MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS, INC. ARTICUL/EZE COBALT-CHROME FEMORAL HEAD SIZE 36MM; PROSTHESIS,HIP SEMI-CONSTRAINED(METAL UNCEMENTED ACETABULAR COMPONENT

Catalog Number 1365-52-000

Device Problems Break (1069); Corroded (1131); Fracture (1260); Material Fragmentation (1261); Migration or Expulsion of Device (1395); Patient-Device Incompatibility (2682); Loosening of Implant Not Related to Bone-Ingrowth (4002)

Patient Problems Edema (1820); Fatigue (1849); Failure of Implant (1924); Muscle Weakness (1967); Weakness (2145); Toxicity (2333); Cognitive Changes (2551); Test Result (2695)

Event Date 03/21/2019

Event Type  Injury  

Event Description

On (b)(6) 2002, cd received a left tha by dr (b)(6).The implant consisted of a depuy pinnacle acetabular cup size 52mm (ref# 1217-03-052, lo# wd2gy1010), ultamet cobalt-chrome metal insert neutral 36mm 52od (ref # 121887352, lot ygp-25), articul/eze cobalt-chrome femoral head size 36mm +5 neck length with a 12/14 taper (ref # 1365-52-000, lot wc3jd1012), and a replica hip stem 10.5mm diameter and 180mm length (cat no.1530-42-000, lot te7bk1009).This report is for the left tha.However, it should be noted that she previously also received a primary right tha on (b)(6) 2002 with the same depuy pinnacle metal-on-metal implant.In 2012, she began experiencing symptoms of fatigue and difficulties with memory and muscle weakness in her legs.On (b)(6) 2017, her blood cobalt level was 14.0 ppb and her urine cobalt level was 109.9.The stem of the right tha was found by x-ray to be broken at the distal tip.On (b)(6) 2017, she elected to have the right tha revised due to symptoms related to the broken stem and her rising cobalt levels.This hip was revised to cemented stryker exeter stem and a ceramic-on-polyethylene articulation.Despite this revision her cobalt level remained high.On (b)(6) 2018, her blood cobalt level 9.4 ppb and her urine cobalt level was 35.6 ppb.She continued to experience cognitive issues and mental fogginess and had progression of neuropathic weakness in both legs.An fdg pet brain scan showed focal and generalized hypometabolism consistent with chronic toxic encephalopathy.On (b)(6) 2019, her left tha was revised for significantly elevated cobalt level, adverse reaction to metal debris, non-union of trochanteric osteotomy with proximal migration.The replica stem was retained and the cobalt chrome metal-on-metal articulation was revised to a depuy altrex polyethylene neutral liner and a 36mm +5 neck length delta option sleeved ceramic head.The bore of the head and the trunion of the retained stem showed moderate corrosion wear.The cobalt chrome femoral head showed a wear elipse.Retrieval analysis of the explant showed minor corrosion wear of the articular surface of the cobalt-chrome acetabular component.The anterior capsule and the abductor tendons were involved in the adverse reaction to metallic debris and both required repair.About 2 months post-revision surgery, she suffered recurrent dislocation of the revised left tha, requiring yet another revision to a zimmer cemented constrained liner to a 32mm +5 ceramic option head.Her multiple dislocations are due to significant tissue damage from adverse reaction to metal debris and her neuropathic loss of proprioception due to cobalt toxicity.Fda safety report id# (b)(4).

