Equinoxe 300-30-06Recalls & reported problems

Summary

The FDA's MAUDE database contains 28 adverse event reports that list this exact device (DI 10885862515742), received between Nov 14, 2020 and Jun 2, 2026 — classified as 27 injuries, 1 malfunction.

The most frequently reported specific device problem is “Loosening of Implant Not Related to Bone-Ingrowth” (11 reports).

1 other recall cover devices cleared under the same FDA submission (K162726); 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 25 most recent of 28 reports, in the reporter's own words as published by the FDA.

• InjuryJun 2, 2026Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED VIA CLINICAL STUDY THAT THIS PATIENT UNDERWENT A SHOULDER REPLACEMENT. SUBSEQUENTLY, THE PATIENT EXPERIENCED SHOULDER DISLOCATION AND ASEPTIC HUMERAL LOOSENING AFTER PERFORMING YARDWORK AND FEELING THE SHOULDER ¿TWEAK.¿ THE PATIENT UNDERWENT A REVISION TO A STANDARD REVERSE WITH PRESERVE STEM CONSTRUCT. DURING THE REVISION PROCEDURE, THE TORQUE SCREW, PRESERVE STEM, HUMERAL TRAY, HUMERAL LINER, GLENOSPHERE, AND GLENOSPHERE LOCKING SCREW WERE REMOVED. THE OUTCOME IS CONSIDERED RESOLVED. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Joint Dislocation

  MAUDE report 25365781 ↗
• InjuryApr 8, 2026Detachment of Device or Device Component

  IT WAS REPORTED THAT A MALE PATIENT, WHO HAD A RIGHT RTSA, UNDERWENT A REVISION PROCEDURE. THE PATIENT¿S TRAY DISASSOCIATED FROM THE STEM. DEVICE BREAKAGE OCCURRED DURING THE PROCEDURE. THE TRIAL TRAY BROKE DURING THE PROCEDURE ALMOST DAMAGING THE PREVIOUSLY IMPLANTED PRESERVE STEM. NO PARTS OR PIECES FELL INTO THE WOUND SITE AND ALL PARTS AND PIECES WERE REMOVED. THERE WAS NO SURGICAL DELAYS DURING THE PROCEDURE. THE EXPLANTED DEVICES ARE NOT AVAILABLE FOR RETURN. NO IMAGES WERE PROVIDED. NO FURTHER INFORMATION. THIS IS 1 OF 2 REPORTS FOR THIS EVENT.

  Patient problems: Joint Dislocation

  MAUDE report 24821869 ↗
• InjuryDec 23, 2025Migration; Implant subsidence; Migration; Implant subsidence

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN INITIAL TOTAL SHOULDER ARTHROPLASTY ON THE RIGHT SIDE. SUBSEQUENTLY, THE PATIENT EXPERIENCED HUMERAL STEM SUBSIDENCE AND PAIN. AS A RESULT, THE SURGEON REVISED THEIR GLENOSPHERE, ADAPTER TRAY, LINER AND STEM. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: Pain

  MAUDE report 23880150 ↗
• InjuryAug 20, 2025Detachment of Device or Device Component; Naturally Worn; Detachment of Device or Device Component; Naturally Worn

  IT WAS REPORTED APPROXIMATELY FIVE (5) YEARS AFTER A LEFT REVERSE TOTAL SHOULDER REPLACEMENT SURGERY, A PATIENT UNDERWENT A REVISION PROCEDURE OF THE HUMERAL TRAY, LINER AND HUMERAL STEM. X-RAYS AND IMAGES WERE PROVIDED. OBSERVATIONS OF THE TRAY AND LINER NOTED THE TORQUE SCREW WAS INTACT BETWEEN THE LINER AND THE TRAY BUT THERE WAS NO SCREW THREADS LEFT. THERE WAS NO SCREW OBSERVED ON X RAY, AND NO METALLOSIS OBSERVED. IT WAS REPORTED THE SURGEON COULD NOT FIND THE THREADED PART OF THE BREAK OFF SCREW ANYWHERE IN THE STEM OR THE PATIENT. THE HUMERAL LINER WAS NOTED TO HAVE MINIMAL WEAR. THERE WERE NO SURGICAL DELAYS OR PROLONGATION. NO MEDICAL OR SURGICAL INTERVENTIONS WERE REPORTED. THE PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Insufficient Information

  MAUDE report 22855036 ↗
• InjuryAug 1, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN INITIAL TOTAL SHOULDER REPLACEMENT ON THE RIGHT SIDE, DURING WHICH, THE PATIENT EXPERIENCED A HUMERAL FRACTURE. THE CALCAR SPLIT DURING IMPLANTATION OF HUMERAL STEM AND WAS STABILIZED WITH A CABLE INTRA-OPERATIVELY. NO FURTHER IMPACT TO THE PATIENT WAS REPORTED. NO OTHER INFORMATION IS AVAILABLE.

