Equinoxe 314-13-03 (UDI 10885862172686)Recalls & reported problems

Summary

The FDA's MAUDE database contains 51 adverse event reports that list this exact device (DI 10885862172686), received between Feb 26, 2019 and Dec 31, 2024 — classified as 50 injuries, 1 malfunction.

The most frequently reported specific device problem is “Loosening of Implant Not Related to Bone-Ingrowth” (23 reports).

1 FDA recall record name this device's identifier, 1 still open.

7 other recalls cover devices cleared under the same FDA submission (K113309); 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-1412-2024 · Root cause: Nonconforming Material/Component · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 51 reports, in the reporter's own words as published by the FDA.

• InjuryDec 31, 2024Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  APPROXIMATELY 12 YEAR(S), 1 MONTH(S) AND 24 DAY(S) POST-OPERATIVE OF AN INITIAL LEFT TSA, IT WAS REPORTED VIA CLINICAL STUDY THAT THE PATIENT EXPERIENCED ASEPTIC GLENOID LOOSENING. PATIENT WAS PULLED BY HER DOG WHILE HOLDING A LEASH. THE PATIENT WAS EXAMINED THROUGH CT SCAN THAT REVEALED SOME LYSIS AROUND THE INFERIOR PEGS. PATIENT WILL BE OBSERVED. THE OUTCOME OF THIS EVENT IS CONSIDERED RESOLVED AND THE CASE REPORT FORM INDICATES THAT THIS EVENT IS POSSIBLY RELATED TO THE DEVICE AND UNLIKELY RELATED TO THE PROCEDURE. THIS WAS REPORTED THROUGH CLINICAL TRIAL STUDY DATA COLLECTION ACTIVITIES AND NO OTHER INFORMATION IS AVAILABLE AT THIS TIME.

  Patient problems: Osteolysis

  MAUDE report 21047938 ↗
• InjuryDec 27, 2024Crack; Naturally Worn; Crack; Naturally Worn

  IT WAS REPORTED THAT A 72 YO FEMALE PATIENT, INITIAL LEFT SHOULDER IMPLANTED IN (B)(6) 2018, UNDERWENT A REVISION PROCEDURE IN (B)(6) 2024, APPROXIMATELY 6 YEARS 11 MONTHS POST THE INITIAL PROCEDURE. THE SURGEON CONVERTED THE LEFT TSA TO A RSA. EXTREME PITTING ON THE BACKSIDE OF THE IMPLANT WAS INDICATED. 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 ABLE TO BE OBTAINED. THE EXPLANTED DEVICES ARE AVAILABLE FOR RETURN. NO DEVICE IMAGES WERE ABLE TO BE OBTAINED. NO FURTHER INFORMATION.

  Patient problems: Insufficient Information

  MAUDE report 21029583 ↗
• InjuryDec 2, 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 3 YEARS AND 9 MONTHS POST INITIAL LEFT PRIMARY TOTAL SHOULD ARTHROPLASTY (TSA), THE PATIENT PRESENTED BACK TO THE DOCTOR¿S OFFICE WITH COMPLAINTS OF PAIN AND INSTABILITY IN THEIR LEFT SHOULDER. UPON RADIOLOGIC EXAMINATION AND PHYSICAL EXAMINATION, IT SHOWED THE PATIENT TO POTENTIALLY HAVE A LOOSE IMPLANT AND OSTEOPHYTE BONE GROWTH AROUND THE GLENOID. PRE-OP PLANNING SOFTWARE SHOWED THAT THE GLENOID IMPLANT MAY HAVE BEEN IN THE INCORRECT POSITION. THE PATIENT WAS SCHEDULED FOR A REVISION OF THEIR PRIMARY TSA TO A REVERSE TSA USING COMPETITOR GLENOID IMPLANTS. DURING THE REVISION, THE SURGEON EXPOSED THE PRIMARY TOTAL SHOULDER. THE HUMERAL HEAD AND REPLICATOR PLATE WERE REMOVED. THE HUMERAL STEM WAS TESTED WITH THE STEM INSERTED AND SHOWED THE STEM TO BE IN 30 DEGREES OF RETROVERSION. THE SURGEON WAS SATISFIED WITH THE HUMERAL STEM COMPONENT POSITION AND STABILITY. NEXT, THE SURGEON ACCESSED THE GLENOID AND SAW THAT THE POLY IMPLANT AND THREE PERIPHERAL PEGS WERE FLOATING IN THE JOINT NOT SECURED IN BONE. THE POLY AND THREE PERIPHERAL PEGS WERE INTACT AND REMOVED FROM THE JOINT. THE CENTRAL GLENOID CAGE WAS STILL IN THE GLENOID VAULT. THE GLENOID CAGE IMPLA

