Equinoxe 320-01-42Recalls & reported problems

Summary

The FDA's MAUDE database contains 39 adverse event reports that list this exact device (DI 10885862086396), received between May 31, 2019 and Mar 24, 2026 — classified as 39 injuries.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (11 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 25 most recent of 39 reports, in the reporter's own words as published by the FDA.

• InjuryMar 24, 2026Naturally Worn

  IT WAS REPORTED THAT THE PATIENT PREVIOUSLY UNDERWENT A LEFT SHOULDER REPLACEMENT. THE PATIENT LATER PRESENTED WITH LINER DISSOCIATION AND METALLOSIS. DURING THE REVISION PROCEDURE, THE SURGEON REMOVED THE HUMERAL STEM, GLENOSPHERE, HUMERAL TRAY, AND HUMERAL LINER. THE HUMERAL STEM WAS REPLACED WITH A STEM OF THE SAME SIZE. THE HUMERAL TRAY, HUMERAL LINER, AND GLENOSPHERE WERE REPLACED WITH COMPONENTS ONE SIZE LARGER. THE PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. NO ADDITIONAL INFORMATION HAS BEEN PROVIDED.

  Patient problems: Metal Related Pathology

  MAUDE report 24681362 ↗
• InjuryFeb 10, 2026Naturally Worn

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN INITIAL RIGHT REVERSE TOTAL SHOULDER ARTHROPLASTY. SUBSEQUENTLY, IT WAS REPORTED THAT THE HUMERAL LINER DISASSOCIATED FROM THE HUMERAL TRAY WHICH RESULTED IN WEAR OF THE GLENOSPHERE AND HUMERAL TRAY. AS A RESULT, THE PATIENT UNDERWENT A RIGHT SHOULDER REVISION APPROXIMATELY 1 YEAR AND 11 MONTHS AFTER INITIAL IMPLANTATION. NO FURTHER PATIENT IMPACT REPORTED. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: Metal Related Pathology

  MAUDE report 24304207 ↗
• InjuryDec 8, 2025Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN INITIAL TSA (TOTAL SHOULDER ARTHROPLASTY) ON THE RIGHT SIDE. SUBSEQUENTLY, THE PATIENT WAS REVISED DUE TO THE INITIAL GLENOSPHERE BEING TOO BIG. THE SURGEON INITIALLY THOUGHT THE STEM WAS LOOSE. AS A RESULT, THE SURGEON REMOVED THE 42MM GLENOSPHERE AND REPLACED WITH 38MM GLENOSPHERE. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 23745597 ↗
• InjuryNov 17, 2025Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT A 67 YO MALE PATIENT WHO HAD AN INITIAL RIGHT TSA IMPLANTED, UNDERWENT A REVISION PROCEDURE APPROXIMATELY 4 YEARS 10 MONTHS POST THE INITIAL PROCEDURE. THE PATIENT WAS INDICATED FOR SURGERY DUE TO ¿CLUNKING¿ FEELING IN SHOULDER, FOLLOWED BY LOSS OF FUNCTION. X-RAY REVEALED THAT THE GLENOSPHERE LOCKING SCREW HAD DISENGAGED FROM THE GLENOSPHERE, WHICH WAS STILL SEATED CORRECTLY ON THE BASEPLATE, AND WAS FLOATING IN THE JOINT SPACE. THE POLYETHYLENE LINER WAS NOT VISIBLE BETWEEN THE HUMERAL ADAPTOR TRAY AND GLENOSPHERE, WHICH WERE IN CONTACT, SUGGESTING IT HAS DISASSOCIATED FROM THE HUMERAL ADAPTOR TRAY. DURING SURGERY, SIGNIFICANT METALOSIS OF SURROUNDING SOFT TISSUE WAS NOTED. GLENOSPHERE SCREW WAS REMOVED FROM THE JOINT SPACE, AND POLYETHYLENE LINER WAS CONFIRMED TO HAVE DISASSOCIATED FROM THE HUMERAL ADAPTOR TRAY, WHICH WAS DAMAGED DUE TO CONTACT WITH THE GLENOSPHERE. POLYETHYLENE LINER WAS SEVERELY DAMAGED DUE TO CONTACT WITH THE GLENOSPHERE LOCKING SCREW. ALL AFFECTED IMPLANTS, (LINER, ADAPTOR TRAY, GLENOSPHERE AND SCREW) WHERE REPLACED LIKE FOR LIKE. THERE WAS DEVICE BREAKAGE DURING THE PROCEDURE, PARTS AND PIECED DID FALL INTO THE WOUND SITE BUT WERE REMOV

