Equinoxe 320-01-38Recalls & reported problems

Summary

The FDA's MAUDE database contains 60 adverse event reports that list this exact device (DI 10885862086389), received between Apr 8, 2019 and Aug 31, 2026 — classified as 59 injuries, 1 malfunction.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (13 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 60 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 31, 2026Mechanical Problem

  Patient problems: Insufficient Information

  MAUDE report 50528134 ↗
• InjuryApr 7, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A FEMALE PATIENT, WHO HAD A RIGHT RTSA, UNDERWENT A REVISION PROCEDURE. THE PATIENT WAS SENT FOR PATHOLOGY ASSESSMENT ON THE SHOULDER. THE RESULTS CAME BACK POSITIVE WITH INFECTION. INTRAOP FINDINGS SHOWED PUS ON THE GLENOID PROSTHESIS. ALL IMPLANTS WERE REMOVED AND A CEMENT SPACER WAS PUT IN. THERE WAS NO DEVICE BREAKAGE OR SURGICAL DELAYS DURING THE PROCEDURE. THE PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. NO X-RAYS WERE PROVIDED. THE EXPLANTED DEVICES ARE NOT AVAILABLE FOR RETURN AS THEY WERE DISCARDED BY THE CUSTOMER. NO IMAGES WERE AVAILABLE. NO FURTHER INFORMATION.

  Patient problems: Unspecified Infection

  MAUDE report 24811484 ↗
• 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 24203841 ↗
• InjuryOct 29, 2025Naturally Worn; Naturally Worn

  AS REPORTED, APPROXIMATELY 2 YEARS POST OP INITIAL TSA, THIS MALE PATIENT WAS REVISED DUE TO POLY DISASSOCIATION. SOME METALOSIS WAS FOUND AND DAMAGE TO THE SURFACES OF THE GLENOSPHERE AND ADAPTOR TRAY WERE NOTED DUE TO METAL ON METAL. NEW GLENOSPHERE, ADAPTOR TRAY, SET SCREWS, AND POLY OF SAME SIZE WERE IMPLANTED AND FOUND TO BE STABLE. NO COMPLICATIONS WITH THE SURGERY. EXPLANTS ARE RETURNING.

  Patient problems: Insufficient Information; Metal Related Pathology

  MAUDE report 23417495 ↗
• InjurySep 19, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED A PATIENT UNDERWENT AN INITIAL RIGHT TOTAL SHOULDER ARTHROPLASTY. SUBSEQUENTLY, 13 DAYS LATER, THE PATIENT REPORTED SLEEPING ON THE OPERATED SHOULDER AND WAS DIAGNOSED WITH DISASSOCIATION OF THE GLENOSPHERE COMPONENT. AS A RESULT, ONE (1) MONTH AND FIVE (5) DAYS AFTER INITIAL IMPLANT SURGERY, THE PATIENT UNDERWENT A RIGHT SHOULDER REVISION. NO FURTHER IMPACT TO THE PATIENT WAS REPORTED. THE PATIENT OUTCOME WAS REPORTED AS RESOLVED FOLLOWING THE EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Insufficient Information

  MAUDE report 23096856 ↗
• InjuryAug 27, 2025Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN INITIAL REVERSE TOTAL SHOULDER REPLACEMENT ON THE LEFT SIDE. SUBSEQUENTLY, THE PATIENT EXPERIENCED PAIN. IMAGING REVEALED A BROKEN SCREW IN THE GLENOID AND WHAT APPEARED TO BE LOOSENING AROUND THE IMPLANT, BOTH GLENOID AND HUMERUS. AS A RESULT, APPROXIMATELY TEN YEARS POST-SURGERY, THE PATIENT UNDERWENT A REVISION. THE STEM WAS WELL FIXED, STABLE AND REMAINS IMPLANTED. METALLOSIS WAS REPORTED WITHIN THE JOINT. INTRAOPERATIVE CULTURES WERE NEGATIVE FOR INFECTION. THE PATIENT REPORTED TO ANESTHESIA THAT AT SOME POINT IN THE PAST, THEY HAD A FALL. IT IS UNKNOWN WHEN THE FALL OCCURRED. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. NO FURTHER IMPACT TO THE PATIENT WAS REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME.

