Equinoxe 320-15-05Recalls & reported problems

Summary

The FDA's MAUDE database contains 35 adverse event reports that list this exact device (DI 10885862086495), received between Apr 3, 2019 and Jun 30, 2026 — classified as 35 injuries.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (17 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 35 reports, in the reporter's own words as published by the FDA.

• InjuryJun 30, 2026Structural Problem

  AS REPORTED, THE PATIENT UNDERWENT AN INITIAL REVERSE TOTAL SHOULDER ARTHROPLASTY. SUBSEQUENTLY, IT WAS OBSERVED IN AN X-RAY THAT THERE WAS LOOSENING OF THE GLENOSPHERE LOCKING SCREW. THE PATIENT WAS REVISED AND A NEW 36MM GLENOSPHERE, GLENOSPHERE LOCKING SCREW, AND HUMERAL LINER SIZE 36/0 WERE IMPLANTED. THERE WAS NO REPORTED BREAKAGE OF A DEVICE OR SURGICAL DELAY/PROLONGATION. PATIENT OUTCOME NOT PROVIDED.

  Patient problems: Insufficient Information

  MAUDE report 25668201 ↗
• InjuryMar 2, 2026Detachment of Device or Device Component

  AS REPORTED, APPROXIMATELY SEVEN DAYS POST INITIAL RIGHT TSA, THE PATIENT HAD REVISION DUE TO GLENOSPHERE DISASSOCIATION. THE GLENOSPHERE WAS SECURED AGAIN AND THE LINER WAS EXCHANGED. THE PATIENT IS FINE; AND LIKELY A USER ERROR. THERE WAS NO BREAKAGE OF DEVICE OR SURGICAL DELAY/PROCEDURE. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. SALES REP WAS UNABLE TO OBTAIN PHOTOS/X-RAYS. THE DEVICE IS NOT AVAILABLE FOR EVALUATION AS THE DEVICES WERE DISPOSED BY THE HOSPITAL.

  Patient problems: Insufficient Information

  MAUDE report 24489628 ↗
• InjuryJan 28, 2026Structural Problem

  IT WAS REPORTED A PATIENT WHO HAD A RTSA, UNDERWENT AN EXPLANT PROCEDURE. ALL IMPLANTS WERE REMOVED DUE TO INFECTION FOLLOWING A LONG-STANDING TRAUMA, (FRACTURE DISLOCATION OVER A YEAR PRIOR), WHICH BECAME INFECTED. THE PATIENT WILL FINISH A COURSE OF ANTIBIOTICS AND THEN LIKELY UNDERGO A REVISION TO HRP. THEY ARE AWAITING A CT AS THERE IS ALSO BONE LOSS PRESENT ON THE GLENOID. THERE WERE NO DEVICE BREAKAGES OR SURGICAL DELAYS DURING THE PROCEDURE. THE PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. NO X-RAYS WERE PROVIDED. AWAITING APPROVAL FOR RELEASE OF REVISED IMPLANTS. DEVICE IMAGES WERE PROVIDED. NO FURTHER INFORMATION. THIS IS 1 OF 6 REPORTS FOR THIS EVENT.

  Patient problems: Bone Fracture(s); Joint Dislocation; Unspecified Infection

  MAUDE report 24203149 ↗
• InjuryDec 22, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT A MALE PATIENT, WHO HAD A RIGHT RTSA, UNDERWENT A REVISION PROCEDURE. THE LOCKING SCREW CAME OUT OF THE SPHERE. THE SPHERE, TRAY, POLY, AND LOCKING SCREW WERE REVISED WITH NEW IMPLANTS. THERE WERE NO DEVICE BREAKAGES DURING THE PROCEDURE. THE PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. AN X-RAY WAS PROVIDED. THE EXPLANTED DEVICE IS NOT AVAILABLE FOR RETURN DUE TO HOSPITAL POLICIES. NO FURTHER INFORMATION. THIS IS 1 OF 3 REPORTS FOR THIS EVENT. THIS IS 1 OF 2 EVENTS FOR THIS PATIENT.

