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Equinoxe 320-10-05Recalls & reported problems

Exactech, Inc. · Class 2 · Implant

All models of Equinoxe (305)

Data updated Oct 16, 2026 from official FDA records · Editorial policy

Quick summary

This Exactech Equinoxe shoulder implant is a cemented metal-and-polymer replacement for the shoulder joint. The 32 reports mostly describe the plastic liner or the tray coming loose or separating from the other parts, sometimes with the shoulder dislocating or metal debris in the tissue, and many patients needing revision surgery years after implantation. All 32 involve injuries and none involve death. Reports dropped from 18 in the earlier 12 months to 5 in the most recent 12 months, and no recalls name this device.

AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.

Adverse event reports
34
Deaths reported
0
Injuries reported
34
Recalls naming it
0

Summary

The FDA's MAUDE database contains 34 adverse event reports that list this exact device (DI 10885862086426), received between May 31, 2019 and Sep 30, 2026 — classified as 34 injuries.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (24 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Reports received per month

Nov 2023: 0 reportsDec 2023: 0 reportsJan 2024: 0 reportsFeb 2024: 0 reportsMar 2024: 0 reportsApr 2024: 0 reportsMay 2024: 0 reportsJun 2024: 1 reportsJul 2024: 0 reportsAug 2024: 0 reportsSep 2024: 1 reportsOct 2024: 1 reportsNov 2024: 2 reportsDec 2024: 0 reportsJan 2025: 1 reportsFeb 2025: 2 reportsMar 2025: 0 reportsApr 2025: 4 reportsMay 2025: 3 reportsJun 2025: 1 reportsJul 2025: 2 reportsAug 2025: 2 reportsSep 2025: 0 reportsOct 2025: 1 reportsNov 2025: 0 reportsDec 2025: 0 reportsJan 2026: 1 reportsFeb 2026: 1 reportsMar 2026: 2 reportsApr 2026: 0 reportsMay 2026: 0 reportsJun 2026: 1 reportsJul 2026: 0 reportsAug 2026: 0 reportsSep 2026: 2 reportsOct 2026: 0 reports2024202520264
Last 36 months. The most recent month may be incomplete.

Most reported problems

Device problems

  • Detachment of Device or Device Component24
  • Device Dislodged or Dislocated4
  • Migration4
  • Naturally Worn4
  • Unstable3
  • Activation, Positioning or Separation Problem1
  • Adverse Event Without Identified Device or Use Problem1
  • Appropriate Device Problem Term/Code Not Available1

Patient problems

  • Joint Dislocation11
  • Pain9
  • Insufficient Information7
  • Failure of Implant4
  • Joint Laxity3
  • Metal Related Pathology3
  • Loss of Range of Motion2
  • Muscle/Tendon Damage2

Recent adverse event reports

The 25 most recent of 34 reports, in the reporter's own words as published by the FDA.

  • InjurySep 30, 2026Detachment of Device or Device Component

    Patient problems: Joint Dislocation

    MAUDE report 50945417 ↗
  • InjurySep 24, 2026Detachment of Device or Device Component

    Patient problems: Pain

    MAUDE report 50885954 ↗
  • InjuryJun 4, 2026Detachment of Device or Device Component

    REPORT #2 OF 2 FOR THIS EVENT. IT WAS REPORTED THIS PATIENT HAD A RIGHT REVERSE TOTAL SHOULDER ARTHROPLASTY REVISION PROCEDURE DUE TO DISASSOCIATION OF THE TRAY AND TORQUE SCREW COMPONENTS. SUBSEQUENTLY, FOUR (4) MONTHS LATER, THE PATIENT WAS REVISED FOR THE SECOND TIME DUE TO DISASSOCIATION OF THE TRAY AND TORQUE SCREW COMPONENTS. IT WAS REPORTED THE PATIENT IS OKAY AFTER THE REVISION. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Patient problems: Insufficient Information

    MAUDE report 25390171 ↗
  • InjuryMar 24, 2026Detachment of Device or Device Component; Naturally 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 24681028 ↗
  • InjuryMar 24, 2026Inadequacy of Device Shape and/or Size

