MAUDE Adverse Event Report: ARTIFICIAL SHOULDER COCR COMPONENTS ; PROSTHESIS, SHOULDER, SEMI-CONSTRAINED

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Emotional Changes (1831); Unspecified Infection (1930); Memory Loss/Impairment (1958); Myalgia (2238); Toxicity (2333); Sleep Dysfunction (2517)

Event Date 03/20/2017

Event Type  Injury  

Event Description

Pt id: (b)(6); as part of a 2-stage revision for a (b)(6) infection, on (b)(6) 2012, he underwent revision of pmma spacers to a cemented total hip arthroplasty.The cemented hip components included a zimmer tm augment 50 mm by 10mm socket, zca longevity liner, palacos x1 with 1.2 grams of tobramycin and 3 grams of vancomycin, 180 mm size 3 valgus neck cpt stem, 32mm +0 cocr head, 2.5 lv palacos with 2.4 grams of tobramycin and 6 grams of vancomycin.Of note, he also has a left tha with osteonics with a c-taper titanium stem with a cobalt head, both of these artificial knees have cocr femoral components, and both artificial shoulders have cocr components.On (b)(6) 2017, his serum / plasma cobalt level was 2.9 mcg/l and urine cobalt level was 9.7 mcg/l.On (b)(6) 2019, his whole blood cobalt level was 4.0 mcg/l and his urine cobalt level was 9.2 mcg/l.He has some new issues with mood and memory.He also notes new sleep disturbances and myalgia namely affecting his shoulders.Fda safety report id# (b)(4).

• Brand Name: ARTIFICIAL SHOULDER COCR COMPONENTS
• Type of Device: PROSTHESIS, SHOULDER, SEMI-CONSTRAINED
• MDR Report Key: 9720745
• MDR Text Key: 180122643
• Report Number: MW5093027
• Device Sequence Number: 5
• 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: 02/12/2020
• 6 Devices were Involved in the Event: 1 2 3 4 5 6

1 Patient was Involved in the Event

• Date FDA Received: 02/14/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Is the Reporter a Health Professional?: No
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 69 YR
• Patient Weight: 120