  Patient problems: Bone Fracture(s); Periprosthetic fracture

  MAUDE report 22688515 ↗
• InjuryJun 23, 2025Unstable; Loosening of Implant Not Related to Bone-Ingrowth; Unstable; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED A FALL.

  Patient problems: Joint Laxity

  MAUDE report 22306564 ↗
• InjuryApr 25, 2025Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  AS REPORTED, APPROXIMATELY 1 YEAR AND 3 MONTHS POST THE INITIAL RIGHT REVERSE TOTAL SHOULDER ARTHROPLASTY, THE PATIENT WAS REVISED DUE TO THE STEM BEING LOOSE AND THE POLY BEING DISSOCIATED. 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: Inadequate Osseointegration

  MAUDE report 21914518 ↗
• InjuryApr 24, 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 TOTAL SHOULDER REPLACEMENT ON THE RIGHT SIDE. SUBSEQUENTLY, THE PATIENT EXPERIENCED ASEPTIC GLENOID LOOSENING. PATIENT FELL POST-OP AND STARTED TO DEVELOP PAIN OVER TIME WITH GLENOID/HUMERAL LOOSENING PRESENT ON X-RAY; HOWEVER, NO BACTERIA GROWTH SO LIKELY ASEPTIC LOOSENING. AS A RESULT, APPROXIMATELY 2.5 YEARS AFTER INITIAL REPLACEMENT, THE PATIENT UNDERWENT A RIGHT SHOULDER REVISION. NO FURTHER IMPACT TO THE PATIENT WAS REPORTED. NO OTHER INFORMATION IS AVAILABLE.

  Patient problems: Aseptic loosening; Pain

  MAUDE report 21904581 ↗
• InjuryApr 21, 2025Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT THIS PATIENT'S LEFT SHOULDER WAS REVISED APPROXIMATELY A WEEK POST INITIAL OPERATION. SUBSEQUENTLY, THE PATIENT HAD A VIOLENT SNEEZE, CAUSING DISLOCATION OF THE SHOULDER. ONCE THE SURGEON GOT INTO THE SHOULDER, HE FOUND OUT THE STEM WAS LOOSE AND WAS ABLE TO PULL IT OUT BY HIS FINGERS. PATIENT WAS REVISED TO A STD STEM SIZE 15 WITH A +0 HUMERAL TRAY AND +2.5 42MM HUMERAL LINER. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT.

  Patient problems: Aseptic loosening; Joint Dislocation

  MAUDE report 21875802 ↗
• InjuryApr 18, 2025Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT APPROXIMATELY 1 MONTHS AFTER A TOTAL SHOULDER REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS LOOSENING AND JOINT DISLOCATION. NO FURTHER ISSUES OR COMPLICATIONS WERE REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Joint Dislocation

  MAUDE report 21865333 ↗
• InjuryMar 19, 2025Unstable; Migration; Unstable; Migration

