MAUDE Adverse Event Report: ZIMMER INC. MIETAL-ON-METAL ZIMMER METASUL DUROM HIP IMPLANT; PROSTHESIS, HIP, HEMI, ACETABULAR, CEMENTED, METAL

Device Problems Corroded (1131); Loose or Intermittent Connection (1371)

Patient Problems Failure of Implant (1924); Pain (1994); Test Result (2695); Device Embedded In Tissue or Plaque (3165)

Event Date 02/11/2019

Event Type  Injury  

Event Description

On (b)(6) 2007, (b)(6) received a left tha and a metal-on-metal zimmer metasul / durom #60 acetabular component with a m-head adaptor and a #11 ml taper femoral component.In 2012, he started experiencing increasing pain in the left hip with activities.Imaging studies revealed possible loosening of the hip socket.He continued to have progressive left hip pain and occasional grinding of the hip.Metal suppression mri of the left hip showed a fluid collection around the left hip replacement, mainly involving intracapsular fluid.The capsule appeared to be distended by the fluid, but intact.Both anterior and posterior capsules appeared to be intact, though the anterior capsule appeared thickened.These changes suggested adverse reaction to metal debris.On (b)(6) 2018, his blood and urine cobalt levels were checked and found to be elevated at 3.5 ppb and 12.9 ppb, respectively.His serum chromium level was 4.3 ppb.He did ot endorse any cognitive changes, energy level and mood were normal.Due to this progressive symptoms, mri findings, and elevated cobalt levels, he elected to have the left hip revised on (b)(6) 2019.The durom acetabular component was grossly loose.He was revised to a biomet g7 multihole 66mm od socket with five dome screws, a cross-linked polyethylene liner and a high wall set posteriorly-inferiorly and a 36 mm delta ceramic option head with a +7 neck length.There was a solid and cystic pseudotumor involving the hip capsule.Gross pathology reports synovium with proliferative changes, abundant fibrin, pigmented laden macrophages, foreign body giant cell reaction with nonpolarizable foreign debris, and perivascular chronic inflammation (alvl).There was also evidence of gross corrosion at the taper adaptor of the head and stem trunnion.Fluid was aspirated from the hip and believe to be diluted by 1:2 with the local anesthetic, and the cobalt level of this diluted fluid was 320ppb.At 3 months post-revision, his blood cobalt level went down to 0.8 ppb and his urine cobalt level went down to 2.3 ppb.Fda safety report id# (b)(4).

• Brand Name: MIETAL-ON-METAL ZIMMER METASUL DUROM HIP IMPLANT
• Type of Device: PROSTHESIS, HIP, HEMI, ACETABULAR, CEMENTED, METAL
• Manufacturer (Section D): ZIMMER INC.; warsaw IN
• MDR Report Key: 9490754
• MDR Text Key: 171981020
• Report Number: MW5091724
• 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: Physician
• Type of Report: Initial
• Report Date: 12/13/2019

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: Lay User/Patient
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/17/2019
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 36 YR
• Patient Weight: 95