INHANCE 5505-32-004Recalls & reported problems

Summary

The FDA's MAUDE database contains 24 adverse event reports that list this exact device (DI 10603295546665), received between Mar 5, 2024 and Sep 22, 2026 — classified as 21 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (11 reports).

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.

Most reported problems

Recent adverse event reports

The 24 most recent of 24 reports, in the reporter's own words as published by the FDA.

• InjurySep 22, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that infection. No other information was provided.DOI: Unknown.DOR: (b)(6)2026.Affected Side: Unknown.

  Patient problems: Unspecified Infection

  MAUDE report 50853904 ↗
• InjurySep 17, 2026Device Dislodged or Dislocated

  It was reported that the patient was revised due to Loosening/dislocation. It was stated that Glenosphere, Reverse Liner, Reverse Humeral shell were loose at the bone to implant interface. DOI: (b)(6) 2026.DOR: (b)(6) 2026.Affected side: Right shoulder.

  Patient problems: Joint Dislocation; Joint Laxity

  MAUDE report 50805340 ↗
• InjurySep 14, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that all Inhance reverse implants were explanted due to infection.DOI: (b)(6) 2026.DOR: (b)(6) 2026.

  Patient problems: Unspecified Infection

  MAUDE report 50751798 ↗
• InjuryJun 22, 2026Device Dislodged or Dislocated

  IT WAS REPORTED THAT IMPLANTS WERE MAL-POSITIONED, POSSIBLY FROM A PATIENT FALL. THIS CAUSED PATIENT TO KEEP DIS-LOCATING. FULL REVISION WAS REQUIRED. AFFECTED SIDE: RIGHT.

  Patient problems: Fall; Joint Dislocation

  MAUDE report 25576440 ↗
• InjuryMay 7, 2026Difficult to Insert

  ADDITIONAL INFORMATION RECEIVED: WAS/WERE THERE ANY ADVERSE CONSEQUENCE/S THAT AFFECTED THE PATIENT BECAUSE OF THE REPORTED EVENT? NO ADVERSE CONSEQUENCES.

  Patient problems: Insufficient Information

  MAUDE report 25116254 ↗
• InjuryApr 7, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT ASEPTIC REVISION FOR INSTABILITY FROM HETEROTOPIC OSSIFICATION. THE SURGEON REVISED GLENOSPHERE FROM 32+4 TO 36+8 AND CHANGED SHELL LARGE 0 AND LINER TO 36+4 RETENTIVE. REMOVED THE HO AND SHOULDER WAS FREE OF IMPINGEMENT. DOI: (B)(6), 2024. DOR: (B)(6) 2026. AFFECTED SIDE: RIGHT SHOULDER.

  Patient problems: Extraskeletal ossification; Joint Laxity

  MAUDE report 24800959 ↗
• InjuryApr 6, 2026Device Dislodged or Dislocated

  IT WAS REPORTED THAT PATIENT HAD SHOULDER DONE ON AN UNKNOWN DATE. POSTOPERATIVELY THE PATIENT SUFFERED A SHOULDER DISLOCATION. SURGEON OPTED TO CHANGE THE GLENOSPHERE, HUMERAL SHELL, AND POLYETHYLENE TO FURTHER TENSION THE SHOULDER JOINT. TRIAL REDUCTIONS WERE PERFORMED AND STABILITY WAS CONFIRMED WITH A 40+8 GLENOSPHERE, +0 HUMERAL SHELL, AND NEW POLYETHYLENE. NO DELAYS OR ADVERSE EVENTS TOOK PLACE. CLOSING PROCESS BEGAN. ACTIVITY LEVEL - YES DOI: UNKNOWN, DOR: (B)(6) 2026, AFFECTED SIDE-UNKNOWN.

  Patient problems: Joint Dislocation

  MAUDE report 24793103 ↗
• InjuryDec 15, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE SHOULDER WAS DISLOCATED.

  Patient problems: Joint Dislocation

  MAUDE report 23804694 ↗
• InjuryNov 14, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PATIENT WAS DISLOCATED. ALL INHANCE COMPONENTS WERE PULLED. DOI: (B)(6) 2025, DOR: (B)(6) 2025, AFFECTED SIDE: RIGHT SHOULDER.

