Equinoxe 320-36-00Recalls & reported problems

Summary

The FDA's MAUDE database contains 27 adverse event reports that list this exact device (DI 10885862086617), received between Jul 2, 2019 and Jul 7, 2026 — classified as 27 injuries.

The most frequently reported specific device problem is “Naturally Worn” (9 reports).

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

1 other recall cover devices cleared under the same FDA submission (K093275); 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. 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-1416-2024 · Root cause: Nonconforming Material/Component · Recall details · 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 · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 27 reports, in the reporter's own words as published by the FDA.

• InjuryJul 7, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A REVERSE TOTAL SHOULDER REVISION SURGERY. SUBSEQUENTLY, THE PATIENT EXPERIENCED AN INFECTION. AS A RESULT, THE PATIENT WAS GIVEN ANTIBIOTICS. NO FURTHER PATIENT IMPACT REPORTED. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: Unspecified Infection

  MAUDE report 25737406 ↗
• InjuryJun 2, 2026Naturally Worn

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A RIGHT SHOULDER REPLACEMENT PROCEDURE. SUBSEQUENTLY, THE PATIENT EXPERIENCED RECURRENT SHOULDER DISLOCATIONS, AND THE GLENOSPHERE BECAME DISSOCIATED. AS A RESULT, ALL IMPLANTED COMPONENTS, WITH THE EXCEPTION OF THE STEM, WERE REMOVED. PHOTOGRAPHS SHOW ONE OF THE COMPRESSION SCREWS HAD FRACTURED AND THAT THE POLY WAS WORN. X-RAYS WERE ALSO PROVIDED AND SHOWED EVIDENCE OF MIGRATION DUE TO THE DISASSEMBLY. THE PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Joint Dislocation

  MAUDE report 25366112 ↗
• InjuryNov 17, 2025Naturally Worn; Naturally Worn

  IT WAS REPORTED, A MALE PATIENT, INITIAL RIGHT REVERSE TSA IMPLANTED AND THEN UNDERWENT A REVISION PROCEDURE APPROXIMATELY 4 YEARS 3 MONTHS POST THE INITIAL PROCEDURE. THE PATIENT PRESENTED TO THE SURGEON¿S OFFICE WITH COMPLAINTS OF DISSATISFACTION WITH THEIR REVERSE SHOULDER. UPON EXAMINATION AND IMAGINING, THE PATIENT WAS SCHEDULED FOR A REVISION REVERSE TSA. THE SURGEON NOTICED SCAPULAR NOTCHING ON THE IMAGING. DURING THE REVISION SURGERY, THE SURGEON SAW THE NOTCHING ON THE POLY IMPLANT. THE SURGEON FOUND THAT THE CENTRAL GLENOSPHERE SCREW WAS LOOSE AND NOT PROPERLY SECURING THE GLENOSPHERE TO THE BASEPLATE. THE GLENOSPHERE SCREW WAS REMOVED AND THE GLENOSPHERE WAS REMOVED. THERE WAS PROMINENT METALOSIS BEHIND THE GLENOSPHERE IMPLANT AND AROUND THE BASEPLATE IMPLANT. THE TISSUE AROUND THE BASEPLATE WAS DEBRIDED, AND THE BASEPLATE WAS CHECKED FOR STABILITY. THE SURGEON THINKS THE LOOSE FIT OF THE GLENOSPHERE AROUND THE BASEPLATE WITHOUT A TAPER MECHANISM POTENTIALLY CAUSES MICROMOTION, THEN LOOSENING OF THE SCREW DUE TO MICROMOTION CAUSES METAL ON METAL REACTION WITHIN THE JOINT. THE JOINT WAS IRRIGATED WELL. A NEW AND LARGER SIZE AND LATERALIZED GLENOSPHERE 40MM WAS IMPLANTED.

