MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS, INC. DEPUY PINNACLE METAL ON METAL WITH AML STEM; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Device Problems Break (1069); Material Fragmentation (1261); Patient-Device Incompatibility (2682)

Patient Problems Failure of Implant (1924); Pain (1994); Depression (2361); Cognitive Changes (2551); Test Result (2695)

Event Date 02/22/2018

Event Type  Injury  

Event Description

On (b)(6) 2007, she received a right tha for osteoarthritis of the hip by dr (b)(6) in (b)(6).In right tha consisted of a depuy pinnacle ultamed metal-on-metal implant on a corail stem.In (b)(6) 2015, she reported discomfort about the right tha especially with right hip flexion against resistance.Of note, she had her left tha, which was depuy pinnacle metal-on-metal with aml stem, previously revised on (b)(6) 2012 for broken aml stem.On (b)(6) 2015, her serum plasma cobalt level was 1.1 ppb.On (b)(6) 2016, her urine cobalt level was 4.2 ppb her blood cobalt level was 0.9 ppb.Prior to these results, her cobalt levels were "none defected".In addition to progressive pain at the right hip.She began noticing problems with her memory and cognitive function.She developed new depressive mood disorder, for which she began treatment with anti-depressants.Metal suppression mri of the right hip showed degenerative spondylosis of lower lumbar spine most notably at l5-s1, no apparent evidence of capsular thickening around the high metal-on-metal hip, hip abductor tendons looked fine, and there was a minimal collection of fluid in right trochanteric bursa.Fdg pet brain scan showed very significant focal and generalized hypometabolism consistent with chronic toxic encephalopathy.On (b)(6) 2018, she elected to have her right tha revised to a depuy polyethylene socket liner 36mm id for existing pinnacle shell and delta option ceramic ball size 36mm +8.5 neck length.The trunion of the stem and the bore of the cobalt-chrome head showed mild corrosion.There was no apparent corrosion at the taper junction of the cobalt chrome liner and the titanium alloy shell.The posterior and anterior capsules were thickened, metal stained, and with a fish flesh appearance consistent with adverse reaction to metallic debris.The abduction tendons were mildly inflamed but intact and trochanteric bursa was mildly inflamed but not effused.Six weeks post-revision, here blood cobalt level was <0.2 ppb and her urine cobalt level was 0.4 ppb.About one year after her revision, she had her fdg pet brain scan repeated and it showed improvement in metabolic activity, but still hypometabolic.Fda safety report id# (b)(4).

• Brand Name: DEPUY PINNACLE METAL ON METAL WITH AML STEM
• Type of Device: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED
• Manufacturer (Section D): DEPUY ORTHOPAEDICS, INC.
• MDR Report Key: 9445038
• MDR Text Key: 170640358
• Report Number: MW5091545
• Device Sequence Number: 2
• 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: 12/05/2019
• 2 Devices were Involved in the Event: 1 2

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
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/09/2019
• 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: 67 YR
• Patient Weight: 71