    IT WAS REPORTED THAT A 77 YO FEMALE PATIENT, WHO HAD A LEFT RTSA, PRESENTED WITH COMPLAINTS OF PAIN AND WAS REVISED APPROXIMATELY 2 YEARS POST THE INITIAL PROCEDURE. A LOOSE BASEPLATE AND BACTEREMIA WERE INDICATED. THERE WERE NO DEVICE BREAKAGES OR SURGICAL DELAYS DURING THE PROCEDURE. THE PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. AN X-RAY WAS PROVIDED. THE EXPLANTED DEVICES ARE NOT AVAILABLE FOR RETURN DUE TO CHAIN OF COMMAND. AN IMAGE OF THE EXPLANTED DEVICES WAS PROVIDED. NO FURTHER INFORMATION.THIS IS 1 OF 2 REPORTS.

    Patient problems: Aseptic loosening; Bacteremia; Pain

    MAUDE report 24680804 ↗
  • InjuryFeb 18, 2026Detachment of Device or Device Component

    AS REPORTED, APPROXIMATELY 10 MONTHS POST OP THE INITIAL LEFT TSA, THIS PATIENT WAS REVISED DUE TO THE HUMERAL POLY DISSOCIATING FROM HUMERAL TRAY. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. NO INFORMATION IS FORTH COMING AT THIS TIME.

    Patient problems: Insufficient Information

    MAUDE report 24379050 ↗
  • InjuryJan 17, 2026Detachment of Device or Device Component; Device Dislodged or Dislocated

    REPORT 2 OF 2 OF THIS EVENT. AS REPORTED A PATIENT UNDERWENT AN INITIAL LEFT REVERSE TOTAL SHOULDER ARTHROPLASTY. SUBSEQUENTLY, THE PATIENT EXPERIENCED DISLOCATION. AS A RESULT, SEVEN (7) YEARS LATER, THE PATIENT WAS REVISED. THE POLY WAS DISASSOCIATED FROM THE TRAY. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. NO FURTHER PATIENT IMPACT WAS REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE. THE REVISION REPORTED IN CASE- (B)(4) WAS LIKELY THE RESULT OF A COMBINATION OF DISLOCATION AND HUMERAL LINER DISASSOCIATION. IT IS UNCLEAR IF THE DISLOCATION ALLOWED FOR THE HUMERAL LINER TO DISASSOCIATE OR IF THE HUMERAL LINER DISASSOCIATION-WHICH MAY HAVE BEEN THE RESULT OF EITHER INCOMPLETE SEATING OF THE LINER DURING IMPLANTATION, BONE IMPINGEMENT, PATIENT CONDITIONS, OR ANY COMBINATION OF THESE POSSIBILITIES-LED TO THE DISLOCATION AS THE EXPLANTED DEVICES WERE NOT RETURNED FOR EVALUATION AND IMAGES/PRE-REVISION RADIOGRAPHS WERE UNABLE TO BE OBTAINED.

    Patient problems: Joint Dislocation

    MAUDE report 24105465 ↗
  • InjuryOct 16, 2025Migration; Migration

    AS REPORTED, APPROXIMATELY 4.5 YEARS POST THE INITIAL TOTAL SHOULDER ARTHROPLASTY, THE PATIENT'S TRAY SNAPPED LOOSE FROM THE PRESERVE STEM AND WAS LOOSE IN THE PATIENT'S ARM. THE SCREW AND POLY LINER REMAINED ATTACHED TO THE TRAY. THE PATIENT WAS LOADING A TRUCK WHEN THE EVENT OCCURRED. THE PATIENT DEVELOPED SORENESS AND SHARP PAIN, WITH AN INABILITY TO LIFT THEIR ARM, AND A PAIN LEVEL OF 9 OUT OF 10. THE PATIENT WAS REVISED TO A 42MM +4 GLENOSPHERE, A +10 HUMERAL TRAY, AND A 42 +2.5 LINER. THERE WAS NO REPORTED SURGICAL DELAY/PROLONGATION. THE PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT.

