MAUDE Adverse Event Report: DEPUY DEPUY; HIP IMPLANT

Model Number 1365-12-000

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Anemia (1706); Inflammation (1932); Pain (1994); Ambulation Difficulties (2544); Alteration In Body Temperature (2682); Cancer (3262)

Event Date 08/29/2005

Event Type  Injury  

Event Description

I'm a female at age (b)(6), fell backwards from pulling object that gave way, landing on garage floor, shattering hip on (b)(6) 2005.Had total hip replacement with depuy articul/eze femoral head ref 1365-12-000.Immediately after surgery developed groin, thigh and hip pain, had to use cane to walk, pain with walking and weight bearing, hip wold lock up when trying to stand, skin was hot to the touch on side of hip replaced.Knew there had to be inflammation in hip.Became anemic, but doctors couldn't find where blood loss was coming from.Did everything doctor said to do, rehab at least 3 times, had steroid shots and was told it was all in my head by doctor.Anemia worsened, went to blood specialist (b)(6) 2014, who suspected myeloma.Went to another hip doctor who replaced hip on (b)(6) 2014.Diagnosed with smoldering myeloma (b)(6) 2015.Feel like the myeloma has developed from a bad hip replacement product that was installed and never worked properly.

• Brand Name: DEPUY
• Type of Device: HIP IMPLANT
• Manufacturer (Section D): DEPUY
• MDR Report Key: 4825009
• MDR Text Key: 5844226
• Report Number: MW5042938
• Device Sequence Number: 1
• Product Code: JDI
• 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: 05/29/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/29/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Model Number: 1365-12-000
• Device Lot Number: 1887045
• Patient Sequence Number: 1
• Treatment: RX MEDS: DIAABETIC MED; HIGH BLOOD PRESSURE MED
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 68 YR
• Patient Weight: 68