inforMED
InjuryKWS

EQUINOXE SHOULDER IMPLANT

Received Jul 13, 2026 · Event occurred May 29, 2026

Report MW5190633 · MDR key 25794906

Device

Generic name

Prosthesis, Shoulder, Semi-constrained, Metal/polymer Cemented

Manufacturer

Exactech, Inc.

Product problems

  • Nonstandard Device
  • Device Dislodged or Dislocated

Patient

56 YR · Female

  • Bone Fracture(s)
  • Hematoma
  • Unspecified Infection
  • Muscle Weakness/Atrophy
  • Pain
  • Ruptured Aneurysm
  • Metal Related Pathology
  • Muscle/Tendon Damage
  • Unspecified Tissue Injury

Narrative

Description of Event or Problem

ON (B)(6) 2018, HAD LEFT TOTAL SHOULDER REPLACEMENT. (B)(6) 2025, HAD RIGHT TOTAL SHOULDER REPLACEMENT. ON (B)(6) 2026, HAD LEFT REVISION REVERSE SHOULDER SURGERY DUE TO TORN ROTATOR CUFF, EXTENSIVE METALLOSIS, DAMAGED TISSUE, GROSS HARDWARE LOOSENING, BONE DAMAGE REQUIRING CADAVER BONE GRAFTING, INFECTION, WEAKNESS, PAIN, INSTABILITY. (B)(6) 2026, WENT TO LOCAL EMERGENCY ROOM WITH ARTERY RUPTURE AND LARGE LEFT CHEST WALL HEMATOMA. (B)(6) 2026, TRANSPORTED TO LARGER HOSPITAL & REQUIRED EMERGENCY VASCULAR SURGERY TO REPAIR ARTERY, EVACUATE HEMATOMA, AND PLACE JP DRAINAGE TUBE FOR EXTERNAL DRAINAGE, AND ORTHO SURGERY FOR IRRIGATION & DEBRIDEMENT OF SHOULDER & TO REPLACE POLYETHYLENE LINERS. ON (B)(6) 2026, PICC LINE PLACED FOR DAILY ANTIBIOTICS FOR 6-8 WEEKS DUE TO POSITIVE C. ACNES. (B)(6) 2026 - (B)(6) 2026: HOSPITALIZATION; (B)(6) 2026 - (B)(6) 2026: NO SHOULDER MOVEMENT OF ANY KIND. FOUND OUT ABOUT EXACTECH'S EQUINOXE SHOULDER IMPLANT RECALL AND DISCOVERED THAT THE LEFT SHOULDER REPLACEMENT I HAD DONE IN 2018, HAD COMPONENTS WITH MATCHING SERIAL/ID NUMBERS ON THE RECALL LIST, AS DOES THE RIGHT SHOULDER I HAD REPLACED IN 2025. THE REPLACEMENT DONE IN 2018 IS THE ONE I HAD ISSUES WITH. HAD THE REVISION DONE IN (B)(6) 2026 (THIS YEAR), THEN HAD MAJOR COMPLICATIONS. I'M NOT CERTAIN WHAT TESTS YOU WANT/NEED, BUT I HAD FULL PANEL LABS DRAWN EVERY SINGLE (B)(6) FOLLOWING THE EMERGENCY SURGERY TO REPAIR THE RUPTURED ARTERY, CHEST WALL HEMATOMA, POLYETHYLENE LINERS EXCHANGE, AND PICC LINE PLACED FOR DAILY ANTIBIOTICS. PATIENT CODES: 4532, 4530, 4559, 1870, 1930, 1967,1994, 4436, 1884. DEVICE CODE: 2923, 1420. REFERENCE REPORT MW5190634. REPORTS ON LEFT EQUINOXE SHOULDER IMPLANT #1.