  IT WAS REPORTED THAT A 53 YO MALE PATIENT, INITIAL LEFT SHOULDER IMPLANTED ON (B)(6) 2023, UNDERWENT A REVISION PROCEDURE ON (B)(6) 2024, APPROXIMATELY 11 MONTHS POST THE INITIAL PROCEDURE. THE PATIENT WAS REVISED DUE TO SHOULDER PAIN AND INSTABILITY. ONCE PATIENT WAS OPENED UP, IT WAS NOTICEABLE THAT THE POLY WAS FLATTENED DOWN QUITE A BIT, AND THAT THE PATIENT HAD BEEN SUBLUXING FOR A WHILE DUE TO HIS SHOULDER BEING LOOSE. THE STEM WAS WELL FIXATED AND LEFT IN PLACE. THE STEM DID SUBSIDE A LITTLE BIT. POLY WAS DISTORTED FROM SUBLUXATION. PATIENTS +0 MM TRAY AND 42MM +0 LINER WERE REPLACED WITH A +10 MM TRAY AND 42MM +0 LINER. THE HUMERAL IMPLANTS WERE REPLACED EXCEPT FOR THE STEM. THERE WERE NO SURGICAL DELAYS OR DEVICE BREAKAGES DURING THE PROCEDURE. THE PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. THE EXPLANTED DEVICES ARE NOT AVAILABLE FOR RETURN AS THE HOSPITAL WON¿T RELEASE THEM. NO X-RAYS OR DEVICE IMAGES WERE ABLE TO BE OBTAINED. NO FURTHER INFORMATION.

  Patient problems: Joint Laxity; Pain; Subluxation

  MAUDE report 21642059 ↗
• InjuryNov 21, 2024Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  AS REPORTED, APPROXIMATELY 24 WEEKS POST INITIAL RIGHT TOTAL SHOULDER ARTHROPLASTY (TSA), A REVISION WAS PERFORMED DUE TO A DISLOCATING FEELING IN THE SHOULDER. THE STEM WAS FOUND TO BE LOOSE. A NEW STEM, EXPANDED GLENOSPHERE AND BUILT UP TRAY AND LINER WERE IMPLANTED WITH NO ISSUE. NO FURTHER INFORMATION WAS AVAILABLE.

  Patient problems: Joint Dislocation; Joint Laxity

  MAUDE report 20750209 ↗
• InjuryNov 7, 2024Unstable; Loosening of Implant Not Related to Bone-Ingrowth; Unstable; Loosening of Implant Not Related to Bone-Ingrowth

  APPROXIMATELY 3 MONTHS AND 26 DAYS POST-OPERATIVE OF A LEFT REVERSE TOTAL SHOULDER ARTHROPLASTY (RTSA), IT WAS REPORTED THAT THE PATIENT EXPERIENCED LOOSENING OF THE HUMERAL STEM. THE PATIENT UNDERWENT STANDARD REVERSE REVISION FOR INSTABILITY AND THE LOOSE HUMERAL STEM. THE HUMERAL COMPONENTS WERE REMOVED AND THE DOCTOR IMPLANTED A COMPETITOR'S HUMERAL COMPONENTS. THE PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. NO BREAKAGE OR SURGICAL DELAYS WERE REPORTED AND THE DEVICES WILL NOT BE RETURNING AS THEY WERE SENT TO PATHOLOGY.

  Patient problems: Joint Laxity

  MAUDE report 20630697 ↗
• InjurySep 3, 2024Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT THIS 69 Y/O MALE PATIENT'S RIGHT RTSA WAS REVISED APPROXIMATELY 3 MONTHS POST OP THE SURGERY IN TURKEY. PATIENT WAS APPARENTLY LIFTING A SUITCASE AND DISLOCATED HIS SHOULDER. APPARENTLY IT WAS NOT ABLE TO BE REDUCED BY A SURGEON IN TURKEY SO PATIENT RETURNED TO THE US. THE GLENOSPHERE, LOCKING SCREW, LINER, TORQUE SCREW, TRAY AND STEM WERE ALL REMOVED AND REVISED. THE STEM WAS LOOSE AND SHOWED NO BONY ON-GROWTH. A LARGER PRESERVE STEM WAS ABLE TO BE USED AS WELL AS AN EXPANDED GLENOSPHERE. NO ADDITIONAL INTRA-OPERATIVE DELAYS. PRODUCT NOT RETURNING: HOSPITAL KEEPS.

  Patient problems: Joint Dislocation

  MAUDE report 20129086 ↗
• InjuryAug 23, 2024Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  APPROXIMATELY 2 YEAR(S) AND 14 DAY(S) POST-OPERATIVE OF A LEFT TSA, IT WAS REPORTED VIA CLINICAL STUDY THAT THE PATIENT EXPERIENCED ASEPTIC HUMERAL LOOSENING. PATIENT PRESENTED WITH INCREASED PAIN. THE HUMERAL STEM WAS FOUND TO BE LOOSE. THE PATIENT UNDERWENT STANDARD REVERSE WITH PRESERVE STEM REVISION SURGERY, AND THE OUTCOME OF THIS EVENT IS CONSIDERED RESOLVED. THE CLINICAL REPORT INDICATES THAT THIS EVENT IS POSSIBLY RELATED TO THE DEVICE(S) AND/OR TO THE PROCEDURE.

