MAUDE Adverse Event Report: ZIMMER BIOMET, INC. LEFT HIP REPLACEMENT; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED

Device Problems Break (1069); Material Fragmentation (1261)

Patient Problems Failure of Implant (1924); Pain (1994); Device Embedded In Tissue or Plaque (3165); No Code Available (3191)

Event Date 02/13/2020

Event Type  Injury  

Event Description

My left hip replacement performed on (b)(6) 2010 (equipment list enclosed) commenced causing severe pain about (b)(6) 2019 that hindered my full use of the left leg.The problem was only fully identified by a mri on (b)(6) 2020 (copy of report enclosed) that revealed the replacement hip had broken into metal shards and damaged the leg muscle.Corrective surgery was performed on (b)(6) 2020 and that surgeon's report is also enclosed.However, i continue to have only limited use of that left leg and remain in pain.

• Brand Name: LEFT HIP REPLACEMENT
• Type of Device: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED
• Manufacturer (Section D): ZIMMER BIOMET, INC.
• MDR Report Key: 10096295
• MDR Text Key: 192731887
• Report Number: MW5094724
• Device Sequence Number: 1
• Product Code: JDI
• 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: 05/26/2020

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
• Device Operator: No Information
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 05/27/2020
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention; Disability
• Patient Age: 77 YR
• Patient Weight: 66