Equinoxe 320-42-13Recalls & reported problems

Summary

The FDA's MAUDE database contains 41 adverse event reports that list this exact device (DI 10885862086723), received between Jul 3, 2019 and Jan 8, 2026 — classified as 41 injuries.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (19 reports).

2 FDA recall records name this device's identifier, 2 still open.

11 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.

Recalls naming this device

1. Mar 6, 2024Open, Classified

   The packaging of these affected UHMWPE humeral liners and glenoids are nonconforming as they do not meet the established packaging specification. They were packaged in vacuum bags that did not contain an additional oxygen barrier layer consisting of Ethylene Vinyl Alcohol (EVOH).

   Z-1423-2024 · Root cause: Nonconforming Material/Component · FDA record ↗

2. Nov 21, 2023Open, Classified

   Exactech has received 3 complaints for 4 devices related to a loss of vacuum in the inner-most vacuum bag.

   Z-0579-2024 · Root cause: Packaging change control · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 41 reports, in the reporter's own words as published by the FDA.

• InjuryJan 8, 2026Naturally Worn

  IT WAS REPORTED THAT A MALE PATIENT, HAD AN INITIAL RIGHT SHOULDER IMPLANTED AND THEN UNDERWENT A REVISION PROCEDURE, APPROXIMATELY 1 YEAR 8 MONTHS POST THE INITIAL PROCEDURE. THE REPORT INDICATED THE GLENOID WAS LOOSE AND INFECTION WAS SUSPECTED. THE PATIENT WAS REVISED TO A 300-10-15 EQUINOXE REPLICATOR PLATE 1.5MM O/S, 300-20-02 EQUINOXE SQUARE TORQUE DEFINE SCREW, AND 310-03-53 EQUINOXE HUMERAL HEAD EXPANDED 53MM. THERE WERE NO DEVICE BREAKAGES OR SURGICAL DELAYS DURING THE PROCEDURE. NO X RAYS OR PATIENT HISTORY WAS ABLE TO BE OBTAINED. THE PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. NO DEVICES ARE RETURNING FOR ANALYSIS DUE TO THE HOSPITAL POLICY. DEVICE IMAGES WERE PROVIDED. NO FURTHER INFORMATION.

  Patient problems: Unspecified Infection

  MAUDE report 24003671 ↗
• InjuryDec 15, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORT THAT MALE PATIENT WHO HAD A RIGHT RTSA THAT WAS REVISED DUE TO A FALL, UNDERWENT A SECOND REVISION APPROXIMATELY 2 MONTHS POST THE PRIOR REVISION. A CONSTRAINED LINER WAS PUT IN DUE TO UNAVAILABILITY OF STANDARD 42MM LINER (INTERNATIONAL RECALL) DURING THE PRIOR PROCEDURE. A COUPLE MONTHS LATER, THE CONSTRAINED LINER DISENGAGED FROM THE HUMERAL TRAY WHILE THE PATIENT WAS PERFORMING DAILY ACTIVITY. THERE WERE NO DEVICE BREAKAGES OR SURGICAL DELAYS DURING THE PROCEDURE. THE PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. X-RAY IMAGES WERE PROVIDED. THE EXPLANTED DEVICES ARE NOT AVAILABLE FOR RETURN AS THEY WERE DISCARDED. NO DEVICE IMAGES PROVIDED. NO FURTHER INFORMATION.

  Patient problems: Insufficient Information; Joint Dislocation

  MAUDE report 23812663 ↗
• InjuryNov 17, 2025Fracture; Detachment of Device or Device Component; Fracture; Detachment of Device or Device Component

