Equinoxe 300-10-15Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 10885862079381), received between Mar 29, 2022 and Dec 31, 2024 — classified as 8 injuries.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (1 report).

10 other recalls cover devices cleared under the same FDA submission (K042021); 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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• InjuryDec 31, 2024Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  APPROXIMATELY 12 YEAR(S), 1 MONTH(S) AND 24 DAY(S) POST-OPERATIVE OF AN INITIAL LEFT TSA, IT WAS REPORTED VIA CLINICAL STUDY THAT THE PATIENT EXPERIENCED ASEPTIC GLENOID LOOSENING. PATIENT WAS PULLED BY HER DOG WHILE HOLDING A LEASH. THE PATIENT WAS EXAMINED THROUGH CT SCAN THAT REVEALED SOME LYSIS AROUND THE INFERIOR PEGS. PATIENT WILL BE OBSERVED. THE OUTCOME OF THIS EVENT IS CONSIDERED RESOLVED AND THE CASE REPORT FORM INDICATES THAT THIS EVENT IS POSSIBLY RELATED TO THE DEVICE AND UNLIKELY RELATED TO THE PROCEDURE. THIS WAS REPORTED THROUGH CLINICAL TRIAL STUDY DATA COLLECTION ACTIVITIES AND NO OTHER INFORMATION IS AVAILABLE AT THIS TIME.

  Patient problems: Osteolysis

  MAUDE report 21047952 ↗
• InjuryMay 22, 2024Device 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 BY THE EQUINOXE SHOULDER STUDY, APPROXIMATELY FIVE MONTHS POST INITIAL RIGHT TSA, THE 80-YEAR-OLD WHITE FEMALE PATIENT EXPERIENCED INSTABILITY/SUBLUXATION. X-RAYS SHOW ANTERIOR SUBLUXATION IN RELATION TO THE GLENOID. THE PATIENT UNDERWENT A STANDARD REVERSE REVISION SURGERY ON THE OUTCOME OF THIS EVENT IS NOW CONSIDERED RESOLVED. THE CLINICAL REPORT INDICATES THAT THIS EVENT IS UNLIKELY RELATED TO THE DEVICE AND/OR TO THE PROCEDURE.

  Patient problems: Failure of Implant; Subluxation

  MAUDE report 19375048 ↗
• InjuryAug 30, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED, APPROXIMATELY NINE MONTHS POST INITIAL LEFT TSA, THE 64 Y/O MALE PATIENT HAD A STAGE 2 REVISION AS PLANNED BY THE SURGEON. PATIENT HAD A WEAK BONE. SURGEON INSERTED A HEMI PLUS A BONE GRAFT IN THE LAST REVISION. SURGEON REMOVED THE GLENOID BONE GRAFT AND INSERTED A REVERSE SHOULDER. 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 OR IMAGES. THE DEVICES ARE NOT AVAILABLE FOR EVALUATION AS THEY WERE DISPOSED BY THE HOSPITAL. NO OTHER PATIENT INFORMATION/MEDICAL HISTORY REPORTED

  Patient problems: Failure of Implant

  MAUDE report 17651974 ↗
• InjuryAug 22, 2022Unstable; Adverse Event Without Identified Device or Use Problem; Unstable; Adverse Event Without Identified Device or Use Problem

  AS REPORTED, APPROXIMATELY 1.5 YEARS POST INITIAL LEFT TSA, THE 79 Y/O FEMALE PATIENT HAD AN ANATOMIC SHOULDER CONVERTED TO A REVERSE SHOULDER DUE INSTABILITY CAUSED BY A DEFICIENT ROTATOR CUFF. PATIENT WAS REVISED TO A REVERSE STANDARD GLENOID, 4 BONE SCREWS 38MM GLENOSPHERE 0 SPACER PLATE 38MM POLY 8 INSERT. THERE WAS NO BREAKAGE OF A DEVICE AND NO SURGICAL DELAY/PROLONGATION. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. THE DEVICE IS NOT AVAILABLE FOR EVALUATION DUE TO PATHOLOGY LAB HAS DISCARDED THE DEVICES. NO ADDITIONAL INFORMATION.

  Patient problems: Failure of Implant; Joint Laxity

  MAUDE report 15264975 ↗
• InjuryJul 20, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE REP RECEIVED A PHONE CALL FROM THE SURGEON EXPLAINING THAT HE NEEDED TO REVISE A RIGHT SHOULDER REPLACEMENT FROM A COUPLE OF YEARS BACK. THE ANATOMIC REPLACEMENT IS NOW POPPING/SUBLAXING, SO A REVISION TO A REVERSE IS NECESSARY. UPON OPENING, THE SURGEON IDENTIFIED SIGNS OF INFECTION, AT WHICH POINT THE DECISION WAS MADE TO DO A 2 STAGE REVISION. THE SURGEON REMOVED THE IMPLANTS AND HAS PUT IN ONE OF EXACTECH'S SHOULDER SPACERS FOR THE TIME BEING. PATIENT CURRENTLY HAS AN EXACTECH SHOULDER SPACER IN-SITU. DEPENDING ON EXTENT OF INFECTION & DAMAGE TO GLENOID, SURGEON IS HOPING TO BE REVISED TO EXACTECH REVERSE IMPLANTS. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. DEVICES ARE NOT RETURNING.

