INHANCE 5500-00-360Recalls & reported problems

Summary

The FDA's MAUDE database contains 30 adverse event reports that list this exact device (DI 10603295546986), received between Nov 30, 2023 and Sep 15, 2026 — classified as 28 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 30 reports, in the reporter's own words as published by the FDA.

• 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 50772368 ↗
• InjurySep 2, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: Unspecified Infection

  MAUDE report 50573229 ↗
• InjuryJun 19, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE HUMERAL SHELL & POLY LINER WERE REMOVED DUE TO LOOSEN & CONVERSION TO A HEMI. THIS WAS DUE TO PATIENT BONE QUALITY. GLENOSPHERE & GLENOID PIECES WERE NOT DEPUY PRODUCTS. DOI: (B)(6) 2025. DOR: (B)(6) 2026. AFFECTED SIDE: LEFT SHOULDER.

  Patient problems: Joint Laxity

  MAUDE report 25562687 ↗
• 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 25456749 ↗
• InjuryJun 9, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED A CLINICAL ADVERSE EVENT RECEIVED FOR PROXIMAL HUMERUS FRACTURE. DEVICE AND PROCEDURE (RELATEDNESS). DEVICE RELATED: NOT RELATED. PROCEDURE RELATED: CAUSAL RELATIONSHIP. DATE OF EVENT: 6 MAY 2026. DATE OF IMPLANT: (B)(6) 2026. DATE OF REVISION: NO INFORMATION PROVIDED. DEVICE LOCATION: RIGHT. TREATMENT/IMPACT: NONE/OBSERVATION: YES. DEPUY SYNTHES PRODUCTS USED: COMPONENT TYPE: SCREW. CATALOG NUMBER: 550310030. LOT NUMBER: 240825. UNIQUE DEVICE ID: (B)(4). CATALOG NUMBER: 550310020. LOT NUMBER: 233599. COMPONENT TYPE: SCREW. UNIQUE DEVICE ID: (B)(4). COMPONENT TYPE: SCREW. CATALOG NUMBER: 550310015. LOT NUMBER: 234384. UNIQUE DEVICE ID: (B)(4). CATALOG NUMBER: 550035600. LOT NUMBER: 238056. COMPONENT TYPE: SCREW. UNIQUE DEVICE ID: (B)(4). CATALOG NUMBER: 520002036. LOT NUMBER: 62141. COMPONENT TYPE: STEM. UNIQUE DEVICE ID: (B)(4). CATALOG NUMBER: 550536108. LOT NUMBER: 344527. COMPONENT TYPE: GLENOSPHERE. UNIQUE DEVICE ID: (B)(4). CATALOG NUMBER: 550000360. LOT NUMBER: 664810. COMPONENT TYPE: SHELL. UNIQUE DEVICE ID: (B)(4). CATALOG NUMBER: 550011240. LOT NUMBER: 665331. COMPONENT TYPE: BASEPLATE. UNIQUE DEVICE ID: (B)(4). CATALOG NUMBER: 550036000. LOT NUMBER: MI192

  Patient problems: Bone Fracture(s)

  MAUDE report 25447768 ↗
• InjuryMay 7, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT WAS REVISED DUE TO INSTABILITY. DOI- (B)(6) 2026, DOR- (B)(6) 2026, AFFECTED SIDE-LEFT SHOULDER.

  Patient problems: Joint Laxity

  MAUDE report 25116310 ↗
• InjuryMay 6, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT HAD AN UNSTABLE SHOULDER. CONVERTED TO 36 AND WENT UP IN POLY SIZE. DOI: (B)(6) 2024, DOR: (B)(6) 2026, AFFECTED SIDE: RIGHT SHOULDER.

  Patient problems: Joint Laxity

  MAUDE report 25103812 ↗
• InjuryApr 21, 2026Use of Device Problem

  IT WAS REPORTED THAT MEDIUM SHORT STEM INHANCE, 36+0 POLY AND MEDIUM +0 SHELL REVISING BECAUSE POLY KEPT SLIPPING OUT AND STEM WAS LEFT PROUD. DOI-UNKNOWN. DOR-(B)(6) 2026. AFFECTED SIDE-UNKNOWN.

  Patient problems: Insufficient Information

  MAUDE report 24945438 ↗
• InjuryApr 16, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT FELL AND HAD A PERI PROSTHETIC FRACTURE. IMPLANTS REVISED DUE TO THE FRACTURE. AFFECTED SIDE: LEFT SHOULDER.