  Patient problems: Bone Fracture(s); Joint Laxity; Pain

  MAUDE report 20819787 ↗
• InjuryNov 15, 2024Fracture; Fracture

  AS REPORTED, APPROXIMATELY TWO YEARS AND 11 MONTHS POST THE INITIAL RIGHT TOTAL SHOULDER ARTHROPLASTY (TSA), THE PATIENT PRESENTED WITH SUBSCAPULARIS FAILURE LEADING TO TENSION ON THE GLENOID COMPONENT, CAUSING THE IMPLANT TO BREAK AT BOTH THE CENTRAL PEG AND PERIPHERAL PEG. NO PARTS OR PIECES FELL INTO THE PATIENT WOUND SITE. THERE WAS NO REPORTED SURGICAL DELAY/PROLONGATION. THE PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT.

  Patient problems: Joint Laxity; Muscle/Tendon Damage; Pain

  MAUDE report 20700928 ↗
• InjuryNov 5, 2024Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  APPROXIMATELY 7 YEAR(S) AND 17 DAY(S) POST-OPERATIVE OF A LEFT TSA, IT WAS REPORTED VIA CLINICAL STUDY THAT THE PATIENT EXPERIENCED ASEPTIC GLENOID LOOSENING. RADIOGRAPHS TAKEN SHOWED EVIDENCE OF LOOSENING OF THE GLENOID COMPONENT, DISPLACEMENT OF POSTERIOR GLENOID PEG, AND PROXIMAL HUMERUS BONE LOSS. THE REPORT INDICATES THAT TOTAL STANDARD REVISION IS NEEDED, BUT NO DATE CURRENTLY AND THE EVENT IS CONSIDERED CONTINUING. THE CLINICAL REPORT INDICATES THAT THIS EVENT IS DEFINITELY RELATED TO THE DEVICE(S) AND/OR TO THE PROCEDURE. THIS EVENT WAS REPORTED THROUGH CLINICAL TRIAL STUDY DATA COLLECTION ACTIVITIES AND NO OTHER INFORMATION IS AVAILABLE AT THIS TIME.

  Patient problems: Osteolysis; Osteopenia/ Osteoporosis

  MAUDE report 20612050 ↗
• InjuryOct 22, 2024Fracture; Loosening of Implant Not Related to Bone-Ingrowth; Migration; Fracture; Loosening of Implant Not Related to Bone-Ingrowth; Migration

  APPROXIMATELY 5 YEAR(S), 3 MONTH(S) AND 21 DAY(S) POST-OPERATIVE OF A LEFT TSA, IT WAS REPORTED VIA CLINICAL STUDY THAT THE PATIENT EXPERIENCED ASEPTIC GLENOID LOOSENING. ALSO REPORTED WAS FAILED TSA, INCREASED PAIN WITH ADLS, ASEPTIC GLENOID AND HUMERAL LOOSENING, BREAKAGE OF COMPONENTS, MIGRATION OF ANCHOR OR SCREW. APPROXIMATELY 3.5 YEARS EARLIER, THE PATIENT EXPERIENCED SHOULDER PAIN THE RADIATES FROM THE NECK DOWN TO THE ELBOW. SHOULDER HURTS WITH ACTIVITY. HAS DDD (DEGENERATIVE DISC DISEASE) OF C-SPINE ON RADIOGRAPHS. THE PATIENT WAS RECOMMENDED A FOLLOW-UP APPOINTMENT VIA TELEMEDICINE VISIT TO DISCUSS REVISION PROCEDURE. THE OUTCOME OF THIS EVENT IS CONSIDERED CONTINUING AND THE CLINICAL REPORT INDICATES THAT THIS EVENT IS DEFINITELY RELATED TO THE DEVICE(S) AND POSSIBLY RELATED TO THE PROCEDURE.

