Equinoxe 314-13-33 (UDI 10885862201010)Recalls & reported problems

Summary

The FDA's MAUDE database contains 38 adverse event reports that list this exact device (DI 10885862201010), received between Nov 14, 2019 and Jan 5, 2026 — classified as 38 injuries.

The most frequently reported specific device problem is “Loosening of Implant Not Related to Bone-Ingrowth” (24 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 18, 2026.

Recalls naming this device

1. Mar 6, 2024Class IIOpen, 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-1415-2024 · Root cause: Nonconforming Material/Component · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 38 reports, in the reporter's own words as published by the FDA.

• InjuryJan 5, 2026Fracture; Peeled/Delaminated

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN INITIAL RIGHT TOTAL SHOULDER ARTHROPLASTY. SUBSEQUENTLY, IT WAS REPORTED THAT THE PATIENT EXPERIENCED INFECTION AND THE PATIENT'S GLENOID COMPONENT WAS FOUND TO BE WORN AND FRACTURED. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION OF THEIR SHOULDER COMPONENTS AND IMPLANTATION OF AN ANTIBIOTIC SPACER AS STAGE 1 OF A 2 STAGE REVISION. NO FURTHER PATIENT IMPACT REPORTED. NO FURTHER INFORMATION AVAILABLE. THIS IS REPORT 1 OF 2 FOR THIS EVENT.

  Patient problems: Unspecified Infection

  MAUDE report 23958184 ↗
• InjuryDec 31, 2025Fracture; Fracture

  IT WAS REPORTED THAT A MALE PATIENT WHO HAD A RIGHT TSA, UNDERWENT A REVISION PROCEDURE. DISLOCATION REPORTED. THE PATIENT HAD A FAILED ANATOMIC SHOULDER DUE TO CENTRAL CAGE BREAKAGE OF THE GLENOID COMPONENT. ADDITIONAL INFORMATION INDICATED THE CAGE WAS COMPLETELY DISENGAGED FROM THE POLY, POTENTIALLY UPON IMPACTION DURING IMPLANTATION. EVERYTHING WAS REMOVED. THERE WAS DEVICE BREAKAGE REPORTED BUT NO PARTS OR PIECES FELL INTO THE WOUND SITE. 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. THEY WERE DISCARDED. NO DEVICE IMAGES WERE PROVIDED. NO FURTHER INFORMATION.

  Patient problems: Joint Dislocation

  MAUDE report 23934859 ↗
• InjuryOct 27, 2025Fracture; Fracture

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN INITIAL RIGHT TOTAL SHOULDER ARTHROPLASTY. SUBSEQUENTLY, IT WAS REPORTED THAT THE PATIENT'S GLENOID COMPONENTS HAD A SHEAR FAILURE WHICH WAS POTENTIALLY CAUSED BY A FALL. AS A RESULT, THE PATIENT UNDERWENT A RIGHT SHOULDER REVISION APPROXIMATELY 7 YEARS AND 2 MONTHS AFTER INITIAL IMPLANTATION. NO FURTHER PATIENT IMPACT REPORTED. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: Insufficient Information

  MAUDE report 23393940 ↗
• InjuryJul 28, 2025Naturally Worn; Naturally Worn

  AS REPORTED, APPROXIMATELY 3 YEARS AND 6 MONTHS POST THE INITIAL RIGHT TOTAL SHOULDER ARTHROPLASTY, THE PATIENT WAS REVISED DUE TO AN OSTEOPHYTE AND NO RANGE OF MOTION. THIS WAS REMOVED, AND WHILE IT HELPED IT WAS NOTED THAT THE SIZE OF THE HEAD WAS ALSO TOO SMALL. IT WAS AT THE MAXIMUM HEAD SIZE ANYWAY. THERE WAS ALSO GLENOID WEAR FROM THE INCORRECT SIZE HEAD, AND ALSO OSTEOPHYTE. THE SURGEON DECIDED TO TAKE THE STEMLESS OUT AND KEEP THE GLENOID. HE OPTED FOR AN EQUINOXE STANDARD STEM WITH AN ANATOMIC HEAD. THIS GIVES THE PATIENT THE OPTION WHEN REVISION IS NEEDED OF THE GLENOID DUE TO WEAR OF A REVERSE STEM. ALL COMPONENTS WERE WELL FIXED FROM THE ORIGINAL SURGERY. 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: Extraskeletal ossification; Loss of Range of Motion

