Equinoxe 320-40-00Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 10885862535030), received between Aug 11, 2021 and Apr 7, 2026 — classified as 11 injuries.

The most frequently reported specific device problem is “Naturally Worn” (4 reports).

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

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-1420-2024 · 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 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

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

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A LEFT SHOULDER REPLACEMENT. A REVISION PROCEDURE IS PLANNED FOR A LATER DATE. THE PATIENT HAS DEVELOPED PAIN AND HAS BEEN PARTICIPATING IN OUTPATIENT PHYSICAL THERAPY. THE PATIENT DOES HAVE A RECALLED LINER. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME.

  Patient problems: Pain

  MAUDE report 24808787 ↗
• InjuryJan 13, 2026Device Dislodged or Dislocated

  IT WAS REPORTED THAT A 41 YO MALE PATIENT, WHO HAD A LEFT RTSA, UNDERWENT A REVISION PROCEDURE. THE PATIENT WAS REVISED DUE TO A DISLOCATION. THE EXPANDED GLENOSPHERE, CONSTRAINED HUMERAL LINER, HRP STEM AND ADAPTER TRAY +0 WERE EXCHANGED. 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 PROVIDED. THE EXPLANTED DEVICES ARE NOT AVAILABLE FOR RETURN AS THEY WERE DISCARDED. NO DEVICE IMAGES WERE ABLE TO BE OBTAINED. NO FURTHER INFORMATION.

  Patient problems: Joint Dislocation

  MAUDE report 24063127 ↗
• InjuryDec 1, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A 66 YO FEMALE PATIENT, UNDERWENT A REVISION PROCEDURE. THE PATIENT PRESENTED WITH INFECTION. THE SURGEON DID A WASHOUT AND REPLACED THE HUMERAL POLY LINER. 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. IT WAS DISCARDED. NO IMAGES WERE PROVIDED. NO FURTHER INFORMATION.

  Patient problems: Unspecified Infection

  MAUDE report 23689150 ↗
• InjuryOct 20, 2025Naturally Worn; Naturally Worn

  AS REPORTED, APPROXIMATELY 10 MONTHS AFTER INITIAL RIGHT TSA, THE PATIENT WAS REVISED AFTER FEELING PAIN WHILE DOING HANDY WORK. THE GLENOSPHERE WAS LOOSE AND WAS REPLACED ALONG WITH A NEW POLY LINER AND SCREW. THE EVENT IS RELATED TO THE BREAKAGE OF A DEVICE. ALL PIECES THAT FELL INTO THE WOUND SITE WERE REMOVED. THE EVENT DID NOT LEAD TO A SURGICAL DELAY/PROLONGATION.

  Patient problems: Pain

  MAUDE report 23335132 ↗
• InjuryJan 14, 2025Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A REVISION OF A RIGHT TOTAL SHOULDER REPLACEMENT 4 YEARS AND 4 MONTHS POST-OP DUE TO PAIN, POLY WEAR, AND INFECTION WITH CONTINUED TREATMENT WITH ANTIBIOTICS FOR 6 MONTHS POST-OP (CAPTURED ON A SEPARATE REPORT). SUBSEQUENTLY, THE PATIENT UNDERWENT AN ASPIRATION OF THE SHOULDER APPROXIMATELY 10 MONTHS AFTER THE REVISION PROCEDURE FOR CONTINUED PAIN AND FLUID ACCUMULATION (CAPTURED ON A SEPARATE REPORT). FOLLOWING THE ASPIRATION, CONTINUED PAIN WAS REPORTED AND AN MRI WAS OBTAINED WHICH SHOWED INFLAMMATION AROUND THE IMPLANT. APPROXIMATELY 1 MONTH LATER, THE PATIENT UNDERWENT A REVISION OF THE RIGHT TOTAL SHOULDER. INTRAOPERATIVELY, SEROSANGUINEOUS FLUID WAS NOTED AND INTRAOPERATIVE CULTURES WERE ALL NEGATIVE. FURTHER, THE SURGICAL PATHOLOGY REPORT NOTED A SOFT TISSUE REACTION TO POLYETHYLENE PARTICULATE DEBRIS. THE PATIENT WAS IMPLANTED WITH A COMPETITOR SYSTEM. THE PATIENT WAS FOLLOWED BY THE PAIN MANAGEMENT SERVICE POST-OPERATIVELY AND WAS DISCHARGED HOME APPROXIMATELY 7 DAYS LATER. THE PATIENT WAS NOTED TO BE DOING WELL AT HIS 1 WEEK POST-OPERATIVE VISIT. RELATED CASES: (REV 1) - MDR# 1038671-2025-00186. (ASPIRATION) MDR# 1038671-2025-00

  Patient problems: Inflammation; Joint effusion; Metal Related Pathology; Muscle/Tendon Damage; Osteolysis; Pain

  MAUDE report 21149867 ↗
• InjuryJan 6, 2025Naturally Worn; Naturally Worn

  IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT APPROXIMATELY 17 MONTHS AFTER A LEFT TOTAL SHOULDER REPLACEMENT PROCEDURE, THE PATIENT HAS EXPERIENCED PROSTHESIS WEAR. THE PATIENT HAS NOT YET UNDERGONE A REVISION PROCEDURE. NO FURTHER ISSUES OR COMPLICATIONS WERE REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Discomfort; Inflammation; Insufficient Information; Loss of Range of Motion; Osteolysis; Pain; Swelling/ Edema

