MAUDE Adverse Event Report: DEPUY SYNTHES/JOHNSON AND JOHNSON MEDICAL DEPUY SYNTHES (JOHNSON AND JOHNSON) GLOBAL ADVANTAGE COCR HUMERAL HEAD; PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED

Catalog Number 1128-52-000

Device Problem Material Erosion (1214)

Patient Problems Dyspnea (1816); Emotional Changes (1831); Fatigue (1849); Headache (1880); Inflammation (1932); Tinnitus (2103); Toxicity (2333); Shaking/Tremors (2515); Confusion/ Disorientation (2553)

Event Date 02/14/2018

Event Type  Injury  

Event Description

Patient id: (b)(6); on (b)(6) 2015, she received a left hemi shoulder arthroplasty with a depuy synthes global advantage system involving a 52mm global advantage cocr humeral head (udi ¿(b)(4)¿) and size 8 global advantage standard stem (udi (b)(4)).She previously also had her knees replaced: right ¿unicompartmental¿ knee arthroplasty done (b)(6) 2002, left total knee arthroplasty ((b)(6) 2003), and conversion of right unicompartmental to total knee arthroplasty ((b)(6) 2003).The right knee implant is a depuy sigma knee with a stabilized 15mm tibial insert sz 2.5 ((b)(4), 93-0053-500), sigma non-porous right sz 3 femoral (112934, 96-0111), knee patella 35mm round 3 peg onset uhmwpe pfc sigma ((b)(4), 1581-25-000, mod tibial tray cemented.The left knee implant is a depuy sigma tib poly stab #2 10mm (1024658, 96-0110), knee patella pfc sigma round/dome 3 peg 32mm ((b)(4), 96-0043-500, sigma nonporous femoral left sz 3.All three artificial joints consist of cocr components.She continuously developed an effusion of the right revised tka.Cobalt and chromium synovial fluid from right knee aspiration done (b)(6) 2018, and chromium level was 2.0 mcg/l and cobalt level was not detected.She reported that the left shoulder arthroplasty constantly bothered her.Ct arthrogram of the left shoulder showed supraspinatus tendon is intact and significant posterior erosion of the glenoid.On (b)(6) 2018, her serum/plasma cobalt level was 2.5mcg/l.On (b)(6) 2018, her whole blood cobalt level was 1.7 mcg/l and urine cobalt level was 11.3 mcg/l.On (b)(6) 2018, blood cobalt level was 2.1 mcg/l and urine cobalt level was 6.8 mcg/l.In (b)(6) of 2017, she experienced sudden and new onset of fatigue, dyspnea, confusion, polyneuropathy, balance issues, headaches, tinnitus, vision and hearing issues, word finding issues, tremor/changes in handwriting, mood changes, and difficulty with multitasking.On (b)(6) 2018, she was diagnosed with idiopathic peripheral neuropathy.Fdg pet brain scan done (b)(6) 2018 analyzed with neuroq and neuro-stst/3d-ssp software.Notable for 21 regions of hypometabolism with a total aggregate score of -42.2 and three significant clusters of abnormality in a pattern compatible with chronic toxic encephalopathy.On (b)(6) 2018, her left shoulder was revised.The revision implant was tornier total shoulder arthroplasty with a small pegged cortilock with 25 degrees posterior build-up erosion glenoid cement was simplex with 1 g vancomycin and a 43mm slight eccentric neutral mm thickness tialv alloy head, and an in growth size 1 ascend flex tialv alloy.The humeral stem was revised because depuy did not have a non-cobalt head option.The glenoid had significant posterior erosion but adequate bone remained for resurfacing with the posteriorly augmented cortilock small glenoid.Pathology report of frozen section of left shoulder synovial tissue notable for signs of chronic inflammation including mild to moderate lymphohistiocytic inflammation and dense chronic perivascular lymphocytic inflammation (alval).Cobalt level of left shoulder fluid was 64 mcg/l and chromium level was 78 mcg/l, her blood and urine cobalt levels initially dropped following revision of the left shoulder.On (b)(6) 2019, about one year out from revision, her urine cobalt level was 1.8 mcg/l and her blood cobalt level was 0.5mcg/l.On (b)(6) 2019, her urine cobalt level rose to 3.2 mcg/l and her blood cobalt level was still 0.5 mcg/l.She still has retained two cocr-containing knee implants.Fda safety report id # (b)(4).

• Brand Name: DEPUY SYNTHES (JOHNSON AND JOHNSON) GLOBAL ADVANTAGE COCR HUMERAL HEAD
• Type of Device: PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED
• Manufacturer (Section D): DEPUY SYNTHES/JOHNSON AND JOHNSON MEDICAL
• MDR Report Key: 9775106
• MDR Text Key: 182217093
• Report Number: MW5093424
• Device Sequence Number: 1
• Product Code: KWS
• 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: 02/26/2020
• 3 Devices were Involved in the Event: 1 2 3

1 Patient was Involved in the Event

• Date FDA Received: 02/28/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 11/01/2019
• Device Catalogue Number: 1128-52-000
• Device Lot Number: D0911045
• 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: 66 YR
• Patient Weight: 56