MAUDE Adverse Event Report: DEPUY ORTHOPEDICS, INC. DEPUY PINNACLE METAL ON METAL HIP DEVICE; PROSTHESIS, HIP, SEMI-CONSTRAINED (METAL UNCEMENTED ACETABULAR COMPONENT)

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Emotional Changes (1831); Fatigue (1849); Hearing Loss (1882); Failure of Implant (1924); Memory Loss/Impairment (1958); Pain (1994); Visual Impairment (2138)

Event Date 01/30/2020

Event Type  Injury  

Event Description

Pt id: (b)(6); pt's left hip was replaced by (b)(6) on (b)(6) 2008.The operative report shows that this is a pinnacle 100 series, 50mm outer diameter titanium cup with a pinnacle metal insert, a size 3 standard offset summit tapered stem with a dual fixed ha coating, and a 36mm +1.5 cobalt chrome femoral head.This was placed via a direct lateral approach.The hip started to become painful laterally in (b)(6) of 2018 and in the groin in the spring of 2019, aggravated with activities.Pain x-rays of the hip show a well-positioned acetabular component which is osseointegrated with a 36-mm metal-on-metal bearing, and a summit stem, which is in slight varus but the stem is well osseointegrated.A metal suppression mri of the left hip was obtained on (b)(6) 2018 showed some fluid in the joint and some fluid in the trochanteric bursal area.She also developed a notable tremor of the ulnar digits of both hands in 2018.She also noted in 2018 that she had poor balance and reduced pain tolerance.In 2016 she noticed short-term memory issues and poor mood and fatigue.In 2017, she noticed numbness and tingling of hands and feet.In 2018 she noticed tinnitus and deafness.In the same period of time, she has noticed difficulty with vision at night with flashing lights.On (b)(6) 2019, serum / plasma cobalt level was 4.5 mcg/l.On (b)(6) 2020, her blood cobalt level was 3.9 mcg/l and her urine cobalt level was 5.8 mcg/l.Her fdg pet brain scan analysis was notable for general and focal hypometabolism consistent with chronic toxic encephalopathy.Due to these compounding symptoms and rising cobalt levels, she elected to have the left hip revised on (b)(6) 2020.The stem was sound and was in 15 degrees of anteversion, the trunnion and head bore showed gross corrosion.There was no lysis about the femoral component.Posterior capsule was intact, anterior capsule was thickened with armd, abduction tendons were intact.Intraoperative frozen section showed no ai.Fluid form the left hip was collected and sent for cobalt level, and those results are still pending.The acetabular component was in 45 degrees of abduction and anteverted about 20 degrees, it was not loose and there was minor lysis.It was revised to allow for use of a 36mm ceramic head.The depuy no hole 50 od socket, 36mm id cobalt chrome liner, and 36mm +1.5 cobalt chrome head were removed and replaced with depuy pinnacle multiple hole 52 od with 4 dome screws.Altrex neutral 36 id socket liner, and a 36mm +1.5 mm length delta ceramic option head.Fda safety report id# (b)(4).

• Brand Name: DEPUY PINNACLE METAL ON METAL HIP DEVICE
• Type of Device: PROSTHESIS, HIP, SEMI-CONSTRAINED (METAL UNCEMENTED ACETABULAR COMPONENT)
• Manufacturer (Section D): DEPUY ORTHOPEDICS, INC.
• MDR Report Key: 9671382
• MDR Text Key: 177970585
• Report Number: MW5092754
• Device Sequence Number: 1
• 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: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 03/31/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/04/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Is the Reporter a Health Professional?: No
• 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: 69 YR
• Patient Weight: 81