  Patient problems: Crepitus; Metal Related Pathology

  MAUDE report 23576421 ↗
• InjuryAug 27, 2025Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT THIS PATIENT'S LEFT SHOULDER WAS REVISED APPROXIMATELY 5 YEARS POST INITIAL OPERATION. THIS WAS A REVISION OF HUMERAL COMPONENTS. SURGEON BELIEVES POLY DISSOCIATED, PATIENT UNSURE HOW INCIDENT OCCURRED. WHEN DEVICES WERE RECEIVED, THERE WAS A VISIBLY DAMAGED GLENOSPHERE. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT.

  Patient problems: Insufficient Information

  MAUDE report 22904912 ↗
• InjuryMay 22, 2025Naturally Worn; Naturally Worn

  AS REPORTED, APPROXIMATELY 5 YEARS AND 1 MONTH POST THE INITIAL RIGHT REVERSE TOTAL SHOULDER ARTHROPLASTY, THE PATIENT WAS REVISED DUE TO POLY WEAR/FRACTURE. THE LINER AND GLENOSPHERE WERE EXCHANGED. PHOTOS PROVIDED INDICATE THERE MAY BE METAL-ON-METAL WEAR BETWEEN THE GLENOSPHERE AND TRAY. THERE WAS NO REPORTED BREAKAGE OF A DEVICE OR SURGICAL DELAY/PROLONGATION. THE PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT.

  Patient problems: Bone Fracture(s); Metal Related Pathology

  MAUDE report 22069551 ↗
• InjuryMay 19, 2025Naturally Worn; Naturally Worn

  IT WAS REPORTED APPROXIMATELY 43 MONTHS POST RIGHT TOTAL SHOULDER ARTHROPLASTY; THE PATIENT UNDERWENT A REVISION PROCEDURE. INTRAOPERATIVELY, THE SURGEON OBSERVED THE POLYETHYLENE COMPONENT WAS DISASSEMBLED, CAUSING THE TRAY AND SPHERE TO ARTICULATE TO THE POINT OF WEARING THROUGH THE TRAY CAUSING METALLOSIS. IT WAS NOTED THAT THE PARTS, PIECES AND FRAGMENTS WERE REMOVED FROM THE PATIENT'S WOUND SITE. THERE WERE NO MEDICAL OR SURGICAL INTERVENTIONS REPORTED. THERE WERE NO MEDICAL OR OPERATIVE REPORTS PROVIDED. POST OPERATIVE PHOTOS WERE PROVIDED. THE PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Metal Related Pathology