    Patient problems: Joint Dislocation; Pain

    MAUDE report 23309230 ↗
  • InjuryAug 25, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

    IT WAS REPORTED IN A PATIENT UNDERWENT A LEFT TOTAL SHOULDER ARTHROPLASTY. SUBSEQUENTLY, SEVEN (7) MONTHS LATER THE PATIENT REPORTED DISLOCATING HIS SHOULDER. X-RAYS WERE OBTAINED AND REVEALED DISASSOCIATION OF THE POLYETHYLENE LINER. AS A RESULT, THE PATIENT UNDERWENT A LEFT SHOULDER REVISION OF THE HUMERAL TRAY, HUMERAL LINER, GLENOSPHERE AND GLENOSPHERE LOCKING SCREW. THE PATIENT OUTCOME WAS REPORTED AS RESOLVED. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Patient problems: Joint Dislocation

    MAUDE report 22882674 ↗
  • InjuryAug 20, 2025Detachment of Device or Device Component; Migration; Detachment of Device or Device Component; Migration

    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 22854557 ↗
  • InjuryJul 18, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

    AS REPORTED BY THE EQUINOXE SHOULDER STUDY, APPROXIMATELY 2.5 YEARS POST INITIAL LEFT TSA, THE PATIENT EXPERIENCED A DISASSOCIATION OF POLYETHYLENE. THE PATIENT REACHED OUT AWKWARDLY WITH HIS LEFT ARM AND FELT "POP" AND PAIN. PATIENT HAD A STANDARD REVERSE REVISION AND THE EVENT WAS RESOLVED. PER CLINICAL REPORT, THE REPORTED EVENT IS NOT RELATED TO THE DEVICE OR TO THE PROCEDURE. NO OTHER INFORMATION IS AVAILABLE.

    Patient problems: Pain

    MAUDE report 22543042 ↗
  • InjuryJul 1, 2025Detachment of Device or Device Component; Device Dislodged or Dislocated; Detachment of Device or Device Component; Device Dislodged or Dislocated

    IT WAS REPORTED THAT THE PATIENT UNDERWENT AN INITIAL REVERSE TOTAL SHOULDER REPLACEMENT ON THE LEFT SIDE. THE PATIENT EXPERIENCED EXCESSIVE DISASSOCIATION OF THE POLYETHYLENE COMPONENT AFTER FALLING AND LANDING ON THE LEFT SHOULDER THAT RESULTED IN A LEFT SHOULDER REVISION, 2 YEARS AFTER INITIAL REPLACEMENT. SUBSEQUENTLY, THE PATIENT HAS AGAIN EXPERIENCED DISASSOCIATION OF POLYETHYLENE; STATING THEY WOKE UP WITH SHOULDER DISLOCATED. AS A RESULT, ALMOST 2 YEARS AFTER REVISION, THE PATIENT UNDERWENT AN ADDITIONAL LEFT SHOULDER REVISION. NO FURTHER IMPACT TO THE PATIENT WAS REPORTED. NO OTHER INFORMATION IS AVAILABLE.

    Patient problems: Joint Dislocation

    MAUDE report 22376714 ↗
  • InjuryJun 9, 2025Structural Problem; Naturally Worn; Structural Problem; Naturally Worn

    IT WAS REPORTED THAT THIS PATIENT'S RIGHT SHOULDER WAS REVISED. SUBSEQUENTLY, THE HUMERAL TRAY HAD BECOME LOOSE. THE HUMERAL TRAY WAS LOOSE WITH THE SCREW CONTAINED IN THE IMPLANT. THE SURGEON WAS ABLE TO SWAP OUT THE GLENOPHERE AND REPLACE THE HUMERAL TRAY AND LINER. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT.

    Patient problems: Inadequate Osseointegration

    MAUDE report 22171991 ↗
  • InjuryMay 15, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

    IT WAS REPORTED THAT THE PATIENT UNDERWENT AN INITIAL LEFT REVERSE SHOULDER REPLACEMENT ON AN UNKNOWN DATE. SUBSEQUENTLY, THE POLYETHYLENE LINER AND HUMERAL TRAY DISASSOCIATED. AS A RESULT, THE PATIENT UNDERWENT A LEFT SHOULDER REVISION AN UNKNOWN AMOUNT OF TIME AFTER INITIAL SURGERY. NO FURTHER PATIENT IMPACT REPORTED. NO ADDITIONAL INFORMATION AVAILABLE.