  Patient problems: Pain

  MAUDE report 20510285 ↗
• InjuryOct 15, 2024Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  AS REPORTED, APPROXIMATELY 9 YEARS AND 3 MONTHS POST THE INITIAL TOTAL SHOULDER ARTHROPLASTY, THE GLENOID COMPONENT BECAME LOOSE AND THE PATIENT WAS REVISED TO REVERSE COMPONENTS. 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 20450390 ↗
• InjurySep 19, 2024Fracture; Detachment of Device or Device Component; Fracture; Detachment of Device or Device Component

  IT WAS REPORTED THAT THIS 65 Y/O FEMALE PATIENT'S LEFT SHOULDER WAS REVISED APPROXIMATELY 8 MONTHS POST OP. PATIENT WAS TRYING TO REMOVE A WETSUIT THAT WAS DIFFICULT TO GET OFF. SHE FELT SOMETHING GIVE WAY AND THEN HAD PAIN FROM THIS EVENT ONWARDS. PATIENT HAD A PRESERVE STEM TSR WITH A STANDARD CAGED GLENOID. DURING THE REVISION, THE METAL PEGS HAVE BROKEN OFF FROM THE POLY /PEG INTERFACE. EVERYTHING WAS REMOVED AND REPLACED INTO A RTSR. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. UNABLE TO OBTAIN IMAGES OR X-RAYS. PRODUCT NOT RETURNING: DISPOSED AT HOSPITAL.

  Patient problems: Pain

  MAUDE report 20256841 ↗
• InjurySep 10, 2024Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  APPROXIMATELY 3 YEAR(S), 7 MONTH(S) AND 30 DAY(S) POST-OPERATIVE OF A LEFT TSA, IT WAS REPORTED VIA CLINICAL STUDY THAT THE PATIENT EXPERIENCED ASEPTIC GLENOID LOOSENING. IT WAS REPORTED AS BOTH TSA STEM AND GLENOID LOOSE - POSSIBLY DUE TO FALL. THE PATIENT UNDERWENT STANDARD TOTAL REVISION, AND THE OUTCOME OF THIS EVENT IS CONSIDERED RESOLVED. THE CLINICAL REPORT INDICATES THAT THIS EVENT IS POSSIBLY RELATED TO THE DEVICE(S) AND/OR TO THE PROCEDURE.

  Patient problems: Fall

  MAUDE report 20184804 ↗
• InjurySep 3, 2024Insufficient Device Problem Information; Loosening of Implant Not Related to Bone-Ingrowth; Insufficient Device Problem Information; Loosening of Implant Not Related to Bone-Ingrowth

  APPROXIMATELY 6 YEAR(S), 2 MONTH(S) AND 9 DAY(S) POST-OPERATIVE OF A RIGHT TSA, IT WAS REPORTED VIA CLINICAL STUDY THAT THE PATIENT EXPERIENCED LOOSENING OF GLENOID COMPONENT. THE PATIENT UNDERWENT A STANDARD REVERSE REVISION, AND THE OUTCOME OF THIS EVENT IS CONSIDERED RESOLVED. THE CLINICAL REPORT DOES NOT INDICATE WHETHER THIS EVENT IS POSSIBLY RELATED TO THE DEVICE(S) AND/OR TO THE PROCEDURE.

  Patient problems: Insufficient Information

  MAUDE report 20131233 ↗
• InjuryAug 26, 2024Fracture; Fracture

  AS REPORTED, APPROXIMATELY 3 YEARS AND ONE MONTH POST THE INITIAL RIGHT TSA, THE PATIENT WAS REVISED DUE TO THE CENTER CAGE DISASSOCIATING FROM THE POLYETHYLENE GLENOID. THE GLENOID WAS BONE GRAFTED AND THE STEM REMOVED. THERE WAS NO REPORTED SURGICAL DELAY/PROLONGATION. THE PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT.

