MAUDE Adverse Event Report: DEPUY ORTHOPEDICS DEPUY PINNACLE HIP IMPLANT

Device Problems Device Operates Differently Than Expected (2913); Device Dislodged or Dislocated (2923)

Patient Problems Pain (1994); Toxicity (2333)

Event Type  Injury  

Event Description

There was fluid retention between the medal of metal liner and socket implant.How this happened is unknown.Also chromium and cobalt levels were elevated.There are over (b)(4) lawsuits regarding the depuy pinnacle hip implant.This implant should have been recalled by the fda just like the depuy asr implant was recalled.The problems between the two implants were exactly the same, elevated chromium and cobalt levels, shifting, grinding, popping, dislocations, and chronic pain.These problems are not limited to just these examples.The fda with the amount of problems this hip implant has caused needs to reconsider and force the company to recall this implant.As a known fact there were many more of the pinnacle hip implants that were used worldwide then there were of the asr implant was used.

• Brand Name: DEPUY PINNACLE HIP IMPLANT
• Type of Device: DEPUY PINNACLE HIP IMPLANT
• Manufacturer (Section D): DEPUY ORTHOPEDICS
• MDR Report Key: 7411555
• MDR Text Key: 105190636
• Report Number: MW5076394
• 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: 04/08/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/09/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Was Device Available for Evaluation?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Disability
• Patient Age: 55 YR
• Patient Weight: 107