  MAUDE report 22629835 ↗
• InjuryMay 16, 2025Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN INITIAL STEMLESS TOTAL SHOULDER REPLACEMENT ON THE RIGHT SIDE. SUBSEQUENTLY, THE PATIENT EXPERIENCED ASEPTIC GLENOID LOOSENING. AS A RESULT, APPROXIMATELY 1.5 YEARS 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: Insufficient Information

  MAUDE report 22040036 ↗
• InjuryMay 13, 2025Fracture; Naturally Worn; Loosening of Implant Not Related to Bone-Ingrowth; Migration; Fracture; Naturally Worn; Loosening of Implant Not Related to Bone-Ingrowth; Migration

  IT WAS REPORTED THAT THIS PATIENT'S RIGHT SHOULDER WAS REVISED APPROXIMATELY 8 YEARS 3 MONTHS POST INITIAL OPERATION. THE PATIENT HAD WEAR ON THE GLENOID CAGE. SUPERIOR PEG AND CENTRAL PEG WERE REMOVED FROM PATIENT. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions; Pain

  MAUDE report 22014289 ↗
• InjuryApr 1, 2025Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN INITIAL TOTAL SHOULDER REPLACEMENT ON THE RIGHT SIDE. SUBSEQUENTLY, THE PATIENT EXPERIENCED ASEPTIC GLENOID LOOSENING. IT WAS ALSO NOTED BY THE PATIENT THAT THEY DEVELOPED WORSENING PAIN OVER TIME WITHOUT INCITING EVENT. AS A RESULT, APPROXIMATELY 6 YEARS AFTER INITIAL SHOULDER REPLACEMENT, THE PATIENT UNDERWENT A RIGHT SHOULDER REVISION. NO FURTHER IMPACT TO THE PATIENT WAS REPORTED. NO OTHER INFORMATION IS AVAILABLE.

  Patient problems: Inadequate Osseointegration; Pain

  MAUDE report 21742118 ↗
• InjuryFeb 12, 2025Fracture; Device Dislodged or Dislocated; Naturally Worn; Loosening of Implant Not Related to Bone-Ingrowth; Migration; Fracture; Device Dislodged or Dislocated; Naturally Worn; Loosening of Implant Not Related to Bone-Ingrowth; Migration

  IT WAS REPORTED THAT A MALE PATIENT, INITIAL RIGHT SHOULDER IMPLANTED ON AN UNKNOWN DATE, UNDERWENT A REVISION PROCEDURE IN (B)(6) 2025. THE PATIENT HAD DISLOCATED AND WAS X-RAYED WHICH SHOWED A BROKEN GLENOID. THEY WERE BOOKED TO REVISE. THE SURGEON REMOVED THE BROKEN IMPLANT. THE CAGE WAS SNAPPED AND HAD MIGRATED AS PER THE X RAY. THE WOUND WAS INFECTED AROUND THE BREAKAGE. ALL PARTS AND PIECES WERE REMOVED, AND NO FRAGMENTS HAD FALLEN INTO THE WOUND SITE. THE CAGE HAD SNAPPED OFF AND WAS NOT ATTACHED TO THE BASEPLATE. THERE WERE SIGNIFICANT SIGNS OF WEAR TO THE POLY. A SPACER WAS IMPLANTED, AND A NEW CT WAS ORDERED. IT LOOKS LIKE THE PATIENT WILL NEED A CUSTOM AND HRP DUE TO BONE LOSS. THE PATIENT REQUIRED PROLONGED HOSPITALIZATION AS A DIRECT RESULT OF THIS ISSUE. THEY ARE WAITING FOR THE INFECTION TO CLEAR AND CTS TO BE DONE TO FORMULATE A PLAN OF NEXT STEPS. THERE WERE NO SURGICAL DELAYS DURING THE PROCEDURE. DEVICE IMAGES AND X-RAYS WERE PROVIDED. THE EXPLANTED DEVICES ARE AVAILABLE FOR RETURN. NO FURTHER INFORMATION.

