INHANCE 5500-00-400Recalls & reported problems
Depuy (Ireland) · INHANCE SHOULDER SYSTEM REVERSE HUMERAL SHELL LARGE Ø40+0mm · Class 2 · Implant
All models of INHANCE (202)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
Quick summary
This DePuy InHance reverse shoulder replacement component (the large humeral shell) appears in 56 adverse event reports, none of which describe a death; 51 report injuries and 5 report malfunctions. Most reports describe problems that led to revision surgery — infection, joint loosening or dislocation, pain and laxity, bone fractures, and shells that were difficult to seat properly during surgery. No recalls name this device.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 58
- Deaths reported
- 0
- Injuries reported
- 53
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 58 adverse event reports that list this exact device (DI 10603295546962), received between Jan 24, 2023 and Sep 18, 2026 — classified as 53 injuries, 5 malfunctions.
The most frequently reported specific device problem is “Device Dislodged or Dislocated” (6 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.
Reports received per month
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem45
- Device Dislodged or Dislocated6
- Difficult to Insert5
- Defective Device1
- Device Markings/Labelling Problem1
- Loss of or Failure to Bond1
- Migration1
- Naturally Worn1
Patient problems
- Unspecified Infection21
- Joint Laxity17
- Insufficient Information8
- Pain7
- Joint Dislocation4
- Bone Fracture(s)3
- No Clinical Signs, Symptoms or Conditions2
- Unspecified Tissue Injury2
Recent adverse event reports
The 25 most recent of 58 reports, in the reporter's own words as published by the FDA.
InjurySep 18, 2026Adverse Event Without Identified Device or Use Problem
Patient problems: Pain
MAUDE report 50825022 ↗InjurySep 17, 2026Adverse Event Without Identified Device or Use Problem
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 Laxity
MAUDE report 50805343 ↗InjurySep 16, 2026Adverse Event Without Identified Device or Use Problem
Patient was revised due to impingment/infection. Surgeon performed washout and reimplantation of prosthesis. DOI: (b)(6)2024.DOR: (b)(6)2026.Affected Side: Right Shoulder.
Patient problems: Joint Laxity; Unspecified Infection
MAUDE report 50791443 ↗InjuryJun 4, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE PATIENT WAS REVISED DUE TO INSTABILITY. DOI: UNKNOWN. DOR: (B)(6) 2026. AFFECTED SIDE: UNKNOWN.
Patient problems: Joint Laxity
MAUDE report 25395187 ↗InjuryMay 28, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT PATIENT WAS REVISED FOR EXPLANT AND WASHOUT OF JOINT DUE TO INFECTION. GLENOSPHERE, HUMERAL SHELL, AND POLY WERE REVISED. NO MORE INFORMATION AT THIS TIME. AFFECTED SIDE: LEFT SHOULDER.
Patient problems: Unspecified Infection
MAUDE report 25317191 ↗InjuryApr 20, 2026Adverse Event Without Identified Device or Use Problem
PATIENT WAS REVISED FOR STRESS FX. STEM AND BASEPLATE WELL FIXED. SO CONVERTED TO TOTAL SHOULDER WHILE FX HEALED. DOI: UNKNOWN. DOR: (B)(6) 2026. AFFECTED SIDE: UNKNOWN SHOULDER.