  Patient problems: Joint Impingement; Metal Related Pathology

  MAUDE report 23574400 ↗
• InjuryOct 28, 2025Naturally Worn; Naturally Worn

  AS REPORTED, APPROXIMATELY 4 YEARS AND 9 MONTHS POST THE INITIAL REVERSE TOTAL SHOULDER ARTHROPLASTY, THE PATIENT PRESENTED TO THE SURGEON'S OFFICE WITH COMPLAINTS OF PAIN AND STIFFNESS IN THEIR RIGHT SHOULDER. UPON EXAMINATION AND X-RAY IMAGING IT APPEARS THERE ARE CHANGES AROUND THE GLENOID IMPLANT, INDICATING BONE LOSS AND POSSIBLE LOOSENING OF THE GLENOID BASEPLATE IMPLANT. THERE ARE CHANGES AND BONE RESORPTION SHOWN AROUND THE HUMERAL STEM AS WELL. THE PATIENT WAS SCHEDULED FOR A REVISION RIGHT TOTAL SHOULDER ARTHROPLASTY WITH REMOVAL OF IMPLANTS AND REIMPLANTATION OF A STABLE REVERSE CONSTRUCT. THE PATIENT WAS REVISED AND THE ORIGINAL HUMERAL TRAY, LINER, GLENOSPHERE, GLENOSPHERE SCREW, PERIPHERAL SCREWS AND CAPS, AND THE BASEPLATE WERE REMOVED. THE HUMERAL STEM WAS WELL FIXED AND WAS RETAINED. THE SHOULDER JOINT AND BONE WERE DEBRIDED AND PREPPED FOR RE-IMPLANT OF A COMPETITOR'S REVERSE GLENOID BASEPLATE AND GLENOSPHERE. AN EXACTECH HUMERAL TRAY AND LINER WERE IMPLANTED ON THE RETAINED STEM AND MATCHED TO THE SIZE OF THE COMPETITOR 36MM GLENOSPHERE. THE PATIENT LEFT THE OPERATING ROOM STABLE.

  Patient problems: Aseptic loosening; Loss of Range of Motion; Osteolysis; Pain

  MAUDE report 23404078 ↗
• InjuryOct 15, 2025Naturally Worn; Naturally Worn

  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 23291893 ↗
• InjuryAug 18, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  AS REPORTED, APPROXIMATELY 2 YEARS AND 2 MONTHS POST THE PATIENT'S PREVIOUS REVISION SURGERY, THE PATIENT DISLOCATED THEIR SHOULDER AND WAS REVISED. THE LINER WAS EXCHANGED TO A CONSTRAINED 36MM. 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 22833386 ↗
• InjuryAug 18, 2025Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN INITIAL BILATERAL SHOULDER REPLACEMENT. SUBSEQUENTLY, THE PATIENT EXPERIENCED PAIN IN BOTH SHOULDERS AND A DETERIORATING PRODUCT IN AN UNKNOWN SHOULDER. AS A RESULT, THE PATIENT UNDERWENT A REVISION SURGERY OF AN UNKNOWN SIDE ON AN UNKNOWN DATE. NO FURTHER PATIENT IMPACT REPORTED. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: Pain

  MAUDE report 22833125 ↗
• InjuryJun 18, 2025Unstable; Unstable

  AS REPORTED, APPROXIMATELY 8 MONTHS AND 23 DAYS POST THE INITIAL LEFT REVERSE TOTAL SHOULDER ARTHROPLASTY, THE PATIENT PRESENTED TO THE SURGEON HAPPY WITH THE PROCEDURE, BUT WITH FEELINGS OF LAXITY OR LOOSENESS WHEN COMPARED WITH THEIR OTHER SIDE, WHICH ALSO HAS AN EXACTECH SHOULDER REPLACEMENT IN-SITU. 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 Laxity

  MAUDE report 22283815 ↗
• InjuryJan 9, 2025Naturally Worn; Naturally Worn

  IT WAS REPORTED VIA A MEDWATCH REPORT, "MEDWATCH (B)(4)", THAT THE PATIENT UNDERWENT AN INITIAL RIGHT TOTAL SHOULDER REPLACEMENT AND RIGHT SHOULDER BICEPS TENODESIS PROCEDURE IN (B)(6) 2019 TO TREAT AN IRREPARABLE RIGHT ROTATOR CUFF TEAR AND BICEPS TENDINITIS. SUBSEQUENTLY, THE PATIENT REPORTED PAIN APPROXIMATELY 6 WEEKS POST-OPERATION THAT WAS RESOLVED WITH REST. APPROXIMATELY 2 YEARS POST-OPERATION, THE PATIENT AGAIN REPORTED PAIN; HOWEVER, NO EVIDENCE OF A MECHANICAL PROBLEM WAS OBSERVED. SUBSEQUENTLY, THE PATIENT REPORTED INTENSE PAIN THAT INTERFERED WITH SLEEP APPROXIMATELY 3 YEARS POST-OPERATION AND AN MRI WAS OBTAINED. THE MRI IDENTIFIED SUBACROMIAL BURSITIS, CONTAINING PARTICULATE DEBRIS AND CREATING AN INDOLENT PATTERN OF EROSION OF THE LATERAL MARGIN OF THE ACROMION PROCESS WITH A STRESS REACTION BUT NO FRACTURE LINE, AS WELL AS CHRONIC TEARS OF THE INFRASPINATUS, SUPRASPINATUS AND SUBSCAPULARIS TENDONS. FURTHER, CT IMAGING NOTED A SUBACUTE STRESS FRACTURE AT THE FAR LATERAL ASPECT OF THE ACROMION WITH AREAS OF BONY RESORPTION. ADJACENT DEGENERATIVE CHANGES OF THE AC JOINT AS WELL AS FLUID EXTENDING INTO THE UNDERLYING SUBACROMIAL SUBDELTOID BURSA. NO COMPLICATION OF THE

