INHANCE 5500-36-104Recalls & reported problems

Summary

The FDA's MAUDE database contains 16 adverse event reports that list this exact device (DI 10603295546801), received between Jan 30, 2024 and Sep 18, 2026 — classified as 15 injuries, 1 malfunction.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (8 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 16 most recent of 16 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 18, 2026Tear, Rip or Hole in Device Packaging; Device Contaminated During Manufacture or Shipping

  It was reported that surgeon requested a 36+4 retentive poly after trialing. Nurse opened package and noted that a portion of the packaging appeared to not be sealed. It was agreed that the integrity of the packaging was in question and a new implant was used. Approximately 30 seconds were added to the case to open the second poly.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50819108 ↗
• InjurySep 15, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that patient was revision due to infection/fracture from fall.DOI: (b)(6) 2025.DOR: (b)(6) 2026.Affected Side: Right.

  Patient problems: Bone Fracture(s); Unspecified Infection

  MAUDE report 50772308 ↗
• InjurySep 2, 2026Device Dislodged or Dislocated

  Patient problems: Joint Dislocation; Unspecified Infection

  MAUDE report 50573231 ↗
• InjuryJul 14, 2026Device Dislodged or Dislocated

  IT WAS REPORTED THAT PATIENT WAS DISLOCATED INHANCE REVERSE TSA. THEY CHANGED THE HUMERAL SHELL AND REVERSE LINER. DOI: UNKNOWN. DOR: (B)(6) 2026. AFFECTED SIDE: UNKNOWN.

  Patient problems: Joint Dislocation

  MAUDE report 25813806 ↗
• InjuryJun 10, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT WAS REVISED FOR PAIN. DOI-UNKNOWN. DOR-(B)(6) 2026. AFFECTED SIDE-UNKNOWN.

  Patient problems: Pain

  MAUDE report 25456783 ↗
• InjuryMay 27, 2026Device Dislodged or Dislocated

  IT WAS REPORTED THAT PATIENT WAS REVISED DUE TO DISLOCATION. DOI: (B)(6) 2026. DOR: UNKNOWN. AFFECTED SIDE: LEFT SHOULDER.

  Patient problems: Joint Dislocation

  MAUDE report 25302703 ↗
• InjuryFeb 2, 2026Adverse Event Without Identified Device or Use Problem

  SUBJECT ID: (B)(6). STUDY NO: (B)(4). CLINICAL ADVERSE EVENT RECEIVED FOR REVISION ¿ INFECTION. DEVICE AND PROCEDURE (RELATEDNESS). DEVICE RELATED: NO INFORMATION PROVIDED. PROCEDURE RELATED: NO INFORMATION PROVIDED. DATE OF EVENT: 8 JAN 2026. DATE OF IMPLANT: (B)(6) 2025. DATE OF REVISION: (B)(6) 2026. DEVICE LOCATION: RIGHT. TREATMENT/IMPACT: COMPONENTS REMOVED (CUP). DEPUY SYNTHES PRODUCTS USED: CATALOG NUMBER: 550011240. LOT NUMBER: 664514. COMPONENT TYPE: BASEPLATE. DESCRIPTION: MODULAR UNITI PLATFORM BASEPLATE S 24. CATALOG NUMBER: 550030600. LOT NUMBER: 227541. COMPONENT TYPE: SCREW. DESCRIPTION: INHANCE CENTRAL SCREW 6.0X30. CATALOG NUMBER: 550300500. LOT NUMBER: 235418. COMPONENT TYPE: SCREW. DESCRIPTION: INHANCE 4PK LOCKING SCRW 2025 SLFDRILL. CATALOG NUMBER: 550536004. LOT NUMBER: 350285. COMPONENT TYPE: GLENOID. DESCRIPTION: INHANCE GLENOSPHERE 36+4. CATALOG NUMBER: 520001040. LOT NUMBER: 664294. COMPONENT TYPE: STEM. DESCRIPTION: INHANCE SHORT STEM L 40. CATALOG NUMBER: 550000400. LOT NUMBER: 664524. COMPONENT TYPE: SHELL. DESCRIPTION: INHANCE REVERSE HUMERAL SHELL L 40+0. CATALOG NUMBER: 550036104. LOT NUMBER: MI125080. COMPONENT TYPE: LINER. DESCRIPTION: INHANCE REVE

  Patient problems: Unspecified Infection

  MAUDE report 24233639 ↗
• InjuryJan 12, 2026Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO SHOULDER WAS INFECTED, SURGEON PULLED COMPONENTS. DOI: (B)(6) 2025. DOR: (B)(6) 2025. AFFECTED SIDE: LEFT SHOULDER.

  Patient problems: Unspecified Infection

  MAUDE report 24039866 ↗
• InjuryJul 29, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD AN INFECTION AND THE IMPLANTS NEEDED TO BE REMOVED. DOI: UNKNOWN. DOR: (B)(6) 2025. AFFECTED SIDE: UNKNOWN SHOULDERIT WAS REPORTED THAT THE PATIENT HAD AN INFECTION AND THE IMPLANTS NEEDED TO BE REMOVED. DOI: UNKNOWN. DOR: (B)(6) 2025. AFFECTED SIDE: UNKNOWN SHOULDER.