  IT WAS REPORTED THAT A 67 YO MALE PATIENT WHO HAD AN INITIAL RIGHT TSA IMPLANTED, UNDERWENT A REVISION PROCEDURE APPROXIMATELY 4 YEARS 10 MONTHS POST THE INITIAL PROCEDURE. THE PATIENT WAS INDICATED FOR SURGERY DUE TO ¿CLUNKING¿ FEELING IN SHOULDER, FOLLOWED BY LOSS OF FUNCTION. X-RAY REVEALED THAT THE GLENOSPHERE LOCKING SCREW HAD DISENGAGED FROM THE GLENOSPHERE, WHICH WAS STILL SEATED CORRECTLY ON THE BASEPLATE, AND WAS FLOATING IN THE JOINT SPACE. THE POLYETHYLENE LINER WAS NOT VISIBLE BETWEEN THE HUMERAL ADAPTOR TRAY AND GLENOSPHERE, WHICH WERE IN CONTACT, SUGGESTING IT HAS DISASSOCIATED FROM THE HUMERAL ADAPTOR TRAY. DURING SURGERY, SIGNIFICANT METALOSIS OF SURROUNDING SOFT TISSUE WAS NOTED. GLENOSPHERE SCREW WAS REMOVED FROM THE JOINT SPACE, AND POLYETHYLENE LINER WAS CONFIRMED TO HAVE DISASSOCIATED FROM THE HUMERAL ADAPTOR TRAY, WHICH WAS DAMAGED DUE TO CONTACT WITH THE GLENOSPHERE. POLYETHYLENE LINER WAS SEVERELY DAMAGED DUE TO CONTACT WITH THE GLENOSPHERE LOCKING SCREW. ALL AFFECTED IMPLANTS, (LINER, ADAPTOR TRAY, GLENOSPHERE AND SCREW) WHERE REPLACED LIKE FOR LIKE. THERE WAS DEVICE BREAKAGE DURING THE PROCEDURE, PARTS AND PIECED DID FALL INTO THE WOUND SITE BUT WERE REMOV

  Patient problems: Crepitus; Metal Related Pathology

  MAUDE report 23576862 ↗
• InjuryNov 3, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT A 69 YO MALE PATIENT WHO HAD A RIGHT RTSA, UNDERWENT A REVISION PROCEDURE APPROXIMATELY 2 YEARS 8 MONTHS POST THE PRIOR PROCEDURE. THE POLY LINER DISSOCIATED FROM THE TRAY WAS REPORTED. THE GLENOSPHERE, LINER, AND TRAY WERE REVISED. THERE WAS DEVICE BREAKAGE REPORTED BUT NO PARTS OR PIECES FELL INTO THE WOUND SITE. THE DISSOCIATED TRAY WAS REMOVED. THERE WERE NO SURGICAL DELAYS REPORTED. THE PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. NO X-RAYS WERE ABLE TO BE OBTAINED. THE EXPLANTED DEVICES ARE NOT AVAILABLE FOR RETURN AS THEY WERE DISCARDED. NO PHOTOS WERE ABLE TO BE OBTAINED. AN EARLIER REVISION HAD OCCURRED TO ADDRESS INSTABILITY. NO FURTHER INFORMATION. THIS IS 1 OF 2 REPORTS FOR THIS EVENT, THIS IS 1 OF 2 EVENTS FOR THIS PATIENT.

  Patient problems: Insufficient Information

  MAUDE report 23459349 ↗
• 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 21920870 ↗
• InjuryApr 25, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  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 21914489 ↗
• InjuryFeb 18, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A 66-YEAR-OLD MALE PATIENT, INITIAL RIGHT SHOULDER IMPLANTED IN (B)(6) 2023, UNDERWENT A REVISION PROCEDURE IN (B)(6) 2025, APPROXIMATELY 1 YEAR 2 MONTHS POST THE INITIAL PROCEDURE. THE PATIENT COMPLAINED OF PAIN. IMPLANT FAIL. THE SURGEON IS SENDING THE EXPLANTS BACK FOR ANALYSIS. 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. THE EXPLANT IS AVAILABLE FOR RETURN. NO DEVICE IMAGES WERE PROVIDED. NO FURTHER INFORMATION.

