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

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Abdominal Pain (1685); Discomfort (2330); Complaint, Ill-Defined (2331); Toxicity (2333)

Event Date 02/14/2018

Event Type  Injury  

Event Description

Had mom implant (zimmer) in left hip in (b)(6) 2007.At that time, we also talked of replacing the right hip.I could tolerate the pain in the right hip and avoided the next surgery.In (b)(6) 2018 began having abdomen pain / discomfort and went through numerous tests and drs in multiple fields to try and identify the issue (cystoscopy, colonoscopy, dye contrast ultrasound, catheterization, etc).In (b)(6) 2018 had 20 x 12 x 20 cm watery mass removed from abdomen after multiple incorrect diagnoses.Mass could not be positively identified though the obgyn that did the surgery suggested it was an ovarian cyst.My right hip was increasingly giving me problems.My shoulder, arms, and knees were having phantom pains.In (b)(6) 2019 began having trouble with my eyes as well.I went to the same orthopedic surgeon in (b)(6) 2019 to discus my right hip.After an x-ray, he focused on the left hip implant and did not want to discuss anything else.He said i needed to be replaced.He did a cobalt / chromium blood test.Chromium was 2.1, cobalt was 8.7.He was concerned that it was high, but not the highest he has seen.I had a mars mri that showed multiple pseudotumors surrounding the hip joint.The dr suggested that the abdominal cyst could have been a pseudotumor.Revision surgery is not yet scheduled but will take place after completion of a heart stress test (stress test schedule for (b)(6) 2019).I am in the middle of trying to get my life back and figuring out how much this mom hip replacement has impacted me.I do not have a copy of blood test (yet).No model name was stated.Fda safety report id# (b)(4).

• Brand Name: ZIMMER MOM HIP
• Type of Device: HIP, PROSTHESIS, METAL ON METAL
• Manufacturer (Section D): ZIMMER BIOMET
• MDR Report Key: 8678970
• MDR Text Key: 147595095
• Report Number: MW5087183
• Device Sequence Number: 1
• Product Code: JDI
• 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: 06/04/2019

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?: Yes
• Device Operator: No Information
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 06/06/2019
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 67 YR
• Patient Weight: 98