Equinoxe 320-38-00Recalls & reported problems

Summary

The FDA's MAUDE database contains 107 adverse event reports that list this exact device (DI 10885862086655), received between Apr 3, 2019 and Sep 30, 2026 — classified as 107 injuries.

The most frequently reported specific device problem is “Naturally Worn” (28 reports).

3 FDA recall records name this device's identifier, 3 still open.

10 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.

Recalls naming this device

1. Aug 15, 2025Open, Classified

   Reverse Shoulder humeral liners have an articular surface position outside of the dimensional specification within the labeling.

   Z-2561-2025 · Root cause: Process design · Recall details · FDA record ↗

2. 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-1418-2024 · Root cause: Nonconforming Material/Component · Recall details · FDA record ↗

3. 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 · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 107 reports, in the reporter's own words as published by the FDA.

• InjurySep 30, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that the patient underwent a left shoulder replacement. Subsequently, the patient experienced swelling and pain at the surgical site and was revised due to a suspected infection. The patient had been treated for recurrent UTIs and was receiving antibiotic therapy. Revision surgery was performed and included irrigation and debridement, collection of tissue samples/biopsies, and replacement of the polyethylene component. The patient was last known to be in stable condition following the event.

  Patient problems: Pain; Swelling/ Edema; Unspecified Infection

  MAUDE report 50950396 ↗
• InjurySep 23, 2026Detachment of Device or Device Component

  Report #2 of 2.It was reported this patient had a right reverse total shoulder arthroplasty. Subsequently, eight (8) years, nine (9) months later, the patient underwent a revision procedure for an unknown reason. Intraoperatively, the surgeon observed a fractured humeral tray and the humeral liner disassociated from the humeral tray. Additionally, it was reported the patient admitted to no wrongdoing in rehab or exercise to cause this damage. The Patient was last known to be in stable condition following the event. No additional information is available.

  Patient problems: Insufficient Information

  MAUDE report 50869846 ↗
• InjuryJun 12, 2026Naturally Worn

  IT WAS REPORTED THAT THIS PATIENT PRESENTED TO SURGEON WITH A PAINFUL SHOULDER AND DECREASED FUNCTION FOLLOWING A RIGHT SHOULDER REPLACEMENT. THE PRE-OP IMAGING AND ASSESSMENT SHOWED WHAT APPEARS TO BE A LOOSE HUMERAL COMPONENT AND INFERIOR SCAPULAR NOTCHING ON THE GLENOID, WITH SOME BONE CHANGES/RESORPTION ON BOTH THE HUMERUS AND GLENOID. IT WAS SUSPECTED THAT THE GLENOID COMPONENT MAY BE LOOSE AS WELL. THE PATIENT WAS SCHEDULED FOR A REVISION REVERSE TOTAL SHOULDER ARTHROPLASTY WITH HUMERAL EXCHANGE AND POSSIBLE GLENOID / COMPLETE REVISION. DURING THE PROCEDURE, IT WAS CONFIRMED THAT THE HUMERAL STEM AND COMPONENT WERE LOOSE AND NOT WELL FIXED IN THE BONE. THE SURGEON WAS ABLE TO PULL THE CONSTRUCT OUT BY HAND NOT NEEDING EXTRACTION TOOLS. THERE WAS NO BONE GROWTH ONTO THE HUMERAL STEM. THE GLENOID BASEPLATE WAS ASSESSED AND SHOWED/PRESENTED TO BE WELL FIXED AFTER TESTING IT WITH A SLAP HAMMER AND LEVERAGE BAR. THE SURGEON DEBRIDED AND IRRIGATED THE SHOULDER JOINT AND KEPT THE WELL-FIXED BASEPLATE IN. A 38MM +4 LATERALIZED GLENOSPHERE WAS REPLACED TO HELP PUSH THE HUMERUS AWAY FROM THE INFERIOR GLENOID BONE, ALONG WITH A NEW HUMERAL STEM THAT WAS CEMENTED INTO THE HUMERAL CANAL A

  Patient problems: Bone Notching; Pain

  MAUDE report 25485768 ↗
• InjuryJan 13, 2026Insufficient Device Problem Information