  Patient problems: Joint Dislocation; Osteolysis; Unspecified Infection

  MAUDE report 21366762 ↗
• InjuryFeb 6, 2025Naturally Worn; Loosening of Implant Not Related to Bone-Ingrowth; Naturally Worn; Loosening of Implant Not Related to Bone-Ingrowth

  APPROXIMATELY 6 YEAR(S), 10 MONTH(S) AND 10 DAY(S) POST-OPERATIVE OF A RIGHT TSA, IT WAS REPORTED VIA CLINICAL STUDY THAT THE PATIENT EXPERIENCED ASEPTIC GLENOID LOOSENING AND POLYETHYLENE WEAR WITH OR WITHOUT OSTEOLYSIS. PATIENT REPORTED INCREASED PAIN AND REPORTED FALLS. THE PATIENT WILL BE MONITORED EVERY 6 MONTHS FOR CHANGES. PATIENT ELECTED TO NOT PURSUE FURTHER WORK UP AND POSSIBLE REVISION AT THIS TIME. THE OUTCOME OF THIS EVENT IS CONSIDERED CONTINUING, AND THE CASE REPORT FORM INDICATES THAT THIS EVENT IS POSSIBLY RELATED TO THE DEVICE(S) AND UNLIKELY 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: Fall; Inadequate Osseointegration; Pain

  MAUDE report 21324123 ↗
• InjuryFeb 3, 2025Detachment of Device or Device Component; Naturally Worn; Detachment of Device or Device Component; Naturally Worn

  AS REPORTED, IT WAS SUSPECTED THAT THE GLENOID POLYETHYLENE HAD DISSOCIATED. APPROXIMATELY 5 YEARS AND 8 MONTHS POST THE INITIAL RIGHT TOTAL SHOULDER ARTHROPLASTY, THE PATIENT WAS REVISED AND THE FINDINGS SHOWED THAT THE POLY HAD SEVERE WEAR PATTERNS THAT HAD CAUSED LYSIS AND METALLOSIS. THE SURGEON SAID THERE HAS BEEN NO EVENT TO CAUSE SUCH WEAR. THE PATIENT HAD THE GLENOID REMOVED AND A JUMBO HEMI LEFT IN PLACE. 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: Metal Related Pathology; Osteolysis

  MAUDE report 21293292 ↗
• InjuryJan 2, 2025Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  APPROXIMATELY 1 YEAR(S), 10 MONTH(S) AND 11 DAY(S) POST-OPERATIVE OF A RIGHT TSA, IT WAS REPORTED VIA CLINICAL STUDY THAT THE PATIENT EXPERIENCED ASEPTIC GLENOID LOOSENING WITH POSTERIOR-SUPERIOR CUFF TEAR AND WEAKNESS. THE PATIENT UNDERWENT A STANDARD TOTAL WITH STEMLESS HUMERAL COMPONENT REVISION FOR THE LOOSENING. THE OUTCOME OF THIS EVENT IS CONSIDERED RESOLVED AND THE CASE REPORT FORM INDICATES THAT THIS EVENT IS POSSIBLY RELATED TO THE DEVICE AND DEFINITELY NOT 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: Muscle Weakness/Atrophy; Muscle/Tendon Damage

