MAUDE Adverse Event Report: BIOMET ACETABULAR CUP/FEMORAL HEAD

Device Problem Insufficient Information (3190)

Patient Problems Pain (1994); Tissue Damage (2104); Toxicity (2333); Limited Mobility Of The Implanted Joint (2671)

Event Date 05/14/2016

Event Type  Injury  

Event Description

I was taken to the er with a kidney stone.When they did an abdominal ct scan, the view of the organs was completely obliterated by metal in fluid that covered them.The ct scan just looked black.They sent me to a local urologist and he sent me to the hip surgeon who did my original hip replacement.He ordered blood work for cobalt and chromium and a mars mri.The blood metal levels were elevated and the mri showed a massive pseudotumor (16x15x14 cm) filled with complex fluid/wall thickening/metallosis.There was atrophy of the pelvic and hip muscles and scalloping along the right femoral shaft.When the pseudotumor was removed in surgery in (b)(6) 2016 they discovered that the metal had also eaten away the pelvic bone which now is so thin, it could not support a manufactured hip cup.The md 'created' a substitute cup, using screws to hold it in, then, with difficulty finally used a replacement ball that did not dislocate as quickly as all the others he tried.For additional security, he put a 'lasso' around it and fastened that down, too, in the hopes it would hold.Five months down the road, it is still holding.However, significant pain and limited mobility remain.In order to use the stairs in my home, i have had to have a stair lift chair installed and can not yet drive my car.It has been very debilitating.

• Brand Name: ACETABULAR CUP/FEMORAL HEAD
• Type of Device: ACETABULAR CUP/FEMORAL HEAD
• Manufacturer (Section D): BIOMET
• MDR Report Key: 6338835
• MDR Text Key: 67822710
• Report Number: MW5067924
• Device Sequence Number: 1
• Product Code: LPH
• 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: 02/14/2017

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
• Device Operator: No Information
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/14/2017
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Treatment: ACTOZA; BENEFIBER; BUMETANIDE; CALTRATE 600 MG; JANUVIA; KLONOPIN; LANSAPROZOLE; LIPITOR; MIRALAX; MULTAQ; OTC MEDS: ECOTRIN 81 MG; RX MEDS: CELEBREX; TOPROLOL TARTRATE; WARFARIN
• Patient Outcome(s): Hospitalization; Other; Required Intervention; Disability
• Patient Age: 77 YR
• Patient Weight: 98