Equinoxe 314-13-23 (UDI 10885862196170)Recalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 10885862196170), received between Jul 29, 2019 and Jun 23, 2025 — classified as 13 injuries.

The most frequently reported specific device problem is “Loosening of Implant Not Related to Bone-Ingrowth” (5 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-1414-2024 · Root cause: Nonconforming Material/Component · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 13 most recent of 13 reports, in the reporter's own words as published by the FDA.

• InjuryJun 23, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THIS PATIENT'S SHOULDER WAS REVISED APPROXIMATELY 1 YEARS 4 MONTHS POST INITIAL OPERATION. THE PATIENT WAS CONVERTED FROM A STEMLESS SHOULDER SYSTEM TO AN ANATOMIC SHOULDER SYSTEM DUE TO ROTATOR CUFF FAILURE. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT.

  Patient problems: Muscle/Tendon Damage

  MAUDE report 22307481 ↗
• InjuryMay 28, 2025Fracture; Naturally Worn; Fracture; Naturally Worn

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN INITIAL ANATOMIC SHOULDER REPLACEMENT ON THE LEFT SIDE. SUBSEQUENTLY, THE PATIENT EXPERIENCED PAIN AND SUSPECTED INFECTION. AS A RESULT, APPROXIMATELY SIX YEARS, FIVE MONTHS POST-SURGERY, THE PATIENT UNDERWENT A REVISION. 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. THIS IS REPORT 1 OF 2 FOR THIS EVENT/PATIENT.

  Patient problems: Pain; Unspecified Infection

  MAUDE report 22096061 ↗
• InjuryOct 2, 2024Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  AS REPORTED, APPROXIMATELY 4 YEARS AND 6 MONTHS POST THE INITIAL LEFT TSA, THE PATIENT COMPLAINED OF PAIN AND WAS REVISED DUE TO ASEPTIC LOOSENING. 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: Pain

  MAUDE report 20352327 ↗
• InjurySep 17, 2024Detachment of Device or Device Component; Device Dislodged or Dislocated; Loosening of Implant Not Related to Bone-Ingrowth; Detachment of Device or Device Component; Device Dislodged or Dislocated; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT THIS MALE PATIENT'S LEFT SHOULDER WAS REVISED APPROXIMATELY 5 YEARS 9 MONTHS POST OP. SURGEON PRESENTED X RAYS TO REP, NOTICING SUPERIOR MIGRATION OF HUMERUS, PROXIMAL HUMERUS/MEDIAL CALCAR BONE LOSS, AND GLENOID DISLODGED. PLAN TO REVISE TO RTSA. UPON EXPOSURE, REPLICATOR PLATE AND HEAD WERE REMOVED. UPON GLENOID EXPOSURE, GLENOID WAS VERY LOOSE AND WAS PULLED OUT WITH A COCHER. THE CENTER CAGE REMAINED BUT THE PEGS CAME WITH THE POLY. THERE WAS SIGNIFICANT BONE LOSS IN THE 1-2 O CLOCK AND 7 TO 8 O CLOCK POSITIONS ON THE GLENOID FACE, LEAVING CORTEX WITH CANCELLOUS BONE GONE/CAVITATED HOLES. THERE WAS SIGNIFICANT BONE LOSS OF THE LESSER TUBEROSITY AND SOME ON THE MEDIAL CALCAR, EXPOSING SOME OF THE PRESS FIT OF THE STEM. STEM WAS VERY WELL FIXATED. CAVITATED HOLES WERE FILLED WITH DBM PUTTY AND CRUSHED CANCELLOUS MIXTURE. PLANNED TO USE +10 PEG FOR REVERSE, DRILLED TO DEPTH, ACHIEVED GREAT SCREW FIXATION AND PRESS FIT OF PEG. REVERSE SHOULDER ARTHROPLASTY WAS ACHIEVED. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT.