  Patient problems: Insufficient Information

  MAUDE report 23866232 ↗
• InjuryAug 1, 2025Structural Problem; Structural Problem

  IT WAS REPORTED THAT APPROXIMATELY 15 MONTHS AFTER A LEFT TOTAL SHOULDER REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS GLENOSPHERE LOOSENING. THE SURGEON FIRST REMOVED THE POLY AND THE HUMERAL PLATE TO GAIN BETTER EXPOSURE TO THE GLENOID. HE THEN REMOVED THE GLENOSPHERE, WHICH WAS LOOSE. THE PATIENT REVISED TO EXACTECH DEVICES. NO FURTHER ISSUES OR COMPLICATIONS WERE REPORTED. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. IMAGES OF THE X-RAYS WERE PROVIDED. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Insufficient Information

  MAUDE report 22687722 ↗
• InjuryJul 8, 2025Structural Problem; Detachment of Device or Device Component; Noise, Audible; Structural Problem; Detachment of Device or Device Component; Noise, Audible

  IT WAS REPORTED APPROXIMATELY SIX YEARS AFTER A REVERSE RIGHT TOTAL SHOULDER REPLACEMENT THE PATIENT EXPERIENCED PAIN. THE PATIENT UNDERWENT A RIGHT TOTAL SHOULDER REVISION PROCEDURE DUE TO DISASSOCIATION OF THE HUMERAL TRAY, HUMERAL LINER, GLENOSPHERE AND LOCKING SCREW. NO MEDICAL OR SURGICAL INTERVENTIONS WERE REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Pain

  MAUDE report 22437006 ↗
• InjuryMay 13, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT THIS PATIENT'S LEFT SHOULDER WAS REVISED. SOMETIME AFTER THE INITIAL SURGERY, THE GLENOSPHERE DISASSOCIATED FROM THE BASEPLATE AND ONCE DISCOVERED, REQUIRED REVISION SURGERY TO SECURE THE NEW GLENOSPHERE. SURGEON REMOVED THE IMPLANTS WITH THE EXCEPTION OF THE HUMERAL TRAY WHICH WENT FROM A +0 TO A +5. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT.

  Patient problems: Insufficient Information

  MAUDE report 22011014 ↗
• InjuryApr 28, 2025Structural Problem; Structural Problem

  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 21920350 ↗
• InjuryMar 13, 2025Unstable; Detachment of Device or Device Component; Unstable; Detachment of Device or Device Component

  IT WAS REPORTED THAT THIS 71 Y/O MALE PATIENT'S LEFT SHOULDER WAS REVISED APPROXIMATELY 1 YEAR 11 MONTHS POST OP. SURGEON BELIEVES THAT THERE WAS SCAPULAR NOTCHING WHICH CAUSED POLY WEAR/INSTABILITY. THE GLENOSPHERE WAS ALSO QUITE LOOSE WHICH SHE BELIEVES ALSO COULD HAVE BEEN A CAUSE. NEITHER PHYSICIAN NOR SALES REP HAD A VERY GOOD EXPLANATION FOR HOW THE SCREW BECAME LOOSE. THERE WAS NO BREAKAGE OF THE DEVICE. THERE WAS A 30-40 MINUTE SURGICAL DELAY DUE TO ALL COMPONENTS OTHER THAN BASEPLATE/SCREWS AND STEM HAD TO BE REMOVED. NEW COMPONENTS TRAILED AND NEW IMPLANTS INSERTED; HOWEVER, THERE WAS NO ADVERSE EVENT AS A RESULT OF THE SURGICAL DELAY. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. PHOTO ATTACHED. UNABLE TO OBTAIN X-RAYS. PRODUCT NOT RETURNING, HOSPITAL POLICY.

  Patient problems: Joint Impingement; Joint Laxity

  MAUDE report 21597052 ↗
• InjuryMar 5, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT THIS PATIENT'S LEFT SHOULDER WAS REVISED APPROXIMATELY 1 YEAR 8 MONTHS POST INITIAL OPERATION. PATIENT COMPLAINED OF PAIN. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT.