Event Description

"(b)(6) depuy pinnacle", on (b)(6) 2002, pt underwent a right total hip arthroplasty for osteoarthritis of the right hip.The implant used was a depuy pinnacle acetabular cup size 52 ref no- 1217-03-051, lot no: wd2gy1010; depuy replica hip system 10.5mm diameter 180 mm length stem, cat no: 1530-42-000, lot no: te7bk 1009; depuy ultamet metal insert neutral 36mm 52od liner, ref no: 121887352, lot no: ygp-25; articul/eze femoral head 35mm+5 12/14 taper, ref no: 1365-52-000, lot: wc3jd1012, apex hole eliminator positive stop call no: 1246-03-000, lot: wf5ab1000.On (b)(6) 2015, her plasma cobalt level was 18.1mcg/l and urine cobalt level was 52.8mcg/l.On (b)(6) 2016, her plasma cobalt level was 21.0mcg/l and urine cobalt level was 21.2 mcg/l.Plain x-rays of the hips made on (b)(6) 2017 showed interval fracture of the right replica stem just proximal to the tip of the prosthesis and apparent subtle linear radiolucency about the proximal fragment of the stem with subtle shift in position.Metal suppression mri of both hips showed fluid collect around the right hip and a possible soft tissue mass at the posterior aspect of both hips.She tried cobalt chelation therapy with n-acetylcysteine to lower her cobalt levels while avoiding risky revision surgery.Her cobalt levels remained elevated and her symptoms progressed.She noted clunking in both her artificial hips (a maude has already been submitted for her left tha mw5091588) and weakness with gait.Neuropsychological evaluation notable for mild cognitive decline and fine motor incoordination.Emg and ncv studies showed baseline mild axonal neurosensory poly neuropathy with overlay of lumbar radiculopathy.Echocardiogram showed grade 1 diastolic dysfunction.On (b)(6) 2017, the right hip was revised for hypercobaltemia, arthroplasty cobalt encephalopathy, adverse reaction to metallic debris, fracture of the distal stem due to proximal femoral lysis, suspected taper corrosion of the cobalt chrome liner and tiaiv acetabular socket.Revision involved removal of the 10.5mm depuy cobalt chrome replica stem with the exception of one distal tine which had broken off and was retained, cobalt chrome ultamet liner, and cobalt chrome articul/eze 36mm+5 head.Revision implant used was a stryker exeter 44 #1 stem, depuy altrex 36 id neutral polyethylene liner, 36mm +0 delta ceramic head, 3 wires.Findings from revision surgery were that the superficial periprosthetic tissues were notable for thickened trochanteric bursa with partial attrition of the gluteus medius tendon consistent with adverse reaction to metallic debris (armd).The anterior capsule was thickened ad had a fish flesh appearance consistent with armd.The posterior capsule was contracted and repaired and the anterior capsule was partially intact after debridement at case end.The hip abductor tendons were repaired with #5 ethibond.There was proximal bone deficiency due to loosening with the stem that was treated with impaction grafting.There was severe corrosion noted at the head-stem taper and minor corrosion noted at the taper of the cobalt chrome acetabular liner and shell.Fluid from the hip was aspirated and cobalt level of this fluid was 120 mcg/l.Formal analysis of the explant involved assessment of corrosion and wear.The analysis revealed that greater than 50% of the head bore was involved in corrosion and 10-50% of the stem taper was involved in corrosion.Comments on the wear observed on the articul / eze cobalt chrome femoral head were as follows: "the articular surface of the cc femoral head shows a moderate retrieval artifact and a faint ellipse.The bore shows severe corrosion (3), which obscures any insertion removal fretting.Markings are dc 36+1.5 1047003.".

• Brand Name: ARTICUL/EZE COBALT-CHROME FEMORAL HEAD SIZE 36MM
• Type of Device: PROSTHESIS,HIP SEMI-CONSTRAINED(METAL UNCEMENTED ACETABULAR COMPONENT
• Manufacturer (Section D): DEPUY ORTHOPAEDICS, INC. ; warsaw IN
• MDR Report Key: 9452463
• MDR Text Key: 170656170
• Report Number: MW5091588
• Device Sequence Number: 3
• Product Code: KWA
• 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,Followup
• Report Date: 12/06/2019
• 9 Devices were Involved in the Event: 1 2 3 4 5 6 7 8 9

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
• Device Catalogue Number: 1365-52-000
• Device Lot Number: WC3JD1012
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/10/2019
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 01/27/2020
• 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: 0
• Patient Outcome(s): Hospitalization; Other; Required Intervention; Disability
• Patient Weight: 73