Patient problems: Bone Fracture(s)
MAUDE report 24925163 ↗MalfunctionApr 15, 2026Difficult to Insert
IT WAS REPORTED THAT DURING THE NORMAL PROCESS OF THE SURGERY, THE SIZE LARGE SHORT STEM WAS IMPLANTED. THE SIZE LARGE HUMERAL SHELL AND 36 +0MM RETENTIVE REVERSE LINER WERE ASSEMBLED ON THE BACK TABLE AND HANDED TO THE SURGEON FOR IMPLANTING. THE IMPLANT SIZES AND EXPIRATION DATES WERE ANNOUNCED AND AGREED UPON BEFORE OPENING. THE SURGEON PLACED THE SHELL\LINER ASSEMBLY ON THE STEM AND IMMEDIATELY NOTICED THE LACK OF CONTACT BETWEEN THE SHELL¿S MORSE TAPER AND STEM. THE SURGEON REMOVED THE SHELL\LINER ASSEMBLY AND CHECKED FOR SOFT TISSUE INTERFERENCE. BOTH SURFACES WERE CLEAN AND APPEARED NORMAL. THE SIZES WERE ONCE AGAIN CONFIRMED AND MULTIPLE ATTEMPTS WERE MADE TO PLACE THE SHELL\LINER ASSEMBLY ON THE STEM, BUT THE SHELL ¿BOTTOMED OUT¿ BEFORE THE TAPER ENGAGED. THERE WAS A BRIEF DISCUSSION TO DETERMINE IF THE PROBLEM COULD BE ATTRIBUTED TO THE STEM OR THE SHELL. THE SURGEON MADE THE DECISION TO LEAVE THE STEM IN PLACE AND ATTEMPT ANOTHER SHELL. A SHELL WITH THE SAME PART NUMBER BUT DIFFERENT LOT WAS OPENED AND TEMPORARILY PLACED ON THE STEM FOR TESTING. THE SURGEON IMMEDIATELY NOTICED THE FEEL OF THE PROPER ENGAGEMENT. A SECOND LINER WAS OPENED AND ASSEMBLED WITH THE NEW SHELL O
Patient problems: Insufficient Information
MAUDE report 24889217 ↗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: ON (B)(6) 2024, DOR: ON (B)(6) 2026, AFFECTED SIDE: RIGHT SHOULDER.
Patient problems: Extraskeletal ossification; Joint Laxity
MAUDE report 24800943 ↗InjuryMar 11, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE PATIENT WAS REVISED DUE TO INFECTION. AFFECTED SIDE: RIGHT SHOULDER.
Patient problems: Unspecified Infection
MAUDE report 24568400 ↗InjuryMar 2, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE PATIENT UNDERWENT I/D POLY AND GLENO SWAP. DOI-UNKNOWN. DOR-(B)(6) 2026. AFFECTED SIDE-RIGHT SHOULDER.
Patient problems: Insufficient Information
MAUDE report 24491491 ↗InjuryFeb 24, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE PATIENT HAD TWO DISLOCATIONS. IT WAS REVISED FOR INSTABILITY. DOI: (B)(6) 2025, DOR: (B)(6) 2026, AFFECTED SIDE: RIGHT SHOULDER.
Patient problems: Joint Laxity
MAUDE report 24427706 ↗InjuryFeb 20, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THERE WAS REOCCURRING DISLOCATION, ROTATOR CUFF REPAIR COMPROMISED. AFFECTED SIDE: RIGHT SHOULDER.
Patient problems: Unspecified Tissue Injury
MAUDE report 24403237 ↗InjuryFeb 2, 2026Adverse Event Without Identified Device or Use Problem
SUBJECT ID: (B)(6). STUDY NO: OASIS PROD 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 REVERSE LINER 36+4 R.
Patient problems: Unspecified Infection
MAUDE report 24233205 ↗InjuryJan 27, 2026Adverse Event Without Identified Device or Use Problem
PATIENT WAS REVISED DUE TO INSTABILITY. DOI: (B)(6) 2025, DOR: JAN 14, 2026, AFFECTED SIDE: LEFT SHOULDER.