  AS REPORTED BY THE EQUINOXE SHOULDER STUDY, APPROXIMATELY 4 YEAR(S) AND 9 MONTH(S) POST IMPLANTATION OF A RIGHT TSA, THE PATIENT PRESENTED WITH INFECTION. THE PATIENT HAD RTSA WITH LOOSE GLENOSPHERE + METAGLENE COMPONENT WITHOUT BROKEN HARDWARE AND SCAPULAR NOTCHING. PLAN FOR REVISION WITH ANTIBIOTIC SPACER. THE PATIENT UNDERWENT A STANDARD REVERSE REVISION IN EARLY 2019 FOLLOWED WITH ANTIBIOTIC SPACER PROCEDURE LATER THAT YEAR. IMPLANTATION OF ANTIBIOTIC DELIVERY SYSTEM DUE TO POSITIVE MRSA SCREEN. PATIENT HAS CLEARED INFECTION AND DESIRES CONVERSION BACK TO A REVERSE TSA. THE CLINICAL REPORT INDICATES THAT THE EVENT IS DEFINITELY RELATED TO THE DEVICE(S) AND UNLIKELY RELATED TO THE PROCEDURE.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Arthritis; Bone Notching; Failure of Implant; Unspecified Infection

  MAUDE report 24055643 ↗
• InjuryDec 3, 2025Naturally Worn; Naturally Worn

  AS REPORTED, APPROXIMATELY 6 YEARS AND 5 MONTHS POST THE INITIAL LEFT REVERSE TOTAL SHOULDER ARTHROPLASTY, THE PATIENT PRESENTED WITH EFFUSION FOLLOWING A FRACTURED SCAPULA SPINE OPEN REDUCTION AND INTERNAL FIXATION AND MULTIPLE DISLOCATIONS. THE JOINT WAS OPENED AND FRANK PUS WAS OBSERVED BEHIND THE GLENOSPHERE. ALL COMPONENTS WERE REMOVED AND A CEMENT SPACER WAS 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: Joint Dislocation; Joint effusion; Medical device site infection

  MAUDE report 23708123 ↗
• InjuryNov 7, 2025Naturally Worn; Naturally Worn

  AS REPORTED, APPROXIMATELY 2 MONTHS AND 15 DAYS POST THE INITIAL RIGHT REVERSE TOTAL SHOULDER ARTHROPLASTY, THE PATIENT WAS REVISED. IT APPEARED THE GLENOSPHERE HAD LOOSENED/NOT BEEN IMPLANTED PROPERLY. WEAR EVIDENCES WERE SHOWN ON THE LINER AND HUMERUS. EVERYTHING WAS REMOVED AND A NEW REVERSE SHOULDER WAS 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: Erosion; Insufficient Information

  MAUDE report 23500958 ↗
• InjuryNov 6, 2025Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN INITIAL TSA (TOTAL SHOULDER ARTHROPLASTY) ON THE RIGHT SIDE. SUBSEQUENTLY, THE PATIENT EXPERIENCED PAIN. AS A RESULT, THE PATIENT WAS REVISED FOR LUCENCY OF THE STEM AND INFECTION. ONCE PARTS WERE REMOVED DURING THE CASE, IT APPEARED THE LIP OF THE POLY HAD BEEN FLATTENED DOWN AND ERODED AWAY. REVERSE SHOULDER COMPONENTS WERE REMOVED, AND AN ANTIBIOTIC SPACER WAS RE IMPLANTED. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT.

  Patient problems: Pain; Radiolucent Lines; Unspecified Infection

  MAUDE report 23488267 ↗
• InjurySep 9, 2025Mechanical Problem; Device Dislodged or Dislocated; Naturally Worn; Mechanical Problem; Device Dislodged or Dislocated; Naturally Worn

