MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS, INC. BONE CEMENT KNEE REPLACEMENT

Catalog Number 00113-140-01

Device Problem Loose or Intermittent Connection (1371)

Patient Problem Unspecified Infection (1930)

Event Date 12/16/2015

Event Type  Injury  

Event Description

Caller stated that he had a knee replacement on (b)(6) 2015.Soon after replacement in (b)(6) 2019 the cement in the tibia bone became loose and his knee was infected.He had the knee revised another cement was placed.

• Brand Name: BONE CEMENT KNEE REPLACEMENT
• Type of Device: BONE CEMENT
• Manufacturer (Section D): DEPUY ORTHOPAEDICS, INC.
• MDR Report Key: 11790159
• MDR Text Key: 249799699
• Report Number: MW5101237
• Device Sequence Number: 1
• Product Code: LOD
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 05/06/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/06/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Catalogue Number: 00113-140-01
• 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): Required Intervention
• Patient Age: 60 YR
• Patient Weight: 109