MAUDE Adverse Event Report: WRIGHT MEDICAL TECHNOLOGY, INC. DYNASTY ACETABULAR CUP SYSTEM AND PROFERMUR HIP REPLACEMENT; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/POLYMER, CEMENTED OR NON-POROUS

Device Problems Break (1069); Degraded (1153); Nonstandard Device (1420); Loosening of Implant Not Related to Bone-Ingrowth (4002)

Patient Problems Failure of Implant (1924); Pain (1994); Joint Dislocation (2374); Unspecified Nervous System Problem (4426); Unspecified Kidney or Urinary Problem (4503); Unspecified Reproductive System or Breast Problem (4513); Metal Related Pathology (4530)

Event Date 10/19/2021

Event Type  Injury  

Event Description

Wright medical mom total hip replacement device failure.Loosening, and deterioration of metal component, metal ions broke screw off inside of me causing a hip dislocation.I required immediate hip revision surgery to replace cup.I have metallosis damage both before and after device failure.I was never notified of recall or problems with wright medical devices.I complained for several years of pain, stiffness, sciatic, cervical nerve pain, went to pain clinic multiple times for injections for pain, i had nerve conduction tests, mri's, other severe health problems with my kidney, thyroid, female reproductive issues (removal of ovary) same side of metal on metal hip replacement.Blood tests of cobalt, chromium are still high after hip replacement.No accountability of wright medical for promoting device that clearly injured people.No notice to patient of recall or fraudulent fda approval of device.Now i'm informed that (b)(6) has 10 year statute of limitation on medical devices even though i've complained of problems, pain, health issues including having x-rays, mri's, no one informed patients that metallosis cannot be seen on mri's or x-ray.Hip replacement was performed (b)(6) 2008.Hip revision surgery of cup, screw was completed (b)(6) 2021.I still have the wright medical stem.Fda safety report id# (b)(4).

• Brand Name: DYNASTY ACETABULAR CUP SYSTEM AND PROFERMUR HIP REPLACEMENT
• Type of Device: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/POLYMER, CEMENTED OR NON-POROUS
• Manufacturer (Section D): WRIGHT MEDICAL TECHNOLOGY, INC.; 5677 airline rd.; arlington TN 38002
• MDR Report Key: 15156172
• MDR Text Key: 297241786
• Report Number: MW5111244
• Device Sequence Number: 1
• Product Code: LZO
• 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: 08/01/2022

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: Lay User/Patient
• Device Expiration Date: 12/23/2008
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/02/2022
• Patient Sequence Number: 1
• Treatment: CELEBREX GENERIC ; ESTRODIAL PATCH ; MOM HIP REPLACEMENT; MULTI VITAMIN ; PROGESTERONE; TUMERIC`; TYROID MEDICINE
• Patient Outcome(s): Other; Life Threatening; Disability; Hospitalization
• Patient Sex: Female
• Patient Weight: 72 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White