  Patient problems: Joint Dislocation

  MAUDE report 23556610 ↗
• InjuryNov 13, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT UNDERWENT AN ENHANCE REVERSE TOTAL IN (B)(6) 2025. IT WAS SUSPECTED THAT THE INITIAL TENSION OF THE ORIGINAL WAS TOO LOOSE. REVISED TO A THICKER POLY CONSTRUCT, BIGGER AND MORE LATERALIZED GLENOSPHERE. DOI: (B)(6) 2025, DOR: (B)(6) 2022, AFFECTED SIDE: RIGHT SHOULDER.

  Patient problems: Joint Laxity

  MAUDE report 23545212 ↗
• InjuryNov 12, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  PATIENT WAS REVISED DUE TO GLENOSPHERE LOCKING BOLT DID NOT FULLY ENGAGE. SURGEON WAS AWARE AND PROCEEDED, NOTING CONCERNS THAT HE DID NOT WANT TO FRACTURE THE GLENOID IN ATTEMPTS TO REMOVE THE GLENOSPHERE. DOI: UNKNOWN. DOR: (B)(6) 2025. AFFECTED SIDE: UNKNOWN.

  Patient problems: Insufficient Information

  MAUDE report 23535439 ↗
• MalfunctionOct 22, 2025Fracture; Fracture

  IT WAS REPORTED THAT THE GLENOSPHERE INSERTER TIP THREADS WERE BROKEN OFF INSIDE GLENOSPHERE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23359349 ↗
• MalfunctionSep 18, 2025Difficult to Insert; Material Deformation; Difficult to Insert; Material Deformation

  IT WAS REPORTED THAT THE INSERTER THREADS BROKE OFF INTO GLENOSPHERE DURING INSERTION. SO THEY WERE NOT ABLE TO TIGHTEN DOWN THE SECURITY SCREW. AFFECTED SIDE: UNKNOWN.

  Patient problems: Insufficient Information

  MAUDE report 23082658 ↗
• InjuryAug 27, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WASN¿T HAPPY WITH THE RESULTS, SO THE DOCTOR DID A PLOY GLENOSPHERE EXCHANGE FOR MORE STABILITY. DOI: UNKNOWN, DOR: (B)(6) 2025, AFFECTED SIDE: UNKNOWN SHOULDER.

  Patient problems: Joint Laxity

  MAUDE report 22908921 ↗
• InjuryAug 13, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PATIENT WAS REVISED DUE TO DISLOCATION. AFFECTED SIDE: RIGHT SHOULDER.

  Patient problems: Joint Dislocation

  MAUDE report 22795099 ↗
• InjuryAug 7, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PATIENT HAD INITIAL SURGERY DONE ON (B)(6) 2025. THE PATIENT UNFORTUNATELY SUFFERED TWO DISLOCATIONS OF THEIR SHOULDER POST OPERATIVELY. THE SURGEON SAID BOTH DISLOCATIONS HAPPENED WHEN THE PATIENT ADDUCTED ARM. THE SURGEON FELT THE PATIENT WOULD BENEFIT FROM INCREASING THE GLENOSPHERE DIAMETER AS WELL AS THE LATERALIZATION. THE SURGEON WENT FROM A 32+4 TO A 36+8 GLENOSPHERE. THE SHELL AND POLY WERE REMOVED AND WAS REPLACED WITH A NEW +0 MEDIUM SHELL AND A 36+4 RETENTIVE POLY. THE SHOULDER WAS THEN REDUCED AND STABILITY WAS CONFIRMED. THERE WAS NO ADVERSE EVENTS OR DELAYS TOOK PLACE. ACTIVITY LEVEL - YES. DOI: (B)(6) 2025. DOR: (B)(6) 2025. AFFECTED SIDE: LEFT SHOULDER.

  Patient problems: Joint Dislocation

  MAUDE report 22736450 ↗
• InjuryJul 24, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT WAS REVISED DUE TO INFECTION. DOI: UNKNOWN, DOR: (B)(6) 2025, AFFECTED SIDE: LEFT SHOULDER.

