ZIMMER CPT STEM AND COCR HEAD
Received Feb 14, 2020 · Event occurred Mar 20, 2017
Report MW5093027 · MDR key 9720745
Device
Generic name
Prosthesis, Hip, Semi-constrained, Metal/polymer Cemented
Manufacturer
Zimmer, Inc.Product problems
- Adverse Event Without Identified Device or Use Problem
Patient
69 YR
- Emotional Changes
- Unspecified Infection
- Memory Loss/Impairment
- Myalgia
- Toxicity
- Sleep Dysfunction
- Emotional Changes
- Unspecified Infection
- Memory Loss/Impairment
- Myalgia
- Toxicity
- Sleep Dysfunction
Narrative
Description of Event or Problem
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).