  Patient problems: Aseptic loosening; Pain; Post Operative Wound Infection

  MAUDE report 20046458 ↗
• InjuryJun 27, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING SURGERY, A PATIENT HAD A GREATER TUBEROSITY AND ANTERIOR GLENOID WALL FRACTURE. THE PATIENT HAD SEVERE OSTEOPOROSIS. THE EVENT WAS NOT RELATED TO THE DEVICE. THE EVENT WAS RELATED TO THE PROCEDURE. THE GREATER TUBEROSITY WAS SUTURED. THE OUTCOME IS CONTINUING.

  Patient problems: Bone Fracture(s); Limb Fracture

  MAUDE report 19630635 ↗
• InjuryApr 25, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED BY THE EQUINOXE SHOULDER STUDY, THE 59-YEAR-OLD NON-HISPANIC WHITE FEMALE HAD A RIGHT TSA (B)(6) 2024. THE PATIENT PRESENT WITH HUMERAL FRACTURE ¿ CALCAR, INTRA-OPERATIVELY ON (B)(6) 2024. THE ACTION OF CERCLAGE WAS TAKEN ON (B)(6) 2024 AND THE OUTCOME OF THIS EVENT IS CONSIDERED RESOLVED. THE CASE REPORT FORM INDICATES THAT THIS EVENT IS DEFINITELY NOT RELATED TO THE DEVICE AND/OR TO THE PROCEDURE. THIS EVENT REPORT WAS RECEIVED THROUGH CLINICAL DATA COLLECTION ACTIVITIES AND NO DEVICE RETURN IS ANTICIPATED.

  Patient problems: Bone Fracture(s); Periprosthetic fracture

  MAUDE report 19182269 ↗
• InjuryMar 4, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED BY THE EQUINOXE SHOULDER STUDY, THE 76-YEAR-OLD FEMALE PATIENT HAD A LEFT TSA ON (B)(6) 2024 AND PRESENTED WITH HUMERAL FRACTURE - MIDSHAFT, INTRA-OPERATIVELY ON (B)(6) 2024. INTRA-OP HUMERAL CALCAR FRACTURE DURING REDUCTION. THE OUTCOME OF THIS EVENT IS CONSIDERED CONTINUING, WITH THE ACTION TAKEN OF OTHER - CERCLAGE CABLE AROUND HUMERUS. THE CASE REPORT FORM INDICATES THAT THIS EVENT IS UNLIKELY RELATED TO THE DEVICE AND DEFINITELY RELATED TO THE PROCEDURE. THIS EVENT REPORT WAS RECEIVED THROUGH CLINICAL DATA COLLECTION ACTIVITIES AND NO DEVICE RETURN IS ANTICIPATED.

  Patient problems: Bone Fracture(s); Periprosthetic fracture

  MAUDE report 18833091 ↗
• InjuryOct 6, 2023Fracture; Adverse Event Without Identified Device or Use Problem; Fracture; Adverse Event Without Identified Device or Use Problem

  AS REPORTED, THE PATIENT HAD AN INITIAL LEFT TSA ON (B)(6) 2023. THE PATIENT PRESENTED HAD NON-DISPLACED CALCAR FRACTURE NOTED AT THE TIME OF HUMERAL IMPLANTATION. THE CASE REPORT FORM INDICATES THAT THIS EVENT IS POSSIBLY UNLIKELY RELATED TO DEVICE, DEFINITELY NOT RELATED TO PROCEDURE.

  Patient problems: Bone Fracture(s); Periprosthetic fracture

  MAUDE report 17884979 ↗
• InjuryJul 27, 2023Fracture; Adverse Event Without Identified Device or Use Problem; Fracture; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED POST-OP VIA CLINICAL STUDY THAT THE 73 YO FEMALE PATIENT EXPERIENCED A PROXIMAL THIRD OF HUMERUS PERIPROSTHETIC FRACTURE (HUMERAL FX TUBEROSITY). THE DATE OF EVENT ONSET IS (B)(6) 2023. THE PATIENT WAS REVISED ON (B)(6) 2023. THE OUTCOME WAS LAST KNOWN AS CONTINUING.