  IT WAS REPORTED A PATIENT UNDERWENT AN INITIAL RIGHT REVERSE TOTAL SHOULDER ARTHROPLASTY. SUBSEQUENTLY, ON AN UNKNOWN DATE AND YEAR LATER, THE PATIENT EXPERIENCED PAIN, DISCOMFORT AND DECREASED MOTION. RADIOGRAPHS WERE TAKEN THAT INDICATED POTENTIAL LOOSENING OF COMPONENTS AND INFERIOR SCAPULAR NOTCHING. AT AN UNKNOWN DATE AND YEAR AFTER THE RADIOGRAPH ASSESSMENT, THE PATIENT RETURNED TO THE SURGEON'S OFFICE WITH A RIGHT SHOULDER DISLOCATION. AS A RESULT, THE PATIENT UNDERWENT A RIGHT SHOULDER REVISION PROCEDURE TEN (10) YEARS, FIVE (5) MONTHS AFTER INITIAL IMPLANT. INTRAOPERATIVELY, THE SURGEON OBSERVED METALOSIS, COMPONENT LOOSENING OF THE GLENOID SIDE, CONSTRUCT DISLOCATION AND OSTEOLYSIS. CULTURES WERE TAKEN INTRAOPERATIVELY WITH NEGATIVE FOR INFECTION RESULTS. ALL DEVICES WERE EXPLANTED. THE PATIENT WAS REVISED TO BONE GRAFTING AND AN ANTIBIOTIC SPACER. NO SURGICAL OR MEDICAL INTERVENTIONS WERE REPORTED. THE PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. IT WAS NOTED THE PATIENT'S POST-OPERATIVE PLAN WAS TO RETURN IN TWO (2) TO THREE (3) MONTHS FOR REVISION TO A STABLE REVERSE IMPLANT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Aseptic loosening; Discomfort; Joint Dislocation; Joint Impingement; Metal Related Pathology; Osteolysis; Pain

  MAUDE report 23005313 ↗
• InjuryAug 26, 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 22899018 ↗
• InjuryAug 13, 2025Naturally Worn; Lack of Effect; Naturally Worn; Lack of Effect

  IT WAS REPORTED THAT A PATIENT, WHO HAD THEIR RIGHT SHOULDER IMPLANTED, UNDERWENT A REVISION PROCEDURE. THE PATIENT WAS COMPLAINING OF STIFFNESS IN THEIR SHOULDER. POSSIBLE HETEROTOPIC OSSIFICATION INDICATED. ONCE OPENED, THE SURGEON NOTICED SLIGHT NOTCHING OF THE HUMERAL LINER AGAINST THE GLENOSPHERE. THE SURGEON CHANGED THE HUMERAL LINER, AND GLENOSPHERE. 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 EXPLANTED DEVICES ARE NOT AVAILABLE FOR RETURN DUE TO THE HOSPITAL¿S TRUST POLICY AND THEIR BEING UNABLE TO DECONTAMINATE THEM FOR RETURN. NO DEVICE IMAGES WERE ABLE TO BE OBTAINED. NO FURTHER INFORMATION. THIS IS 1 OF 2 REPORTS.

  Patient problems: Extraskeletal ossification; Loss of Range of Motion

  MAUDE report 22800866 ↗
• InjuryAug 8, 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 RIGHT SIDE AND WAS IMPLANTED WITH EXACTECH DEVICES. SUBSEQUENTLY, THE PATIENT EXPERIENCED A DISLOCATION. PATIENT HAD SPINE SURGERY AND HAS HAD SHOULDER PAIN SINCE. PHYSICAL THERAPY WAS ORDERED FOR STRENGTHENING EXERCISES. SHOULDER BECAME EASILY AGGRAVATED, SO CT ORDERED. CT COMPLETED SHOWING DISLOCATION. X-RAYS DONE CONFIRMING DISLOCATION W/ POSSIBLE DISSOCIATION OF POLYETHYLENE LINER FROM HUMERAL TRAY DURING PATIENT OFFICE VISIT. AS A RESULT, APPROXIMATELY 1 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: Implant Pain; Joint Dislocation; Metal Related Pathology; Solid Tumor

  MAUDE report 22756059 ↗
• InjuryAug 1, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  AS REPORTED, APPROXIMATELY 2 MONTHS AND 18 DAYS POST THE INITIAL REVERSE TOTAL SHOULDER ARTHROPLASTY, AND APPROXIMATELY 4 WEEKS AND 1 DAY POST THE FIRST REVISION SURGERY, THE PATIENT UNDERWENT A SECOND REVISION OF THE HUMERAL COMPONENT DUE TO UNKNOWN REASONS. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: Insufficient Information