  MAUDE report 22043915 ↗
• InjuryMar 18, 2025Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN INITIAL TOTAL SHOULDER REPLACEMENT ON THE LEFT SIDE. SUBSEQUENTLY, THE PATIENT EXPERIENCED DETERIORATION OF THE POLY OVER THE LAST YEAR. PATIENT'S X-RAY A YEAR AGO LOOKED GOOD, BUT AS OF RECENT, THE X-RAY SHOWS THE HUMERAL TRAY RIGHT UP AGAINST THE GLENOSPHERE. THE SURGEON SAID THAT THE PATIENT SUFFERED A FALL. AS A RESULT, APPROXIMATELY 8 YEARS AFTER INITIAL REPLACEMENT, THE PATIENT UNDERWENT A LEFT SHOULDER REVISION. IN SURGERY, ONCE DOWN TO THE IMPLANTS, A LOT OF THE TISSUE WAS BLACKENED AND THE LINER LOOKED IN VERY BAD SHAPE AS WELL AS THE GLENOSPHERE. PATIENT LINER LOOKED VERY WORN DOWN AND THERE WERE OBVIOUS SIGNS OF METALLOSIS DUE TO THE CONDITION OF THE GLENOSPHERE, LINER, TRAY AND ALL OF THE BLACK TISSUE. NO FURTHER IMPACT TO THE PATIENT WAS REPORTED. NO OTHER INFORMATION IS AVAILABLE. AS OF NOTE: "THERE WAS NO SIGNS OF INFECTION AFTER TAKING CULTURES. GOING INTO THE CASE, THE SURGEON THOUGHT PATIENTS FALL MAY HAVE CRACKED THE LINER WHICH CAUSED THE METAL TRAY TO START ARTICULATING ON THE GLENOSPHERE. LINER DID NOT APPEAR TO BE CRACKED BUT WAS DAMAGED FROM THE ABNORMAL WEAR".

  Patient problems: Metal Related Pathology

  MAUDE report 21635465 ↗
• InjuryFeb 18, 2025Naturally Worn; Naturally Worn

  AS REPORTED, APPROXIMATELY THREE YEARS POST THE INITIAL RIGHT TOTAL SHOULDER ARTHROPLASTY, THE PATIENT'S POLY DISSOCIATED AT AN UNKNOWN POINT, CAUSE UNKNOWN. AFTER DISSECTION, IT WAS NOTED THAT THE MOTION OF THE GLENOSPHERE WITHOUT A POLY IN PLACE HAD WORN AWAY THE HUMERAL TRAY AND LOCKING SCREW. ALL COMPONENTS ABOVE WERE REMOVED AND REPLACED WITH NEW IMPLANTS. THERE WAS NO REPORTED BREAKAGE OF DEVICE OR SURGICAL DELAY/PROLONGATION. THE PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT.

  Patient problems: Insufficient Information

  MAUDE report 21402470 ↗
• InjuryJul 2, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  AS REPORTED APPROXIMATELY 14 DAYS AFTER LEFT TOTAL SHOULDER REVISION, THE PATIENT WAS REVISED DUE TO DISLOCATION. THE HUMERAL STEM, TRAY, LINER, AND GLENOSPHERE WERE REVISED. THE EVENT WAS NOT RELATED TO A BREAKAGE OF THE DEVICE. THE EVENT DID NOT LEAD TO A SURGICAL DELAY/PROLONGATION. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. SALES REP WAS UNABLE TO OBTAIN IMAGES OR X-RAYS. THE DEVICES ARE NOT AVAILABLE FOR EVALUATION AS THEY WERE DISCARDED BY THE HOSPITAL.

  Patient problems: Joint Dislocation

  MAUDE report 19657270 ↗
• InjuryJun 25, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  AS REPORTED, IMPLANTS ARE BEING REVISED DUE TO HUMERAL LINER DISSOCIATION. THE INITIAL IMPLANT DATE IS (B)(6) 2020. THE GLENOSPHERE, LINER, ADAPTER TRAY, SCREW KIT AND LOCKING SCREW WERE REVISED. THE REPORTED EVENT IS NOT RELATED TO THE BREAKAGE OF A DEVICE. THE EVENT DID NOT LEAD TO A SURGICAL DELAY/PROLONGATION. PATIENT, 76 YEAR OLD MALE, WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. NO ADDITIONAL PATIENT/MEDICAL INFORMATION PROVIDED. UNABLE TO OBTAIN IMAGES OR X-RAYS. PRODUCT NOT RETURNING: DISPOSED BY HOSPITAL.