Patient problems: Joint Laxity
MAUDE report 24189928 ↗InjuryJan 12, 2026Adverse Event Without Identified Device or Use Problem
SUBJECT ID: (B)(6). STUDY NO: (B)(4). CLINICAL ADVERSE EVENT RECEIVED FOR ACUTE SUBLUXATION EVENT, DEVICE AND PROCEDURE (RELATEDNESS), DEVICE RELATED: NOT RELATED, PROCEDURE RELATED: PROBABLE, DATE OF EVENT: 20 DEC 2025, DATE OF IMPLANT: ON (B)(6) 2025, DATE OF REVISION: NO INFORMATION PROVIDED, DEVICE LOCATION: RIGHT. TREATMENT/IMPACT: OTHER NON-SURGICAL TREATMENTS: YES. (SPECIFY: HOLD FORMAL PT AND RESUME USING THE SHOULDER IMMOBILIZER FOR THE NEXT 3 WEEKS. HE CAN DO PENDULUM EXERCISES BUT WILL HOLD ON TO THE REMAINDER OF HIS HOME EXERCISE PROGRAM. IN THREE WEEKS, HE CAN WEAN FROM THE IMMOBILIZER AGAIN AND RESUME OUTPATIENT PT.)
Patient problems: Joint Laxity
MAUDE report 24042691 ↗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 24039554 ↗InjuryDec 17, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
SUBJECT ID: (B)(6), STUDY NO: (B)(4). CLINICAL ADVERSE EVENT RECEIVED FOR GREATER TUBEROSITY FRACTURE DEVICE RELATED: PROBABLE, PROCEDURE RELATED: PROBABLE, DATE OF EVENT: 1 DEC 2025, DATE OF IMPLANT: (B)(6) 2025, DATE OF REVISION: NO INFORMATION PROVIDED, DEVICE LOCATION: RIGHT. TREATMENT/IMPACT: RECOVERING/RESOLVING, SURGICAL INTERVENTION FOR THE STUDY SHOULDER, OPEN REDUCTION INTERNAL FIXATION.
Patient problems: Bone Fracture(s)
MAUDE report 23833697 ↗InjuryDec 16, 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 INFECTION. THE INFECTED PRODUCTS WERE EXPLANTED.
Patient problems: Unspecified Infection
MAUDE report 23814248 ↗InjuryDec 10, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
SUBJECT ID: (B)(6); STUDY NO: (B)(6). CLINICAL ADVERSE EVENT RECEIVED FOR WORSENING BILATERAL SHOULDER PAIN. DEVICE RELATED: NOT RELATED. PROCEDURE RELATED: POSSIBLE. DATE OF EVENT: 19 NOV 2025. DATE OF IMPLANT: (B)(6) 2025. DATE OF REVISION: NO INFORMATION PROVIDED. DEVICE LOCATION: RIGHT. TREATMENT/IMPACT: REHABILITATION, INJECTED MEDICATION (TRIAMCINOLONE (KENALOG-40) INJECTION 20-120 MG). DEPUY SYNTHES PRODUCTS USED: CATALOG NUMBER: 520000040, LOT NUMBER: 662039, COMPONENT TYPE: HUMERAL, DESCRIPTION: INHANCE SHOULDER SYSTEM STEMLESS LARGE DIAMETER 40MM CEMENTLESS. CATALOG NUMBER: 550011240, LOT NUMBER: 663949, COMPONENT TYPE: BASEPLATE, DESCRIPTION: INHANCE SHOULDER SYSTEM MODULAR UNITI PLATFORM BASEPLATE SMALL Ø24MM CEMENTLESS. CATALOG NUMBER: 550300500, LOT NUMBER: 220085, COMPONENT TYPE: SCREW, DESCRIPTION: INHANCE SHOULDER SYSTEM SELF-DRILLING & LOCKING SCREW 4 PACK 20MM & 25MM. CATALOG NUMBER: 550035600, LOT NUMBER: 217704, COMPONENT TYPE: SCREW, DESCRIPTION: INHANCE SHOULDER SYSTEM CENTRAL SCREW Ø6.0 X 35MM. CATALOG NUMBER: 550532008, LOT NUMBER: 345531, COMPONENT TYPE: GLENOSPHERE, DESCRIPTION: INHANCE SHOULDER SYSTEM GLENOSPHERE Ø32+8MM. CATALOG NUMBER: 550000400, LOT N
Patient problems: Pain
MAUDE report 23768923 ↗InjuryDec 9, 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. INCREASED GLENO AND ADDED RETENTIVE POLY. NO LOOSENING OR IMPLANT FAILURE. NO CASE DELAY. NO BROKEN PIECES. ALL PIECES WERE REMOVED. NO OTHER INFORMATION KNOWN. DOI (B)(6) 2025, DOR (B)(6) 2025, AFFECTED SIDE-RIGHT SHOULDER.
