MAUDE Adverse Event Report: ZIMMER, INC. ZIMMER PRE ALLOCATED 736196 KNEE IMPLANT; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Model Number 5988-04

Device Problems Mechanical Problem (1384); Noise, Audible (3273)

Patient Problems Failure of Implant (1924); Pain (1994); Swelling (2091)

Event Date 06/01/2020

Event Type  Injury  

Event Description

I've had swelling on and off since device was put in 4 and a half years ago; 2 months ago i started to feel pain, pinching, popping and locking up.I have an appointment scheduled with a knee specialist (b)(6).Fda safety report id# (b)(4).

• Brand Name: ZIMMER PRE ALLOCATED 736196 KNEE IMPLANT
• Type of Device: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL
• Manufacturer (Section D): ZIMMER, INC.
• MDR Report Key: 11236389
• MDR Text Key: 229152228
• Report Number: MW5099020
• Device Sequence Number: 1
• Product Code: JWH
• 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: 01/23/2021

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
• Device Model Number: 5988-04
• Device Catalogue Number: 00598800400
• Device Lot Number: 63338824
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/26/2021
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Disability
• Patient Age: 62 YR
• Patient Weight: 73