  Patient problems: Insufficient Information

  MAUDE report 20072414 ↗
• InjuryJul 12, 2024Fracture; Fracture

  NO KNOWN EVENT OCCURRED. PATIENT PRESENTED TO THE CLINIC WITH PAIN & LOSS OF FUNCTION. IMAGING INDICATED A FAILED GLENOID COMPONENT. IT IS UNCLEAR IF ANY SPECIFIC EVENT LED TO THE FAILURE. THE HUMERAL HEAD, REPLICATOR PLATE, TORQUE DEFINING SCREW, & GLENOID COMPONENT WERE EXPLANTED. THE GLENOID COMPONENT WAS COMPLETELY DISSOCIATED FROM THE GLENOID BONE. ALL THREE PERIPHERAL PEGS REMAINED ON THE GLENOID COMPONENT. THE CENTRAL CAGE WAS STILL IN THE BONE & WAS EXPLANTED WITH THE CAGE REMOVAL TOOL. THE GLENOID WAS OBSERVED TO HAVE SIGNIFICANT BONE LOSS, LEADING THE SURGEON TO OPT FOR A HEMI PROSTHESIS & BONE GRAFT FOR THE GLENOID DEFECT. HE USED A NEW REPLICATOR PLATE, TORQUE DEFINING SCREW, & HUMERAL HEAD FROM EXACTECH, ALONG WITH OPTEFORM RT & & CANCELLOUS CHIPS FOR THE GLENOID.

  Patient problems: Osteolysis; Pain

  MAUDE report 19729001 ↗
• InjuryJul 11, 2024Fracture; Loosening of Implant Not Related to Bone-Ingrowth; Fracture; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT APPROXIMATELY 94 MONTHS AFTER A LEFT TOTAL SHOULDER REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS PAIN, LOSS OF FUNCTION AND OSTEOLYSIS. THE LOSS OF FUNCTION WAS NOT A GRADUAL LOSS OF FUNCTION, BUT MORE OF AN ¿ALL OF SUDDEN¿ EVENT PER THE REPORT. UPON EXTRACTING HARDWARE, THE HUMERAL HEAD, REPLICATOR PLATE, AND STEM WERE ALL EXTRACTED WITHOUT MUCH DIFFICULTY. MOVING TO THE GLENOID SIDE, THE GLENOID CAME OUT QUITE EASILY WITH ALL 3 PERIPHERAL PEGS ATTACHED BUT THE CAGE WAS NOT ATTACHED AS IT HAD SNAPPED FROM THE POLY. THE THREADED CAGE EXTRACTION INSTRUMENT WAS THREADED INTO THE CAGE AND A SLAP HAMMER WAS USED TO REMOVE IT. ALL PARTS AND PIECES WERE REMOVED. THE CAGE HAD BROKEN OFF IN THE GLENOID BUT WAS REMOVED IN ITS ENTIRETY. THERE WERE SOME CLEAR SIGNS OF OSTEOLYSIS AS THE GLENOID HAD BECOME QUITE MEDIALIZED. THE SURGEON EXTRACTED ALL HARDWARE AND CONVERTED TO A COMPETITOR¿S DEVICES PER HIS PLAN. THE PATIENT LEFT THE OPERATING ROOM IN STABLE CONDITION. NO FURTHER ISSUES OR COMPLICATIONS WERE REPORTED. X-RAYS WERE PROVIDED. THE DEVICE IS NOT AVAILABLE FOR RETURN AS THE HOSPITAL KEPT THEM. DEVICE IMAGES WERE PROVIDED. NO ADDITION

  Patient problems: Osteolysis; Pain

  MAUDE report 19726286 ↗
• InjuryJul 9, 2024Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  APPROXIMATELY 4 YEAR(S) AND 17 DAY(S) POST-OPERATIVE OF A RIGHT TSA, THE PATIENT PRESENTED WITH ASEPTIC GLENOID LOOSENING. IT WAS REPORTED AS MIGRATION OF THE CENTRAL PEG, NOW RESULTING IN COMPLETE GLENOID LOOSENING. THE PATIENT IS SCHEDULE FOR REVISION TO HEMIARTHROPLASTY, HOWEVER THE OUTCOME OF THIS EVENT IS STILL CONSIDERED CONTINUING AND THE DEVICE(S) REMAIN IMPLANTED. THE CLINICAL REPORT INDICATES THAT THIS EVENT IS DEFINITELY RELATED TO THE DEVICE(S) AND DEFINITELY NOT RELATED TO THE PROCEDURE.