  Patient problems: Bacterial Infection

  MAUDE report 15068223 ↗
• InjuryJul 6, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED, 8 DAYS POST OP LEFT SHOULDER REPLACEMENT, THIS 75 Y/O MALE PATIENT WAS REVISED DUE TO INFECTION. THE PATIENT HAS NO SOFT TISSUE LEFT AND THE INFECTION IS COMING OUT OF THE WOUND SO HE DECIDED TO REMOVE EVERYTHING COMPLETELY AND HOPE THE INFECTION AND WOUND HEAL. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. PATIENT HAS HAD OTHER EVENT THAT WERE CAPTURED IN CASE-(B)(6)/ ER EX-REV 248 AND CASE-(B)(6)/ EX-REV 249. DEVICES ARE NOT RETURNING.

  Patient problems: Bacterial Infection

  MAUDE report 14930222 ↗
• InjuryJun 28, 2022Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT A COUPLE OF DAYS AFTER SURGERY, THIS 75 Y/O FEMALE PATIENT LEFT SHOULDER ORIGINALLY HAD AN EXACTECH REVERSE SHOULDER IMPLANTED (APPROX. 7 MONTHS AGO), IT BECAME INFECTED SO THE SURGEON DECIDED TO TAKE EVERYTHING OUT AND LET IT HEAL. LAST WEEK WE USED A TRAUMA LONG STEM AND CTA HEAD. UNFORTUNATELY, THE PATIENTS SOFT TISSUES DIDN¿T ALLOW THE CTA HEAD TO BE TO PROUD AND PUT PRESSURE ON THE SUTURES SUPERIORLY. THE SURGEON USED A SIZE 7MM STANDARD STEM WITH A 38MM CTA HEAD TO HELP REDUCED PRESSURE ON THE SOFT TISSUES. THE 7MM STEM WAS CEMENTED IN. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. DEVICES ARE NOT RETURNING. FIRST EVENT STATED IS CAPTURED IN 1038671-2022-00706 / CASE-(B)(4).

  Patient problems: Failure of Implant

  MAUDE report 14841384 ↗
• InjuryMar 29, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED, APPROXIMATELY 7 MONTHS POST OP THE INITIAL RTSA, THIS (B)(6) FEMALE PATIENT WAS REVISED TO A REVERSE FROM A HEMI. REASON HAS NOT BEEN REPORTED. THERE WAS NO SURGICAL DELAY. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. DEVICES WILL NOT BE RETUNING, HOSPITAL DISPOSED OF DEVICES.

  Patient problems: Failure of Implant

  MAUDE report 13937915 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K042021. One submission often covers many models, so check the product and lot details in each record.

• Z-0536-2026 · Sep 5, 2025 · Open, Classified
  Brand Name: Equinoxe Ergo Product Name: Adjustable Angle rTSA Reamer, 46mm Model/Catalog Number: 321-59-46 Software Version: N/A Product Description: rTSA Reamer, 46mm Component: N
• Z-0537-2026 · Sep 5, 2025 · Open, Classified
  Brand Name: Equinoxe Ergo Product Name: Ergo Augments Pilot Tip Converter Model/Catalog Number: 301-11-11 Software Version: N/A Product Description: Pilot Tip Converter Piece Compo
• Z-0535-2026 · Sep 5, 2025 · Open, Classified
  Brand Name: Equinoxe Ergo Product Name: Adjustable Angle rTSA Reamer, 42mm Model/Catalog Number: 321-59-42 Software Version: N/A Product Description: rTSA Reamer, 42mm Component: N
• Z-1403-2024 · Mar 6, 2024 · Open, Classified
  Exactech Equinoxe GLENOID,KEELED, CEMENTED, mates with 47, 50, 53 head, beta curvature, Sizes: a) Small, Item Number 314-01-12, b) Medium, Item Number 314-01-13, c) Large, Item Nu
• Z-1404-2024 · Mar 6, 2024 · Open, Classified
  Exactech Equinoxe GLENOID,KEELED, CEMENTED, mates with 47, 50, 53 head, beta curvature, Sizes: a) Small, Item Number 314-02-02, b) Medium, Item Number 314-02-03, c) Large, Item Nu
• Z-1405-2024 · Mar 6, 2024 · Open, Classified
  Exactech Equinoxe GLENOID,KEELED, CEMENTED,47, 50, 53 head, beta curvature, Sizes: a) Small, Item Number 314-02-12, b) Medium, Item Number 314-02-13, c) Large, Item Number 314-02
• Z-1402-2024 · Mar 6, 2024 · Open, Classified
  Exactech Equinoxe GLENOID,KEELED, CEMENTED, Mates with 38, 41, 44 head, alpha curvature, Sizes: a), Small, Item Number 314-01-02; b) Medium, Item number 314-01-03; c) Large, Item
• Z-0884-2021 · Nov 9, 2020 · Open, Classified
  Equinoxe Humeral Stem, Primary, Press Fit, 11mm
• Z-1459-2015 · Feb 13, 2015 · Terminated
  Equinoxe 44mm Short Humeral Head Catalog Number 310-01-44. Orthopedic shoulder implant component.
• Z-2115-2012 · Jun 15, 2012 · Terminated
  Equinoxe Anatomic Replicator Plate Intended for Primary and Reverse Total Shoulder Arthroplasty