  MAUDE report 22690453 ↗
• InjuryJul 21, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  AS REPORTED, APPROXIMATELY 5 YEARS AND 6 MONTHS POST THE INITIAL LEFT REVERSE TOTAL SHOULDER ARTHROPLASTY, AND 1 YEAR AND 11 MONTHS POST THE FIRST REVISION SURGERY, THE PATIENT WAS REVISED FOR A SECOND TIME DUE TO DISLOCATION, WITH A MASSIVE SOFT TISSUE REPAIR. 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 22554370 ↗
• InjuryJun 26, 2025Naturally Worn; Naturally Worn

  AS REPORTED, APPROXIMATELY 5 YEARS AND 11 MONTHS POST THE INITIAL RIGHT REVERSE TOTAL SHOULDER ARTHROPLASTY, THE PATIENT EXPERIENCED CONTINUED STIFFNESS AND PAIN. THE SURGEON COMPLETED DIAGNOSTIC ARTHROSCOPES OF THE SHOULDER SUBSEQUENTLY, BUT FOUND NO EVIDENCE OF INFECTION. ON X-RAY, SCAPULA NOTCHING OF THE HUMERAL POLY WAS NOTED. UPON EXPOSURE, SIGNIFICANT OSTEOLYSIS OF THE PROXIMAL HUMERAL BONE AND INFERIOR GLENOID WAS NOTED. THE POLYETHYLENE LINER WAS SIGNIFICANTLY DAMAGED, MEDIALLY, LIKELY WHERE IT HAD BEEN IMPINGING ON THE SCAPULA. THE GLENOID AND HUMERUS WERE WELL FIXED BEFORE REMOVAL. REMOVAL OF THE GLENOSPHERE REVEALED APPARENTLY INFECTION BETWEEN THE BASEPLATE AND THE GLENOSPHERE. THE SURGEON IS AWAITING RESULTS OF SAMPLES TAKEN, BUT PROVISIONALLY RULED INFECTION AS THE PRIMARY CAUSE OF REVISION. THE SURGEON REMOVED ALL IMPLANTS AND PLACED A COMPETITOR ANTIBIOTIC SPACER IN SITU WITH THE INTENTION OF INSERTING A SECOND REVERSE IN THE FUTURE. 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 Impingement; Osteolysis; Pain; Unspecified Infection

  MAUDE report 22342128 ↗
• InjuryJun 2, 2025Naturally Worn; Naturally Worn

  AS REPORTED, APPROXIMATELY TWO YEARS POST INITIAL RIGHT TOTAL SHOULDER ARTHROPLASTY, THE MALE PATIENT HAD A REVISION OF THEIR REVERSE SHOULDER DUE TO INFECTION. AFTER EXPOSING THE JOINT, THE IMPLANTS WERE WELL FIXED, HOWEVER THE JOINT WAS OBVIOUSLY INFECTED. THE GLENOID BASEPLATE WAS REMOVED EASILY ENOUGH WITH A SLAP HAMMER WITHOUT SIGNIFICANT BONE LOSS, AND THE STEM WAS REMOVED WITH OSTEOTOMES. AN ANTIBIOTIC CEMENT SPACER WAS IMPLANTED. THERE WAS NO BREAKAGE OF DEVICE OR SURGICAL DELAY/PROLONGATION. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT.

  Patient problems: Unspecified Infection

  MAUDE report 22125922 ↗
• InjuryMay 12, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT, INITIAL LEFT SHOULDER IMPLANTED IN OCTOBER 2023, UNDERWENT A REVISION PROCEDURE ON (B)(6) 2025, APPROXIMATELY 1 YEAR 6 MONTHS POST THE INITIAL PROCEDURE. THE PATIENT WAS REVISED DUE TO PAIN. A NEW 38 +2.5 POLY WAS INSERTED WITH NO ISSUES. X-RAYS WERE PROVIDED. THE EXPLANTED DEVICE IS NOT AVAILABLE FOR RETURN. NO DEVICE IMAGES WERE PROVIDED. NO FURTHER INFORMATION.

