MAUDE Adverse Event Report: ZIMMER KNEE CREATIONS, INC. ZIMMER SUBCHONDROPLASTY (SCP) CONVENIANCE KIT; ORTHOPEDIC TRAY

Device Problem Leak/Splash (1354)

Patient Problems Pain (1994); Numbness (2415); Ambulation Difficulties (2544)

Event Date 02/21/2019

Event Type  Injury  

Event Description

Pt reports pain and complete loss of feeling in knee and could not walk after surgery.On (b)(6) 2019 bone cement started leaking out of injected knee area.X-ray showed bone cement never harden and was not in the bone.On (b)(6) 2019, went back for surgery to remove bone cement.

• Brand Name: ZIMMER SUBCHONDROPLASTY (SCP) CONVENIANCE KIT
• Type of Device: ORTHOPEDIC TRAY
• Manufacturer (Section D): ZIMMER KNEE CREATIONS, INC.
• MDR Report Key: 9369049
• MDR Text Key: 167978299
• Report Number: MW5091273
• Device Sequence Number: 1
• Product Code: OJH
• 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: 11/22/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/22/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Is the Reporter a Health Professional?: No
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 56 YR
• Patient Weight: 64