  Patient problems: Bone Fracture(s); Fall

  MAUDE report 24894448 ↗
• InjuryJan 27, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED A REVERSED TOTAL SHOULDER REVISION OCCURRED DUE TO GLENOSPHERE AND LINER IMPINGEMENT. PATIENT WAS CONVERTED TO HEMI ARTHOPLASTY. DURING THE PROCEDURE THE HEAD TRIAL WAS DAMAGED WHERE THE ADAPTOR FOR HEAD AND TRIAL MEET. THE ATTACHMENT TABS BROKE OFF. THERE WAS NO HARM TO PATIENT AND NO SURGICAL DELAY. DOE: (B)(6) 2026. AFFECTED SIDE: RIGHT SHOULDER.

  Patient problems: Joint Laxity

  MAUDE report 24188180 ↗
• InjuryDec 30, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE DISTAL TIP OF HUMERAL STEM PERFORATED THE HUMERUS. IT WAS REMOVED AND REPLACED WITH A STD STEM. GLENOSPHERE, CUP AND POLY WERE ALSO REPLACED. THERE WAS A LOOSENING OF HUMERAL STEM AT NON-CEMENTED INTERFACE. DOI: (B)(6) 2025, DOR: (B)(6) 2025, AFFECTED SIDE: RIGHT SHOULDER.

  Patient problems: Bone Fracture(s)

  MAUDE report 23924095 ↗
• InjuryDec 3, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT SURGEON REVISED THE GLENOSPHERE AND HUMERAL SHELL DUE TO INSTABILITY AND A DISLODGED SCREW. ALL PIECES WERE REMOVED FROM THE PATIENT. THERE WAS NO DELAY TO THE CASE. DOI: UNKNOWN, DOR: ON (B)(6) 2025, AFFECTED SIDE: LEFT SHOULDER.

  Patient problems: Joint Laxity

  MAUDE report 23709940 ↗
• InjuryOct 15, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A CLINICAL ADVERSE EVENTS WERE RECEIVED FOR CONJOINED TENDINITIS: DEVICE AND PROCEDURE (RELATEDNESS), DEVICE RELATED: NOT RELATED, PROCEDURE RELATED: POSSIBLE, DATE OF EVENT: 05 SEP 2025, DATE OF IMPLANT: ON (B)(6) 2025, DATE OF REVISION: NO INFORMATION PROVIDED, DEVICE LOCATION: NO INFORMATION PROVIDED. SUBJECT ID: (B)(6). STUDY NO: (B)(4). TREATMENT/IMPACT: REHABILITATION, INJECTED MEDICATION (SPECIFY: 2 ML OF 1% LIDOCAINE 2 ML OF 0.25% MARCAINE AND 2 ML OF BETAMETHASONE) AND ORAL/TOPICAL MEDICATION. DEPUY SYNTHES PRODUCT USED: CATALOG NUMBER: 520000036, LOT NUMBER: 662705, COMPONENT TYPE: HUMERAL, UNIQUE DEVICE ID: (B)(4). CATALOG NUMBER: 550011240, LOT NUMBER: 663951, COMPONENT TYPE: BASEPLATE, UNIQUE DEVICE ID: (B)(4). CATALOG NUMBER: 550300500, LOT NUMBER: 229406, COMPONENT TYPE: SCREW, UNIQUE DEVICE ID: (B)(4). CATALOG NUMBER: 550040600, LOT NUMBER: 206414, COMPONENT TYPE: SCREW, UNIQUE DEVICE ID: (B)(4). CATALOG NUMBER: 550532008, LOT NUMBER: 347232, COMPONENT TYPE: GLENOSPHERE, UNIQUE DEVICE ID: (B)(4). CATALOG NUMBER: 550000360, LOT NUMBER: 664116, COMPONENT TYPE: SHELL, UNIQUE DEVICE ID: (B)(4). CATALOG NUMBER: 550032000, LOT NUMBER: MI1777, COMPONEN

  Patient problems: Muscle/Tendon Damage

  MAUDE report 23286021 ↗
• InjuryJul 25, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT COMPONENTS WERE REMOVED DUE TO LOCKING SCREW BEING BROKEN & INFECTION OF THE JOINT. DOI: (B)(6) 2024, DOR: (B)(6) 2025, AFFECTED SIDE: LEFT SHOULDER.

  Patient problems: Unspecified Infection

  MAUDE report 22615760 ↗
• 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 22594544 ↗
• InjuryJul 8, 2025Osseointegration Problem; Osseointegration Problem

  IT WAS REPORTED THAT THE PATIENT WAS REVISED DUE TO PAIN. THERE WAS LOOSENING OF HUMERAL STEM. THE LOOSENING INTERFACE WAS NON-CEMENTED. DOI: (B)(6) 2025. DOR: (B)(6) 2025. AFFECTED SIDE: LEFT SHOULDER.