  Patient problems: Pain

  MAUDE report 22004150 ↗
• InjuryMay 6, 2025Detachment of Device or Device Component; Naturally Worn; Detachment of Device or Device Component; Naturally Worn

  IT WAS REPORTED THAT FEMALE PATIENT WHO HAD AN INITIAL REVERSE SHOULDER IMPLANTED ON THE RIGHT SIDE, UNDERWENT A REVISION PROCEDURE APPROXIMATELY 5 YEARS POST THE INITIAL PROCEDURE. THE PATIENT WAS DOING WELL UNTIL SHE HAD SPINAL FUSION SURGERY IN (B)(6) 2025. THE SURGEON STATED THE PATIENT HAD TO PUSH HERSELF IN AND OUT OF BED A LOT BUT HAD NO MEMORY OF AN EXACT INSTANCE WHERE THE POLY MAY HAVE POPPED OUT OF THE HUMERAL TRAY. IMAGING SHOWED TRAY AND SPHERE ARTICULATION, SO IT WAS CLEAR THE LINER HAD DISASSOCIATED. REVISION OCCURRED AND THE POLYETHYLENE WAS IN FACT DISASSOCIATED WITH THE HUMERAL TRAY POSTERIORLY. IT WAS PULLED OUT AND OBSERVATION INDICATED THERE WAS SOME WEAR ON THE INFERIOR LIP OF THE POLY DUE TO POTENTIAL SCAPULAR NOTCHING AND ON THE OUTSIDE POSTERIOR LIP PORTION OF THE LINER, LIKELY DUE TO FLOATING IN THE JOINT AND RUBBING ON AN ADJACENT STRUCTURE. THERE WAS NO NOTICEABLE POLY WEAR ON THE ARTICULATING AREA OF IT. THE TRAY WAS REMOVED, AS WELL AS THE GLENOSPHERE LOCKING SCREW AND GLENOSPHERE. THE SURGEON WOUND UP UPSIZING TO A 42 SPHERE AND CONSTRAINED LINER FOR ADDITIONAL STABILITY. THERE WERE NO DEVICE BREAKAGES OR SURGICAL DELAYS DURING THE PROCEDURE. THE PATI

  Patient problems: Joint Impingement; Metal Related Pathology

  MAUDE report 21971638 ↗
• InjuryApr 22, 2025Naturally Worn; Lack of Effect; Naturally Worn; Lack of Effect

  IT WAS REPORTED THAT THIS PATIENT'S SHOULDER WAS REVISED APPROXIMATELY 7 YEARS 8 MONTHS POST INITIAL OPERATION. SUBSEQUENTLY, THE PATIENT CAME BACK IN DUE TO DECREASING RANGE OF MOTION. WEAR WAS ALSO OBSERVED AND OCCURRED AFTER THE PRIMARY SURGERY. PATIENT WAS REVISED TO A TO AN EXPANDED 38 GLENOSPHERE AND A NEW 38MM +0MM POLY. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT.

  Patient problems: Loss of Range of Motion

  MAUDE report 21881833 ↗
• InjuryMar 25, 2025Naturally Worn; Naturally Worn

  IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT APPROXIMATELY 71 MONTHS AFTER A RIGHT TOTAL SHOULDER REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS PROSTHESIS WEAR AND PAIN. POST OPERATIVE DIAGNOSIS NOTED WEAR OF THE IMPLANT. NO FURTHER ISSUES OR COMPLICATIONS WERE REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Pain

  MAUDE report 21688499 ↗
• InjuryMar 4, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED, A PARTY STATED HER HUSBAND UNDERWENT RIGHT SHOULDER REPLACEMENT SURGERY AND THAT THEY EXPERIENCED PAIN AND AN INFECTION. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: Pain; Unspecified Infection

  MAUDE report 21517786 ↗
• InjuryFeb 24, 2025Naturally Worn; Adverse Event Without Identified Device or Use Problem; Naturally Worn; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A 76 YO MALE PATIENT, INITIAL SHOULDER IMPLANTED IN (B)(6) 2016, UNDERWENT A REVISION PROCEDURE IN (B)(6) 2025, APPROXIMATELY 8 YEARS 6 MONTHS POST THE INITIAL PROCEDURE. REASON FOR THE REVISION IS UNKNOWN. THE SURGEON DID NOT PROVIDE ANY DETAILS. EVERYTHING WAS REMOVED. 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 OR DEVICE IMAGES WERE ABLE TO BE OBTAINED. THE EXPLANTED DEVICES ARE NOT AVAILABLE FOR RETURN AS THEY WERE DISPOSED OF BY THE CUSTOMER. NO FURTHER INFORMATION.