  Patient problems: Unspecified Infection

  MAUDE report 22594500 ↗
• InjuryJun 26, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT HAD SHOULDER DONE ORIGINALLY ON (B)(6) 2024. PATIENT WAS COMPLAINING OF SOME PAIN ASSOCIATED WITH IMPINGEMENT OF THE CONJOINT TENDON. THE SURGEON FELT THE PATIENT WOULD BENEFIT FROM AN EXCHANGE OF THE GLENOSPHERE, HUMERAL SHELL, AND POLY. A 32+4 GLENOSPHERE WAS REMOVED AND REPLACED WITH A 36+4 ECCENTRIC. THE ECCENTRICITY WAS DIALED POSTERIOR. A NEW SHELL AND POLY WERE TRAILED AND THE SHOULDER WAS FOUND TO BE STABLE WITH IMPROVED RANGE OF MOTION. THE REAL SHELL AND POLY WERE OPENED AND IMPLANTED AND STABILITY WAS CONFIRMED ONCE REDUCED. NO DELAYS OR ADVERSE EVENTS TOOK PLACE. ACTIVITY LEVEL - YES. DOI: (B)(6) 2024. DOR: UNKNOWN. AFFECTED SIDE: LEFT SHOULDER.

  Patient problems: Joint Laxity; Pain

  MAUDE report 22340541 ↗
• InjuryJun 10, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  PATIENT WAS REVISED DUE TO DISLOCATION OF SHOULDER POST OP. SURGEON CHANGED HEAD SHELL AND LINER. DOI: (B)(6) 2025, DOR: (B)(6) 2025, AFFECTED SIDE: UNKNOWN SHOULDER.

  Patient problems: Joint Dislocation

  MAUDE report 22179123 ↗
• InjuryMar 18, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PATIENT HAD THEIR SHOULDER DONE BY SURGEON ON (B)(6) 2025. UNFORTUNATELY THEY DISLOCATED THEIR SHOULDER. THE SURGEON OPTED TO REVISE THE SHOULDER AND UPSIZE THE COMPONENTS TO PROVIDE STABILITY. A 32 GLENOSPHERE WAS REMOVED, AS WELL AS THE MEDIUM +0 HUMERAL SHELL AND 32 POLY. A 36+8 GLENOSPHERE WAS IMPLANTED. A TRIAL REDUCTION WAS PERFORMED WITH A 0 SHELL AND 36+0 RETENTIVE POLY. STABILITY OF THE SHOULDER WAS CONFIRMED AND THE REAL SHELL AND POLY WERE OPENED AND IMPLANTED. NO ADVERSE EVENTS OR DELAYS TOOK PLACE. ONCE NEW IMPLANTS WERE INSERTED, THE CLOSING PROCESS BEGAN. DOI: (B)(6) 2025. DOR: (B)(6) 2025. AFFECTED SIDE: LEFT SHOULDER.

  Patient problems: Joint Dislocation; Joint Laxity

  MAUDE report 21633259 ↗
• InjuryFeb 6, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PATIENT WAS REVISED DUE TO LOOSE/DISLOCATION. THE SURGICAL DELAY IS UNKNOWN. DOI: UNKNOWN . DOR: (B)(6) 2025. AFFECTED SIDE: RIGHT SHOULDER.

  Patient problems: Joint Dislocation; Joint Laxity

  MAUDE report 21325234 ↗
• InjurySep 10, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION RECEIVED STATES THAT THE PATIENT'S SOFT TISSUE STRUCTURES WERE LOOSE AND THEREFORE THE SURGEON NEEDED TO REVISE TO LARGER COMPONENTS. THERE WAS NO SURGICAL DELAY NOR ANY HARM TO THE PATIENT.

  Patient problems: Joint Laxity

  MAUDE report 20181102 ↗
• MalfunctionSep 10, 2024Difficult to Insert; Difficult to Insert

  IT WAS REPORTED THAT THE GLENOSPHERE WOULD NOT PROPERLY SEAT. DOI: UNKNOWN. DOR: (B)(6) 2024. AFFECTED SIDE: UNKNOWN.

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

  MAUDE report 20179594 ↗
• InjuryMar 5, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT BROUGHT BACK FOR A WASHOUT FOR A POSSIBLE INFECTION. WHILE THERE, A 50MM METAGLEN SCREW WAS REMOVED. A NEW GLONOSPHERE , HUMERAL SHELL AND LINER WERE REPLACED. DOI: (B)(6) 2023. DOE: (B)(6) 2024.

  Patient problems: Unspecified Infection

  MAUDE report 18838136 ↗