    Patient problems: Insufficient Information

    MAUDE report 22029383 ↗
  • InjuryMay 7, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

    IT WAS REPORTED THAT THE PATIENT UNDERWENT AN INITIAL REVERSE TOTAL SHOULDER REPLACEMENT ON THE LEFT SIDE. SUBSEQUENTLY, APPROXIMATELY 5 YEARS LATER THE PATIENT NOTED FEELING A PINCH IN THEIR LEFT SHOULDER FOLLOWED BY INTENSE PAIN AND INABILITY TO RAISE THEIR ARM. THE PATIENT WENT TO THE EMERGENCY ROOM AND DISCOVERED THE HUMERAL TRAY HAD DETACHED FROM THE HUMERAL STEM. THE PATIENT NOTED THEY DID NOT EXPERIENCE ANY FORM OF TRAUMA TO THE PROSTHESIS. REVISION SURGERY HAS BEEN SCHEDULED. NO FURTHER PATIENT IMPACT WAS PROVIDED. NO ADDITIONAL IS AVAILABLE AT THIS TIME.

    Patient problems: Loss of Range of Motion; Pain

    MAUDE report 21978483 ↗
  • InjuryMay 7, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

    IT WAS REPORTED THAT APPROXIMATELY 29 MONTHS AFTER A TOTAL SHOULDER REPLACEMENT PROCEDURE, THE PATIENT HAS EXPERIENCED PAIN AND DETACHMENT OF DEVICE. NO FURTHER ISSUES OR COMPLICATIONS WERE REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Patient problems: Insufficient Information

    MAUDE report 21975589 ↗
  • InjuryApr 30, 2025Detachment of Device or Device Component; Migration; Detachment of Device or Device Component; Migration

    IT WAS REPORTED THAT THIS PATIENT'S RIGHT SHOULDER WAS REVISED APPROXIMATELY 3 YEARS 4 MONTHS POST OPERATION. SUBSEQUENTLY, THE HUMERAL TRAY DETACHED FROM THE HUMERAL STEM. THE PATIENT'S PROSTHESIS WAS NOT ARTICULATING AS INTENDED. SURGEON REMOVED, THE TRAY, LINER, TORQUE SCREW, GLENOSPHERE LOCKING SCREW, AND GLENOSPHERE. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT.

    Patient problems: Joint Dislocation; Joint Laxity

    MAUDE report 21938499 ↗
  • InjuryApr 28, 2025Detachment of Device or Device Component; Naturally Worn; Detachment of Device or Device Component; Naturally Worn

    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 21920718 ↗
  • InjuryApr 28, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

    IT WAS REPORTED THAT THE PATIENT UNDERWENT AN INITIAL TOTAL SHOULDER REPLACEMENT ON THE RIGHT SIDE; FOLLOWED BY A REVISION FOR DISASSOCIATION OF POLYETHYLENE, APPROXIMATELY 1.5 YEARS AFTER INITIAL REPLACEMENT. SUBSEQUENTLY, THE PATIENT EXPERIENCED ANOTHER DISASSOCIATION OF POLYETHYLENE; STATING THEY REACHED OUT IN HORIZONTAL ADDUCTED POSITION AND HELT "POP" WITH PAIN. AS A RESULT, APPROXIMATELY 3.5 YEARS AFTER FIRST REVISION OF RIGHT SHOULDER, THE PATIENT UNDERWENT A SECOND REVISION. NO FURTHER IMPACT TO THE PATIENT WAS REPORTED. NO OTHER INFORMATION IS AVAILABLE.

    Patient problems: Implant Pain; Pain

    MAUDE report 21918494 ↗
  • InjuryApr 26, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

    IT WAS REPORTED THAT THE PATIENT UNDERWENT AN INITIAL TOTAL SHOULDER REPLACEMENT ON THE RIGHT SIDE. SUBSEQUENTLY, THE PATIENT EXPERIENCED DISASSOCIATION OF POLYETHYLENE. PATIENT REPORTED IMMEDIATE PAIN AFTER WEIGHTLIFTING; NOTICED SWELLING AND "POPEYE" MUSCLE ABOUT THE RIGHT ARM. AS A RESULT, APPROXIMATELY 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: Muscle/Tendon Damage; Pain; Swelling/ Edema

    MAUDE report 21915732 ↗
  • InjuryFeb 20, 2025Mechanical Problem; Detachment of Device or Device Component; Loosening of Implant Not Related to Bone-Ingrowth; Mechanical Problem; Detachment of Device or Device Component; Loosening of Implant Not Related to Bone-Ingrowth