  Patient problems: Pain

  MAUDE report 21529956 ↗
• InjuryFeb 13, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  APPROXIMATELY 5 YEAR(S), 2 MONTH(S) AND 11 DAY(S) POST-OPERATIVE OF A RIGHT RTSA, IT WAS REPORTED VIA CLINICAL STUDY THAT THE PATIENT EXPERIENCED DISASSOCIATION OF GLENOSPHERE. THE PATIENT, FOLLOWING A RIGHT HEMILATED HEMORRHAGIC STROKE 2 YEARS PRIOR, REPORTS PAIN AND FUNCTIONAL IMPOTENCE. THE PATIENT WAS GIVEN MEDICATION AND REFUSES PROSTHESIS REVISION SURGERY, SO THE OUTCOME OF THIS EVENT IS UNKNOWN. THE CASE REPORT FORM INDICATES THAT THIS EVENT IS DEFINITELY NOT RELATED TO THE DEVICE(S) AND/OR 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: Failure of Implant; Pain

  MAUDE report 21380648 ↗
• InjuryJan 29, 2025Fracture; Fracture

  IT WAS REPORTED THAT THIS PATIENT'S SHOULDER WAS REIVSED APPROXIMATELY 1 YEAR 6 MONTHS POST INITIAL OPERATION. IT WAS SUSPECTED THAT THE GLENOSPHERE SCREW HAD BACKED OUT. HOWEVER, SURGEON HAD FOUND THAT THE GLENOSPHERE SCREW HAD BROKEN INTO THE GLENOID BASEPLATE. THE SCREW HAD SUBSEQUENTLY BACKED OUT AND WEARING THE HUMERAL POLY CAUSING LYSIS. AFTER REMOVAL, SURGEON RE INSERTED A LONG PEG BASEPLATE AND NEW IMPLANTS AS THE STEM WAS WELL FIXED. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT.

  Patient problems: Osteolysis

  MAUDE report 21263630 ↗
• InjuryJan 3, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  APPROXIMATELY 7 MONTH(S) AND 13 DAY(S) POST-OPERATIVE OF A REVISED RIGHT RTSA, IT WAS REPORTED VIA CLINICAL STUDY THAT THE PATIENT EXPERIENCED DISASSOCIATION OF GLENOSPHERE WITH INCREASED PAIN AND SIGNIFICANT POLY WEAR. THE PATIENT WAS PREVIOUSLY REVISED FOR ASEPTIC GLENOID LOOSENING. THE PATIENT UNDERWENT A STANDARD REVERSE WITH PRESERVE STEM REVISION FOR THE DISASSOCIATION WITH THE REPORTED REMOVAL OF THE HUMERAL LINER, GLENOSPHERE, AND GLENOID BASE PLATE COMPONENTS. THE OUTCOME OF THIS EVENT IS CONSIDERED RESOLVED AND THE CASE REPORT FORM INDICATES THAT THIS EVENT IS POSSIBLY RELATED TO THE DEVICE AND/OR 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: Pain

  MAUDE report 21069135 ↗
• InjuryNov 5, 2024Fracture; Fracture

  IT WAS REPORTED THAT THIS PATIENT'S RIGHT SHOULDER WAS REVISED. THE PATIENT DESCRIBED FEELING ROCKING IN THE SHOULDER WITH RANGE OF MOTION. SURGEON REACHED OUT TO REQUEST INSTRUMENTS FOR EXTRACTION AND REVISION OF CURRENT IMPLANT. AXIAL VIEW DEMONSTRATED A MISALIGNED GLENOSHPERE WHICH APPEARED TO BE SITTING OFF THE BASEPLATE. NO GLENOSPHERE LOCKING SCREW WAS VISUALIZED ON X-RAY. CORONAL VIEW APPEARED NORMAL. UPON EXPOSURE OF THE JOINT, THE GLENOSPHERE WAS LOOSE AND THE LOCKING SCREW APPEARED TO BE BROKEN. SURGEON INSPECTED BASEPLATE AND NOTICED SCREW WAS BROKEN INTO THE CENTER HOLE, WHICH IT INSERTS INTO. SURGEON PROCEEDED TO EXTRACT LOCKING CAPS AND SCREWS USING THE HEX DRIVER AND SUCCESSFULLY EXTRACTED WITHOUT SCREWS BREAKING. ONCE SCREWS WHERE TAKEN OUT OF THE PATIENT, ANOTHER SURGEON ASSISTING ON THE CASE, EXTRACTED THE BASEPLATE VIA HOSPITAL INSTRUMENTS. DOCTORS TOOK THE LINER OFF VIA MALLET AND ELEVATOR, THEN REMOVED TORQUE SCREW WITH REMOVAL TOOL TO TAKE THE TRAY OFF. STEM WAS WELL FIXED. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. PRODUCT NOT RETURNING: PLEASE ASK HOSPITAL FOR RETURN OF PRODUCTS.

