Equinoxe 320-20-22Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 10885862086532), received between Apr 3, 2019 and May 29, 2026 — classified as 8 injuries.

The most frequently reported specific device problem is “Loosening of Implant Not Related to Bone-Ingrowth” (3 reports).

13 other recalls cover devices cleared under the same FDA submission (K063569); 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• InjuryMay 29, 2026Naturally Worn

  AS REPORTED, APPROXIMATELY 5 YEARS AND 2 MONTHS POST THE INITIAL RIGHT REVERSE TOTAL SHOULDER ARTHROPLASTY, THE PATIENT PRESENTED TO THE SURGEON'S OFFICE WITH COMPLAINTS OF PAIN AND DECREASED RANGE OF MOVEMENT. UPON EXAMINATION AND IMAGING REVIEW FROM PREVIOUS POST-OP, AND THE RECENT OFFICE VISIT X-RAYS, AND ACCORDING TO THE IMPLANT RECORD WITH A STANDARD BASEPLATE BEING USED, IT APPEARED THE GLENOSPHERE WAS NOT COMPLETELY ENGAGED AND DOWN ON THE BASEPLATE. HOWEVER, THE LOCKING SCREW WAS STILL ENGAGED AND GAVE THE SURGEON A FALSE FEEDBACK IN THE INITIAL SURGERY THAT THE IMPLANT WAS DOWN AND SECURE. THE IMPLANT WAS NOT DOWN COMPLETELY AND SECURE, AND OVER TIME THE GLENOSPHERE LOCKING SCREW DISENGAGED FROM THE MECHANISM AND THE GLENOSPHERE IMPLANT LEVERAGED OFF OF THE GLENOID BASEPLATE. THERE WAS/IS EVIDENCE OF HUMERAL POLY LINER WEAR AND BONE RESORPTION/OSTEOLYSIS AROUND THE IMPLANTS. THE PATIENT WAS REVISED, AND DURING THE REVISION, THE PATIENT'S SHOULDER JOINT AND SURROUNDING TISSUE SHOWED METALLOSIS. THE JOINT AND TISSUES WERE DEBRIDED. THE BROKEN AND DISENGAGED IMPLANTS WERE REMOVED. THE HUMERAL STEM WAS TESTED FOR STABILITY. THE GLENOID BASEPLATE SHOWED TO BE STABLE, SO THE SUR

  Patient problems: Loss of Range of Motion; Metal Related Pathology; Osteolysis; Pain

  MAUDE report 25335234 ↗
• InjuryAug 26, 2025Fracture; Naturally Worn; Fracture; Naturally Worn

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN INITIAL REVERSE TOTAL SHOULDER REPLACEMENT ON THE LEFT SIDE. SUBSEQUENTLY, THE PATIENT EXPERIENCED PAIN. IMAGING REVEALED A BROKEN SCREW IN THE GLENOID AND WHAT APPEARED TO BE LOOSENING AROUND THE IMPLANT, BOTH GLENOID AND HUMERUS. AS A RESULT, APPROXIMATELY TEN YEARS POST-SURGERY, THE PATIENT UNDERWENT A REVISION. THE STEM WAS WELL FIXED, STABLE AND REMAINS IMPLANTED. METALLOSIS WAS REPORTED WITHIN THE JOINT. INTRAOPERATIVE CULTURES WERE NEGATIVE FOR INFECTION. THE PATIENT REPORTED TO ANESTHESIA THAT AT SOME POINT IN THE PAST, THEY HAD A FALL. IT IS UNKNOWN WHEN THE FALL OCCURRED. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. NO FURTHER IMPACT TO THE PATIENT WAS REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME.

  Patient problems: Aseptic loosening; Metal Related Pathology; Pain

  MAUDE report 22898788 ↗
• InjuryJun 3, 2025Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN INITIAL REVERSE TOTAL SHOULDER REPLACEMENT ON THE RIGHT SIDE WITH A COMPETITOR'S DEVICES. SUBSEQUENTLY, THE PATIENT WAS REVISED TO EXACTECH DEVICES AND HAS EXPERIENCED DISASSOCIATION OF THE GLENOSPHERE COMPONENT, APPROXIMATELY 2 YEARS AFTER THE SHOULDER REVISION. IT WAS REPORTED, THE PATIENT REACHED BEHIND CAR SEAT AND IMMEDIATELY EXPERIENCED PAIN AND THE SHOULDER FELT "STUCK." THIS RESULTED IN LOOSENING OF BASEPLATE SCREWS AND HUMERAL STEM LUCENCY. AS A RESULT, AFTER THE REVISION TO EXACTECH DEVICES, THE PATIENT REPORTEDLY UNDERWENT AN ADDITIONAL RIGHT SHOULDER REVISION BUT NO OFFICIAL DATE WAS STATED OR COULD BE LOCATED. NO FURTHER IMPACT TO THE PATIENT WAS REPORTED. NO OTHER INFORMATION IS AVAILABLE.