  MAUDE report 21061233 ↗
• InjuryNov 19, 2024Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT THIS PATIENT UNDERWENT RIGHT TOTAL SHOULDER REPLACEMENT AND RIGHT SHOULDER BICEPS TENODESIS FOR OSTEOARTHRITIS AND BICEPS TENDINITIS OF THE RIGHT SHOULDER. THE PATIENT WAS DISCHARGED HOME. THE PATIENT DID WELL POSTOPERATIVELY FOR 4+ YEARS. HE PRESENTED FOR AN OFFICE VISIT AT WHICH TIME HE REPORTED HE DEVELOPED PAIN ABOUT A YEAR AGO. XR OF THE RIGHT SHOULDER SHOWED SOME SUPERIOR MIGRATION OF THE HUMERAL HEAD. DISRUPTION OF THE TITANIUM PEGS ON THE BACK OF THE GLENOID COMPONENT WAS QUESTIONED. CT SCAN DONE, SURGEON DISCUSSED WITH THE PATIENT ON THAT THE CT SHOWED LOOSENING OF THE GLENOID COMPONENT, AND DISCUSSED REVISION TO REVERSE SHOULD REPLACEMENT, WHICH THE PATIENT WAS GOING TO THINK ABOUT. AT OFFICE VISIT, ON RIGHT SHOULDER X-RAY SHOWED "ANATOMIC SHOULDER REPLACEMENT IN ALIGNMENT. THERE IS SOME SUPERIOR MIGRATION OF THE HUMERAL HEAD. THERE IS SOME DISRUPTION OF THE TITANIUM PEGS ON THE BACK OF THE GLENOID COMPONENT." THE PATIENT UNDERWENT RIGHT SHOULDER REVISION - REVERSE SHOULDER PLACEMENT AND RIGHT ARTHROTOMY SHOULDER BICEPS TENODESIS FOR LOOSENING OF THE GLENOID ASSOCIATED WITH PAIN. INTRAOPERATIVELY THERE WERE NO GROSS SIGNS FOR INFECTION. HUMERAL COMPON

  Patient problems: Arthralgia; Joint Laxity; Joint effusion; Osteolysis; Pain

  MAUDE report 20724241 ↗
• InjuryNov 4, 2024Fracture; Insufficient Device Problem Information; Lack of Effect; Fracture; Insufficient Device Problem Information; Lack of Effect

  IT WAS REPORTED THAT THIS PATIENT'S RIGHT SHOULDER WAS REVISED APPROXIMATELY 4 YEARS 8 MONTHS POST OP. THE PATIENT COMPLAINED ABOUT SOME MILD PAIN & REDUCED MOVEMENT IN SHOULDER. SURGEON SUSPECTED IMPLANT FAILURE, WHICH WAS CONFIRMED VIA CT SCAN AND DURING REMOVAL WITH A SPACER CONSTRUCTED AND LEFT IN. FIRST STAGE REVISION COMPLETED WITH ANTIBACTERIAL SPACER USED TO COMBAT INFECTION AND MAINTAIN JOINT SPACE. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. PRODUCT NOT RETURNING: DISCARDED.

  Patient problems: Loss of Range of Motion; Pain; Unspecified Infection

  MAUDE report 20599581 ↗
• InjuryOct 22, 2024Naturally Worn; Loosening of Implant Not Related to Bone-Ingrowth; Naturally Worn; Loosening of Implant Not Related to Bone-Ingrowth

  THE MALE PATIENT UNDERWENT A REVISION PROCEDURE ON (B)(6) 2025, APPROXIMATELY 7 YEARS 6 MONTHS POST THE INITIAL PROCEDURE. IT WAS DETERMINED THERE WAS OSTEOLYSIS AROUND THE GLENOID PEGS AND IN THE PROXIMAL HUMERUS. EVERYTHING WAS REMOVED. 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 PROVIDED. THE DEVICES ARE NOT AVAILABLE FOR RETURN AS THEY WERE DISPOSED BY THE CUSTOMER. NO FURTHER INFORMATION.