  Patient problems: Insufficient Information; Joint Laxity

  MAUDE report 20611734 ↗
• InjuryOct 30, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  AS REPORTED, APPROXIMATELY ONE YEAR AND EIGHT MONTHS POST TOTAL SHOULDER ARTHROPLASTY (TSA), THE PATIENT UNDERWENT A REVISION OF THE RIGHT HYBRID REVERSE SHOULDER DUE TO THE GLENOSPHERE AND GLENOSPHERE LOCKING SCREW BACKING OUT AWAY FROM A WELL FIXED REVERSE BASEPLATE. IT WAS NOTED THAT THE PATIENT WAS INVOLVED IN AN ATV ACCIDENT THAT MAY HAVE AFFECTED THE PROSTHESIS. THE SURGEON REPLACED THE GLENOSPHERE AND GLENOSPHERE LOCKING SCREW. THERE WAS NO REPORTED DEVICE BREAKAGE OR SURGICAL DELAY/PROLONGATION. THE PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT.

  Patient problems: Insufficient Information

  MAUDE report 20569363 ↗
• InjuryOct 16, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT THIS PATIENT'S LEFT KNEE WAS REVISED. SOMETIME SINCE THAT SURGERY THE SURGEON DISCOVERED THAT THE GLENOSPHERE HAD DISSOCIATED FROM THE BASEPLATE WHICH MEANT THE LOCKING SCREW BACKED OUT. IT APPEARED THAT THE GLENOSPHERE SEEMED TO STILL BE ARTICULATING WITH THE LINER, BUT OBVIOUSLY NEEDED TO BE REVISED. THE SURGEON DISCOVERED THE PATIENT'S GLENOSPHERE AND LOCKING SCREW HAD BACKED OUT AND DISSOCIATED FROM THE BASEPLATE, REQUIRING REVISION SURGERY. THE SURGEON WAS ABLE TO REMOVE THE OLD POLY, GLENOSPHERE AND LOCKING SCREW. FROM THERE, TENSIONING REQUIRED A LARGER TRAY, SO HE REMOVED THE ORIGINAL TORQUE SCREW AND TRAY AND IMPLANTED LARGER 40MM COMPONENTS AND A 5MM TRAY. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT.

  Patient problems: Insufficient Information

  MAUDE report 20466489 ↗
• InjurySep 20, 2024Use of Device Problem; Damaged Thread; Use of Device Problem; Damaged Thread

  SECOND DEVICE WAS FOUND DURING THE INVESTIGATION ON 9/19/2024. IT WAS REPORTED THAT THIS PATIENT'S RIGHT SHOULDER WAS REVISED APPROXIMATELY 6 MONTHS POST OP. THE PATIENCE FELT PAIN AND DIDN'T FEEL COMFORTABLE WHEN HE MOVES THE RIGHT SHOULDER. HE COULD HEAR A STRANGER SOUND. IT WAS NOTICED DURING REMOVAL THAT THE IMPLANT WAS DAMAGED AND IDENTIFIED WEAR OF THE POLYETHYLENE. AFTER THE REVISION SURGICAL PROCEEDING, THE PATIENT FELLS MUCH BETTER, HE DOESN'T FELL PAIN AND DOESN'T LISTEN STRANGE SOUND WHEN MOVES THE RIGHT SHOULDER. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT.