Patient problems: Joint Laxity
MAUDE report 23761251 ↗InjuryDec 8, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
PATIENT WAS REVISED DUE TO INFECTION. SURGEON DECIDED INTRAOP TO INCREASE GLENOSPHERE SIZE. THERE WAS NO COMPLAINT OR LOOSENING. NO DELAY. NO BROKEN PIECES, NOTHING LEFT BEHIND. NOT SURE OF ORIGINAL IMPLANTATION DATE. NO OTHER INFORMATION KNOWN. DOI: UNKNOWN, DOR: (B)(6) 2025, AFFECTED SIDE: RIGHT SHOULDER.
Patient problems: Unspecified Infection
MAUDE report 23744194 ↗InjuryNov 18, 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, NO IMPLANT FAILURE. UPON EXTRACTION OF GLENOSPHERE THE SET SCREW WAS RETAINED IN THE BASEPLATE, STRIPPED UNABLE TO USE STAR 20. REMOVED WITH BROKEN SCREW SET. NO OTHER INFORMATION KNOWN. AFFECTED SIDE: RIGHT SHOULDER.
Patient problems: Joint Laxity
MAUDE report 23581228 ↗InjuryNov 13, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT ON (B)(6) 2025, A PATIENT WAS IMPLANTED WITH A INHANCE SHOULDER CONSTRUCT. PATIENT WAS DOING GOOD AT FIRST AND THEN FELT DISCOMFORT RECENTLY. PATIENT WENT TO THE EMERGENCY ROOM WHERE INFECTION WAS DIAGNOSED. SURGEON DID I&D AND EXCHANGED THE GLENOSPHERE, SHELL, AND THE POLY. THE HUMERAL STEM, BASEPLATE WERE LEFT IN SITU. DOI: ON (B)(6) 2025, DOR: UNKNOWN, AFFECTED SIDE: LEFT SHOULDER.
Patient problems: Discomfort; Unspecified Infection
MAUDE report 23545255 ↗MalfunctionOct 22, 2025Difficult to Insert; Difficult to Insert
IT WAS REPORTED THAT THE SHELL WOULD NOT PROPERLY SEAT ON THE STEM. NORMAL TECHNIQUE WAS USED TO SEAT THE SHELL. SURGEON TRIED TWICE. BOTH TIMES, THE SHELL SEEMED CROOKED AND THE SURGEON REQUESTED NEW IMPLANTS. NEW PRODUCTS NEEDED TO BE SENT TO REPLACE THESE TWO IMPLANTS. AFFECTED SIDE: UNKNOWN.
Patient problems: Insufficient Information
MAUDE report 23356401 ↗InjurySep 5, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE PATIENT GROSSLY INFECTED HAD TO REMOVE IMPLANTS. DOI: UNKNOWN, DOR: (B)(6) 2025, AFFECTED SIDE: UNKNOWN.
Patient problems: Unspecified Infection
MAUDE report 22977421 ↗
Other PROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED devices
- DJO SURGICAL 509-02-032Encore Medical, L.P. · PROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED364 reports
- DELTA XTEND 130790036Depuy (Ireland) · PROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED171 reports
- DELTA XTEND 130770018Depuy (Ireland) · PROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED159 reports
- TRIGEN 71118200Smith & Nephew, Inc. · PROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED123 reports
- DJO SURGICAL 509-02-432Encore Medical, L.P. · PROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED119 reports
- DELTA XTEND 130738206Depuy (Ireland) · PROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED116 reports
- COMPREHENSIVE SHOULDER SYSTEM 113633Biomet Orthopedics, LLC · PROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED2 recalls4 reports
- DELTA XTEND 130742206Depuy (Ireland) · PROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED99 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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