MAUDE Adverse Event Report: ZIMMER, INC. ZIMMER HERITAGE HIP DEVICE; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER,CEMENTED

Device Problems Corroded (1131); Material Deformation (2976)

Patient Problems Tinnitus (2103); Visual Impairment (2138); Toxicity (2333); Shaking/Tremors (2515); No Code Available (3191)

Event Date 06/12/2018

Event Type  Injury  

Event Description

Pt id: (b)(6); on (b)(6) 1998, the pt received a right total hip arthroplasty for end-stage coxarthrosis secondary to dysplasia.The components were a cemented zimmer heritage size one stem (polished with old morse taper) and an ingrowth trilogy socket with a single screw fixation, 26mm medium plus cobalt chrome head, neutral unlift 26 inner diameter polyethylene liner, 11 mm tip centralizer osteobond cement.Urine cobalt level collected on (b)(6) 2018 was 14.4 mcg/l.Blood cobalt level collected on (b)(6) 2018 was 1.3 mcg/l.She developed mild tinnitus and deafening, vision problems, a fine rest tremor of the right hand.Fdg pet brain scan and neuro q analysis notable for significantly abnormal hypometabolism focally and generally in a pattern consistent with chronic toxic encephalopathy.Metal suppression mri of the right hip was notable for a small amount of intra-articular fluid at the right hip.There also appeared to be some synovial and capsular thickening of the right hip joint.The right hip abductor tendons looked fine.There was a possible decreet pseudotumor along the lateral shoulder of the right femoral stem, about 2 cm in diameter and a corresponding area medially, also about 2 cm in diameter.On (b)(6) 2018, the right tha was revised due to rising cobalt levels, pseudotumor of the right hip, increasing cognitive symptoms consistent with arthroplasty cobalt encephalopathy.Explants included heritage stem, 26mm cocr head and the 26mm id polyethylene liner; 5 cc of fluid was collected from the right hip joint during the time of revision and the cobalt level of this fluid was 50 mcg/l.The posterior capsule was intact but thickened, and so it was repaired.The hip abductor tendons were intact.There was proximal femoral bone deficiency due to extraction of the stem that was treated with impaction grafting.There was moderate corrosion evident at the taper junction between the cocr head and the stem.There was corrosion evident at the stem / pmma interface.The stem was well fixed.The old polyethylene showed minimal eccentric wear.Post revision cobalt levels, measured on (b)(6) 2019, were 0.3 mcg/l in blood and 0.3 mcg/l in urine.Fda safety report id# (b)(4).

• Brand Name: ZIMMER HERITAGE HIP DEVICE
• Type of Device: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER,CEMENTED
• Manufacturer (Section D): ZIMMER, INC. ; warsaw IN
• MDR Report Key: 9677041
• MDR Text Key: 178263620
• Report Number: MW5092813
• 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: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 02/03/2020

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?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/05/2020
• 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 Weight: 59