  Patient problems: Pain

  MAUDE report 21401607 ↗
• InjuryFeb 18, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT A 64 YO MALE PATIENT, WHOSE LEFT SHOULDER WAS INITIALLY IMPLANTED IN (B)(6) 2024, AND WHO WAS REVISED IN (B)(6) 2024, DUE TO THE SHOULDER DISLOCATING, UNDERWENT A SECOND REVISION ON (B)(6) 2025. THE PATIENT PRESENTED WITH COMPONENT DISSOCIATION. THE SURGEON EXTRACTED AND CHANGED THE HUMERAL LINER. 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 AVAILABLE. THE EXPLANTED PRODUCT IS NOT AVAILABLE FOR RETURN. IT WAS DISPOSED OF BY THE CUSTOMER. NO DEVICE IMAGES WERE AVAILABLE. NO FURTHER INFORMATION. SEPTEMBER REVISION REPORTED UNDER MDR# 1038671-2024-03725.

  Patient problems: Insufficient Information; Joint Dislocation

  MAUDE report 21398743 ↗
• InjuryDec 2, 2024Unstable; Detachment of Device or Device Component; Device Dislodged or Dislocated; Naturally Worn; Unstable; Detachment of Device or Device Component; Device Dislodged or Dislocated; Naturally Worn

  AS REPORTED, APPROXIMATELY 3 YEARS AND 1 MONTHS FOLLOWING A REVISION OF THE RIGHT TOTAL SHOULDER ARTHROPLASTY (TSA), ANOTHER REVISION SURGERY WAS PERFORMED DUE TO DISLOCATION. THE PATIENT'S SHOULDER AT SOME POINT BECAME UNSTABLE AGAIN AND DISLOCATED. DURING THE REVISION SURGERY, THE LINER WAS FOUND TO HAVE DISSOCIATED FROM THE TRAY AND WAS NO LONGER BETWEEN THE TRAY AND SPHERE. METALLOSIS IN THE TISSUE WAS OBSERVED, AS WELL AS WEAR ON THE LINER, TRAY AND SPHERE. THE GLENOSPHERE, LOCKING SCREW, LINER, REVERSE TORQUE SCREW, AND TRAY WERE SWAPPED OUT AND THE PATIENT WAS UPSIZED TO A 46 EXPANDED GLENOSPHERE, 0MM 46MM CONSTRAINED LINER AND 5MM TRAY. THE EVENT WAS NOT RELATED TO THE BREAKAGE OF A DEVICE. THE EVENT LEAD TO A SURGICAL DELAY/PROLONGATION OF APPROXIMATELY 30-45 MINUTES. THE DELAY/PROLONGATION WAS IN REFERENCE TO THE NEED FOR REVISION SURGERY DUE TO DISLOCATION OF THE PROSTHESIS AND DISSOCIATION OF THE POLY. THERE WAS AN ADVERSE EVENT OF METAL ON METAL WEAR OF THE GLENOSPHERE AND TRAY AND THE ASSOCIATED METALLOSIS. THE PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT.

  Patient problems: Joint Dislocation; Joint Laxity; Metal Related Pathology

  MAUDE report 20823700 ↗
• InjuryOct 19, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  APPROXIMATELY 2 YEAR(S), 2 MONTH(S) AND 16 DAY(S) POST-OPERATIVE OF A REVISED LEFT RTSA, IT WAS REPORTED VIA CLINICAL STUDY THAT THE PATIENT EXPERIENCED ANOTHER DISASSOCIATION OF POLYETHYLENE. ADDITIONAL NOTES INDICATE PATIENT FELL AND DISASSOCIATED POLY. IN AN EARLIER REPORTED EVENT ((B)(4)), THE PATIENT EXPERIENCED DISASSOCIATION OF POLYETHYLENE RESULTING FROM A FALL THAT WAS RESOLVED BY REVISION. THE PATIENT UNDERWENT A STANDARD REVERSE WITH PRESERVE STEM REVISION WITH THE REPORTED REMOVAL OF THE HUMERAL LINER, GLENOSPHERE, AND GLENOSPHERE LOCKING SCREW. THE OUTCOME OF THIS EVENT IS CONSIDERED RESOLVED AND THE CLINICAL REPORT INDICATES THAT THIS EVENT IS DEFINITELY RELATED TO THE DEVICE(S) AND/OR TO THE PROCEDURE.

