INHANCE 5500-00-320Recalls & reported problems

Summary

The FDA's MAUDE database contains 18 adverse event reports that list this exact device (DI 10603295547006), received between Aug 14, 2023 and Sep 30, 2026 — classified as 16 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Difficult to Insert” (2 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 18 most recent of 18 reports, in the reporter's own words as published by the FDA.

• InjurySep 30, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that the revised was performed due to instability following a post op fracture causing the stem to loosen and it was stated that the humeral stem was loose and at the bone to implant interface.DOI - (b)(6)2026.DOR - (b)(6)2026.Affected side -Right.

  Patient problems: Joint Laxity

  MAUDE report 50944877 ↗
• InjurySep 22, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that infection. DOI: Unknown.DOR: (b)(6)2026.Affected Side: Unknown.

  Patient problems: Unspecified Infection

  MAUDE report 50853965 ↗
• 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), 2026DOR: (b)(6), 2026

  Patient problems: Unspecified Infection

  MAUDE report 50751631 ↗
• InjuryMay 28, 2026Adverse Event Without Identified Device or Use Problem

  (B)(6). CLINICAL ADVERSE EVENT RECEIVED FOR NON-DISPLACED LESSER TUBEROSITY FRACTURE ON AXILLARY VIEW DEVICE RELATED: POSSIBLE PROCEDURE RELATED: POSSIBLE DATE OF EVENT: (B)(6) 2025 DATE OF IMPLANT: (B)(6) 2025 DATE OF REVISION: NO INFORMATION PROVIDED DEVICE LOCATION: LEFT TREATMENT/IMPACT: OBSERVATION DEPUY SYNTHES PRODUCTS USED: CATALOG NUMBER: 520002032 LOT NUMBER: 58471 COMPONENT TYPE: STEM DESCRIPTION: INHANCE SHOULDER SYSTEM STANDARD STEM SMALL Ø32MM X 109MM CATALOG NUMBER: 550300500 LOT NUMBER: 230242 COMPONENT TYPE: SCREW DESCRIPTION: INHANCE SHOULDER SYSTEM SELF-DRILLING & LOCKING SCREW 4 PACK 20MM & 25MM CATALOG NUMBER: 550011240 LOT NUMBER: 663948 COMPONENT TYPE: BASEPLATE DESCRIPTION: INHANCE SHOULDER SYSTEM MODULAR UNITI PLATFORM BASEPLATE SMALL Ø24MM CEMENTLESS CATALOG NUMBER: 550035600 LOT NUMBER: 226421 COMPONENT TYPE: SCREW DESCRIPTION: INHANCE SHOULDER SYSTEM CENTRAL SCREW Ø6.0 X 35MM CATALOG NUMBER: 550532004 LOT NUMBER: 351203 COMPONENT TYPE: GLENOSPHERE DESCRIPTION: INHANCE SHOULDER SYSTEM GLENOSPHERE Ø32+4MM CATALOG NUMBER: 550000320 LOT NUMBER: 664124 COMPONENT TYPE: SHELL DESCRIPTION: INHANCE SHOULDER SYSTEM REVERSE HUMERAL SHELL SMALL Ø32+0MM CATALOG NUMBE

  Patient problems: Bone Fracture(s)

  MAUDE report 25314869 ↗
• InjuryNov 13, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

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

  Patient problems: Joint Laxity

  MAUDE report 23545207 ↗
• InjuryOct 15, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD INITIAL SURGERY DONE ON (B)(6) 2024. PATIENT WAS DEALING WITH INSTABILITY ISSUES WITH DISLOCATIONS. THE SURGEON FELT THE PATIENT'S HUMERAL COMPONENT WAS IN VARUS AND THAT COULD BE CONTRIBUTING TO INSTABILITY. THEY REMOVED THE HUMERAL COMPONENTS AND OPTED FOR A STANDARD-LENGTH STEM IN HOPES TO STRAIGHTEN OUT THE HUMERAL SIDE. THEY ALSO SWAPPED OUT THE OLD GLENOSPHERE FOR A NEW ONE. A TRIAL REDUCTION WAS PERFORMED WITH A +0 HUMERAL SHELL AND +4 RETENTIVE POLY. THE SURGEON FELT IT WAS MUCH MORE STABLE, SO THE REAL IMPLANTS WERE OPENED AND IMPLANTED. STABILITY WAS CONFIRMED AND THE CLOSING PROCESS BEGAN. NO DELAYS OR ADVERSE EVENTS TOOK PLACE. DOI: (B)(6) 2024, DOR: UNKNOWN, AFFECTED SIDE: RIGHT SHOULDER.

  Patient problems: Joint Laxity

  MAUDE report 23285036 ↗
• InjurySep 11, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS REVISED DUE TO PERI PROSTHETIC FRACTURE. AFFECTED SIDE: LEFT SHOULDER.

  Patient problems: Bone Fracture(s)

  MAUDE report 23024662 ↗
• 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 22909024 ↗
• InjuryJul 31, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT DEVELOPED A HEMATOMA. THE SURGEON WAS GOING TO REPLACE THE POLY IN CASE OF INFECTION. WHILE REMOVING THE POLY, THE STEM HAD A LITTLE MOVEMENT. THE SURGEON REMOVED IT AND REPLACED THE STEM, SHELL AND POLY. DOI: (B)(6) 2025. DOR: (B)(6) 2025. AFFECTED SIDE: RIGHT SHOULDER.