  Patient problems: Insufficient Information

  MAUDE report 19609677 ↗
• InjuryDec 26, 2023Naturally Worn; Adverse Event Without Identified Device or Use Problem; Naturally Worn; Adverse Event Without Identified Device or Use Problem

  AS REPORTED, APPROXIMATELY FOUR YEARS POST INITIAL RIGHT TSA, THE 75 Y/O MALE PATIENT COMPLAINED OF PAIN AND POLY FAILURE. PATIENT WAS NOT REVISED TO EXACTECH DEVICES. THERE WAS NO BREAKAGE OF DEVICE OR SURGICAL DELAY/PROLONGATION REPORTED. PATIENT LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. IMAGES RECEIVED. THE DEVICE IS NOT AVAILABLE FOR EVALUATION DUE TO HOSPITAL WILL NOT RELEASE DUE TO CHAIN OF COMMAND.

  Patient problems: Metal Related Pathology; Pain

  MAUDE report 18395070 ↗
• InjuryAug 21, 2023Naturally Worn; Loosening of Implant Not Related to Bone-Ingrowth; Naturally Worn; Loosening of Implant Not Related to Bone-Ingrowth

  THE 79 Y/O 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. THE SHOULDER WAS OPENED AND UPON EXAMINATION OF THE SHOULDER JOINT, THE POLY SHOWED TO BE DISASSOCIATED FROM THE HUMERAL TRAY. THERE SHOWED TO BE SIGNS OF METALOSIS AROUND THE IMPLANTS, PARTICULARLY THE HUMERAL STEM. THE ORIGINAL POLY WAS REMOVED AND SHOWED TO BE DEFORMED SIGNIFICANTLY. THE HUMERAL TRAY WAS REMOVED FROM THE HUMERAL STEM AND THE JOINT WAS CLEANED OUT AND EXCESS TISSUES AROUND THE STEM WERE REMOVED. THE SURGEON THEN ASSESSED THE GLENOID / GLENOSPHERE, WHICH SHOWED TO BE UNSTABLE. THE GLENOSPHERE WAS SHIFTING SO THE LOCKING SCREW WAS REMOVED AND THE GLENOSPHERE WAS REMOVED FROM THE JOINT. THERE SHOWED TO BE METALOSIS INSIDE THE BASEPLATE / GLENOID AREA. THE LOCKING CAPS ON THE BASEPLATE FELL OUT AND PULLED OUT EASILY WITH A RONGE

  Patient problems: Failure of Implant; Metal Related Pathology; Osteolysis; Pain

  MAUDE report 17586314 ↗
• InjuryMay 16, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated

  AS REPORTED, 3 DAYS POST OP INITIAL RIGHT TSA, THIS 49 Y/O MALE PATIENT WAS REVISED DUE TO DISLOCATION. SURGEON DECIDED TO CHANGE THE LINER AND GLENOSPHERE TO CREATE A TIGHTER CONSTRUCT. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. NO OTHER PATIENT INFORMATION/MEDICAL HISTORY REPORTED. UNABLE TO OBTAIN PHOTOS/X-RAYS. PRODUCT NOT RETURNING - DISPOSED BY HOSPITAL.

  Patient problems: Joint Dislocation

  MAUDE report 16941087 ↗
• InjuryMay 9, 2023Device Dislodged or Dislocated; Adverse Event Without Identified Device or Use Problem; Device Dislodged or Dislocated; Adverse Event Without Identified Device or Use Problem

  AS REPORTED, APPROXIMATELY FOUR YEARS POST INITIAL RIGHT TSA, THE 75 Y/O MALE PATIENT HAD A REVISION DUE TO DISLOCATION. PATIENT WAS REVISED TO AN EXACTECH DEVICES. GLENOSPHERE AND LOCKING SCREW WERE REPLACED. THERE WAS NO BREAKAGE OF THE DEVICE OR SURGICAL DELAY/PROLONGATION. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. SALES REP WAS UNABLE TO OBTAIN PHOTO/X-RAYS. THE DEVICES ARE NOT AVAILABLE FOR EVALUATION BECAUSE THEY WERE DISCARDED BY HOSPITAL. NO ADDITIONAL INFORMATION AVAILABLE.