  Patient problems: Bacterial Infection; Bone Fracture(s); Bursitis; Erosion; Implant Pain; Muscle/Tendon Damage; Osteolysis; Pain; Scar Tissue

  MAUDE report 21120505 ↗
• InjuryDec 27, 2024Unintended Collision; Naturally Worn; Unintended Collision; Naturally Worn

  IT WAS REPORTED THAT A 58 YO PATIENT, INITIAL RIGHT SHOULDER IMPLANTED IN APRIL 2021, UNDERWENT A REVISION PROCEDURE IN (B)(6) 2024, APPROXIMATELY 3 YEARS 8 MONTHS POST THE INITIAL PROCEDURE. THE PATIENT PRESENTED WITH HUMERAL PAIN. A CT REVEALED SOME IMPINGEMENT ON THE INFERIOR GLENOID. THE SURGEON REMOVED GLENOID AND FOLLOWING TRIALING, IMPLANTED A 36 EXPANDED GLENOID. 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 DEVICES ARE NOT AVAILABLE FOR RETURN. THEY WERE DISCARDED. DEVICE IMAGES WERE PROVIDED. NO FURTHER INFORMATION.

  Patient problems: Joint Impingement; Pain

  MAUDE report 21030206 ↗
• InjuryDec 10, 2024Naturally Worn; Naturally Worn

  EXPERIENCE REPORT USA. IT WAS REPORTED THAT THIS PATIENT'S RIGHT KNEE WAS REVISED. SINCE THE INDEX SURGERY, THE PATIENT HAD A COLOSTOMY PLACED. AT SOME POINT AFTER, PATIENT DEVELOPED AN INFECTION. IT IS UNCLEAR IF HER INFECTION IS RELATED TO THE COLOSTOMY PROCEDURE. PATIENT HAD AN ABSCESS WITHIN THE SOFT TISSUE OF HER DELTOID. SURGEON DRAINED THE ABSCESS AND PERFORMED A ONE-STAGE REVISION. HE EXPLANTED ALL THE ORIGINAL HARDWARE AND IMPLANTED A NEW SMALL SUPERIOR AUGMENT BASEPLATE, BLUE, RED, AND BLACK SCREWS AND CAPS, 40 EXPANDED SPHERE, LOCKING SCREW, CEMENTED 12MM STEM, 0 TRAY, REVERSE TORQUE SCREW AND A 2.5MM LINER. ORIGINAL LINER HAD SOME WEAR ALREADY. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. IS THE REPORTED EVENT ASSOCIATED WITH REVISION OF EXACTECH IMPLANTS? YES. WHAT SIDE WAS EFFECTED? RIGHT. DO YOU KNOW THE INITIAL IMPLANT DATE (INDEX SURGERY DATE)? KNOWN. PROVIDE THE INITIAL IMPLANT DATE (INDEX SURGERY DATE) (B)(6)2023. WAS THE PATIENT REVISED TO EXACTECH DEVICES? YES. PLEASE DESCRIBE BELOW: DR. (B)(6) PERFORMED A ONE-STAGE REVISION. HE EXPLANTED ALL THE ORIGINAL HARDWARE AND IMPLANTED A NEW SMALL SUPERIOR AUGMENT BASEPLATE, BLUE, RED, AND BLAC

  Patient problems: Abscess; Unspecified Infection

  MAUDE report 20893579 ↗
• InjuryJun 27, 2024Unstable; Device Dislodged or Dislocated; Unstable; Device Dislodged or Dislocated

  APPROXIMATELY 1 YEAR, 7 MONTHS. AND 7 DAYS AFTER AN INITIAL LEFT TSA, THE PATIENT DISLOCATED THE SHOULDER DUE TO RECURRENT INSTABILITY EPISODES OVER 2 YEARS. 3 YEARS AND 5 MONTHS AFTER INITIAL IMPLANTATION, THE PATIENT UNDERWENT STANDARD REVERSE WITH PRESERVE STEM REVISION AND THE EVENT IS CONSIDERED RESOLVED. THE CASE REPORT INDICATES THAT THE EVENT IS POSSIBLY RELATED TO DEVICE(S) AND/OR TO THE PROCEDURE.