  Patient problems: Implant Pain

  MAUDE report 20267705 ↗
• InjuryAug 12, 2024Fracture; Fracture

  IT WAS REPORTED THAT A 79 YO MALE PATIENT, INITIAL LEFT SHOULDER IMPLANTED IN (B)(6) 2018, UNDERWENT A REVISION PROCEDURE IN (B)(6) 2024, APPROXIMATELY 7 YEARS POST THE INITIAL PROCEDURE. THE PATIENT PRESENTED TO THE SURGEON WITH COMPLAINTS ABOUT SOME MILE PAIN IN THEIR SHOULDER. DURING THE PROCEDURE, WHEN OPENED, THEY PRESENTED WITH LOOSENING ON THE GLENOID SIDE AND A SNAPPED SCREW. IT WAS INDICATED A FALL WAS SUSPECTED. ALL DEVICES WERE REMOVED. THERE WERE NO SURGICAL DELAYS OR DEVICE BREAKAGES DURING THE PROCEDURE. THE PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. NO X-RAYS WERE PROVIDED. NO EXPLANTED DEVICES WERE AVAILABLE FOR RETURN AS THEY WERE SENT TO ¿RPH FOR STUDY¿. DEVICE IMAGES WERE PROVIDED. NO FURTHER INFORMATION.

  Patient problems: Implant Pain

  MAUDE report 19963207 ↗
• InjuryJul 15, 2024Fracture; Detachment of Device or Device Component; Fracture; Detachment of Device or Device Component

  AS REPORTED, THE SURGEON NOTICED THE GLENOSPHERE SCREW WAS LOOSE WITH THE END DISENGAGED DURING A LEFT SHOULDER SCOPE NECESSITATING A REVISION. DURING THE REVISION, THE BASEPLATE AND STEM WERE FOUND TO BE WELL FIXED. THE LINER TRAY AND GLENOSPHERE WERE REPLACED. CULTURES CAME BACK NEGATIVE FOR INFECTION. THE PATIENT WAS REVISED TO EXACTECH DEVICES. THE EVENT WAS NOT ASSOCIATED WITH THE BREAKAGE OF A DEVICE. THE EVENT DID NOT CAUSE A SURGICAL DELAY/PROLONGATION. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. X-RAYS WERE UNABLE TO BE OBTAINED. NO DEVICE RETURN FOR ANALYSIS ANTICIPATED DUE TO THE HOSPITAL KEPT THE DEVICE. DEVICE IMAGES WERE PROVIDED.

  Patient problems: Insufficient Information

  MAUDE report 19742843 ↗
• InjuryJul 12, 2024Detachment of Device or Device Component; Loosening of Implant Not Related to Bone-Ingrowth; Detachment of Device or Device Component; Loosening of Implant Not Related to Bone-Ingrowth

  AS REPORTED, APPROXIMATELY 10 MONTHS AFTER INITIAL RIGHT TSA, THE PATIENT WAS REVISED AFTER FEELING PAIN WHILE DOING HANDY WORK. THE GLENOSPHERE WAS LOOSE AND WAS REPLACED ALONG WITH A NEW POLY LINER AND SCREW. THE EVENT IS RELATED TO THE BREAKAGE OF A DEVICE. ALL PIECES THAT FELL INTO THE WOUND SITE WERE REMOVED. THE EVENT DID NOT LEAD TO A SURGICAL DELAY/PROLONGATION.

  Patient problems: Pain

  MAUDE report 19728721 ↗
• InjuryMay 25, 2023Detachment of Device or Device Component; Device Dislodged or Dislocated; Detachment of Device or Device Component; Device Dislodged or Dislocated

  AS REPORTED VIA CLINICAL STUDY, THE PATIENT HAD AN INITIAL LEFT TSA ON (B)(6) 2019. THE PATIENT PRESENTED TO THE SURGEON ON (B)(6) 2021 WITH DISASSOCIATION OF THE GLENOSPHERE AND REPORTED PAIN AND FUNCTIONAL IMPOTENCE. THE PATIENT WAS REVISED ON (B)(6) 2022 AND THE GLENOSPHERE REMOVED. OUTCOME: RESOLVED. THE CASE REPORT FORM INDICATES THIS EVENT IS DEFINITELY NOT RELATED TO THE DEVICES OR PROCEDURE.