  Patient problems: Aseptic loosening; Pain

  MAUDE report 22135431 ↗
• InjuryJun 3, 2025Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN INITIAL REVERSE TOTAL SHOULDER REPLACEMENT ON THE RIGHT SIDE WITH A COMPETITOR'S DEVICES. SUBSEQUENTLY, THE PATIENT WAS REVISED TO EXACTECH DEVICES AND HAS EXPERIENCED DISASSOCIATION OF THE GLENOSPHERE COMPONENT, APPROXIMATELY 2 YEARS AFTER THE SHOULDER REVISION. IT WAS REPORTED, THE PATIENT REACHED BEHIND CAR SEAT AND IMMEDIATELY EXPERIENCED PAIN AND THE SHOULDER FELT "STUCK." THIS RESULTED IN LOOSENING OF BASEPLATE SCREWS AND HUMERAL STEM LUCENCY. AS A RESULT, AFTER THE REVISION TO EXACTECH DEVICES, THE PATIENT REPORTEDLY UNDERWENT AN ADDITIONAL RIGHT SHOULDER REVISION BUT NO OFFICIAL DATE WAS STATED OR COULD BE LOCATED. NO FURTHER IMPACT TO THE PATIENT WAS REPORTED. NO OTHER INFORMATION IS AVAILABLE.

  Patient problems: Aseptic loosening; Pain

  MAUDE report 22135402 ↗
• InjuryJun 3, 2025Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN INITIAL REVERSE TOTAL SHOULDER REPLACEMENT ON THE RIGHT SIDE WITH A COMPETITOR'S DEVICES. SUBSEQUENTLY, THE PATIENT WAS REVISED TO EXACTECH DEVICES AND HAS EXPERIENCED DISASSOCIATION OF THE GLENOSPHERE COMPONENT, APPROXIMATELY 2 YEARS AFTER THE SHOULDER REVISION. IT WAS REPORTED, THE PATIENT REACHED BEHIND CAR SEAT AND IMMEDIATELY EXPERIENCED PAIN AND THE SHOULDER FELT "STUCK." THIS RESULTED IN LOOSENING OF BASEPLATE SCREWS AND HUMERAL STEM LUCENCY. AS A RESULT, AFTER THE REVISION TO EXACTECH DEVICES, THE PATIENT REPORTEDLY UNDERWENT AN ADDITIONAL RIGHT SHOULDER REVISION BUT NO OFFICIAL DATE WAS STATED OR COULD BE LOCATED. NO FURTHER IMPACT TO THE PATIENT WAS REPORTED. NO OTHER INFORMATION IS AVAILABLE.

  Patient problems: Aseptic loosening; Pain

  MAUDE report 22135373 ↗
• InjuryApr 28, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  THE MALE PATIENT PRESENTED TO SURGEON'S OFFICE IN THE (B)(6) 2023 WITH COMPLAINTS OF SUDDEN AND THEN ONGOING PAIN AND DISSATISFACTION WITH HIS LEFT REVERSE TSA. UPON IMAGING THE IMPLANTS LOOKED MAL-POSITIONED AND THE GLENOID LOOKED LIKE IT HAS BONE GROWTH FROM POLY WEAR. THE SURGEON THOUGHT POLY WEAR AND OSTEOLYSIS CAUSED ONGOING ISSUES AND POTENTIAL LOOSENING OF THE IMPLANTS. THE PATIENT WAS SCHEDULED FOR REVISION LEFT REVERSE TSA. REVISION SURGERY OPERATIVE NOTES WERE PROVIDED. PATIENT LEFT THE OPERATING ROOM IN STABLE CONDITION. NO FURTHER ISSUES OR COMPLICATIONS WERE REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Metal Related Pathology; Osteolysis; Pain

