MAUDE Adverse Event Report: BIOMET METAL ON METAL HIP IMPLANT; PROSTHESIS, HIP

Device Problem Material Disintegration (1177)

Patient Problems Abdominal Pain (1685); Diarrhea (1811); Nausea (1970); Pain (1994); Tissue Damage (2104); Discomfort (2330)

Event Date 05/14/2012

Event Type  Injury  

Event Description

I received a biomed brand metal on metal hip implant in my right hip.Four weeks after it was implanted, it had to be replaced.Either the implant broke or hip was improperly installed.Dr never really explained what happened.The second implant was always painful and never seemed to feel right.Over time it began to "pop," when walking.Approx one year later, i began running a constant low grade fever with bowel problems.Abdominal pain, diarrhea and nausea.There were also emotional problems and prescribed medications not working properly.My drs were attempting to treat individual symptoms, but were unaware of the real problem.I had developed "metallosis." there were television ads running for the recall of metal on metal hip implants, so i began having bloodwork.My cobalt and chromium levels were monitored at six month intervals.They both increased.In (b)(6) 2017, i had surgery to remove the metal on metal portion of my implant.My orthopedist confirmed i had developed metallosis.There was significant tissue damage around the implant.I had my cobalt and chromium checked for the first time in (b)(6) 2018 and there was no sign of either in my blood.I continue to have digestive issues, but the metal poisoning seems to have been eliminated.

• Brand Name: METAL ON METAL HIP IMPLANT
• Type of Device: PROSTHESIS, HIP
• Manufacturer (Section D): BIOMET
• MDR Report Key: 7673372
• MDR Text Key: 113742435
• Report Number: MW5078293
• Device Sequence Number: 2
• 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: 07/06/2018
• 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
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 07/09/2018
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention; Disability
• Patient Age: 61 YR
• Patient Weight: 93