MAUDE Adverse Event Report: BIOMED, INC. M2A MODULAR HEAD COMPONENT; PROSTHESIS, HIP, SEMI-CONSTRAINED (METAL UNCEMENTED ACETABULAR COMPONENT)

Lot Number 224730

Device Problems Patient-Device Incompatibility (2682); Therapeutic or Diagnostic Output Failure (3023)

Patient Problems Dyspnea (1816); Headache (1880); Nausea (1970); Pain (1994); Rash (2033); Dizziness (2194); Neck Pain (2433); Osteopenia/ Osteoporosis (2651); Metal Related Pathology (4530)

Event Date 03/04/2004

Event Type  Injury  

Event Description

Patient called to report an adverse reaction to her biomet m2a right hip replacement device.Patient stated that after the implant surgery on (b)(6) 2004, she experienced pain and complained to doctors for several years but kept being told it was her back or a tendon causing the pain.Patient said she couldn't walk some days, needed crutches, and couldn't put weight on her right leg.Patient stated she went to the doctor and was finally diagnosed with metallosis and bone loss.Patient stated she had tests, nuclear scans, mri's and blood work done, and it was discovered chromium cobalt was the cause.Patient stated on (b)(6) 2021, she had a revision procedure where the right hip was cleaned up and replaced with cadaver bone.Before the revision the patient experienced dizziness, neck and back pain, tooth ache, shortness of breath, headaches, groin pain, nausea, rashes, and thumb pain.Patient stated since the revision, many of her symptoms have improved or gone away.Patient stated the doctor said that her case of metal poisoning was the worst case he's seen.

• Brand Name: M2A MODULAR HEAD COMPONENT
• Type of Device: PROSTHESIS, HIP, SEMI-CONSTRAINED (METAL UNCEMENTED ACETABULAR COMPONENT)
• Manufacturer (Section D): BIOMED, INC.
• MDR Report Key: 12662644
• MDR Text Key: 277671852
• Report Number: MW5104757
• Device Sequence Number: 4
• Product Code: KWA
• 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: 10/13/2021
• 4 Devices were Involved in the Event: 1 2 3 4

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
• Device Lot Number: 224730
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/18/2021
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 65 YR