  Patient problems: Inflammation; Osteolysis; Pain

  MAUDE report 20505127 ↗
• InjurySep 30, 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 5 YEARS AND 5 MONTHS POST THE INITIAL RIGHT TOTAL SHOULDER REPLACEMENT AND RIGHT SHOULDER BICEPS TENODESIS, THE PATIENT CAME IN FOR AN OFFICE VISIT AND REPORTED THAT THEY DEVELOPED PAIN IN THE RIGHT SHOULDER ABOUT 2 YEARS PRIOR. X-RAY OF THE RIGHT SHOULDER SHOWED EVIDENCE OF LOOSENING OF THE GLENOID COMPONENT AND OSTEOLYSIS AROUND THE HUMERAL COMPONENT. THE PLAN WAS FOR A CT SCAN OF THE RIGHT SHOULDER AND ASPIRATION OF THE JOINT TO RULE OUT INFECTION. THE PATIENT'S ESR WAS ELEVATED, BUT THE CRP, WHITE COUNT, ASPIRATION, AND CULTURES WERE ALL NEGATIVE FOR INFECTION. THE SURGEON EXPLAINED TO THE PATIENT THAT THE TEST RESULTS ARE CONSISTENT WITH GLENOID LOOSENING WITH OSTEOLYSIS IN THE GLENOID. IT WAS DISCUSSED THAT THE PLAN MOVING FORWARD WOULD BE A REVISION TO A REVERSE SHOULDER REPLACEMENT. HOWEVER, IN THAT THERE WAS A FAIR AMOUNT OF BONE LOSS IN THE GLENOID, THE PATIENT WOULD EITHER REQUIRE BULK ALLOGRAFTING OR A CUSTOM IMPLANT. 5 YEARS AND 11 MONTHS POST THE INITIAL TOTAL SHOULDER REPLACEMENT THE PATIENT UNDERWENT RIGHT REVISION SHOULDER ARTHROPLASTY, CONVERSION FROM ANATOMIC TO REVERSE SHOULDER ARTHROPLASTY, FOR RIGHT SHOULDER GLENOID LOOSENING. INTRA-

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Implant Pain; Osteolysis

  MAUDE report 20340894 ↗
• InjurySep 17, 2024Fracture; Unstable; Fracture; Unstable

  AS REPORTED, APPROXIMATELY 5 YEARS AND 11 MONTHS POST THE INITIAL RIGHT TSA, THE PATIENT UNDERWENT REVISION SURGERY. MP STATES THAT HE SUSPECTS THE CENTRAL CAGE SHEARED OFF OF THE GLENOID IMPLANT. THE HUMERAL HEAD WAS UPSIZED. THERE WAS NO REPORTED SURGICAL DELAY/PROLONGATION. THE PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT.

  Patient problems: Insufficient Information; Joint Laxity; Pain

  MAUDE report 20242952 ↗
• InjuryAug 27, 2024Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  APPROXIMATELY 5 YEAR(S), 7 MONTH(S) AND 15 DAY(S) POST-OPERATIVE OF A RIGHT TSA, IT WAS REPORTED VIA CLINICAL STUDY THAT THE PATIENT EXPERIENCED ASEPTIC GLENOID LOOSENING. PATIENT PRESENTED WITH GLENOID LOOSENING, DISASSOCIATION OF POLY. THE PATIENT UNDERWENT A 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 DEFINITELY NOT RELATED TO THE PROCEDURE.

  Patient problems: Insufficient Information

  MAUDE report 20076335 ↗
• InjuryJun 28, 2024Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  APPROXIMATELY 3 YEAR(S) 1 MONTH(S) AFTER AN INITIAL RIGHT TSA, THE PATIENT EXPERIENCED PROGRESSIVE PAIN WITHOUT INJURY OVER THE COURSE OF 1 YEAR, REPORTEDLY DUE TO ASEPTIC GLENOID LOOSENING. NO ACTION HAS BEEN TAKEN, THE DEVICE(S) REMAIN IMPLANTED, AND THE OUTCOME IS CONTINUING. THE EVENT IS DEFINITELY NOT RELATED TO THE DEVICE AND IS POSSIBLY RELATED TO THE PROCEDURE.