  Patient problems: Hematoma; Unspecified Infection

  MAUDE report 22682671 ↗
• InjuryMay 30, 2025Use of Device Problem; Use of Device Problem

  IT WAS REPORTED THAT THE PATIENT HAD THEIR SHOULDER STEM ORIGINALLY IMPLANTED IN VARUS WITH A PERFORATION OF HUMERAL SHAFT CORTEX. THE GLENOID COMPONENT WAS WELL FIXED. THE HUMERAL STEM, SHELL, AND LINER WERE EXPLANTED. A LONG STEM, SHELL, LINER WAS IMPLANTED. THE FINAL STEM WAS WELL FIXED AND THIS WAS CONFIRMED BY C-ARM. DOI: UNKNOWN, DOR: (B)(6) 2025, AFFECTED SIDE: RIGHT SHOULDER.

  Patient problems: Insufficient Information

  MAUDE report 22116528 ↗
• InjuryFeb 6, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  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 Laxity

  MAUDE report 21325788 ↗
• InjuryJan 22, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS REVISED DUE TO INSTABILITY. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. NO FURTHER INFORMATION WAS PROVIDED. DOI: UNKNOWN; DOR: (B)(6) 2025; AFFECTED SIDE: RIGHT SHOULDER.

  Patient problems: Joint Laxity

  MAUDE report 21213401 ↗
• MalfunctionJan 7, 2025Difficult to Insert; Difficult to Insert

  HUMERAL SHELL DID NOT SEAT CORRECTLY NO OTHER INFORMATION WAS PROVIDED AT THIS TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21094075 ↗
• InjurySep 16, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE SURGEON REVISED THE ENHANCE POLY CUP AND SHELL FOR INSTABILITY. DOI: UNKNOWN DOR: (B)(6) 2024 AFFECTED SIDE : RIGHT SHOULDER.

  Patient problems: Joint Laxity

  MAUDE report 20226032 ↗
• InjuryMay 15, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS INFECTED AND NEEDED A WASHOUT AND POLY SWAP. HER ORIGINAL SURGERY WAS ON (B)(6) 2024. THE SURGEON WASHED OUT THIS PATIENT AND REPLACED THE POLY WITH A NEW ONE. HE ALSO DECIDED THAT SHE SEEMED TOO LOOSE AND DECIDED TO SWAP THE +0 SHELL FOR A +8 SHELL. SURGICAL DELAY WAS UNKNOWN. DOI: (B)(6) 2024. DOR: (B)(6) 2024. AFFECTED SIDE: RIGHT SHOULDER.

  Patient problems: Unspecified Infection

  MAUDE report 19321537 ↗
• MalfunctionApr 30, 2024Difficult to Insert; Difficult to Insert

  IT WAS REPORTED THAT THE SURGEON SAID REVERSE SHELL WOULD NOT SEAT. THEY ASKED FOR A NEW ONE. SECOND IMPLANT SEATED NO ISSUE. THERE WAS NO SURGICAL DELAY.

  Patient problems: Insufficient Information

  MAUDE report 19211747 ↗
• InjuryDec 6, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT'S SHOULDER WAS ORIGINALLY DONE ON (B)(6) 2022 AT A HOSPITAL. PATIENT SHOULDER BECAME INFECTED SO THE SURGEON FELT THEY WOULD BENEFIT FROM A THOROUGH WASHOUT OF THEIR SHOULDER WITH IMPLANT EXCHANGE. THE GLENOSPHERE, NUMERAL SHELL, AND POLY WERE REMOVED AND THE SHOULDER WAS THOROUGHLY CLEANED. A NEW 36 GLENOSPHERE WAS IMPLANTED. A TRIAL REDUCTION WAS PERFORMED WITH A NEW SHELL AND POLY. THE SHOULDER WAS FOUND TO BE STABLE, SO THE REAL SHELL AND POLY WERE OPENED AND IMPLANTED. STABILITY OF THE SHOULDER WAS CONFIRMED AND THE CLOSING PROCESS BEGAN. NO ADVERSE EVENTS TOOK PLACE. (B)(6). AFFECTED SIDE: RIGHT SHOULDER

  Patient problems: Unspecified Infection

  MAUDE report 18274483 ↗
• InjuryAug 14, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD HER SHOULDER REPLACED APPROXIMATELY A YEAR AGO AND HAVE AN INHANCE REVERSE SHOULDER IMPLANTED. PATIENT CAME TO DOCTOR BECAUSE OF SHOULDER PAIN. AFTER TRYING OTHER NON-SURGICAL TREATMENTS THE DECISION WAS MADE TO REVISE THE SHOULDER TO FIND THE PAIN SOURCE. DURING THE REVISION PROCEDURE SCAR TISSUE WAS EXCISED, THE COMPONENTS WERE WELL FIXED, AND TEST FOR INFECTION CAME BACK NEGATIVE. THE HUMERAL TRAY AND POLY WERE EXPLANTED AND NEW COMPONENTS WERE REPLACED. DOI: APPROXIMATELY A YEAR AGO DOR: (B)(6), 2023 AFFECTED SIDE: RIGHT SHOULDER.

  Patient problems: Adhesion(s); Pain

  MAUDE report 17540023 ↗