Equinoxe 320-01-36Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 10885862086372), received between Jul 24, 2019 and Jun 16, 2023 — classified as 7 injuries.

The most frequently reported specific device problem is “Patient Device Interaction Problem” (2 reports).

3 other recalls cover devices cleared under the same FDA submission (K093275); they may or may not involve this specific model.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• InjuryJun 16, 2023Adverse Event Without Identified Device or Use Problem; Patient Device Interaction Problem; Adverse Event Without Identified Device or Use Problem; Patient Device Interaction Problem

  AS REPORTED, APPROXIMATELY 3 MONTHS POST OP INITIAL TSA, THIS 86 Y/O FEMALE PATIENT WAS REVISED. SURGEON HAD SUSPECTED INFECTION DUE TO RAISED CRP AND LFT. ONCE IMPLANTS WERE REMOVED AND SAMPLES TAKEN, NO INFECTION WAS FOUND.

  Patient problems: Failure of Implant; Unspecified Infection

  MAUDE report 17144860 ↗
• InjuryDec 20, 2022Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THIS 72 Y/O FEMALE PATIENT HAD REPEATEDLY DISLOCATED RIGHT SHOULDER. PATIENT WAS REVISED APPROXIMATELY 5 YEARS POST OP INITIAL REVERSE TOTAL SHOULDER ARTHROPLASTY. THE PATIENT WAS REVISED TO 320-02-38 EXPANDED GLENOSPHERE +4 OFFSET AND 38MM HUMERAL CONSTRAINED LINER +0. THERE WERE NO REPORTED ISSUES DURING THE REVISION PROCEDURE. THE PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. DEVICES WILL NOT BE RETURNED; HOSPITAL POLICY. NO ADDITIONAL INFORMATION.

  Patient problems: Joint Dislocation

  MAUDE report 16016699 ↗
• InjuryOct 26, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED, THE PATIENT HAD AN INITIAL LEFT TSA ON (B)(6) 2022. THE SURGEON REMOVED THE GLENOSPHERE AND HUMERAL LINER, COMPLETED A WASHOUT AND THEN REPLACED THE COMPONENTS WITH NEW ONES, DUE TO INFECTION. NO BREAKAGE OF DEVICE OR SURGICAL DELAY/PROLONGATION. THE PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. NO OTHER PATIENT INFORMATION/MEDICAL HISTORY REPORTED.

  Patient problems: Bacterial Infection; Unspecified Infection

  MAUDE report 15675729 ↗
• InjuryApr 6, 2022Patient Device Interaction Problem; Patient Device Interaction Problem

  AS REPORTED, APPROXIMATELY 3 MONTHS POST OP THE INITIAL RIGHT TSA, THIS 60 Y/O FEMALE PATIENT WAS REVISED TO AN HRP FOR PROXIMAL BONE LOSS. THERE WAS NO SURGICAL DELAY/PROLONGATION. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. DEVICES WERE DISPOSED OF BY THE HOSPITAL, WILL NOT BE RETURNING.

  Patient problems: Failure of Implant

  MAUDE report 14023352 ↗
• InjuryDec 1, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED APPROXIMATELY 3 YRS POSTOP THE INITIAL IMPLANT, THIS (B)(6) FEMALE PATIENT¿S LEFT SHOULDER WAS REVISED DUE TO INSTABILITY. THE PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. DEVICES NOT RETURNING DUE TO FACILITY POLICY.

  Patient problems: Failure of Implant

  MAUDE report 12913412 ↗
• InjurySep 30, 2019Loose or Intermittent Connection

  IT WAS REPORTED THAT THE PATIENT HAD GONE THROUGH A SHOULDER REVERSE ON THE (B)(6) OF (B)(6) 2019, DUE TO BASEPLATE LOOSENING AND INSTABILITY ON THE GLENOID THE SHOULDER WAS REVISED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9134811 ↗
• InjuryJul 24, 2019Appropriate Device Problem Term/Code Not Available

  REVISION DUE TO FAILED ANATOMIC SHOULDER. PATIENT WAS EXPERIENCING UNEXPLAINED PAIN.

  Patient problems: Pain

  MAUDE report 8821719 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K093275. One submission often covers many models, so check the product and lot details in each record.

• Z-1417-2024 · Mar 6, 2024 · Open, Classified
  Exactech Equinoxe REVERSE SHOULDER,36mm Constrained Humeral Liner: a) +0mm, Item Number 320-36-10, b) +2.5mm, Item Number 320-36-13; Shoulder Arthroplasty
• Z-1416-2024 · Mar 6, 2024 · Open, Classified
  Exactech Equinoxe REVERSE SHOULDER,36mm Humeral Liner: a) +0mm, Item Number 320-36-00, b) +2.5mm, Item Number 320-36-03; Shoulder Arthroplasty
• Z-0579-2024 · Nov 21, 2023 · Open, Classified
  Exactech Equinoxe Reverse Shoulder System, Catalog Numbers: a) 320-36-00, b) 320-36-03, c) 320-36-04, d) 320-36-10, e) 320-36-13, f) 320-38-00, g) 320-38-13, h) 320-40-00,