  MAUDE report 21918743 ↗
• InjuryApr 28, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  THE MALE PATIENT PRESENTED TO SURGEON'S OFFICE IN THE SPRING OF 2023 WITH COMPLAINTS OF SUDDEN AND THEN ONGOING PAIN AND DISSATISFACTION WITH HIS LEFT REVERSE TSA. UPON IMAGING THE IMPLANTS LOOKED MAL-POSITIONED AND THE GLENOID LOOKED LIKE IT HAS BONE GROWTH FROM POLY WEAR. THE SURGEON THOUGHT POLY WEAR AND OSTEOLYSIS CAUSED ONGOING ISSUES AND POTENTIAL LOOSENING OF THE IMPLANTS. THE PATIENT WAS SCHEDULED FOR REVISION LEFT REVERSE TSA. REVISION SURGERY OPERATIVE NOTES WERE PROVIDED. PATIENT LEFT THE OPERATING ROOM IN STABLE CONDITION. NO FURTHER ISSUES OR COMPLICATIONS WERE REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Metal Related Pathology; Osteolysis; Pain

  MAUDE report 21918577 ↗
• InjuryApr 3, 2019Loose or Intermittent Connection

  REVISION DUE TO INFECTION. IT WAS INFECTED AND LOOSE.

  Patient problems: Unspecified Infection

  MAUDE report 8477690 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K063569. One submission often covers many models, so check the product and lot details in each record.

• Z-2561-2025 · Aug 15, 2025 · Open, Classified
  Exactech Equinoxe, Reverse Shoulder Humeral Liners, REF: 320-38-00,145-DEG PE 38MM HUM LINER +0/ 320-38-03,145-DEG PE 38MM HUM LINER +2.5/ 320-42-00,145-DEG PE 42MM HUM LINER +0/
• Z-1425-2024 · Mar 6, 2024 · Open, Classified
  Exactech Equinoxe REVERSE SHOULDER,46mmConstrained Humeral Liner, a) +0mm, Item number 320-46-10, b) +2.5mm, Item Number 320-46-13; Shoulder Arthroplasty
• Z-1423-2024 · Mar 6, 2024 · Open, Classified
  Exactech Equinoxe REVERSE SHOULDER,42mm Constrained Humeral Liner, a) +0mm, Item number 320-42-10, b) +2.5mm, Item Number 320-42-13; Shoulder Arthroplasty
• Z-1424-2024 · Mar 6, 2024 · Open, Classified
  Exactech Equinoxe REVERSE SHOULDER,46mm Humeral Liner, a) +0mm, Item number 320-46-00, b) +2.5mm, Item Number 320-46-03; Shoulder Arthroplasty
• Z-1422-2024 · Mar 6, 2024 · Open, Classified
  Exactech Equinoxe REVERSE SHOULDER,42mm Humeral Liner, a) +0mm, Item number 320-42-00, b) +2.5mm, Item Number 320-42-03; Shoulder Arthroplasty
• Z-1419-2024 · Mar 6, 2024 · Open, Classified
  Exactech Equinoxe REVERSE SHOULDER,38mm Constrained Humeral Liner: a) +0mm, Item Number 320-38-10, b) +2.5mm, Item Number 320-38-13, Shoulder Arthroplasty
• Z-1418-2024 · Mar 6, 2024 · Open, Classified
  Exactech Equinoxe REVERSE SHOULDER, 38mm Humeral Liner: a) +0mm, Item Number 320-38-00, b) +2.5mm, Item Number 320-38-03; 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,
• Z-3020-2020 · Aug 24, 2020 · Terminated
  Equinoxe Reverse Shoulder Compression Screw/Locking Cap Kit 4.5 x 22 mm.
• Z-3019-2020 · Aug 24, 2020 · Terminated
  Equinoxe Reverse Shoulder Compression Screw/Locking Cap Kit 4.5 x 18 mm.
• Z-0012-2019 · Aug 21, 2018 · Open, Classified
  Equinoxe Reverse Drill Bit Kit, Catalog Number 321-20-00 Product Usage: Shoulder surgery
• Z-0900-2017 · Oct 25, 2016 · Terminated
  Equinoxe Reverse Shoulder Fixed Angle Torque Defining Screw Kit
• Z-2117-2012 · Jun 15, 2012 · Terminated
  Equinoxe Reverse Compression Screw Intended for Primary and Reverse Total Shoulder Arthroplasty.