  Patient problems: Inadequate Osseointegration; Pain

  MAUDE report 19633514 ↗
• InjuryJun 27, 2024Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  APPROXIMATELY 5 YEARS 3 MONTHS AFTER INITIAL RIGHT TSA, THE PATIENT EXPERIENCED INCREASING PAIN OVER 2 YEARS AND ASEPTIC GLENOID LOOSENING. THE PATIENT WAS REVISED TO A STANDARD TOTAL SHOULDER WITH A STEMLESS AND THE OUTCOME IS CONSIDERED RESOLVED. THE CASE REPORT INDICATES THAT THE EVENT IS NOT RELATED TO THE DEVICE OR TO THE PROCEDURE.

  Patient problems: Pain

  MAUDE report 19629687 ↗
• InjuryJun 25, 2024Naturally Worn; Loosening of Implant Not Related to Bone-Ingrowth; Naturally Worn; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT THIS 74 Y/O MALE PATIENT UNDERWENT A RIGHT TOTAL SHOULDER REPLACEMENT APPROXIMATELY 4 YEARS AND 11 MONTHS POST OP. PATIENT HAD RIGHT SHOULDER OSTEOARTHRITIS AND BICEPS TENDONITIS. THE PATIENT WAS DISCHARGED HOME. THE PATIENT WAS DOING WELL AS OF (B)(6) 2018. THE PATIENT CONTACTED THE SURGEON TO REPORT THAT OVER THE PAST YEAR HE EXPERIENCED INCREASING PAIN AND DECREASING FUNCTION OF HIS RIGHT SHOULDER UNTIL THE POINT WHERE HE HAS VERY LITTLE FUNCTION OF THE RIGHT SHOULDER. HE WAS WORKED UP BY A SURGEON OUTSIDE OF HSS AND WAS DIAGNOSED WITH GLENOID FAILURE, FOR WHICH HE WAS INDICATED FOR REVISION TO REVERSE SHOULDER, PROVIDED THERE WAS NO EVIDENCE OF INFECTION. SURGEON REVIEWED HIS X-RAYS (FROM FACILITY OUTSIDE OF HSS) THAT SHOWED IT APPEARED THAT HE HAD LOOSENING OF THE GLENOID COMPONENT. THE PATIENT UNDERWENT A REVISION/CONVERSION OF FAILED RIGHT TOTAL SHOULDER TO REVERSE SHOULDER REPLACEMENT WITH GLENOID BONE GRAFTING AND HUMERAL OSTEOTOMY W/ CERCLAGE REPAIR AT AN OUTSIDE FACILITY. INTRAOPERATIVELY, WITH DISSECTION ON THE PROXIMAL HUMERUS DOWN TO THE LEVEL OF THE DELTOID LATERALLY, RELEASING SUBDELTOID ADHESIONS " THERE IS SIGNIFICANT STIFFNESS AND ALREADY POL

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Pain

  MAUDE report 19611245 ↗
• InjuryApr 30, 2024Adverse Event Without Identified Device or Use Problem; Loosening of Implant Not Related to Bone-Ingrowth; Adverse Event Without Identified Device or Use Problem; Loosening of Implant Not Related to Bone-Ingrowth

  AS REPORTED BY THE EQUINOXE SHOULDER STUDY, THE 69-YEAR-OLD WHITE FEMALE HAD A RIGHT TSA ON (B)(6) 2020. THE PATIENT PRESENTED WITH ASEPTIC GLENOID LOOSENING ON (B)(6) 2024. THE PATIENT UNDERWENT A 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 19218038 ↗
• InjuryApr 23, 2024Fracture; Fracture

  AS REPORTED, APPROXIMATELY FIVE YEARS POST INITIAL RIGHT TSA, THE FEMALE PATIENT HAD A FAILURE OF ANATOMIC SHOULDER REPLACEMENT. PATIENT HAD A REVISION OF LEGACY CAGED GLENOID, THE CENTRAL CAGE APPEARED TO HAVE DISASSOCIATED FROM THE POLY. THERE WERE NO FRAGMENTS, PARTS OR PIECES THAT FELL INTO THE PATIENT WOUND SITE. THERE WAS NO SURGICAL DELAY/PROLONGATION. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT . IMAGES RECEIVED. SALES REP WAS UNABLE TO OBTAIN X-RAYS. THE DEVICE IS NOT AVAILABLE FOR EVALUATION DUE TO LOST AFTER CASE.