  Patient problems: Insufficient Information

  MAUDE report 20489174 ↗
• InjurySep 27, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  AS REPORTED, APPROXIMATELY 5 MONTHS AND 9 DAYS POST THE INITIAL LEFT TSA, THE PATIENT DISLOCATED HER SHOULDER AND 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.

  Patient problems: Joint Dislocation

  MAUDE report 20319337 ↗
• InjurySep 7, 2024Detachment of Device or Device Component; Device Dislodged or Dislocated; Naturally Worn; Detachment of Device or Device Component; Device Dislodged or Dislocated; Naturally Worn

  IT WAS REPORTED THAT A MALE PATIENT, PREVIOUS RIGHT SHOULDER IMPLANTED IN (B)(6) 2023, UNDERWENT A REVISION PROCEDURE IN (B)(6) 2024, APPROXIMATELY 1 YEAR 8 MONTHS POST THE PAST PROCEDURE. THE PATIENT CAME BACK WITH ANOTHER DISLOCATION FROM A PREVIOUS RTSA. HE SAID HE WAS CHANGING A TIRE ON A TRACTOR AND PUSHING VERY HARD, WHEN HIS SHOULDER POPPED OUT. THE SURGEON BELIEVED THE POLY DISASSOCIATED AND VIEWED IMAGING WITH THE REP. THE TRAY WAS ARTICULATING WITH THE SPHERE SO IT WAS BELIEVED THIS TO BE THE CASE. DURING THE PROCEDURE, UPON EXPOSURE, THE POLY WAS DISASSOCIATED AND LIVED POSTERIOR TO THE HUMERUS. IT WAS REMOVED. THE TRAY HAD WEAR AND METALLOSIS WAS PRESENT. IT WAS RECOMMENDED THAT BOTH THE TRAY AND SPHERE BE EXCHANGED, BUT THE SURGEON DID NOT WANT TO EXCHANGE THE SPHERE DUE TO FEAR OF "DOING TOO MUCH". THE REP RECOMMENDED TO FEEL THE SPHERE AND MAKE SURE THERE WERE NO SHARP, WORN, ETC SURFACES THAT WOULD COMPROMISE A NEW POLY AND CAUSE ANY FURTHER WEAR. THE SURGEON SAID IT FELT SMOOTH AND FINE TO HIM, AND HE DID NOT EXCHANGE THE SPHERE EVEN AFTER RECOMMENDATION. THE TRAY WAS EXCHANGED, UPSIZED, AND IMPLANTED WITH A NEW POLY. THERE WAS BREAKAGE OF DEVICE REPORTED, BUT NO P

  Patient problems: Joint Dislocation; Metal Related Pathology

  MAUDE report 20164959 ↗
• InjurySep 3, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  APPROXIMATELY 1 YEAR(S), 8 MONTH(S) AND 29 DAY(S) POST-OPERATIVE OF A LEFT TSA, IT WAS REPORTED VIA CLINICAL STUDY THAT THE PATIENT EXPERIENCED DISASSOCIATION OF POLYETHYLENE. POLY POPPED OUT WITHOUT REAL TRAUMA. DECREASING MOTION OVER LAST SEVERAL MONTHS. THE PATIENT UNDERWENT A STANDARD REVERSE REVISION, AND THE OUTCOME OF THIS EVENT IS CONSIDERED RESOLVED. THE CLINICAL REPORT INDICATES THAT THIS EVENT IS DEFINITELY RELATED TO THE DEVICE(S) AND POSSIBLY RELATED TO THE PROCEDURE.