  Patient problems: Insufficient Information

  MAUDE report 19702748 ↗
• InjuryJun 23, 2024Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT APPROXIMATELY 63 MONTHS AFTER A TOTAL SHOULDER REPLACEMENT PROCEDURE, A PATIENT HAS EXPERIENCED PAIN AND ASEPTIC GLENOID LOOSENING. NO FURTHER ISSUES OR COMPLICATIONS WERE REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Pain

  MAUDE report 19591797 ↗
• InjuryJun 5, 2024Naturally Worn; Adverse Event Without Identified Device or Use Problem; Naturally Worn; Adverse Event Without Identified Device or Use Problem

  AS REPORTED BY THE U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES (REF# MW5154620), THE EXACTECH EQUINOXE SHOULDER SYSTEM WAS IMPLANTED IN 2021 FOR ALL WAS WELL. HOWEVER, GRADUALLY THE SHOULDER BECAME MORE AND MORE PAINFUL. THEN 0N 2024, I RECEIVED NOTICE THAT THE SHOULDER SYSTEM HAD BEEN RECALLED. A CAT SCAN REVEALED THAT THE SOCKET IS FAILING. THE RELEVANT SERIA NUMBER WAS CHECKED ON THE WEBSITE AND THIS SERIAL NUMBER IS ON THE ¿AFFECTED¿ LIST. I HAVE A SCHEDULED SURGERY TO REMOVE THE SOCKET IN 2024. I WILL KEEP THE REMOVED SOCKET AS EVIDENCE.

  Patient problems: Failure of Implant; Implant Pain; Pain

  MAUDE report 19473032 ↗
• InjuryMay 23, 2024Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  THIS EVENT REPORT WAS RECEIVED VIA MW5154427. TOTAL SHOULDER ARTHROPLASTY PROCEDURE. SHOWED SEVERE SIGNS OF EROSION OF THE GLENOID. MULTIPLE CYSTIC EROSIVE CHANGES WITHIN THE GLENOID, LARGEST INDIVIDUAL CYSTIC EROSION OF 1.2CM. GLENOID PEGS/ SCREWS SHOW SEVERE SIGNS OF LOOSENING AND EROSION. SURGEON SAYS TOO MUCH BONE LOSS TO DO SECOND SHOULDER REPLACEMENT.

  Patient problems: Cyst(s); Failure of Implant; Osteolysis

  MAUDE report 19388854 ↗
• InjuryMay 8, 2024Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT THIS 74 Y/O FEMALE PATIENT'S SHOULDER WAS REVISED 6 YEARS 4 MONTHS POST OP INITIAL SURGERY. SURGEON REVISED TO REVERSE. A +10 EXT CAGE BASEPLATE WITH A FEMORAL HEAD STRUCTURAL ALLOGRAFT WAS IMPLANTED. WORN AND DAMAGED DEVICE WAS REMOVED. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. DEVICE IS RETURNING.

  Patient problems: Failure of Implant; Metal Related Pathology

  MAUDE report 19274735 ↗
• InjuryMay 6, 2024Unstable; Loosening of Implant Not Related to Bone-Ingrowth; Unstable; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT THIS PATIENT WAS REVISED ON (B)(6) 2024. ALL THE COMPONENTS WERE LOOSE AND EASILY REMOVED. ARTHREX REVERSE WAS THEN PERFORMED AFTER BONE GRAFTING THE DEFECTS. NO ISSUES WITH SURGERY. EXPLANTS NOT AVAILABLE.

  Patient problems: Failure of Implant; Insufficient Information

  MAUDE report 19246503 ↗
• InjuryApr 29, 2024

  TOTAL SHOULDER ARTHROPLASTY PROCEDURE. SHOWED SEVERE SIGNS OF EROSION OF THE GLENOID. MULTIPLE CYSTIC EROSIVE CHANGES WITHIN THE GLENOID, LARGEST INDIVIDUAL CYSTIC EROSION OF 1.2CM. GLENOID PEGS/SCREWS SHOW SEVERE SIGNS OF LOOSENING AND EROSION. SURGEON SAYS TOO MUCH BONE LOSS TO DO SECOND SHOULDER REPLACEMENT.