  Patient problems: Insufficient Information; Osteolysis

  MAUDE report 21454185 ↗
• InjuryFeb 11, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  APPROXIMATELY 3 MONTH(S) POST-OPERATIVE OF A RIGHT RTSA, IT WAS REPORTED VIA CLINICAL STUDY THAT THE PATIENT EXPERIENCED A SUPERFICIAL INFECTION; DESCRIBED AS A CIRCULAR LUMP PROTRUDING THROUGH THE SURGICAL SCAR, WITH FLAKING SKIN AROUND IT. NO BLEEDING OR DISCHARGE. THE PATIENT WAS ADMINISTERED MEDICATION AND NOTED TO HAVE DEBRIDEMENT, WASH OUT AND LINER EXCHANGE. THE OUTCOME OF THIS EVENT IS CONSIDERED CONTINUING AND THE CASE REPORT FORM INDICATES THAT THIS EVENT IS UNLIKELY RELATED TO THE DEVICE(S) AND POSSIBLY 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: Nodule; Skin Infection

  MAUDE report 21358478 ↗
• InjuryFeb 6, 2025Naturally Worn; Naturally Worn

  EXPERIENCE REPORT AUSTRALIA. IT WAS REPORTED THAT THE PATIENT HAD INITIAL LEFT SHOULDER IMPLANTED AND UNDERWENT A REVISION PROCEDURE APPROXIMATELY 9 YEARS 4 MONTHS POST THE INITIAL PROCEDURE. THE PATIENT COMPLAINED ABOUT SOME MILD PAIN IN THEIR SHOULDER. THE SURGEON OBTAINED A CT WHICH CONFIRMED REMODELING OF THE GLENOID WITH THE COMPONENT MIGRATING MEDIALLY AND SUPERIORLY. THE FIRST STAGE REVISION WAS COMPLETED WITH THE STEM LEFT INSITE. A REPLICATOR PLATE AND ANTIBACTERIAL SPACER WERE USED TO COMBAT ANY POTENTIAL INFECTION. THERE WERE NO SURGICAL DELAYS OR DEVICE BREAKAGES DURING THE PROCEDURE. THE PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. X-RAYS WERE NOT AVAILABLE. THE EXPLANTED DEVICES ARE NOT AVAILABLE FOR RETURN, THEY WERE SENT TO RPH FOR STUDY. DEVICE IMAGES WERE PROVIDED. NO FURTHER INFORMATION. X-RAY AND EBI UNAVAILABLE. THE REVISION REPORTED MAY BE THE RESULT OF GLENOID LOOSENING AND PROSTHESIS WEAR OVER THE COURSE OF 9.5 YEARS OF IMPLANTATION. HOWEVER, THE GLENOID LOOSENING CANNOT BE CONFIRMED AND THE UNDERLYING REASON AND/OR ANY CONTRIBUTING FACTORS TO THE EVENT CANNOT BE CONFIRMED AS THE DEVICES WERE NOT RETURNED FOR EVALUATION AND RADIOGRAP

  Patient problems: Pain

  MAUDE report 21326824 ↗
• InjuryDec 9, 2024Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT THIS MALE PATIENT'S LEFT SHOULDER WAS REVISED APPROXIMATELY 3 YEARS 6 MONTHS POST OP. PATIENT PRESENTED WITH PAIN AND REDNESS IN SHOULDER JOINT. SWABS SUGGESTED UNDERLYING INFECTION. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. PRODUCT NOT RETURNING: DISPOSED.

  Patient problems: Erythema; Implant Pain; Medical device site infection

  MAUDE report 20879519 ↗
• InjuryNov 19, 2024Naturally Worn; Naturally Worn

  AS REPORTED, APPROXIMATELY 7 YEARS AND 4 MONTHS POST THE INITIAL RIGHT TOTAL SHOULDER ARTHROPLASTY, THE PATIENT WAS REVISED DUE TO POLY WEAR. EVERYTHING WAS REMOVED. 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: Insufficient Information

  MAUDE report 20718513 ↗

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-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-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-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-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.