Equinoxe 320-38-03Recalls & reported problems

Summary

The FDA's MAUDE database contains 43 adverse event reports that list this exact device (DI 10885862086662), received between Nov 19, 2019 and Sep 21, 2026 — classified as 43 injuries.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (15 reports).

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

11 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. How this data works · Data updated Oct 13, 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 · 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 · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 43 reports, in the reporter's own words as published by the FDA.

• InjurySep 21, 2026Naturally Worn

  It was reported that the patient underwent a right shoulder replacement. Subsequently, the patient experienced implant loosening and an infection. As a result, the patient had a revision procedure, with removal of all implants and implantation of a competitive system per surgeon preference. The patient was last known to be in stable condition following the event. No further information has been provided.

  Patient problems: Unspecified Infection

  MAUDE report 50841215 ↗
• InjuryApr 27, 2026Unstable; Detachment of Device or Device Component

  IT WAS REPORTED THAT THIS PATIENT UNDERWENT A RIGHT SHOULDER REPLACEMENT. SUBSEQUENTLY, THE PATIENT'S POLY DISSOCIATED WHICH LED TO PAIN AND INSTABILITY. THE PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Joint Laxity; Pain

  MAUDE report 25007126 ↗
• InjuryFeb 10, 2026Insufficient Device Problem Information

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN INITIAL REVERSE TOTAL SHOULDER ARTHROPLASTY. SUBSEQUENTLY, IT WAS REPORTED THAT THE PATIENT EXPERIENCED PAIN AND AN UNKNOWN ISSUE WITH THE HUMERAL LINER. AS A RESULT, THE PATIENT UNDERWENT A SHOULDER REVISION APPROXIMATELY 5 YEARS AND 9 MONTHS AFTER INITIAL IMPLANTATION. NO FURTHER PATIENT IMPACT REPORTED. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: Pain

  MAUDE report 24303764 ↗
• InjuryJan 9, 2026Detachment of Device or Device Component; Naturally Worn

  AS REPORTED, AT A DOCTOR APPOINTMENT PER SURGEON, THE MALE PATIENT DOES A LABOR JOB (FLOORING), PICKED UP A HEAVY OBJECT AND FELT A "POP'. THERE WERE FRAGMENTS, PARTS, OR PIECES THAT FELT INTO THE PATIENT, ALL THE FRAGMENTS, PARTS OR PIECES WERE REMOVE. THE PATIENT WAS REVISED TO A 38 +2.5 LINER AND +0 TRAY EXACTECH DEVICES. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. IMAGES AND X-RAYS RECEIVED. THE DEVICES ARE AVAILABLE FOR EVALUATION.

  Patient problems: Insufficient Information

  MAUDE report 24022139 ↗
• InjuryMar 24, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT A PATIENT, WHO HAD AN INITIAL RIGHT SHOULDER IMPLANTED ON AN UNKNOWN DATE, UNDERWENT A REVISION PROCEDURE IN (B)(6) 2025. THIS WAS A HUMERAL LINER EXCHANGE AS THE PATIENT KEPT DISLOCATING POST-OP. THE SURGEON REMOVED THE LINER, INSERTED A CONSTRAINED LINER, REDUCED AND CLOSED THE WOUND. 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 ABLE TO BE OBTAINED. THE EXPLANTED DEVICE IS NOT AVAILABLE FOR RETURN AS IT WAS DISPOSED OF BY THE CUSTOMER. DEVICE IMAGES WERE PROVIDED. NO FURTHER INFORMATION.

  Patient problems: Subluxation

  MAUDE report 21684548 ↗
• InjuryMar 11, 2025Device Dislodged or Dislocated; Naturally Worn; Device Dislodged or Dislocated; Naturally Worn

  AS REPORTED, APPROXIMATELY 6 YEARS AND 11 MONTHS POST THE INITIAL RIGHT TOTAL SHOULDER ARTHROPLASTY, THE PATIENT FELL AND DISLOCATED THEIR SHOULDER. THEY WERE UNABLE TO RELOCATE IN THE EMERGENCY DEPARTMENT, SO OPEN REDUCTION WAS PERFORMED. THE SURGEON CHANGED THE POLY LINER AS IT HAD BEEN IN FOR 7 YEARS. PHOTOS PROVIDED SHOW WEAR. 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: Fall; Joint Dislocation