  Patient problems: Aseptic loosening; Metal Related Pathology; Pain

  MAUDE report 22902120 ↗
• InjuryMay 28, 2025Misassembly by Users; Misassembly by Users

  AS REPORTED, THE PATIENT HAD AN INITIAL LEFT TSA. THE PATIENT WAS REVISED ON AN UNKNOWN DATE. PART OF THE POLY HAD WORN AWAY. THE SURGEON DEEMED IT INFECTED. HE ALSO, AFTER TRYING TO REMOVE THE GLENOSPHERE, REALIZED THAT IT WAS NEVER PUT ON PROPERLY. PRIMARY IMPLANT WAS BY ANOTHER SURGEON. AN ANTIBIOTIC SPACER WAS IMPLANTED. THERE WAS NO REPORTED BREAKAGE OF A DEVICE OR SURGICAL DELAY/PROLONGATION. NO OTHER PATIENT INFORMATION/MEDICAL HISTORY REPORTED. NO X-RAYS OR PHOTOS PROVIDED, UNABLE TO OBTAIN. NO PRODUCT RETURN. THE TECH THREW OUT THE IMPLANTS. THE OCCURRENCE DATE WAS NOT PROVIDED.

  Patient problems: Unspecified Infection

  MAUDE report 22094930 ↗
• InjuryApr 29, 2025Unstable; Naturally Worn; Unstable; Naturally Worn

  IT WAS REPORTED THAT A MALE PATIENT, INITIAL LEFT SHOULDER IMPLANTED, DATE UNKNOWN, UNDERWENT A REVISION PROCEDURE. THE PATIENT¿S TRAY AND POLY WERE REVISED DUE TO INSTABILITY. THE XRAY SHOWED THE TRAY RIGHT UP AGAINST THE GLENOSPHERE, (METAL ON METAL), SO THE POLY HAD BECOME DISLODGED. THE +0 TRAY AND 38MM +0 CONSTRAINED LINER WERE SWAPPED FOR A NEW +0 TRAY WITH A 38MM +2.5 CONSTRAINED LINER. THERE WERE NO DEVICE BREAKAGES OR SURGICAL DELAYS. THE PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. X-RAYS WERE UNABLE TO BE OBTAINED. THE EXPLANTED DEVICES ARE NOT ABLE TO BE RETURNED AS THE HOSPITAL DOES NOT ALLOW IT. DEVICE IMAGES WERE PROVIDED. NO FURTHER INFORMATION. NO OTHER PATIENT INFORMATION/MEDICAL HISTORY REPORTED.

  Patient problems: Joint Laxity; Metal Related Pathology

  MAUDE report 21925094 ↗
• InjuryJul 1, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  APPROXIMATELY 4 MONTHS AFTER A TOTAL SHOULDER REPLACEMENT, THE PATIENT WAS REVISED DUE TO INFECTION. EVERYTHING WAS REMOVED. THE EVENT IS NOT RELATED TO THE BREAKAGE OF A DEVICE. THE EVENT DID NOT LEAD TO A SURGICAL DELAY OR PROLONGATION. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. THIS IS THE THIRD REVISION OF THE PATIENT'S SHOULDER. SALES REP WAS UNABLE TO OBTAIN IMAGES OR X-RAYS. THE DEVICES ARE NOT RETURNING AS THEY WERE DISPOSED.

  Patient problems: Medical device site infection

  MAUDE report 19645787 ↗
• InjuryJun 20, 2024Unstable; Unstable

  AS REPORTED, APPROXIMATELY 2 YEARS AND 7 MONTHS POST INITIAL LEFT TSA, THE PATIENT WAS REVISED DUE TO INSTABILITY. THE LINER WAS EXCHANGED. 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. NO OTHER MEDICAL HISTORY/PATIENT INFORMATION PROVIDED. THE EXPLANT WAS DISCARDED. 320-01-38 - EQUINOXE REVERSE 38MM GLENOSPHERE SERIAL: (B)(6). 510K: K063569. UDI: (B)(4). PRODUCT CODE: KWT. CONCOMITANTS: EQ REV COMPRESS SCREW LCK CAP KIT, 4.5 X 38MM 320-20-38 S301782. EQ REV COMPRESS SCREW LCK CAP KIT, 4.5 X 26MM 320-20-26 S295194. EQ REV COMPRESS SCREW LCK CAP KIT, 4.5 X 34MM 320-20-34 S304912. EQUINOXE, HUMERAL STEM PRIMARY, PRESS FIT 13MM 300-01-13 5512132. EQ REV LOCKING SCREW 320-15-05 7110980. EQUINOXE REVERSE 38MM HUMERAL LINER +2.5 320-38-03 S259336. ***S259336 IS AFFECTED BY THE RECALL. EQUINOXE REVERSE TRAY ADAPTER PLATE TRAY +0 320-10-00 7046253. EQ REVERSE TORQUE DEFINING SCREW KIT 320-20-00 6942895. EQ REV GLENOID PLATE 320-15-01 7074989. EQ REV COMPRESS SCREW LCK CAP KIT, 4.5 X 34MM 320-20-34 S304889. EQ REV COMPRESS SCREW LCK CAP KIT, 4.5 X 38MM 320-20-38 S247792.