  Patient problems: Loss of Range of Motion

  MAUDE report 20130951 ↗
• InjuryAug 22, 2024Detachment of Device or Device Component; Adverse Event Without Identified Device or Use Problem; Detachment of Device or Device Component; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN INITIAL TOTAL SHOULDER REPLACEMENT ON THE LEFT SIDE WITH EXACTECH DEVICES. SUBSEQUENTLY, THE PATIENT PRESENTED WITH DISASSOCIATION OF OTHER COMPONENT. PATIENT SUFFERED ACUTE INJURY IN LATE 2019. AS A RESULT, APPROXIMATELY 3 MONTH(S) AFTER INITIAL IMPLANTATION, 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 UNLIKELY RELATED TO THE PROCEDURE. NO FURTHER IMPACT TO THE PATIENT WAS REPORTED. NO OTHER INFORMATION IS AVAILABLE.

  Patient problems: Insufficient Information; Muscle/Tendon Damage; Unspecified Tissue Injury

  MAUDE report 20034945 ↗
• InjuryJun 27, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  AS REPORTED, APPROXIMATELY 8 MONTHS AND 8 DAYS POST A PREVIOUS REVISION, THE PATIENT WAS REVISED AGAIN DUE TO HUMERAL LINER DISSOCIATION. THE PATIENT WAS USING AN ANGLE GRINDER WHEN THE LINER DISSOCIATED. THE GLENOSPHERE, LINER, ADAPTER TRAY, SCREW KIT AND LOCKING SCREW WERE REVISED. 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. PREVIOUS REVISION REPORTED UNDER 1038671-2023-02616.

  Patient problems: Joint Dislocation

  MAUDE report 19623711 ↗
• InjuryApr 22, 2024Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT A 81 YO MALE PATIENT, INITIAL LEFT SHOULDER IMPLANTED ON (B)(6) 2022, UNDERWENT A REVISION PROCEDURE ON (B)(6) 2024, APPROXIMATELY 1 YEAR 5 MONTHS POST THE INITIAL PROCEDURE. THE PATIENT PRESENTED WITH COMPLAINTS OF PAIN. BAD POLY INDICATED. THE POLY WAS REPLACED. THERE WERE NO DEVICE BREAKAGES OR SURGICAL DELAYS DURING THE PROCEDURE. NO X-RAYS WERE PROVIDED. THE PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. THE EXPLANTED DEVICE IS NOT AVAILABLE FOR RETURN. CHAIN OF COMMAND, DUE TO THE RECALL THE HOSPITAL WILL NOT RELEASE IT. A DEVICE IMAGE WAS PROVIDED. NO FURTHER INFORMATION. NO OTHER PATIENT INFORMATION/MEDICAL HISTORY REPORTED.

  Patient problems: Failure of Implant; Pain

  MAUDE report 19153302 ↗
• InjuryApr 4, 2024Detachment of Device or Device Component; Device Dislodged or Dislocated; Detachment of Device or Device Component; Device Dislodged or Dislocated

  AS REPORTED BY THE EQUINOXE SHOULDER STUDY, THE 69-YEAR-OLD WHITE MALE PATIENT HAD A RIGHT TSA ON (B)(6) 2020. THE PATIENT PRESENTED WITH DISASSOCIATION OF POLYETHYLENE ON (B)(6)2023. PATIENT REPORTED PULLING ON A 4-WHEELER CABLE AND INJURED SHOULDER. THIS EVENT IS RELATED TO (B)(4). THE OUTCOME OF THIS EVENT IS CONSIDERED RESOLVED BY THE ACTION OF REVISION ON (B)(6) 2023. 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: Failure of Implant; Insufficient Information

