MAUDE Adverse Event Report: HIP PROSTHESIS; PROSTHESIS, HIIP, SEMI - CONSTRAINED METAL / POLYMER, CEMENTED

Device Problem Microbial Contamination of Device (2303)

Patient Problems Death (1802); Unspecified Infection (1930); Respiratory Acidosis (2482); No Code Available (3191)

Event Date 08/02/2019

Event Type  Death  

Event Description

Left hip prosthesis, joint infection - hip surgery (b)(6) 2019.Resp, acidosis - malignant and melanoma of scalp.

• Brand Name: HIP PROSTHESIS
• Type of Device: PROSTHESIS, HIIP, SEMI - CONSTRAINED METAL / POLYMER, CEMENTED
• MDR Report Key: 9530051
• MDR Text Key: 173177033
• Report Number: MW5091927
• Device Sequence Number: 1
• Product Code: JDI
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Type of Report: Initial

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?: No
• Device Operator: No Information
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/27/2019
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Death; Hospitalization; Life Threatening; Other; Disability
• Patient Age: 82 YR
• Patient Weight: 111