  Patient problems: Insufficient Information; Joint Laxity

  MAUDE report 19574220 ↗
• InjuryMay 30, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THIS 75 Y/O MALE PATIENT'S RIGHT SHOULDER WAS REVISED DUE TO DISLOCATION. GLENOSPHERE WAS REVISED FROM 38MM TO 42MM. 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. OCTOBER 2022 REVISION REPORTED UNDER 1038671-2022-01379

  Patient problems: Joint Dislocation

  MAUDE report 19430677 ↗
• InjuryFeb 19, 2024Naturally Worn; Adverse Event Without Identified Device or Use Problem; Naturally Worn; Adverse Event Without Identified Device or Use Problem

  AS REPORTED, APPROXIMATELY FOURTEEN DAYS POST INITIAL LEFT TSA, THE 65 Y/O MALE PATIENT REVERSE SHOULDER WAS REVISED DUE TO INFECTION. ALL COMPONENTS WERE REVISED DUE TO AN INFECTION. 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 PHOTOS/X-RAYS. THE DEVICES ARE NOT AVAILABLE FOR EVALUATION DUE TO HOSPITAL DISPOSED THE IMPLANTS.

  Patient problems: Unspecified Infection

  MAUDE report 18735595 ↗
• InjuryJan 17, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED, APPROXIMATELY SEVEN YEARS POST INITIAL LEFT TSA, THE 70 Y/O MALE PATIENT WAS REVISED DUE TO HETEROTOPIC OSSIFICATION. PATIENT'S GLENOSPHERE AND LINER WERE REVISED TO EXACTECH DEVICES. 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 X-RAYS OR PHOTOS. THE DEVICES ARE NOT AVAILABLE FOR EVALUATION AS THEY WERE DISPOSED AT HOSPITAL.

  Patient problems: Extraskeletal ossification; Failure of Implant

  MAUDE report 18530988 ↗
• InjuryJan 16, 2024Detachment 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 18518988 ↗
• InjuryNov 2, 2023Structural Problem; Detachment of Device or Device Component; Structural Problem; Detachment of Device or Device Component

  IT WAS REPORTED THAT THIS 72 Y/O MALE PATIENT'S RIGHT SHOULDER WAS REVISED TO A REVERSE SHOULDER. THE GLENOSPHERE LOCKING SCREW AND GLENOSPHERE APPEARED TO HAVE BACKED AWAY FROM THE GLENOID BASEPLATE. THE GLENOSPHERE LOCKING SCREW WAS SITTING PROUD AND ENDED UP WEARING THROUGH THE LINER AND MADE CONTACT WITH THE HUMERAL TRAY. SURGEON REPLACED THE 38 GLENOSPHERE, GLENOSPHERE LOCKING SCREW, LINER, REVERSE SHOULDER TORQUE SCREW AND HUMERAL TRAY WITH NEW COMPONENTS. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. PHOTOS ATTACHED. UNABLE TO OBTAIN X-RAYS. DEVICES ARE NOT RETURNING.

  Patient problems: Failure of Implant; Insufficient Information

  MAUDE report 18061026 ↗
• InjurySep 15, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated

  AS REPORTED, APPROXIMATELY 3 MONTHS POST OP INITIAL LEFT TSA, THIS 50 Y/O FEMALE PATIENT WAS REVISED DUE TO DISLOCATION. REVERSE COMPONENTS WERE REMOVED AND SURGEON PUT A HEMI IN. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. DEVICE NOT RETURNING - DISPOSED AT HOSPITAL. NO DELAY/PROLONGATION.

  Patient problems: Joint Dislocation

  MAUDE report 17756950 ↗
• InjuryAug 29, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated

  AS REPORTED, APPROXIMATELY 4 YEARS POST OP INITIAL LEFT TKA, THIS 88 Y/O FEMALE PATIENT WAS REVISED DUE TO DISLOCATION. GLENOSPHERE AND LINER WERE EXCHANGED TO EXPANDED 38MM GLENOSPHERE AND +2.5 CONSTRAINED LINER. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. DEVICE IS NOT RETURNING - DISPOSED AT THE HOSPITAL.