  MAUDE report 21572718 ↗
• InjuryJan 29, 2025Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT THIS PATIENT'S SHOULDER WAS REVISED APPROXIMATELY 1 YEAR 6 MONTHS POST INITIAL OPERATION. IT WAS SUSPECTED THAT THE GLENOSPHERE SCREW HAD BACKED OUT. HOWEVER, SURGEON HAD FOUND THAT THE GLENOSPHERE SCREW HAD BROKEN INTO THE GLENOID BASEPLATE. THE SCREW HAD SUBSEQUENTLY BACKED OUT AND WEARING THE HUMERAL POLY CAUSING LYSIS. AFTER REMOVAL, SURGEON RE INSERTED A LONG PEG BASEPLATE AND NEW IMPLANTS AS THE STEM WAS WELL FIXED. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT.

  Patient problems: Osteolysis

  MAUDE report 21263633 ↗
• InjuryJan 27, 2025Detachment of Device or Device Component; Device Dislodged or Dislocated; Detachment of Device or Device Component; Device Dislodged or Dislocated

  APPROXIMATELY 2 MONTH(S) AND 21 DAY(S) POST-OPERATIVE OF A LEFT RTSA, IT WAS REPORTED VIA CLINICAL STUDY THAT THE PATIENT EXPERIENCED DISLOCATION OF SHOULDER JOINT WITH LIKELY DISSOCIATION OF POLYETHYLENE. THE PATIENT UNDERWENT A STANDARD REVERSE WITH PRESERVE STEM REVISION, WITH THE REPORTED REMOVAL OF THE HUMERAL LINER AND GLENOSPHERE. THE OUTCOME OF THIS EVENT IS CONSIDERED RESOLVED AND THE CASE REPORT FORM INDICATES THAT THIS EVENT IS POSSIBLY RELATED TO THE DEVICE(S) AND DEFINITELY 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: Joint Dislocation

  MAUDE report 21246480 ↗
• InjuryJan 9, 2025Device Dislodged or Dislocated; Naturally Worn; Device Dislodged or Dislocated; Naturally Worn

  IT WAS REPORTED THAT A LEFT EQUINOXE SHOULDER PROTHESIS FAILED IN-SITU APPROXIMATELY 3 YEARS AFTER IMPLANTATION. PATIENT HAD RECURRENT DISLOCATION AND HAD SCAPULAR NOTCHING. SURGEON SWAPPED OUT THE 38 GLENOSPHERE TO A 42MM +4 LATERALIZED GLENOSHPERE AND WENT TO A +5MM HUMERAL ADAPTER TRAY WITH A 42MM +0 POLY. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. NO DEVICE WAS RETURNED FOR EVALUATION.

  Patient problems: Joint Dislocation; Joint Impingement; Subluxation

  MAUDE report 21117255 ↗
• InjuryNov 20, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  AS REPORTED, APPROXIMATELY 1 MONTH POST INITIAL LEFT TOTAL SHOULDER ARTHROPLASTY (TSA), THE PATIENT PRESENTED WITH A DISLOCATION. THE SURGEON DECIDED TO REPLACE AND CHANGE TO A CONSTRAINED HUMERAL LINER. THE EVENT WAS NOT RELATED TO THE BREAKAGE OF A DEVICE AND DID NOT LEAD TO A SURGICAL DELAY/PROLONGATION. THE PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT.

  Patient problems: Joint Dislocation

  MAUDE report 20737617 ↗
• InjuryNov 5, 2024Unstable; Device Dislodged or Dislocated; Naturally Worn; Unstable; Device Dislodged or Dislocated; Naturally Worn

  IT WAS REPORTED THAT APPROXIMATELY 1 YEAR PORT OP THIS PATIENT WAS EXPERIENCING ISSUES WITH THEIR SHOULDER. THE SURGEON HAD SEVERAL PLANS PRIOR TO SURGERY HOWEVER DUE TO THE POOR BONE QUALITY, HE ELECTED TO LEAVE THE STEM INSITU AND DRILL A BURR HOLE (2MM) THROUGH THE LATERAL FIN OF THE STEM IN ORDER TO RUN A SUTURE THROUGH AND ONTO THE GREATER TUBEROSITY. HE ALSO REMOVED THE GLENOSPHERE AND TRIED A +4MM GLENOSPHERE. THIS CREATED TOO MUCH PRESSURE ON THE GT, SO HE WENT BACK TO THE ORIGINAL GLENOSPHERE. HE THEN REMOVED THE LINER AND IDENTIFIED EXCESSIVE WEAR ON THE MEDIAL ASPECT WHICH HAD BEEN ARTICULATING WHILST DISPLACED. HE TRIED A 38MM CONSTRAINED HUMERAL LINER +2.5MM AND WAS HAPPY WITH THE STABILITY. HE IMPLANTED THIS LINER AND REDUCED THE CONSTRUCT AND WAS HAPPY WITH THE RESULT.