  Patient problems: Insufficient Information

  MAUDE report 20239707 ↗
• InjuryAug 22, 2024Fracture; Naturally Worn; Fracture; Naturally Worn

  IT WAS REPORTED THAT THIS PATIENT'S SHOULDER WAS REVISED APPROXIMATELY 5 YEARS 10 MONTHS POST OP. THE REVISION WAS DUE TO PAIN. EXTENSIVE BONE GRAFTING WAS DONE. NO BASEPLATE WAS IMPLANTED AT THIS TIME. SURGEON WANTED TO LET THE BONE GRAFT HEAL AS MUCH AS POSSIBLE AND THEN WILL COMPLETE THE SURGERY IN A FEW MONTHS. NO ISSUES WITH SURGERY TODAY.

  Patient problems: Insufficient Information; Pain

  MAUDE report 20040922 ↗
• InjuryApr 30, 2024Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  AS REPORTED BY THE EQUINOXE SHOULDER STUDY, THE 61-YEAR-OLD WHITE FEMALE HAD A LEFT TSA ON (B)(6) 2016. THE PATIENT PRESENTED WITH ASEPTIC GLENOID LOOSENING ON UNK-UNK-2023. THE PATIENT HAD NOT BEEN SEEN SINCE 2021. LIMITED INFORMATION AVAILABLE. APPEARED TO BE ASEPTIC GLENOID LOOSENING. THE PATIENT UNDERWENT A STANDARD TOTAL REVISION SURGERY ON (B)(6) 2024 AND THE OUTCOME OF THIS EVENT IS CONSIDERED RESOLVED. THE CASE REPORT FORM INDICATES THAT THIS EVENT IS POSSIBLY RELATED TO THE DEVICE AND DEFINITELY NOT RELATED 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 19217958 ↗
• InjuryApr 15, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED BY THE EQUINOXE SHOULDER STUDY, THE 38-YEAR-OLD WHITE MALE HAD A LEFT TSA ON (B)(6) 2017. THE PATIENT PRESENT WITH INFECTION ON (B)(6) 2018. PATIENT HAS AN INCREASINGLY STIFF SHOULDER THAT BEGAN QUITE SUDDENLY HOWEVER, GETTING WORSE AND FEAR P-ACNES INFECTION. THE PATIENT UNDERWENT THE ACTION OF STANDARD TOTAL W-PRESERVE STEM REVISION SURGERY ON (B)(6) 2018. TOOK CULTURES DURING PROCEDURE AND THEY PRESENTED NEGATIVE. PATIENT FORMED A SIGNIFICANT AMOUNT OF CALCIFICATION AROUND AT THE SUBSCAP INSERTION. THE OUTCOME OF THIS EVENT IS CONSIDERED TO BE RESOLVED. THE CASE REPORT FORM INDICATES THAT THIS EVENT IS POSSIBLY RELATED TO THE DEVICE AND DEFINITELY RELATED TO THE PROCEDURE. THIS EVENT REPORT WAS RECEIVED THROUGH CLINICAL DATA COLLECTION ACTIVITIES AND NO DEVICE RETURN IS ANTICIPATED.

  Patient problems: Unspecified Infection

  MAUDE report 19112288 ↗
• InjurySep 22, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  AS REPORTED, THE PATIENT HAD AN INITIAL TSA ON (B)(6) 2020. THE PATIENT PRESENTED ON (B)(6) 2023 AND HAD MECHANICAL LOOSENING OF PROSTHETIC JOINT. THE PATIENT WAS REVISED (B)(6) 2023. THE CASE REPORT FORM INDICATES THAT THIS EVENT IS DEFINITELY RELATED TO DEVICE, UNLIKELY RELATED TO PROCEDURE. OUTCOME: CONTINUING.

