

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
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/16/2023
• Patient Sequence Number: 1
• Treatment: ATORVASTATIN.; HUMALOG.; HYDROXYCHLORAQUINE.; IRON.; LANTUS.; MULTIVITAMIN.; PRESERVISION.; PROZAC.; STOOL SOFTENER.; SYNTHROID.; TYLENOL.; TYLENOL.
• Patient Outcome(s): Hospitalization; Required Intervention; Disability
• Patient Age: 66 YR
• Patient Sex: Female
• Patient Weight: 53 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White