  Patient problems: Failure of Implant; Pain

  MAUDE report 17001286 ↗
• InjuryMar 14, 2023Break; Break

  AS REPORTED APPROXIMATELY ONE YEAR POST INITIAL TSA, THE FEMALE PATIENT COMPLAINED OF PAIN. THE DOCTOR REQUESTED AN MRI AND VERIFIED THAT THE SCREW. REVERSE GLENOSPHERE WAS BROKEN. VERIFIED BY RESONANCE THAT THE PROSTHESIS WAS CORRECTLY FIXED. EXPLANTED MATERIAL WILL BE SENT FOR ANALYSIS.

  Patient problems: Failure of Implant

  MAUDE report 16541948 ↗
• InjuryJun 28, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  AS REPORTED, APPROXIMATELY 3 MONTHS POSTOP THE INITIAL FRACTURE RSA, THE FEMALE PATIENT HAD COMPLAINED OF PAIN, THE SURGEON FOUND BY X-RAY THAT THE SCREW HAD BACKED OUT FROM THE APPROPRIATE POSITION. AS A RESULT, THE SURGEON DECIDED TO PERFORM REVISION SURGERY. THE LINER, GLENOSPHERE AND LOCKING SCREW ONLY WERE REPLACED. THE GLENOID PLATE WAS NOT REPLACED DUE TO THE ASSEMBLY CONDITION BETWEEN GLENOID BASE PLATE AND LOCKING SCREW THAT USED AT PRIMARY SURGERY WAS CONFIRMED AND IT WAS NOTED THAT THE LOCKING SCREW COULD NOT INSERT INTO THE HOLE OF THE GLENOID BASE PLATE CORRECTLY. BASED ON THE THIS, A NEW LOCKING SCREW WAS TRIED AND COULD BE INSERTED INTO THE HOLE OF GLENOID BASE PLATE THAT WAS USED BY PRIMARY SURGERY CORRECTLY. THE SURGEON DID NOTE THAT DURING THE PRIMARY RSA, WHEN HE PLACED THE GLENOSPHERE, HE FOUND AN OSTEOPHYTE ABOVE THE GLENOID, AND REMOVED IT. HE NOTED THIS STEP MAY HAVE AFFECTED THE PLACEMENT/SEATING OF THE GLENOSPHERE FULLY. THE LOCKING SCREW WAS NOTED TO HAVE FULLY COME OFF, SO THE REMOVAL PROCEDURE OF IMPLANTS WAS EASY. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT.

  Patient problems: Failure of Implant

  MAUDE report 14843136 ↗
• InjuryApr 29, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  AS REPORTED, 8 DAYS POST OP THE INITIAL RIGHT TSA, THIS (B)(6) FEMALE PATIENT WAS REVISED BECAUSE THE ORIGINAL RTSA FAILED TO SEAT THE GLENOSPHERE CORRECTLY ON THE 8 DEGREE POSTERIOR AUGMENT. SURGEON TOOK SCREW OUT, SEATED GLENOSPHERE AND USED NEW LOCKING SCREW. THERE WAS NO SURGICAL DELAY/PROLONGATION. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. DEVICE WILL NOT BE RETURNING, DISPOSED BY HOSPITAL.

  Patient problems: Failure of Implant

  MAUDE report 14249250 ↗
• InjuryApr 1, 2022Break; Break

  AS REPORTED, APPROXIMATELY 5 MONTHS POST OP THE INITIAL RTSA, THIS FEMALE PATIENT WAS REVISED. THE GLENOSPHERE LOCKING SCREW WAS BROKEN CAUSING THE GLENOSPHERE TO DISASSOCIATE FROM THE GLENOID BASEPLATE. SURGEON REPLACED THE GLENOSPHERE, GLENOID, HUMERAL TRAY AND HUMERAL LINER. EVENT STARTED BY DOING NORMAL, EVERYDAY ACTIVITIES. FEMALE PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. NO OTHER PATIENT INFORMATION/MEDICAL HISTORY REPORTED.

  Patient problems: Failure of Implant

  MAUDE report 13975678 ↗

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-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-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-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-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-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.