  Patient problems: Joint Dislocation

  MAUDE report 17640866 ↗
• InjuryAug 24, 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 MONTH POST INITIAL RIGHT TSA, THE 59 Y/O FEMALE PATIENT HAD A REVISION DUE TO DISLOCATION. SURGEON EXCHANGED THE GLENOSPHERE, LINER AND ADAPTER TRAY. NEW DEVICES INCLUDED A +4MM, 42MM GLENOSPHERE, CONSTRAINED LINER AND A +10MM ADAPTER TRAY. 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 STAFF.

  Patient problems: Joint Dislocation

  MAUDE report 17612127 ↗
• InjuryJul 25, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated

  AS REPORTED, THE PATIENT HAD AN INITIAL RIGHT TSA (B)(6) 2023. THE PATIENT WAS DISLOCATING POST-OPERATIVELY AND WAS REVISED ON (B)(6) 2023. THE SURGEON REVISED THE HUMERAL COMPONENTS TO CHANGE THE VERSION. HE ALSO CHANGED THE GLENOSPHERE OPTION FOR INCREASED STABILITY. THE PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. THERE WAS NO REPORTED BREAKAGE OF A DEVICE OR SURGICAL DELAY/PROLONGATION.

  Patient problems: Failure of Implant; Joint Dislocation

  MAUDE report 17393924 ↗
• InjuryJul 14, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED, THE PATIENT HAD AN INITIAL RIGHT TSA ON (B)(6) 2016. THE PATIENT PRESENTED WITH SWELLING AND PAIN IN THEIR RIGHT SHOULDER. THE SURGEON OPENED THE SHOULDER AND FOUND FRANK PUS IN JOINT. THE GLENOSPHERE, TRAY AND LINER WERE REMOVED, BUT COULD NOT GET THE STEM OUT. DECISION TO PERFORM DAIR PROCEDURE MADE. 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: Failure of Implant; Pain; Purulent Discharge; Swelling/ Edema; Unspecified Infection

  MAUDE report 17330010 ↗
• InjuryJul 13, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated

  AS REPORTED, THE PATIENT HAD AN INITIAL LEFT TSA ON (B)(6) 2018. THE PATIENT WAS REVISED ON (B)(6) 2023 DUE TO REPEAT DISLOCATIONS. NEW REVERSE COMPONENTS WERE 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. NO OTHER PATIENT INFORMATION/MEDICAL HISTORY REPORTED.

  Patient problems: Failure of Implant; Joint Dislocation

  MAUDE report 17322286 ↗
• InjuryJul 6, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED, THE PATIENT HAD AN INITIAL LEFT TSA ON (B)(6) 2022. THE PATIENT WAS REVISED ON (B)(6) 2023, DUE TO PERIPROSTHETIC JOINT INFECTION. A CEMENT SPACER WAS INSERTED TO TREAT THE INFECTION. THERE WAS NO REPORTED BREAKAGE OF DEVICE OR 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: Failure of Implant; Medical device site infection

  MAUDE report 17265636 ↗
• InjuryJun 29, 2023Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED VIA CLINICAL STUDY THAT THE 60 YO MALE PATIENT ASEPTIC GLENOID LOOSENING. LOOSE RTSA BASEPLATE IN PREVIOUSLY REVISION FROM TSA. NO MOI NOTED. THE DATE OF EVENT ONSET IS (B)(6) 2022. THE PATIENT WAS REVISED ON (B)(6) 2023. THE OUTCOME WAS LAST KNOWN AS RESOLVED.

  Patient problems: Aseptic loosening; Joint Laxity

  MAUDE report 17233753 ↗
• InjuryJun 19, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED, THE PATIENT HAD AN INITIAL RIGHT TSA ON (B)(6) 2023. THE PATIENT DEVELOPED A PROSTHETIC JOINT INFECTION AND WAS REVISED ON (B)(6) 2023. EVERYTHING WAS REMOVED TO TREAT THE INFECTION. 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: Failure of Implant; Medical device site infection

  MAUDE report 17159846 ↗
• InjuryJun 19, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED, THE PATIENT HAD AN INITIAL LEFT TSA ON (B)(6) 2023. THE PATIENT PRESENTED WITH SYSTEMIC SEPSIS SECONDARY TO ANKLE WOUND. CRP WAS HIGH SO THE SHOULDER WAS SCANNED AND SHOWED POSSIBLE INFECTION. THE PATIENT WAS REVISED ON (B)(6) 2023. THE LINER, ADAPTER TRAY AND GLENOSPHERE WERE REMOVED AND REPLACED. 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: Failure of Implant; Unspecified Infection

  MAUDE report 17159835 ↗

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-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-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-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-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-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-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.