MAUDE Adverse Event Report: BIOMET, INC. PROSTHESIS, HIP, HEMI-, FEMORAL, METAL/POLYMER, CEMENTED OR UNCEMENTED

Patient Problems Pain (1994); Myalgia (2238); Osteopenia/ Osteoporosis (2651)

Event Date 12/08/2022

Event Type  Injury  

Event Description

I was diagnosed with osteporosis.(b)(6) of 2022 l received a dose of prolia.In the next months i developed severe bilat thigh pain and moderate back pain.My primary dr did an mri (unchanged) and i was taking nsaids (non-steroidal anti-inflammatory drugs) and tylenol for the pain.It was very similar to when i had an intolerance to lipitor, severe muscle aching made worse by activity (i had been walking 3-5 miles a day and had to cut that back).I have had a knee replacement and hip replacement on the right.(also thr on left).I thought that the prolia had caused the severe thigh pain, so i relayed off to reclast ((b)(6) 2023).The severe pain abated over the next months but then i was still having more right thigh pain and r knee pain.The right hip was replaced over 10 years ago and had been stable.I have seen an orthopod and looking at xrays and bone scan: there is abnormal activity at the stem tip on the right and some bone loss at the plate of the knee replacement.About 3 months after the prolia would have been due again, the general thigh pain (except for the right knee/hip) has/had abated.Please note this is a biomet mom (metal-on-metal) hip and i have serial metal levels done as well (stable) as the fda did not ever recall biomet mom (metal-on-metal) before i got mine although many countries already had.I was not notified by my doctor or fda about the metal problems with these hips for years.I checked the recall list when the ads were on tv about metal hips but of course you didn¿t recall biomet.I am concerned that the prolia caused bone remodeling/loss in my prosthesis, and i have recurrent appts lined up to monitor the stability of the r knee and r hip.Lf it does progress or becomes more unstable i will have to have another replacement.Reference report: mw5149170.

• Brand Name: PROSTHESIS, HIP, HEMI-, FEMORAL, METAL/POLYMER, CEMENTED OR UNCEMENTED
• Type of Device: PROSTHESIS, HIP, HEMI-, FEMORAL, METAL/POLYMER, CEMENTED OR UNCEMENTED
• Manufacturer (Section D): BIOMET, INC.
• MDR Report Key: 18318162
• MDR Text Key: 330639658
• Report Number: MW5149169
• Device Sequence Number: 1
• Product Code: KWY
• Combination Product (y/n): Y
• 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: 12/01/2023

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?: No
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/12/2023
• Patient Sequence Number: 1
• Treatment: AMLODIPINE 5MG QD.; B COMPLEX.; CALCIUM.; CELEBREX 100MG PRN ARTHRITIS.; MAGNESIUM.; NSAIDS (NON-STEROIDAL ANTI-INFLAMMATORY DRUGS); PLAVIX 75MG QD.; RECLAST INFUSION LAST DONE JUNE 2023.; REPATHA 140 SQ EVERY 3 WEEKS (CHOLESTEROL).; TYLENOL 500X 2 HS ARTHRITIS.; VALTREX 500 MG (GENERIC) PREVENTIVE HSV Q DAY.; VITAMIN D HERBAL REMEDIES BEING USED.; XIIDRA BID EYES DROPS.
• Patient Outcome(s): Disability
• Patient Age: 73 YR
• Patient Sex: Female
• Patient Weight: 73 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White