MAUDE Adverse Event Report: ZIMMER MANUFACTURING B.V. KNEE ZIMMER; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Patient Problems Cellulitis (1768); Unspecified Infection (1930); Pain (1994); Sepsis (2067); Discomfort (2330)

Event Date 10/26/2019

Event Type  Injury  

Event Description

Zimmer knee product total knee replacement (b)(6) 2017 pain and discomfort.(b)(6) developed sepsis and cellulitis and (b)(6) 2019 removed implant loosing parts and infection.

• Brand Name: KNEE ZIMMER
• Type of Device: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL
• Manufacturer (Section D): ZIMMER MANUFACTURING B.V.
• MDR Report Key: 18978445
• MDR Text Key: 338749301
• Report Number: MW5153145
• Device Sequence Number: 1
• Product Code: JWH
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Unknown
• Type of Report: Initial
• Report Date: 03/22/2024

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: 03/25/2024
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Hospitalization
• Patient Age: 60 YR
• Patient Sex: Female
• Patient Race: White