  Patient problems: Joint Laxity

  MAUDE report 20611907 ↗
• InjuryOct 8, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT A 59 YO MALE PATIENT, INITIAL RIGHT SHOULDER IMPLANTED IN (B)(6) 2023, UNDERWENT A REVISION PROCEDURE IN (B)(6) 2024, APPROXIMATELY 1 YEAR 3 MONTHS POST THE INITIAL PROCEDURE DUE TO DISASSOCIATED HUMERAL POLY. 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 DEVICE IS NOT AVAILABLE FOR RETURN DUE TO HOSPITAL POLICY. NO DEVICE IMAGES WERE PROVIDED. NO FURTHER INFORMATION AT THIS TIME.

  Patient problems: Insufficient Information

  MAUDE report 20403962 ↗
• InjuryJul 1, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  AS REPORTED, APPROXIMATELY TWO YEARS POST INITIAL RIGHT TSA, THE 78 Y/O MALE PATIENT¿S IMPLANTS WERE REVISED DUE TO HUMERAL LINER DISSOCIATION. PATIENT¿S GLENOSPHERE, LINER, ADAPTER TRAY, SCREW KIT AND LOCKING SCREW WERE REVISED. THERE WAS NO BREAKAGE OF THE 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 OR IMAGES. THE DEVICES ARE NOT AVAILABLE FOR EVALUATION DUE TO THE DEVICES WERE DISPOSED BY THE HOSPITAL.

  Patient problems: Insufficient Information; Joint Dislocation

  MAUDE report 19644976 ↗
• InjuryJun 21, 2024Device Dislodged or Dislocated; Naturally Worn; Device Dislodged or Dislocated; Naturally Worn

  AS REPORTED BY THE EQUINOXE SHOULDER STUDY, APPROXIMATELY 0 YEAR(S) AND 7 MONTH(S) POST IMPLANTATION OF LEFT (SECOND) REVISED TSA (REVISIONS REPORTED ON (B)(4), THE PATIENT PRESENTED WITH POLYETHYLENE WEAR WITH OR WITHOUT OSTEOLYSIS. PATIENT HAS HISTORY OF SUBLUXATIONS SINCE SECOND REVISION SUGGESTING WEAR OF THE POLYETHYLENE. THE PATIENT REPORTS REGULAR SUBLUXATION EPISODES AT A POST OP VISIT 7 MONTHS AFTER ABOVE REPORTED EVENT. THE PATIENT HAS ADAPTED HIS ACTIVITIES AND AVOIDS ANY FORCED MOVEMENT. PATIENT WAS SEEN APPROXIMATELY 1 YEAR AND 3 MONTHS LATER AND WAS LAST REPORTED IN STABLE CONDITION. THE OUTCOME OF THE EVENT IS CONTINUING AND THE CLINICAL REPORT INDICATES THAT THE EVENT IS DEFINITELY NOT 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: Osteolysis; Subluxation

  MAUDE report 19581668 ↗
• InjuryJun 5, 2024Naturally Worn; Naturally Worn

  AS REPORTED, APPROXIMATELY SEVEN YEARS POST INITIAL TSA, THE PATIENT UNDERGOES SURGERY AND A SHOULDER REVISION WAS PERFORMED WHICH SHOWS SOFT TISSUE INFLAMMATION AND THE PRESENCE OF METALLOSIS DUE TO THE FRICTION OF THE PLATFORM WITH THE GLEHOESPHERE, SINCE THERE WAS NO PRESENCE OF THE LINER PREVIOUSLY PLACED IN THE PREVIOUS SURGERY. THE CAVITY WAS CHECKED TO VERIFY IF THERE WAS PRESENCE OF THE LINER IN IT BUT THE CONCLUSION WAS REACHED THAT IT WAS COMPLETELY WORN (THERE WAS NO PRESENCE OF THE LINER OR POLYETHYLENE RESIDUES). SALES REP WAS UNABLE TO OBTAIN IMAGES OR X-RAYS. THE DEVICE IS NOT AVAILABLE FOR EVALUATION. AS OF NOTE: "PRIOR TO THIS SURGERY, THE DOCTOR HAD BEEN INFORMED ABOUT THE RECALL OF THE EQUINOXE SYSTEM LINERS. AT THE TIME OF PERFORMING THE SURGERY AND SEEING ITS COMPLEXITY, ON THE SAME DAY WE VERIFIED THE INFORMATION ON THE LINER WITH REFERENCE TO THE RECALL AND THE DOCTOR WAS INFORMED THAT THE LINER THAT WAS PLACED ON THE PATIENT WAS PART OF THE RECALL. THE MANUFACTURING DATE IS 2015 AND THE PATIENT WAS PLACED IN 2017".