  MAUDE report 21085843 ↗
• InjuryJun 19, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED BY THE EQUINOXE SHOULDER STUDY, APPROXIMATELY 0 YEAR(S) AND 1 MONTH(S) POST-OPERATIVE OF A LEFT IMPLANTED TSA, THE PATIENT PRESENTED WITH DEEP INFECTION. FOR A DURATION OF 2-1/2 MONTHS POST OPERATIVELY, THE PATIENT HAD WOUND DEHISCENCE AND WAS TAKEN TO OR FOR IRRIGATION AND DEBRIDEMENT, CULTURE POSITIVE FOR MRSA. THIS OUTCOME OF THE EVENT IS REPORTED TO BE RESOLVED BY IRRIGATION AND DEBRIDEMENT PERFORMED FOR MRSA INFECTION, ALONG WITH EXCHANGE OF THE POLYETHYLENE LINER IN THE LEFT SHOULDER. 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: Bacterial Infection

  MAUDE report 19570589 ↗
• InjuryApr 9, 2024Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT A 73 YO FEMALE PATIENT, INITIAL RIGHT SHOULDER IMPLANTED ON (B)(6) 2022, UNDERWENT A REVISION PROCEDURE ON (B)(6) 2024, APPROXIMATELY 1 YEAR 10 MONTHS POST THE INITIAL PROCEDURE. UPON THE REVISION, POLY WEAR WAS NOTICED. THE PATIENT HAD A COMPETITOR¿S ANTIBIOTIC SPACER PLACED DUE TO INFECTION. THERE WERE NO DEVICE BREAKAGES OR SURGICAL DELAYS DURING THE PROCEDURE. NO X-RAYS WERE PROVIDED. THE EXPLANTED DEVICE IS NOT AVAILABLE FOR ANALYSIS. IT WAS SENT TO PATHOLOGY AT THE FACILITY. DEVICE IMAGES WERE PROVIDED. NO FURTHER INFORMATION.

  Patient problems: Unspecified Infection

  MAUDE report 19074231 ↗
• InjuryFeb 12, 2024Inadequacy of Device Shape and/or Size; Device Dislodged or Dislocated; Inadequacy of Device Shape and/or Size; Device Dislodged or Dislocated

  IT WAS REPORTED VIA A CLINICAL STUDY, ¿EQUINOXE SHOULDER STUDY¿, THAT A 55 YO FEMALE PATIENT, INITIAL LEFT SHOULDER IMPLANTED ON (B)(6) 2023, UNDERWENT A REVISION PROCEDURE ON (B)(6) 2023. THE PATIENT DISLOCATED THEIR LEFT SHOULDER ANTERIORLY/INFERIORLY ON (B)(6) 2023, WITH NO INJURY REPORTED, AND UNDERWENT REVISION DUE TO AN ACUTE INFERIOR DISLOCATION. THE HUMERAL LINER WAS REVISED. THE STUDY INDICATES THE EVENT WAS DEFINITELY NOT RELATED TO THE DEVICE OR THE PROCEDURE. THE EVENT WAS RESOLVED ON (B)(6) 2023. NO FURTHER DETAILS.

  Patient problems: Joint Dislocation

  MAUDE report 18692367 ↗
• InjuryDec 19, 2023Unstable; Device Dislodged or Dislocated; Unstable; Device Dislodged or Dislocated

  AS REPORTED BY THE EQUINOXE SHOULDER STUDY, THE PATIENT, (B)(6), HAD AN INITIAL LEFT TSA ON (B)(6) 2019. PATIENT (B)(6) PRESENTED ON 01-MAR-2020 WITH INSTABILITY / SUBLUXATION. PATIENT DESCRIBES 2 SUBLUXATION EPISODES AT HOME; BOTH "SELF-REDUCED." THE CASE REPORT FORM INDICATES THAT THIS EVENT IS POSSIBLY RELATED TO DEVICE AND/OR TO PROCEDURE. OUTCOME IS RESOLVED ON 01-APR-2021 WITH DELTOID STRENGTHENING EXERCISES. DUE TO CLINICAL STUDY, NO DEVICES WILL BE RETURNED FOR EVALUATION.

  Patient problems: Joint Dislocation; Joint Laxity; Subluxation

  MAUDE report 18358902 ↗
• InjuryAug 11, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED, APPROXIMATELY 2.5 YRS POSTOP THE INITIAL LTSA, THE (B)(6) Y/O MALE PATIENT WAS DIAGNOSED WITH A PAINFUL PROSTHESIS AND DEEP INFECTION. THE PATIENT WAS REVISED. THE CASE REPORT FORM INDICATES THIS EVENT IS NOT RELATED TO DEVICES AND DEFINITELY RELATED TO THE PROCEDURE. THERE WAS NO FOLLOWUP INFORMATION REGARDING THE PATIENT PROVIDED BY THE STUDY. THIS EVENT REPORT WAS RECEIVED THROUGH CLINICAL DATA COLLECTION ACTIVITIES.

  Patient problems: Bacterial Infection

  MAUDE report 12306346 ↗