  Patient problems: Failure of Implant; Osteolysis

  MAUDE report 19169322 ↗
• InjuryApr 22, 2024Fracture; Fracture

  IT WAS REPORTED THAT A 78 YO MALE PATIENT, INITIAL RIGHT SHOULDER IMPLANTED ON (B)(6) 2019, UNDERWENT A REVISION PROCEDURE ON (B)(6) 2024, APPROXIMATELY 4 YEARS 3 MONTHS POST THE INITIAL PROCEDURE. THE PATIENT HAD PROGRESSIVE DETERIORATION OF THEIR IMPLANT. THE SURGEON ELECTED TO REMOVE THE IMPLANTS DUE TO IMPLANT FAILURE WHICH WERE WORN OVER TIME WHILE IN SITU. THE PATIENT WAS REVISED TO EXACTECH DEVICES. DURING THE PROCEDURE, THE SURGEON WAS ABLE TO RETAIN THE EXISTING STEM AND HE REVISED THE GLENOID TO A REVERSE CONSTRUCT. ALL PIECES OF THE IMPLANT WHICH WERE WORN AND FRAGMENTED WERE REMOVED FROM THE PATIENT. THERE WERE NO 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 AVAILABLE FOR RETURN, DEVICE IMAGES WERE PROVIDED. NO FURTHER INFORMATION.

  Patient problems: Failure of Implant; Insufficient Information

  MAUDE report 19153924 ↗
• InjuryJan 11, 2024Fracture; Loosening of Implant Not Related to Bone-Ingrowth; Fracture; Loosening of Implant Not Related to Bone-Ingrowth

  AS REPORTED BY THE EQUINOXE SHOULDER STUDY, APPROXIMATELY THREE YEARS POST INITIAL RIGHT TSA, THE 61 Y/O PATIENT STARTED EXPERIENCING PAIN, CATCHING, CRUNCHING. X-RAYS SHOWED GLENOID LOOSENING AND DISASSOCIATION OF POLYETHYLENE. PATIENT HAD A REVISION ON (B)(6) 2023 AND THE EVENT WAS RESOLVED. PER CLINICAL STUDY THE REPORTED EVENT IS DEFINITELY RELATED TO THE DEVICE AND THE PROCEDURE.

  Patient problems: Aseptic loosening; Failure of Implant; Pain

  MAUDE report 18498011 ↗
• InjurySep 20, 2023Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  AS REPORTED, THE PATIENT HAD AN INITIAL RIGHT TSA ON (B)(6) 2020. THE PATIENT PRESENTED ON (B)(6) 2022 AND BEGAN HAVING PAIN IN (B)(6) 2022; NO INJURY. THE PATIENT WAS REVISED (B)(6) 2023. THE CASE REPORT FORM INDICATES THAT THIS EVENT IS DEFINITELY NOT RELATED TO DEVICE, DEFINITELY NOT RELATED TO PROCEDURE. OUTCOME: RESOLVED ON (B)(6) 2023.

  Patient problems: Failure of Implant; Pain

  MAUDE report 17780978 ↗

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-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-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-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-0459-2021 · Oct 6, 2020 · Terminated
  Catalog 314-13-23, Equinoxe Cage Glenoid, Posterior Augment, Left, Medium
• Z-0460-2021 · Oct 6, 2020 · Terminated
  Catalog 314-13-33, Equinoxe Cage Glenoid, Posterior Augment, Right, Medium
• 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
• 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