MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS, INC. PINNACLE HIP REPLACEMENT; PROSTHESIS, HIP, SEMI - CONSTRAINED, METAL / POLYMER, POROUS UNCEMENTED

Device Problems Material Fragmentation (1261); Mechanical Problem (1384); Structural Problem (2506)

Patient Problems Failure of Implant (1924); Neurological Deficit/Dysfunction (1982); Pain (1994); Test Result (2695)

Event Date 12/26/2018

Event Type  Injury  

Event Description

Fda: i had an emergency room visit on (b)(6) 2018 and was admitted for debilitating back pain.After four scans (ct and mri) they discovered both of my hip implants had failed and were now rubbing metal on metal which then started creating soft tissue tumors behind each hip.These tumors are filled with metal ions from both failed hip devices.The tumor on the left side then started pressing on the nerves along my vertebrae thus creating excruciating pain the evening of (b)(6) 2018.Both hip devices (pinnacle by depuy) originally were implanted bilaterally in (b)(6) 2008, by dr (b)(6) at (b)(6) orthopedics in (b)(6).Due to the tumors, my lab work notates that i have very high cobalt and chromium plasma levels.According to the lab report from (b)(6) lab services on blood collected on (b)(6) 2019, my cobalt plasma level was at 11.9.The referenced range on the report lists the normal range at 0.0-0.9.On the same date, (b)(6) 2019, my chromium plasma level was at 2.8.The referenced normal range is listed at 0.1-2.1.As you can note, both levels are very high.My current orthopedic surgeon is dr (b)(6) of (b)(6) orthopedics.On (b)(6) 2019 dr (b)(6) replaced my left hip and removed/drained the left side tumor.Dr (b)(6) has scheduled the 2nd surgery to replace the right hip and remove the tumor for (b)(6) 2019.Dr (b)(6) has informed me that due to these high metal levels in my blood, neurological damages are already happening, but at this time i just don't know what they are or to what extent i will be affected in the future.He simply said that we could not delay in getting the right side done and removing that tumor.I even asked the dr when we were in his office last week if he could go ahead and drain the remaining tumor before the surgery.He stated that it would not accomplish anything due to the faulty right hip apparatus still being in there and it would refill with these metal ions within a day or two.I am preparing for my next surgery in (b)(6), but i am now very concerned about the future neurological issues which i may be facing.I have no idea how long these tumors have been present and how long these metal levels have been so elevated in my body, all due to these faulty hip devices from depuy.Any help from you to get depuy to admit these replacement hips were faulty and have a recall on them.Would like some financial help from them for the pain, suffering, medical expenses and long-term health problems that i might have.

• Brand Name: PINNACLE HIP REPLACEMENT
• Type of Device: PROSTHESIS, HIP, SEMI - CONSTRAINED, METAL / POLYMER, POROUS UNCEMENTED
• Manufacturer (Section D): DEPUY ORTHOPAEDICS, INC.
• MDR Report Key: 8456105
• MDR Text Key: 140162225
• Report Number: MW5085184
• Device Sequence Number: 1
• Product Code: LPH
• 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: 03/22/2019
• 2 Devices were Involved in the Event: 1 2

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
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/26/2019
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 64 YR
• Patient Weight: 93