  Patient problems: Erosion; Failure of Implant

  MAUDE report 19212526 ↗
• InjuryApr 24, 2024Fracture; Naturally Worn; Fracture; Naturally Worn

  AS REPORTED, THE 71 YEAR OLD FEMALE PATIENT HAD AN INITIAL RIGHT TSA ON (B)(6) 2019. THE PATIENT WAS REVISED ON (B)(6) 2024 DUE TO A FAILED GLENOID. 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; Insufficient Information

  MAUDE report 19177881 ↗
• InjuryApr 22, 2024Fracture; Fracture

  IT WAS REPORTED THAT A MALE PATIENT, INITIAL RIGHT SHOULDER IMPLANTED ON (B)(6) 2016, UNDERWENT A REVISION PROCEDURE ON (B)(6) 2024, APPROXIMATELY 7 YEARS 11 MONTHS POST THE INITIAL PROCEDURE. THE PATIENT HAD A PREVIOUS TOTAL SHOULDER REPLACEMENT THEN FAILED ROTATOR CUFF WHICH REQUIRED THE CHANGE TO A REVERSE SHOULDER REPLACEMENT. EVERYTHING WAS REMOVED. IMAGE OF DEVICE PROVIDED APPEARED TO BE FRACTURED WHICH WAS REPORTED TO BE FOUND UPON OPENING THE WOUND SITE. THERE WERE NO DEVICE BREAKAGES OR SURGICAL DELAYS DURING THE PROCEDURE. NO X-RAYS WERE ABLE TO BE OBTAINED. THE PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. THE EXPLANTED DEVICES ARE NOT AVAILABLE FOR ANALYSIS AS THEY WERE DISCARDED AT THE HOSPITAL. DEVICE IMAGES WERE PROVIDED. NO FURTHER INFORMATION.

  Patient problems: Insufficient Information; Muscle/Tendon Damage

  MAUDE report 19153877 ↗
• InjuryApr 16, 2024Fracture; Naturally Worn; Loosening of Implant Not Related to Bone-Ingrowth; Fracture; Naturally Worn; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED VIA A VOLUNTARY MEDWATCH, THAT A PATIENT, INITIAL RIGHT SHOULDER IMPLANTED ON (B)(6) 2020, UNDERWENT A REVISION PROCEDURE ON (B)(6) 2024, APPROXIMATELY 3 YEARS 6 MONTHS POST THE INITIAL PROCEDURE. AROUND THE FALL OF 2022, THE PATIENT STARTED TO EXPERIENCE PAIN IN THEIR RIGHT SHOULDER AND RIGHT ARM. GRADUALLY, THE PAIN WORSENED, AND THEY CONTACTED THE ORTHOPEDIC SURGEON WHO DID THE REPLACEMENT IN EARLY 2024. THEY COULD FEEL AND HEAR GRINDING IN THEIR SHOULDER WITH MOVEMENT AND WERE CONCERNED SOMETHING WAS WRONG. THEY HAD IMAGING DONE VIA THEIR ORTHOPEDIC SURGEON AND WAS TOLD THE SCREWS LOOKED LIKE THEY HAD LOOSENED. THEY COMPLETED 2 MONTHS OF THERAPY, WITH NO RELIEF. AFTER REPEAT IMAGING LATER IN 2023, THE SURGEON TOLD THEM THAT IT LOOKED LIKE THE GLENOID PART OF THEIR REPLACEMENT FAILED. THEY WERE GIVEN OPTIONS, ALL INCLUDING DIFFERENT SURGERIES. THEY CHOSE TO HAVE THE FAILED, FRACTURED PORTION SURGICALLY REMOVED ONLY. DURING THE SURGERY, IT WAS DISCOVERED THAT THE PROSTHETIC SOCKET WAS FRACTURED, WITH ALL 5 SCREWS LOOSE, AND THAT THE INSIDE OF THEIR SHOULDER JOINT WAS BLACK FROM THE GRINDING OF THE PROSTHESIS AND THE SCREWS. UNFORTUNATELY, 3 OF THE SCREWS FLOATED I

  Patient problems: Bone Fracture(s); Implant Pain; Metal Related Pathology

  MAUDE report 19122493 ↗
• InjuryApr 15, 2024Insufficient Device Problem Information; Loosening of Implant Not Related to Bone-Ingrowth; Insufficient Device Problem Information; Loosening of Implant Not Related to Bone-Ingrowth

  AS REPORTED, THE 69 YEAR OLD FEMALE PATIENT HAD AN INITIAL LEFT TSA ON (B)(6) 2016. THE PATIENT WAS REVISED AND ALL EXPLANTS REMOVED ON (B)(6) 2024; REASON NOT REPORTED. 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