  Patient problems: Joint Dislocation; Joint Laxity

  MAUDE report 19630124 ↗
• InjuryJun 19, 2024Device 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 BY THE EQUINOXE SHOULDER STUDY, APPROXIMATELY 0 YEAR(S), 0 MONTH(S), AND 20 DAY(S) POST-OPERATIVE OF A LEFT IMPLANTED TSA, THE PATIENT PRESENTED WITH DISLOCATION. COMPLETE DISLOCATION OF PROSTHESIS THAT REQUIRES REVISION SURGERY. THE OUTCOME OF THE EVENT WAS RESOLVED BY STANDARD REVERSE REVISION OF THE RIGHT SHOULDER. IT IS NOTED THAT THE PATIENT HAS SIGNIFICANT SCOLIOSIS, PLACES SCAPULA IN PROTRACTED POSITIONING, MAKING IT AT-RISK. THE CLINICAL REPORT INDICATES THAT THE EVENT IS DEFINITELY RELATED TO THE DEVICE(S) AND/OR TO THE PROCEDURE. THIS EVENT REPORT WAS RECEIVED THROUGH CLINICAL DATA COLLECTION ACTIVITIES AND NO DEVICE RETURN IS ANTICIPATED.

  Patient problems: Joint Dislocation; Subluxation

  MAUDE report 19568481 ↗
• InjuryApr 10, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  AS REPORTED, THE 77 YEAR OLD FEMALE PATIENT HAD AN INITIAL RIGHT TSA ON (B)(6) 2023. THE PATIENT UNDERWENT A PREVIOUS REVISION ON (B)(6) 2024 (REPORTED UNDER 1038671-2024-00468). THE PATIENT WAS REVISED AGAIN ON (B)(6) 2024 DUE TO RECURRENT DISLOCATION - ASSUMING THE SECOND DISLOCATION WAS TRAUMATIC. THE STEM, ADAPTER TRAY, LINER AND GLENOSPHERE WERE EXCHANGED. THE GLENOSPHERE AND LINER WERE INCREASED TO 40MM AND THE TRAY WAS EXCHANGED TO +10 WITH A HOPE TO IMPROVE THE STABILITY. 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 19084562 ↗
• InjuryMar 11, 2024Device Dislodged or Dislocated; Adverse Event Without Identified Device or Use Problem; Device Dislodged or Dislocated; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A 77 YO FEMALE PATIENT, INITIAL RIGHT SHOULDER IMPLANTED ON (B)(6) 2023, UNDERWENT A REVISION PROCEDURE ON (B)(6) 2024, APPROXIMATELY 2 MONTHS POST THE INITIAL PROCEDURE. THE PATIENT WAS REVISED DUE TO A DISLOCATION FROM THEIR PREVIOUS SURGERY. THE PATIENT¿S GLENOSPHERE AND LINER WERE EXCHANGED TO A CONSTAINED LINER TO PROVIDE BETTER STABILITY. THERE WERE NO DEVICE BREAKAGES OR SURGICAL DELAY DURING THE PROCEDURE. THE PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. NO EXPLANTED DEVICES ARE AVAILABLE FOR RETURN AS THE HOSPITAL DISPOSED OF THE DEVICES. NO PHOTOS OF THE DEVICES OR X-RAYS WERE ABLE TO BE PROVIDED. NO FURTHER INFORMATION.

  Patient problems: Joint Dislocation

  MAUDE report 18882777 ↗
• InjuryNov 10, 2023Fracture; Fracture

  AS REPORTED, THE PATIENT HAD AN INITIAL RIGHT TSA ON (B)(6) 2020. THE PATIENT PRESENTED ON (B)(6) 2023 AND AFTER INITIALLY DOING WELL WHEN PUT IN A SLING FOR FX 1 YEAR AGO, SUBJECT CAME TO CLINIC (B)(6) 2021 WITH INCREASED PAIN. CT WAS ORDERED AND SHOWN THAT THE FX HAD GONE ON TO BECOME A NON-UNION. SUBJECT GOING TO FOLLOW UP REGARDING TREATMENT PLAN, AND HAS NOT FOLLOWED UP SINCE. THE CASE REPORT FORM INDICATES THAT THIS EVENT IS DEFINITELY NOT RELATED TO DEVICE, DEFINITELY NOT RELATED TO PROCEDURE. OUTCOME: CONTINUING.