  MAUDE report 19048182 ↗
• InjuryApr 4, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  STUDY: EQUINOXE SHOULDER STUDY. SUBJECT: (B)(4). RELATED TO: CASE: (B)(4). IMPLANT DATE: ON (B)(6) 2020. EX-PLANT DATE: ON (B)(6) 2020. DATE OF EVENT ONSET: 08-05-2020. ADVERSE EVENT NAME : SUPERFICIAL INFECTION. SERIOUS ADVERSE EVENT? YES. AE RELATED TO DEVICE? DEFINITELY NOT RELATED. AE RELATED TO PROCEDURE? POSSIBLY RELATED. ACTION TAKEN: REVISION - STANDARD REVERSE W-PRESERVE STEM, OTHER - IRRIGATION AND DEBRIDEMENT SCHEDULED FOR ON (B)(6) 2020. REVISION DATE: ON (B)(6) 2020. OUTCOME: RESOLVED. P/N: 320-42-13. DEVICE NAME: EQUINOXE REVERSE 42MM HUMERAL CONST LINER +2.5. S/N: (B)(6) CONFIRMED TO HAVE BEEN PACKAGED IN A VACUUM BAG THAT DOES NOT CONTAIN EVOH. 510K: K063569. UDI: (B)(4). PRODUCT CODE: KWT. CONCOMITANTS: 320-02-42 - RS EXPANDED GLENOSPHERE 42MM, +4MM OFFSET: 6528876. 320-10-05 - EQUINOXE REVERSE TRAY ADAPTER PLATE TRAY +5: 6429883. 320-15-05 - EQ REV LOCKING SCREW : 6520143. 320-20-00 - EQ REVERSE TORQUE DEFINING SCREW KIT: 6486713. 321-20-00 - EQUINOXE REVERSE SHOULDER DRILL KIT: 6525408. 69-YEAR-OLD WHITE MALE. HEIGHT: 72 IN. BMI: 30. PREVIOUS SURGERY ON INVOLVED SHOULDER? YES - 1999- OPEN ROTATOR CUFF REPAIR, ON (B)(6) 2018- REVERSE SHOULDER ARTHROPLASTY. DIAGNOS

  Patient problems: Bacterial Infection; Medical device site infection

  MAUDE report 19048164 ↗
• InjuryApr 1, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED, THE 78 Y/O MALE PATIENT HAD A REVISION DUE TO RTSA WAS UNSTABLE AND ANTERIORLY DISLOCATED WITHIN 1 WEEK POST OP. PATIENT WAS REVISED TRAY/LINER/TORQUE SCREW TO HAT, A NEW LINER, NEW TORQUE SCREW. THERE WAS NO BREAKAGE OF THE DEVICE OR SURGICAL DELAY/PROLONGATION. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. IMAGES AND X-RAYS RECEIVED. THE DEVICES ARE NOT AVAILABLE FOR EVALUATION DUE TO HOSPITAL WOULD NOT DECONTAMINATE. NO ADDITIONAL PATIENT/MEDICAL INFORMATION PROVIDED.

  Patient problems: Joint Dislocation

  MAUDE report 19010607 ↗
• InjuryMar 6, 2024Detachment of Device or Device Component; Device Dislodged or Dislocated; Detachment of Device or Device Component; Device Dislodged or Dislocated

  AS REPORTED BY THE EQUINOXE SHOULDER STUDY, THE PATIENT HAD A LEFT TSA ON (B)(6) 2018 AND PRESENTED WITH DISASSOCIATION OF POLYETHYLENE, ON (B)(6) 2024. PATIENT DISLOCATED HIS REVERSE AND DISASSOCIATED HIS POLY COMPONENT GETTING OFF THE FLOOR. THE OUTCOME OF THIS EVENT IS CONSIDERED RESOLVED ON 1/17/2024. THE ACTION TAKEN WAS REVISION ON (B)(6) 2024 WITH THE REMOVAL OF THE TORQUE SCREW, HUMERAL TRAY, HUMERAL LINER, GLENOSPHERE, GLENOSPHERE LOCKING SCREW. 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: Failure of Implant; Joint Dislocation

  MAUDE report 18852012 ↗
• InjuryNov 10, 2023Detachment of Device or Device Component; Device Dislodged or Dislocated; Detachment of Device or Device Component; Device Dislodged or Dislocated

  AS REPORTED, THE PATIENT HAD AN INITIAL RIGHT TSA ON (B)(6) 2020. THE PATIENT PRESENTED ON (B)(6) 2023 AND PATIENT REACHED OUR IN HORIZONTAL ADDUCTED POSITION AND FELT "POP" WITH PAIN. THE PATIENT WAS REVISED ON (B)(6) 2023. THE CASE REPORT FORM INDICATES THAT THIS EVENT IS POSSIBLY RELATED TO DEVICE, DEFINITELY NOT RELATED TO PROCEDURE. OUTCOME: RESOLVED ON (B)(6) 2023.

