MAUDE Adverse Event Report: BIOMET, INC. METAL REINFORCED HIP CUP; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED

Patient Problems Emotional Changes (1831); Pain (1994); Scar Tissue (2060); Metal Related Pathology (4530); Muscle/Tendon Damage (4532)

Event Date 09/08/2021

Event Type  Injury  

Event Description

Litigation records alleges heavy metal poisoning from the toxic heavy metals released by the pinnacle system resulting in injury and requiring surgery to remove the defective hip replacements.Patient was consequently revised due to injury to muscle and tissue, suffered additional scar tissue formation, and now has a hip replacement with decreased longevity.Additionally, patient suffered pain , injury caused by metallosis, metal wear, metal poisoning, loss of enjoyment of life, limitation of daily activities, incurred additional medical expenses, lost earning potential/ income, and ultimately emotional trauma and distress in the future.This report reflects information received by fda in the form of a notification per 803.22 (b)(2).

• Brand Name: METAL REINFORCED HIP CUP
• Type of Device: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED
• Manufacturer (Section D): BIOMET, INC.
• MDR Report Key: 17643881
• MDR Text Key: 322254772
• Report Number: MW5145036
• 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
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 08/25/2023

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
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/28/2023
• Patient Sequence Number: 1