  Patient problems: Bone Fracture(s)

  MAUDE report 18109831 ↗
• InjuryOct 2, 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) 2020. THE PATIENT PRESENTED HAD DEEP INFECTION. THE CASE REPORT FORM INDICATES THAT THIS EVENT IS DEFINITELY NOT RELATED TO DEVICE, POSSIBLY RELATED TO PROCEDURE.

  Patient problems: Bacterial Infection; Unspecified Infection

  MAUDE report 17850963 ↗
• InjurySep 28, 2023Naturally Worn; Naturally Worn

  AS REPORTED, APPROXIMATELY THREE YEARS POST INITIAL RIGHT TSA, THE 80 Y/O FEMALE PATIENT PRESENTED BACK TO SURGEON'S OFFICE WITH COMPLAINTS OF PAIN AND DISSATISFACTION WITH THEIR RIGHT REVERSE TSA. UPON EXAMINATION AND IMAGING, THE SURGEON BELIEVED THE PATIENT'S GLENOID POSITIONING WAS TOO SUPERIOR, THIS LED TO INFERIOR SCAPULAR NOTCHING OF THE POLY LINER IMPLANT ONTO THE SCAPULAR BONE. EVIDENCE OF BONE REABSORPTION AND OSTEOLYSIS DUE TO POLY WEAR IS PRESENT. THE SURGEON FELT THE BASEPLATE IMPLANT WAS UNSTABLE AND LOOSE ON IMAGING. THE SURGEON WOULD LIKE IT REPORTED THAT THIS PATIENT OBTAINED A SCAPULAR SPINE FRACTURE AS WELL. THE PATIENT WAS SCHEDULED FOR A REVISION RIGHT REVERSE TSA SURGERY. DURING THE REVISION SURGERY, THE JOINT WAS EXPOSED. THE HUMERAL LINER, TORQUE SCREW, AND TRAY WERE REMOVED FROM THE STEM. THE STEM WAS CHECKED FOR STABILITY. THE GLENOID WAS THEN ACCESSED AND THE LOCKING SCREW AND GLENOSPHERE WERE REMOVED. THE LOCKING CAPS AND COMPRESSION SCREWS WERE REMOVED AND THE BASEPLATE SHOWED TO BE LOOSE IN THE GLENOID BONE. THERE WAS INFERIOR GLENOID BONE COMPLETELY MISSING DUE TO WEAR AND OSTEOLYSIS. CULTURES WERE TAKEN THROUGHOUT THE PROCEDURE. THE BASEPLATE WAS REM

  Patient problems: Bone Fracture(s); Failure of Implant; Osteolysis; Pain

  MAUDE report 17840853 ↗
• InjuryJun 9, 2023Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED VIA CLINICAL STUDY THAT THE 68 YO FEMALE EXPERIENCE ASEPTIC GLENOID LOOSENING WITH GLENOID GRAFT/COMPONENT LOOSENING. THE DATE OF EVENT ONSET IS (B)(6) 2023. THE PATIENT WAS REVISED ON (B)(6) 2023. THE OUTCOME WAS LAST KNOWN AS RESOLVED ON (B)(6) 2023.

  Patient problems: Reaction to Medicinal Component of Device

  MAUDE report 17099422 ↗
• InjuryApr 3, 2023Device Dislodged or Dislocated; Adverse Event Without Identified Device or Use Problem; Device Dislodged or Dislocated; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A 70 YO FEMALE PATIENT, INITIAL LEFT SHOULDER IMPLANTED ON (B)(6) 2023, UNDERWENT A REVISION PROCEDURE ON (B)(6) 2023. THE PATIENT DISLOCATED REACHING DOWN FOR SOMETHING. THE POLY WAS REPLACED. THERE WERE NO SURGICAL DELAYS. THE PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. NO DEVICE RETURNS ANTICIPATED DUE TO HOSPITAL POLICY.