  Patient problems: Failure of Implant; Pain

  MAUDE report 18109654 ↗
• InjuryJun 28, 2023Unstable; Detachment of Device or Device Component; Naturally Worn; Unstable; Detachment of Device or Device Component; Naturally Worn

  AS REPORTED, ON (B)(6) SURGEON BROUGHT A MALE PATIENT AGED 63 BACK FOR A REVISION SURGERY. THE INDEX PROCEDURE WAS DONE SOMETIME IN 2018. THE PATIENT PRESENTED WITH PAIN AND FEELING UNSTABLE. THE 42MM 2.5MM CONSTRAINED IMPLANT WAS DISENGAGED AND FLOATING LOOSELY IN THE JOINT. SALES REP WAS UNABLE TO GET A SERIAL NUMBER. SURGEON ALSO REMOVED THE 0MM TRAY. THE TRAY WAS REPLACED WITH A 5MM TRAY AND THE LINER WAS REPLACED WITH A +0 CONSTRAINED LINER. THE PATIENT APPEAR TO DO WELL WITH THE SURGERY. IMAGE RECEIVED. THE DEVICES ARE NOT AVAILABLE FOR EVALUATION.

  Patient problems: Failure of Implant; Joint Laxity; Pain

  MAUDE report 17216363 ↗
• InjuryMay 15, 2023Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT A FEMALE PATIENT, INITIAL RIGHT SHOULDER IMPLANTED ON (B)(6) 2021, UNDERWENT A REVISION PROCEDURE ON (B)(6) 2023, APPROXIMATELY 1 YEAR 11 MONTHS POST THE INITIAL PROCEDURE. THE PATIENT COMPLAINED OF PAIN. INFECTION AND POLY WEAR WERE REPORTED. THEY WERE REVISED TO A COMPETITOR¿S DEVICES. THERE WAS NO DEVICE BREAKAGE OR SURGICAL DELAYS. THE PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. NO X-RAY WERE AVAILABLE. NO DEVICE IMAGES WERE PROVIDED. THE EXPLANTED DEVICES ARE NOT AVAILABLE FOR RETURN DUE TO CHAIN OF COMMAND. HOSPITAL WILL NOT RELEASE THEM. NO FURTHER INFORMATION.

  Patient problems: Pain; Unspecified Infection

  MAUDE report 16935348 ↗
• InjuryFeb 15, 2023Detachment of Device or Device Component; Device Dislodged or Dislocated; Detachment of Device or Device Component; Device Dislodged or Dislocated

  AS REPORTED, APPROXIMATELY 10 MONTHS POST OP THE INITIAL LEFT TSA, THIS 64 Y/O MALE PATIENT WAS REVISED DUE TO THE HUMERAL POLY DISSOCIATING FROM HUMERAL TRAY.

  Patient problems: Failure of Implant; Insufficient Information

  MAUDE report 16379051 ↗
• InjuryMay 24, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  BETWEEN REVISION ON 4/13 AND 4/26, PATIENT HAD REVERSE SHOULDER SURGERY ON (B)(6) 2022. ON (B)(6) 2022, PATIENT HAD REVISION DUE TO AN INFECTION AT THE WOUND SITE. HUMERAL LINER WAS UPSIZED TO A 42MM +2.5 CONSTRAINED. AN EXPERIENCE REPORT WAS SUBMITTED ON (B)(6) 2022. ON (B)(6) 2022 PATIENT HAD ANOTHER REVISION DUE TO SUSPECTED INFECTION. SURGEON EXCHANGED STEM, GLENOSPHERE, ADAPTER PLATE TRAY AND HUMERAL LINER. FIRST REVISION IS CAPTURED IN (B)(6) / MDR# 1038671-2022-00525.

  Patient problems: Bacterial Infection

  MAUDE report 14491062 ↗

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-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-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-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-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.