  Patient problems: Failure of Implant; Inflammation; Metal Related Pathology

  MAUDE report 19472978 ↗
• InjuryMar 18, 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 62 YO MALE PATIENT, WHO HAD AN INITIAL RTSA ON (B)(6) 2020, AND HAD A REVISION PROCEDURE ON (B)(6) 2022, UNDERWENT A 2ND REVISION PROCEDURE ON (B)(6) 2024, APPROXIMATELY 1 YEAR 11 MONTHS POST THE FIRST REVISION IN (B)(6) 2022. THE PATIENT DID VERY WELL FOR ABOUT 2 YEARS, UNTIL HE RECENTLY DISLOCATED, CAUSING THIS REVISION. THE PATIENT WAS REVISED TO A 42MM +4MM GLENOSPHERE, NEW LOCKING SCREW, +0MM 38MM CONSTRAINED LINER, +15MM TRAY AND NEW REVERSE TORQUE SCREW. FIBER TAPE CERCLAGE WAS ALSO USED AROUND PROXIMAL HUMERUS AND TRAY. THERE WERE NO DEVICE BREAKAGES DURING THE PROCEDURE. THERE WAS A 30-45 MINUTE SURGICAL DELAY DURING THE PROCEDURE WITH NO ADVERSE EVENT TO THE PATIENT AS A RESULT. THE PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. NO X-RAYS WERE ABLE TO BE OBTAINED. NO EXPLANTED DEVICES ARE AVAILABLE FOR ANALYSIS AS THE HOSPITAL IS KEEPING THE DEVICES. A DEVICE IMAGE WAS PROVIDED. NO FURTHER INFORMATION. THE (B)(6) 2022 REVISION PROCEDURE WAS REPORTED UNDER MDR #1038671-2024-00546.

  Patient problems: Joint Dislocation

  MAUDE report 18927418 ↗
• InjuryFeb 27, 2024Unstable; Device Dislodged or Dislocated; Adverse Event Without Identified Device or Use Problem; Unstable; Device Dislodged or Dislocated; Adverse Event Without Identified Device or Use Problem

  AS REPORTED BY THE EQUINOXE SHOULDER STUDY, THE 70-YEAR-OLD MALE PATIENT HAD AN INITIAL LEFT TSA ON (B)(6) 2023 AND PRESENTED WITH INSTABILITY/SUBLUXATION, APPROXIMATELY 2 MONTH(S) AND 0 YEAR(S) POST-OPERATIVELY ON (B)(6) 2023. PATIENT REACHED OVER SHOULDER TO BUCKLE SEATBELT ON (B)(6) 23 AND HAD A SUBLUXATION INCIDENT. SECOND SUBLUXATION OCCURRED IN (B)(6) 2023 AFTER CARRYING A 10 LB BOX. THE OUTCOME OF THIS EVENT IS CONSIDERED CONTINUING, AND NO ACTION WAS TAKEN. THE CASE REPORT FORM INDICATES THAT THIS EVENT IS POSSIBLY RELATED TO THE DEVICE AND/OR TO THE PROCEDURE. THIS EVENT REPORT WAS RECEIVED THROUGH CLINICAL DATA COLLECTION ACTIVITIES AND NO DEVICE RETURN IS ANTICIPATED.

