MAUDE Adverse Event Report: ZIMMER, INC. ZIMMER ROTATING HINGE KNEE; PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER

Device Problems Detachment of Device or Device Component (2907); Appropriate Term/Code Not Available (3191)

Patient Problem Insufficient Information (4580)

Event Date 11/16/2021

Event Type  Injury  

Event Description

The screw in my zimmer rotating hinge knee came out after being installed for about 10 months.This resulted in hospitalization and a procedure to replace the screw.This was followed by 6 weeks of a full length leg cast and rehab after that.The screw from my new knee was found on x-rays taken on this date.Fda safety report id# (b)(4).

• Brand Name: ZIMMER ROTATING HINGE KNEE
• Type of Device: PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER
• Manufacturer (Section D): ZIMMER, INC.
• MDR Report Key: 13224580
• MDR Text Key: 283691597
• Report Number: MW5106566
• Device Sequence Number: 1
• Product Code: KRO
• 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: 01/06/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/10/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: Yes
• Patient Sequence Number: 1
• Patient Outcome(s): Disability
• Patient Age: 72 YR
• Patient Sex: Male
• Patient Weight: 129 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White