  Patient problems: Joint Dislocation

  MAUDE report 16898698 ↗
• InjuryApr 12, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED, APPROXIMATELY 6 MONTHS POST OP THE INITIAL LEFT TSA, THIS 66 Y/O MALE PATIENT WAS REVISED DUE INFECTION. NO BREAKAGE OF DEVICE OR SURGICAL DELAY/PROLONGATION. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. NO OTHER PATIENT INFORMATION/MEDICAL HISTORY REPORTED. PHOTOS ATTACHED, UNABLE TO OBTAIN X-RAYS. PRODUCT NOT RETURNING - SURGEON TOOK IT.

  Patient problems: Radiation Burn; Unspecified Infection

  MAUDE report 16723646 ↗
• InjuryApr 7, 2023Device Dislodged or Dislocated; Adverse Event Without Identified Device or Use Problem; Device Dislodged or Dislocated; Adverse Event Without Identified Device or Use Problem

  AS REPORTED, APPROXIMATELY ONE MONTHS POST INITIAL RIGHT TSA, THE 59 Y/O MALE PATIENT HAD A REVISION DUE TO DISLOCATION. PATIENT WAS TOO ACTIVE AFTER SURGERY. PATIENT WAS REVISED TO EXACTECH DEVICES. THERE WAS NO BREAKAGE OF DEVICE OR SURGICAL DELAY/PROLONGATION. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. SALES REP WAS UNABLE TO OBTAIN X-RAYS/PHOTOS. THE DEVICES ARE NOT AVAILABLE FOR EVALUATION AS THEY WERE DISPOSED BY HOSPITAL.

  Patient problems: Joint Dislocation

  MAUDE report 16700816 ↗
• InjuryFeb 22, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED, THE MALE PATIENT HAD AN INITIAL LEFT TSA ON (B)(6) 2021. THE EVENT WAS A STAGE 1 REVISION OF AN EXACTECH REVERSE SHOULDER. THE IMPLANTS WERE REMOVED WITH AN ANTIBIOTIC SPACER IMPLANTED. AT THIS STAGE THE PLAN IS TO REVISE TO AN EXACTECH NAVIGATED SHOULDER ONCE THE INFECTION IS GONE. THERE WAS NO REPORTED 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 16419854 ↗
• InjuryFeb 22, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THIS MALE PATIENT'S LEFT SHOULDER WAS REVISED DUE TO INFECTION. NO BREAKAGE OF DEVICE OR SURGICAL DELAY/PROLONGATION. PATIENT REQUIRED PROLONGED HOSPITALIZATION AS A DIRECT RESULT OF THIS ISSUE. NO OTHER PATIENT INFORMATION/MEDICAL HISTORY REPORTED. PRODUCT NOT RETURNING - DISPOSED BY HOSPITAL.

  Patient problems: Bacterial Infection; Unspecified Infection

  MAUDE report 16417330 ↗
• InjuryOct 26, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A 67 YO MALE PATIENT, HAD AN INITIAL LEFT SHOULDER IMPLANTED ON (B)(6) 2022, THEN UNDERWENT A 2-STAGE REVISION, APPROXIMATELY 5 MONTHS POST THE INITIAL PROCEDURE. THE REVERSE TOTAL SHOULDER WAS REMOVED FOR INFECTION AS A PART OF A 2-STAGE REVISION. THE PATIENT WAS NOT REVISED TO EXACTECH DEVICES. THERE WERE NO REPORTED ISSUES DURING THE SURGICAL REVISION PROCEDURE. THE PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. THE PRODUCTS ARE NOT RETURNING; IMPLANTS REQUIRED FOR COLLECTION OF INFECTED MATERIALS ¿ SENT TO HOSPITAL PATHOLOGY. NO ADDITIONAL INFORMATION.