  Patient problems: Joint Laxity; Subluxation

  MAUDE report 18791697 ↗
• InjuryFeb 3, 2024Detachment of Device or Device Component; Device Dislodged or Dislocated; Detachment of Device or Device Component; Device Dislodged or Dislocated

  AS REPORTED BY THE EQUINOXE SHOULDER STUDY, THE 71 YEAR OLD FEMALE PATIENT HAD AN INITIAL LEFT TSA ON (B)(6) 2019 AND PRESENTED WITH DISASSOCIATION OF POLYETHYLENE APPROXIAMTELY 3 YEAR(S) AND 1 MONTH(S) POST INITIAL PROCEDURE ON (B)(6) 2023. PATIENT WAS WORKING ON HIS CAR USING VICE GRIPS, TWISTED HIS ARM, AND FELT INCREASED PAIN. HE WAS FOUND TO BE DISLOCATED IN THE EMERGENCY DEPARTMENT WITH A DISSOCIATED POLYETHYLENE LINER. THE CASE REPORT FORM INDICATES THAT THIS EVENT IS DEFINITELY RELATED TO THE DEVICE AND TO THE PROCEDURE. THE REPORT ALSO INDICATES THE ACTION TAKEN WAS SURGICAL REVISION WITH THE REMOVAL OF HUMERAL LINER, HUMERAL TRAY, GLENOSPHERE, LOCKING SCREWS, AND TORQUE SCREWS ON (B)(6) 2023. THE CASE IS RESOLVED. DUE TO CLINICAL STUDY, NO DEVICES WILL BE RETURNED FOR EVALUATION.

  Patient problems: Failure of Implant; Joint Dislocation; Pain

  MAUDE report 18637074 ↗
• InjuryDec 4, 2023Naturally Worn; Naturally Worn

  AS REPORTED, THE PATIENT HAD AN INITIAL RIGHT TSA ON AN UNKNOWN DATE. THE PATIENT WAS REVISED ON (B)(6) 2023 DUE TO SEVERE WEAR AND OXIDATION. EVERYTHING WAS REMOVED EXCEPT FOR THE STANDARD STEM. 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 18263888 ↗
• InjurySep 15, 2023Naturally Worn; Adverse Event Without Identified Device or Use Problem; Naturally Worn; Adverse Event Without Identified Device or Use Problem

  AS REPORTED, APPROXIMATELY 4 MONTHS POST OP INITIAL LEFT TSA, THIS 82 Y/O MALE PATIENT WAS REVISED DUE TO AN INFECTION. ALL REVERSE IMPLANTS WERE REMOVED & SHOULDER SPACER LEFT IN ( 48 - FORTCEM SPACER PROVIDED BY EXACTECH). PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. NO OTHER PATIENT INFORMATION/MEDICAL HISTORY PROVIDED. PHOTO ATTACHED. UNABLE TO OBTAIN X-RAYS. DEVICE IS NOT RETURNING.

  Patient problems: Bacterial Infection; Medical device site infection

  MAUDE report 17757239 ↗
• InjuryAug 15, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED, APPROXIMATELY (B)(6) MONTHS POST OP INITIAL RIGHT TSA. THIS 73 Y/O MALE PATIENT WAS REVISED, DUE TO INFECTION. LINER, TRAY, GLENOPSHERE WERE REMOVED AND REPLACED. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. PRODUCT NOT RETURNING. HOSPITAL DID NOT RETURN.

  Patient problems: Bacterial Infection; Unspecified Infection

  MAUDE report 17549219 ↗
• InjuryJun 1, 2023Loosening of Implant Not Related to Bone-Ingrowth; Migration; Loosening of Implant Not Related to Bone-Ingrowth; Migration

  AS REPORTED, APPROXIMATELY 2 YEARS POST OP INITIAL LEFT TSA, THIS 72 Y/O MALE PATIENT WAS REVISED. THE PATIENT ORIGINALLY HAD AN EXACTECH REVERSE SHOULDER IMPLANTED. AT SOME POINT THE GLENOSPHERE BECAME DISASSOCIATED FROM THE BASEPLATE. ANOTHER SURGEON IN (B)(6) IL REVISED THE SHOULDER IMPLANTING THE ABOVE LISTED IMPLANTS ON (B)(6) 2021 AT (B)(6)(CAPTURED IN CASE: (B)(4). THE BASEPLATE AND STEM WERE NOT REMOVED BUT SCREWS WERE ADDED AND A NEW GLENOSPHERE AND LINER WERE IMPLANTED. AFTER THAT CASE THE GLENOID BASEPLATE BECAME PULLED OUT FROM THE GLENOID AND WAS FREE FLOATING IN THE SHOULDER BASED ON XRAY. SURGEON SCHEDULED A CASE TO REVISE THE SHOULDER TO A HEMI ON (B)(6) 2023. DURING THE CASE THE SURGEON EXPOSED THE HUMERUS AND REMOVED BOTH THE LINER AND THE +0 TRAY HE THEN MOVED ON TO THE GLENOID WHERE HE WAS ABLE TO PULL OUT THE GLENOSPHERE INCLUDING THE BASEPLATE AND ALL SCREWS. ONE SCREW HAD BEEN BROKEN OFF IN THE GLENOID FROM A PREVIOUS SURGERY OR FROM WHEN THE GLENOID COMPONENT BECAME LOOSE. THE BROKEN SCREW WAS NOT RETRIEVED AND WAS LEFT IN THE GLENOID. SURGEON THEN IMPLANTED A 1.5 REPLICATOR PLATE (300-21-00 A197490) AND 47 X 18 HEAD (310-01-47 A373263). SURGEON DID TAKE 5 C