  Patient problems: Failure of Implant; Insufficient Information

  MAUDE report 17802825 ↗
• InjuryFeb 16, 2023Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information

  AS REPORTED, APPROXIMATELY SIX MONTHS POST INITIAL LEFT SIDE TSA, THE 68 Y/O FEMALE PATIENT HAD A REVISION DUE TO PRIMARY GLENOID FAILURE AND PATIENT WAS CONVERTED TO A REVERSE TSA. THERE WAS NO BREAKAGE OF DEVICE OR SURGICAL DELAY/PROLONGATION. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. SALES REP WAS UNABLE TO OBTAIN X-RAYS. THE DEVICE IS NOT AVAILABLE FOR EVALUATION. NO OTHER PATIENT INFORMATION/MEDICAL HISTORY REPORTED.

  Patient problems: Failure of Implant; Insufficient Information

  MAUDE report 16390063 ↗
• InjuryDec 22, 2021Fracture; Fracture

  AS REPORTED, ALMOST 2 YEARS POST OP LEFT TSA, THIS MALE PATIENT EXPERIENCED DISCOMFORT FOR LESS THAN A 1 YEAR AFTER SURGERY. SURGEON REMOVED THE CAGED GLENOID, POLY HAD SHEERED OFF. CENTER CAGE WAS WELL FIXED IN GLENOID BUT POLY + 3 PERIPHERAL PEGS WERE LOOSE. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT.

  Patient problems: Failure of Implant

  MAUDE report 13060454 ↗
• InjuryJun 25, 2021Fracture; Fracture

  AS REPORTED, APPROXIMATELY ONE YEAR POSTOP THE INITIAL LTSA FOR THIS 70 Y/O MALE, THE GLENOID PLASTIC SHEARED OFF THE CENTER PEG AND WAS CAUSING THE PATIENT A LOT OF PAIN AND WAS REVISED TO A REVERSE WITH A SHORT STEM. IT WAS REPORTED THERE WAS NO TRAUMA. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. DEVICE WILL NOT RETURN DUE TO FACILITY POLICY.

  Patient problems: Failure of Implant

  MAUDE report 12067150 ↗
• InjuryFeb 10, 2021Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  AS REPORTED, THIS (B)(6) PATIENT EXPERIENCED LEFT ASEPTIC GLENOID LOOSENING. COMPLETE GLENOID LOOSENING MIGRATION OF THE PEGS. THE CASE REPORT FORM INDICATES THIS EVENT IS POSSIBLY RELATED TO DEVICES AND NOT RELATED TO PROCEDURE. THIS PATIENT HAS A HISTORY OF OSTEOARTHRITIS. THIS EVENT REPORT WAS RECEIVED THROUGH CLINICAL DATA COLLECTION ACTIVITIES. THE DEVICE IS RETURNING FOR EVALUATION.

  Patient problems: Failure of Implant

  MAUDE report 11306670 ↗
• InjuryJul 29, 2019Loosening of Implant Not Related to Bone-Ingrowth; Loss of Osseointegration; Loosening of Implant Not Related to Bone-Ingrowth

  PRIMARY SURGERY: (B)(6) 2019. SURGEON HAD TO DO SURGERY ON A PATIENT WITH NONUNION OF THE TUB. MINUS ON LEFT SHOULDER. HE TREATED THE NONUNION WITHOUT COMPLICATIONS. WHILE HE WAS DOING SO, HE REALIZED THAT THE POLY OF THE GLENOID WAS LOOSE. THE CAGE AND TWO PEGS WHERE TIGHTLY CONNECTED TO THE BONE; ONE PEG WAS STILL CONNECTED TO THE POLY BUT NOT INTEGRATED IN THE BONE. THE POLY WAS SHEERED OF THE CAGE AND THE TWO INTEGRATED PEGS.

  Patient problems: Failure of Implant; Inadequate Osseointegration

  MAUDE report 8837795 ↗

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-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-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-1412-2024 · Mar 6, 2024 · Open, Classified
  Exactech Equinoxe CAGE GLENOID, CEMENTED, alpha curvature, Mates with: a) 38, 41, 44 head, Small, Item Number 314-13-02, b) 38, 41, 44 head, Medium, Item Number 314-13-03, c) 3
• 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