  Patient problems: Inadequate Osseointegration; Pain

  MAUDE report 22437391 ↗
• 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 TRIALED 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 22340503 ↗
• InjuryJun 25, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS REVISED FOR INSTABILITY. THE GLENOSPHERE, SHELL, AND POLY WERE REMOVED AND REPLACED WITH DIFFERENT SIZES. DOI: (B)(6) 2025. DOR: (B)(6) 2025. AFFECTED SIDE: RIGHT SHOULDER.

  Patient problems: Joint Laxity

  MAUDE report 22332735 ↗
• MalfunctionMay 14, 2025Difficult to Insert; Defective Device; Difficult to Insert; Defective Device

  IT WAS REPORTED THAT THE SURGEON PERFORMED A REVERSE INHANCE TOTAL SHOULDER. AT THE END OF THE CASE, A 36+0 HUMERAL SHELL WAS OPENED TO MATCH THE MEDIUM (36) INHANCE STEM THAT HAD ALREADY BEEN IMPLANTED. THE SURGEON ATTEMPTED TO SNAP THE SHELL ONTO THE STEM AND COULD NOT GET IT TO ENGAGE. AN ADDITIONAL 36+0 INHANCE HUMERAL SHELL WAS OPENED AND SNAPPED INTO PLACE TO COMPLETE THE CASE. PRIOR TO IMPLANTING THE SECOND HUMERAL SHELL, THE FIRST SHELL WAS EXAMINED AND IT WAS FOUND THAT THE BOTTOM OF THE SHELL AND THE INNER RING APPEARED TO BE A DIFFERENT DIAMETER THAN THE 36+0 THAT WAS IMPLANTED. IT IS UNKNOWN IF THERE WAS A SURGICAL DELAY. AFFECTED SIDE: LEFT SHOULDER.

  Patient problems: Insufficient Information

  MAUDE report 22017653 ↗
• InjuryApr 21, 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. NOTHING FURTHER TO REPORT. THICKNESS WAS INCREASED ON THE SHELL AND LINER WAS SWAPPED FOR A RETENTIVE. DOI: UNKNOWN. DOR: UNKNOWN . AFFECTED SIDE: UNKNOWN SHOULDER SIDE.

  Patient problems: Joint Laxity

  MAUDE report 21873241 ↗
• InjuryMar 25, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE SHOULDER WAS LOOSE AND DISLOCATED A FEW TIMES. LINER AND SHELL WERE REPLACED TO TENSION THE JOINT. THERE WAS NO LOSS OF TIME. DOI: (B)(6) 2024. DOR: (B)(6) 2025. AFFECTED SIDE: LEFT SHOULDER.

  Patient problems: Joint Laxity

  MAUDE report 21687211 ↗
• InjuryMar 18, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  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 Laxity

  MAUDE report 21633125 ↗
• MalfunctionJan 9, 2025Difficult to Insert; Inaccurate Information; Wrong Label; Difficult to Insert; Inaccurate Information; Wrong Label

  IT WAS REPORTED THAT THERE WAS AN IMPROPERLY LABELLED INHANCE SHOULDER SYSTEM REVERSE SHELL. BOTH THE BOX AND IMPLANT INDICATE IT WAS A SIZE MEDIUM (36 + 0), HOWEVER IT WOULD NOT FIT THE SIZE MEDIUM STEM. SURGERY WAS DELAYED BY LESS THAN 30 MINUTES DUE TO THE EVENT. ANOTHER IMPLANT BROUGHT AND USED TO COMPLETE THE CASE SUCCESSFULLY. THERE WAS NO PATIENT CONSEQUENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21111381 ↗
• InjuryOct 22, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED A PATIENT WAS REVISED ON (B)(6) 2024 DUE TO PROBABLE INFECTION. ORIGINAL IMPLANT DATE WAS ON (B)(6) 2023.

  Patient problems: Unspecified Infection

  MAUDE report 20502215 ↗
• InjurySep 26, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  PATIENT WAS REVISED DUE TO DISLOCATIONS. SURGICAL DELAY WAS UNKNOWN. DOI: UNKNOWN. DOR: (B)(6) 2024. AFFECTED SIDE: RIGHT SHOULDER.

  Patient problems: Joint Dislocation

  MAUDE report 20312488 ↗