  Patient problems: Unspecified Infection

  MAUDE report 15674606 ↗
• InjurySep 29, 2022Detachment of Device or Device Component; Device Dislodged or Dislocated; Detachment of Device or Device Component; Device Dislodged or Dislocated

  AS REPORTED, APPROXIMATELY 70 YEARS POST OP THE INITIAL LEFT REVERSE TSA, THIS 70 Y/O MALE PATIENT WAS REVISED DUE TO DISLOCATION. THE POLY WAS DISASSOCIATED FROM THE TRAY. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. DEVICE IS NOT RETURNING, PRODUCT WAS SENT TO SPD.

  Patient problems: Joint Dislocation

  MAUDE report 15502131 ↗
• InjurySep 28, 2022Device Dislodged or Dislocated; Adverse Event Without Identified Device or Use Problem; Device Dislodged or Dislocated; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A 78 YO MALE PATIENT, INITIAL LEFT SHOULDER IMPLANTED ON (B)(6) 2022, DISLOCATED POSTOPERATIVELY, AND WAS REVISED TO EXACTECH DEVICES ON (B)(6) 2022. THE PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. THE DEVICE IS AVAILABLE FOR RETURN.

  Patient problems: Joint Dislocation

  MAUDE report 15499874 ↗
• InjurySep 9, 2022Device Dislodged or Dislocated; Adverse Event Without Identified Device or Use Problem; Device Dislodged or Dislocated; Adverse Event Without Identified Device or Use Problem

  AS REPORTED, APPROXIMATELY 7 YEARS POST OP THE INITIAL TSA, THIS PATIENT'S RIGHT SHOULDER WAS REVISED DUE TO DISLOCATION AND SCAPULAR SPINE FRACTURE.

  Patient problems: Joint Dislocation; Limb Fracture

  MAUDE report 15391073 ↗
• InjuryMar 30, 2022Device Dislodged or Dislocated; Device Dislodged or Dislocated

  AS REPORTED, APPROXIMATELY 2 YEARS POST OP SHOULDER SURGERY, THIS (B)(6) MALE PATIENT REPORTED INSTABILITY AND 2 SUBLUXATIONS OVER THE PAST YEAR, 4 TOTAL SINCE THE SURGERY, NONE REQUIRING FORMAL REDUCTION. THE CASE REPORT FORM INDICATES THIS EVENT IS POSSIBLY RELATED TO DEVICES AND PROCEDURE. THIS EVENT REPORT WAS RECEIVED THROUGH CLINICAL DATA COLLECTION ACTIVITIES. REVISION HAS NOT OCCURRED, CONTINUING DELTOID STRENGTHENING IN PHYSICAL THERAPY. OUTCOME IS CONTINUING.

  Patient problems: Joint Dislocation

  MAUDE report 13949094 ↗
• InjuryMar 23, 2022Detachment of Device or Device Component; Device Dislodged or Dislocated; Detachment of Device or Device Component; Device Dislodged or Dislocated

  AS REPORTED, SIX DAYS AFTER INITIAL LEFT TSA, THIS (B)(6) OLD MALE PATIENT WAS REVISED DUE TO THE POST OP SCAN REVEALING THAT THE SPHERE WAS NOT PROPERLY SEATED. SURGEON IMPLANTED THE GLENOSPHERE INCORRECTLY. THE SAME SIZED COMPONENTS WERE USED. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. DEVICES WILL NOT BE RETUNING.

  Patient problems: Failure of Implant

  MAUDE report 13858827 ↗

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-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-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-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-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-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-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-3019-2020 · Aug 24, 2020 · Terminated
  Equinoxe Reverse Shoulder Compression Screw/Locking Cap Kit 4.5 x 18 mm.
• Z-3020-2020 · Aug 24, 2020 · Terminated
  Equinoxe Reverse Shoulder Compression Screw/Locking Cap Kit 4.5 x 22 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.