  Patient problems: Joint Dislocation

  MAUDE report 16668662 ↗
• InjuryDec 21, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED BY THE EQUINOXE SHOULDER STUDY, APPROXIMATELY 9 MONTHS POST OP THE INITIAL REVERSE TSA, THIS 83 Y/O FEMALE PATIENT DEVELOPED PAIN OVER THE LAST TWO WEEKS. WHENEVER SHE GOT IN AND OUT OF VAN, SHE HAD TO PULL HERSELF UP TO THE SEATS USING THE RIGHT HAND MULTIPLE TIMES. THE CASE REPORT FORM INDICATES THIS EVENT IS POSSIBLY RELATED TO DEVICES AND/OR PROCEDURE. THIS EVENT REPORT WAS RECEIVED THROUGH CLINICAL DATA COLLECTION ACTIVITIES. ACTION TAKEN: APPLY ICE AND HEAT PACKS. THE OUTCOME IS CONTINUING. NO ADDITIONAL INFORMATION.

  Patient problems: Bursitis; Failure of Implant; Muscle/Tendon Damage; Pain

  MAUDE report 16029002 ↗
• InjuryOct 4, 2022Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information

  IT WAS REPORTED THAT THIS PATIENT'S LEFT SHOULDER WAS REVISED AND AN ANTIBIOTIC SPACER WAS INSERTED. ALL REVERSE SHOULDER PARTS WERE EXPLANTED. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. DEVICES WILL NOT BE RETUNING DUE TO HOSPITAL POLICY.

  Patient problems: Failure of Implant; Unspecified Infection

  MAUDE report 15536367 ↗
• InjuryJul 26, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A 76 YO FEMALE, WHO UNDERWENT AN INITIAL IMPLANT PROCEDURE ON THE RIGHT SIDE ON (B)(6) 2022, HAD A HEMATOMA THAT CAUSED HER SHOULDER TO DISLOCATE. SHE WAS REVISED TO A BIGGER TRAY AND LINER ON (B)(6) 2022. THE PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. THE EXPLANTED DEVICES ARE AVAILABLE FOR RETURN.

  Patient problems: Hematoma

  MAUDE report 15102893 ↗
• InjuryAug 13, 2021Fracture; Fracture

  AS REPORTED, APPROXIMATELY 4 MONTHS POST THE L REVERSE TSA, THIS (B)(6) FEMALE PATIENT TRIED TO LIFT A CAN OF SODA AND FELT A POP IN THE REGION OF HER L SHOULDER WITH INCREASED PAIN, DECREASED RANGE OF MOTION. A REVISION WAS COMPLETED TO REPAIR AN ACROMIAL FRACTURE. THE PATIENT WAS DISCHARGED WITH ORDERS FOR RELATIVE REST, REFERRAL TO PAIN MANAGEMENT FOR DISCUSSION OF A NERVE BLOCK IN THE INTRASCAPULAR REGION. OUTCOME IS REPORTED AS CONTINUING. DEVICE WILL NOT RETURN DUE TO CLINICAL STUDY POLICY.

  Patient problems: Bone Fracture(s)

  MAUDE report 12317875 ↗
• InjuryJul 30, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED, THIS (B)(6) Y/O FEMALE PATIENT HAD A PROXIMAL HUMERAL FRACTURE AND RECEIVED A REVERSE L TSA ON/NEAR (B)(6) 2021. AN I&D WAS BEING PERFORMED WITH THE PLAN TO CHANGE THE HUMERAL LINER, GLENOSPHERE, HUMERAL TRAY THEN WASH OUT THE WOUND AND RE-IMPLANT NEW IMPLANTS OF THE SAME TAKEN OUT. WHEN RE-IMPLANTING, THERE WAS A 36 LINER IMPLANTED ALONG WITH A 40MM GLENOSPHERE. SUBSEQUENTLY TAKEN TO THE OR ON (B)(6) 2021 FOR AN I&D. ANOTHER SURGERY WAS PERFORMED THIS MORNING ((B)(6) 2021) TO EXCHANGE THE 36 HUMERAL LINER FOR A 40MM HUMERAL LINER. THIS WAS UNEVENTFUL. THE HUMERAL LINER WILL RETURN; HOWEVER, THE GLENOSPHERE IS DISPOSED BY HOSPITAL.

  Patient problems: Bacterial Infection

  MAUDE report 12251977 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K093275. One submission often covers many models, so check the product and lot details in each record.

• Z-1417-2024 · Mar 6, 2024 · Open, Classified
  Exactech Equinoxe REVERSE SHOULDER,36mm Constrained Humeral Liner: a) +0mm, Item Number 320-36-10, b) +2.5mm, Item Number 320-36-13; Shoulder Arthroplasty