    AS REPORTED, APPROXIMATELY 4 YEARS AND 11 MONTHS POST THE PATIENT'S INITIAL RIGHT REVERSE TOTAL SHOULDER ARTHROPLASTY, THE PATIENT WAS BROUGHT BACK WITH LIMITED RANGE OF MOTION. THE POLY WAS FOUND TO BE LOOSE FROM THE HUMERAL TRAY. THE POLY AND HUMERAL TRAY WERE REMOVED. IMPLANTS OF THE SAME SIZE WERE THEN IMPLANTED. 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: Loss of Range of Motion

    MAUDE report 21429078 ↗
  • InjuryFeb 11, 2025Unstable; Detachment of Device or Device Component; Unstable; Detachment of Device or Device Component

    APPROXIMATELY 8 YEAR(S), 4 MONTH(S) AND 2 DAY(S) POST-OPERATIVE OF A REVISED RIGHT RTSA, IT WAS REPORTED VIA CLINICAL STUDY THAT THE PATIENT EXPERIENCED DISASSOCIATION OF POLYETHYLENE. PATIENT'S SHOULDER 'LOCKED UP' WHILE AT WORK WITH FEELINGS OF INSTABILITY THEREAFTER. THE PATIENT UNDERWENT A TENDON TRANSFER WITH ROTATOR CUFF REPAIR 3 MONTHS POST OPERATIVELY (SEE (B)(4)) AND WAS REVISED APPROXIMATELY 5 MONTHS POST OPERATIVE OF THE INITIAL IMPLANTATION OF DEVICES FOR UNKNOWN REASONS. (SEE (B)(4)) ONE MONTH AND FIVE DAYS FOLLOWING THE ONSET OF SYMPTOMS, THE PATIENT UNDERWENT A STANDARD REVERSE REVISION WITH REPORTED REMOVAL OF THE TORQUE SCREW, HUMERAL TRAY, HUMERAL LINER, GLENOSPHERE, AND GLENOSPHERE LOCKING SCREW COMPONENTS. THE OUTCOME OF THIS EVENT IS CONSIDERED RESOLVED, AND THE CASE REPORT FORM INDICATES THAT THIS EVENT IS POSSIBLY RELATED TO THE DEVICE(S) AND DEFINITELY RELATED TO THE PROCEDURE. THIS WAS REPORTED THROUGH CLINICAL TRIAL STUDY DATA COLLECTION ACTIVITIES, NO DEVICE RETURN IS ANTICIPATED, AND NO OTHER INFORMATION IS AVAILABLE AT THIS TIME.

    Patient problems: Joint Laxity; Muscle/Tendon Damage

    MAUDE report 21358632 ↗
  • InjuryJan 16, 2025Migration; Migration

    THIS IS 1 OF 2 REPORTS - SEE MDR# 1038671-2025-00291 FOR OTHER DEVICE REPORTING.

    Patient problems: Failure of Implant; Joint Dislocation

    MAUDE report 21173333 ↗
  • InjuryNov 26, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

    AS REPORTED, APPROXIMATELY 3 YEARS AND 3 MONTHS POST INITIAL LEFT TOTAL SHOULDER ARTHROPLASTY (TSA) FOR SECONDARY ARTHRITIS AND A MASSIVE ROTATOR CUFF TEAR, A REVISION WAS PERFORMED DUE TO PROSTHETIC DISLOCATION CAUSED BY DISASSEMBLY OF THE POLYETHYLENE INSERT. THE GLENOSPHERE, HUMERAL LINER, AND HUMERAL ADAPTER TRAY WERE REPLACED. EVENT AND PATIENT OUTCOME WERE NOT PROVIDED.

    Patient problems: Joint Dislocation

    MAUDE report 20789581 ↗
  • InjuryNov 15, 2024Unstable; Unstable

    AS REPORTED, THE PATIENT UNDERWENT A THIRD RIGHT SIDE SHOULDER REVISION SURGERY DUE TO INSTABILITY AFTER HER REVERSE REPLACEMENT. THE HUMERAL TRAY WAS REVISED FROM A 0 TO A +10. THE POLY WAS ALSO REVISED TO A CONSTRAINED LINER. 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: Joint Laxity

    MAUDE report 20694847 ↗

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-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-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-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-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-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.

Other Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented devices

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Sources and updates

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