  Patient problems: Bone Fracture(s); Periprosthetic fracture

  MAUDE report 17411030 ↗
• InjuryJul 27, 2023Loosening of Implant Not Related to Bone-Ingrowth; Migration; Loosening of Implant Not Related to Bone-Ingrowth; Migration

  IT WAS REPORTED VIA CLINICAL STUDY THAT THE 57 YO MALE PATIENT EXPERIENCED SEPTIC LOOSENING. THE DATE OF EVENT ONSET IS (B)(6)2021. THE PATIENT WAS REVISED ON (B)(6)2022. PREVIOUS: RIGHT ARTHROSCOPIC ROTATOR CUFF REPAIR IN 2012, 2 ADDITIONAL ARTHROSCOPIES IN 2014. THE PATIENT¿S OUTCOME WAS LAST KNOWN AS RESOLVED ON (B)(6)2023.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Medical device site infection; Pain; Septic loosening

  MAUDE report 17410964 ↗
• InjuryMay 24, 2023Fracture; Adverse Event Without Identified Device or Use Problem; Fracture; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED VIA CLINICAL STUDY THAT THE 55 YO FEMALE PATIENT EXPERIENCED A HUMERAL FRACTURE AND CRACK IN CALCAR WHEN BROACHING FOR HUMERAL STEM. THE OUTCOME WAS LAST KNOWN AS CONTINUING.

  Patient problems: Bone Fracture(s); Limb Fracture; Multiple Fractures

  MAUDE report 16998670 ↗
• InjuryJun 8, 2022Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT A (B)(6) Y/O MALE PATIENT, UNDERWENT A REVISION OF EXACTECH IMPLANTS ON HIS RIGHT SHOULDER. THE HUMERAL COMPONENTS WERE REPLACED WITH ARTHREX COMPONENTS. THE PATIENT HAD BEEN DISLOCATING HIS SHOULDER. THE LINER APPEARED TO STILL BE LOCKED INTO THE TRAY AT TIME OF REVISION. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. UNABLE TO OBTAIN PHOTOS OR X-RAYS. THE PRODUCT IS NOT AVAILABLE FOR RETURN.

  Patient problems: Joint Dislocation

  MAUDE report 14631306 ↗
• InjuryMay 27, 2022Fracture; Fracture

  AS REPORTED BY THE EQUINOXE SHOULDER STUDY, THIS (B)(6) FEMALE PATIENT EXPERIENCED A HUMERAL FRACTURE. CORTICAL SPLIT WAS TREATED WITH CABLES. THE CASE REPORT FORM INDICATES THIS EVENT IS DEFINITELY RELATED TO DEVICES AND PROCEDURE. THIS EVENT REPORT WAS RECEIVED THROUGH CLINICAL DATA COLLECTION ACTIVITIES.

  Patient problems: Bone Fracture(s)

  MAUDE report 14521136 ↗
• InjuryApr 12, 2022Fracture; Fracture

  AS REPORTED, DURING STEM IMPACTION IN A L TOTAL SHOULDER PROCEDURE ON A (B)(6) FEMALE PATIENT, THERE WAS A CALCAR FRACTURE TO THE L SHOULDER. IT WAS REPAIRED WITH A CERCLAGE AND THE PROCEDURE WAS COMPLETED. THE PATIENT HAS A HISTORY OF OSTEOARTHRITIS. THERE IS NO DEVICE TO BE RETURNED. THE CASE REPORT FORM INDICATES THIS EVENT IS POSSIBLY RELATED TO DEVICES AND/OR POSSIBLY RELATED TO PROCEDURE. THIS EVENT REPORT WAS RECEIVED THROUGH CLINICAL DATA COLLECTION ACTIVITIES.

  Patient problems: Bone Fracture(s)

  MAUDE report 14082980 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K162726. One submission often covers many models, so check the product and lot details in each record.

• Z-0958-2019 · Dec 5, 2018 · Terminated
  Equinoxe Preserve Humeral Stem, 8mm Product Usage: The Equinoxe Preserve Stems are indicated for use in skeletally mature individuals with degenerative diseases of the glenohumera