  Patient problems: Failure of Implant; Insufficient Information

  MAUDE report 17037723 ↗
• InjuryMay 11, 2023Unstable; Adverse Event Without Identified Device or Use Problem; Unstable; Adverse Event Without Identified Device or Use Problem

  AS REPORTED, APPROXIMATELY 5 YEARS POST OP INITIAL RIGHT TSA, THIS 68 Y/O FEMALE PATIENT'S RIGHT KNEE WAS REVISED DUE TO INSTABILITY. GLENOSHERE, LOCKING SCREW , LINER , ADAPTER TRAY AND TORQUE SCREW WERE CHANGED. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. NO OTHER PATIENT INFORMATION/MEDICAL HISTORY REPORTED. UNABLE TO OBTAIN X-RAYS/PHOTOS. PRODUCT NOT RETURNING - DISPOSED BY HOSPITAL.

  Patient problems: Failure of Implant; Joint Laxity

  MAUDE report 16910094 ↗
• InjuryDec 6, 2022Naturally Worn; Naturally Worn

  AS REPORTED, THIS MALE PATIENT HAD AN INITIAL RIGHT TSA ON (B)(6) 2017. THE PATIENT WAS REVISED ON (B)(6) 2022 DUE TO A WORN POLY. THE REPORTED EVENT IS NOT RELATED TO THE BREAKAGE OF A DEVICE AND DID NOT LEAD TO A SURGICAL DELAY/PROLONGATION. THE PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. NO OTHER INFORMATION PROVIDED.

  Patient problems: Failure of Implant; Insufficient Information

  MAUDE report 15923287 ↗
• InjuryAug 4, 2022Device Dislodged or Dislocated; Device Dislodged or Dislocated

  THIS 76 YEAR OLD, MALE PATIENT PRESENTED TO THE HOSPITAL WITH A DISLOCATED RIGHT SHOULDER. THE PATIENT CONSENTED TO REVISION SURGERY, HAVING PREVIOUSLY HAD A TOTAL SHOULDER REPLACEMENT FOR TRAUMA. THE SURGEON DISCOVERED THAT THE TRAUMA STEM WAS RETROVERTED MORE THAN USUAL, WHICH EXPLAINED THE DISLOCATION. MICROBIOLOGY SAMPLES WERE TAKEN AND THE 0MM HUMERAL TRAY AND 0MM HUMERAL LINER WERE REMOVED AND REPLACED WITH A NEW 0MM HUMERAL TRAY AND A 5MM HUMERAL LINER. THE SURGEON WAS UNABLE TO REATTACH THE GREATER TROCHANTER, SO LEFT IT. THE SHOULDER WAS STABLE AND SECURE. THERE WAS NO REPORTED BREAKAGE OF DEVICES OR SURGICAL DELAY/PROLONGATION. THE PATIENT WAS LAST KNOWN TO BE INSTABLE CONDITION FOLLOWING THE EVENT. NO OTHER PATIENT INFORMATION/MEDICAL HISTORY REPORTED. THE DEVICES ARE NOT RETURNING AS THE HOSPITAL WILL NOT ALLOW IMPLANTS TO BE DESTERILIZED FOR RETURN.

  Patient problems: Joint Dislocation

  MAUDE report 15171797 ↗

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-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-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-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-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-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-0579-2024 · Nov 21, 2023 · Open, Classified
  Exactech Equinoxe Reverse Shoulder System, Catalog Numbers: a) 320-36-00, b) 320-36-03, c) 320-36-04, d) 320-36-10, e) 320-36-13, f) 320-38-00, g) 320-38-13, h) 320-40-00,
• 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.