  Patient problems: Unspecified Infection

  MAUDE report 22649775 ↗
• InjuryJun 24, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PATIENT'S SHOULDER DISLOCATED. THE SURGEON FELT THE NEED TO INCREASE IMPLANT THICKNESS TO FURTHER TENSION THE SHOULDER. A 36 GLENOSPHERE WAS REMOVED AND WAS EXCHANGED FOR A 40MM GLENOSPHERE. THE HUMERAL SHELL WAS ALSO REMOVED AND REPLACED WITH A +8 SHELL. A 40+0 RETENTIVE TRIAL WAS USED AND THE SHOULDER WAS REDUCED AND RUN THROUGH A FULL RANGE OF MOTION. TENSION WAS FOUND TO BE SATISFACTORY, SO THE REAL POLY WAS OPENED AND IMPLANTED. THERE WAS NO DELAYS OR ADVERSE EVENTS TOOK PLACE. ONCE FINAL IMPLANTS WERE IN, STABILITY WAS CONFIRMED AND THE CLOSING PROCESS BEGAN. ACTIVITY LEVEL - YES. DOI: (B)(6) 2025. DOR: (B)(6) 2025. AFFECTED SIDE: LEFT SHOULDER.

  Patient problems: Joint Dislocation

  MAUDE report 22323556 ↗
• InjuryJun 23, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PATIENT HAD A REVERSE SHOULDER DONE IN (B)(6) 2024 AND HAD SEVERAL DISLOCATIONS. SURGEON WENT BACK, REVISED THE HEAD AND HUMERAL SHELL. DOI: (B)(6) 2024. DOR: (B)(6) 2025. AFFECTED SIDE: RIGHT SHOULDER.

  Patient problems: Joint Dislocation

  MAUDE report 22309849 ↗
• InjuryJun 13, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THIS PATIENT HAD THEIR ORIGINAL SURGERY DONE ON (B)(6) 2023. PATIENT WAS BROUGHT BACK DUE TO INSTABILITY AFTER LOSING OVER 100LBS IN 9 MONTHS AND FINDING THAT THE GLENOSPHERE HAD DISASSOCIATED FROM THE BASEPLATE. THE GLENOSPHERE WAS REMOVED AS WELL AS THE HUMERAL SHELL, AND POLY TO GAIN ACCESS TO THE GLENOID. A LARGER GLENOSPHERE WAS THEN IMPLANTED, AND A NEW SHELL AND POLY AS WELL. DOI: (B)(6) 2023. DOR: (B)(6) 2025. AFFECTED SIDE: LEFT SHOULDER.

  Patient problems: Joint Laxity

  MAUDE report 22207114 ↗
• InjuryMar 21, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT ON (B)(6) 2025, THE PATIENT UNDERWENT REVERSE TOTAL SHOULDER SURGERY. SUBSEQUENTLY, THE PATIENT DISLOCATED. ON (B)(6) 2025, THE SURGERY WAS PERFORMED AND SOFT TISSUE WAS RELEASED WITH 30 +4 RETENTIVE LINER EXCHANGE. THE REVISION WENT WITHOUT ANY INCIDENT. NO SURGICAL DELAY. DOI: (B)(6) 2025. DOR: (B)(6) 2025. AFFECTED SIDE: LEFT SHOULDER.

  Patient problems: Joint Dislocation

  MAUDE report 21665456 ↗
• InjuryNov 15, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PATIENT WAS REVISED DUE TO FREQUENT DISLOCATION. DOI: (B)(6) 2024. DOR: (B)(6) 2024. AFFECTED SIDE: UNKNOWN SHOULDER.

  Patient problems: Joint Dislocation

  MAUDE report 20693800 ↗
• InjuryNov 5, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  PATIENTS RIGHT SHOULDER WAS REVISED ON (B)(6) 2024 DUE TO DISLOCATION. SURGICAL DELAY UNKNOWN. DATE OF IMPLANT WAS ON (B)(6) 2024.

  Patient problems: Joint Laxity

  MAUDE report 20608917 ↗
• InjuryJan 30, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE ORIGINAL SHOULDER WAS DONE BY THE PRIMARY SURGEON AND THE ORIGINAL IMPLANT DATE AND LOCATION WERE UNKNOWN. THE PATIENT HAD STABILITY ISSUES WITH THEIR SHOULDER. THE REVISING SURGEON FELT THEY WOULD BENEFIT FROM AN EXCHANGE OF IMPLANTS TO IMPROVE RANGE OF MOTION. A NEW GLENOSPHERE, HUMERAL SHELL, AND POLY WAS TRAILED AND STABILITY IMPROVED. THE REAL IMPLANTS WERE OPENED AND INSERTED. STABILITY WAS CONFIRMED AND THE CLOSING PROCESS BEGAN. NO ADVERSE EVENTS TOOK PLACE. SURGICAL DELAY WAS UNKNOWN. DOI: UNKNOWN. DOR: (B)(6) 2024. AFFECTED SIDE: RIGHT SHOULDER.

  Patient problems: Joint Laxity

  MAUDE report 18606583 ↗