  MAUDE report 19112109 ↗
• InjuryMar 25, 2024

  I HAD A RIGHT SHOULDER REPLACEMENT ON (B)(6) 2020. AROUND THE FALL OF 2022, I STARTED TO EXPERIENCE PAIN IN MY RIGHT SHOULDER AND RIGHT ARM. GRADUALLY, THE PAIN WORSENED, AND I CONTACTED THE ORTHOPEDIC SURGEON WHO DID THE REPLACEMENT IN EARLY 2023. I COULD FEEL AND HEAR GRINDING IN MY SHOULDER WITH MOVEMENT, AND WAS CONCERNED SOMETHING WAS WRONG. I HAD IMAGING DONE VIA MY ORTHOPEDIC SURGEON, AND WAS TOLD THE SCREWS LOOKED LIKE THEY HAD LOOSENED. I COMPLETED 2 MONTHS OF THERAPY, WITH NO RELIEF. AFTER REPEAT IMAGING LATER ON IN 2023, HE TOLD ME THAT IT LOOKED LIKE THE GLENOID PART OF MY REPLACEMENT FAILED. I WAS GIVEN OPTIONS, ALL INCLUDING DIFFERENT SURGERIES. I CHOSE TO HAVE THE FAILED, FRACTURED PORTION REMOVED ONLY SURGICALLY (B)(6) 2024. DURING THE SURGERY, IT WAS DISCOVERED THAT PROSTHETIC SOCKET WAS FRACTURED, WITH ALL 5 SCREWS LOOSE, AND THAT THE INSIDE OF MY SHOULDER JOINT WAS BLACK FROM THE GRINDING OF THE PROSTHESIS AND THE SCREWS. UNFORTUNATELY, 3 OF THE SCREWS FLOATED INTO MY TISSUES AND WERE UNABLE TO BE SAFELY REMOVED BECAUSE OF THEIR LOCATION TO NERVES. BECAUSE OF THIS, I LOST OVER A YEAR OF QUALITY OF LIFE, AS I AM RIGHT-HAND DOMINANT AND WAS UNABLE TO COMPLETE SIMPL

  Patient problems: Bone Fracture(s); Foreign Body In Patient; Pain

  MAUDE report 18977533 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K113309. One submission often covers many models, so check the product and lot details in each record.

• Z-1413-2024 · Mar 6, 2024 · Open, Classified
  Exactech Equinoxe CAGE GLENOID, CEMENTED, beta curvature, Mates with: a) 47, 50, 53 head, Medium, Item Number 314-13-13, b) 47, 50, 53 head, Large, Item Number 314-13-14, c) 47
• Z-1414-2024 · Mar 6, 2024 · Open, Classified
  Exactech Equinoxe CAGE GLENOID,POSTERIOR AUGMENT, CEMENTED, Left, Mates with: a) 38, 41, 44, 47 head, Small, Item Number 314-13-22, b) 41, 44, 47, 50, head, Medium, Item Number
• Z-1415-2024 · Mar 6, 2024 · Open, Classified
  Exactech Equinoxe CAGE GLENOID,POSTERIOR AUGMENT, CEMENTED, Right, Mates with: a) 38, 41, 44, 47 head, Small, Item Number 314-13-32, b) 41, 44, 47, 50, head, Medium, Item Numbe
• Z-0460-2021 · Oct 6, 2020 · Terminated
  Catalog 314-13-33, Equinoxe Cage Glenoid, Posterior Augment, Right, Medium
• Z-0459-2021 · Oct 6, 2020 · Terminated
  Catalog 314-13-23, Equinoxe Cage Glenoid, Posterior Augment, Left, Medium
• Z-0415-2018 · Aug 31, 2017 · Terminated
  Equinoxe Cage, Glenoid, Alpha, Medium Product Usage: The Equinoxe Shoulder System is indicated for use in skeletally mature individuals with degenerative diseases or fractures of
• Z-0414-2018 · Aug 31, 2017 · Terminated
  Equinoxe Cage, Glenoid, Alpha, Small Product Usage: The Equinoxe Shoulder System is indicated for use in skeletally mature individuals with degenerative diseases or fractures of t