MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS, INC. DEPUY KNEE IMPLANT; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Catalog Number 5450501

Device Problem Patient-Device Incompatibility (2682)

Patient Problem Pain (1994)

Event Date 04/01/2021

Event Type  Injury  

Event Description

My knee replacement failed and i had extreme pain and couldn't put any weight on it.Fda safety report id# (b)(4).

• Brand Name: DEPUY KNEE IMPLANT
• Type of Device: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL
• Manufacturer (Section D): DEPUY ORTHOPAEDICS, INC.
• MDR Report Key: 12301421
• MDR Text Key: 265996480
• Report Number: MW5103112
• Device Sequence Number: 2
• 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: 08/05/2021
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: 5450501
• Device Lot Number: 3533661
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/09/2021
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Disability
• Patient Age: 62 YR