INHANCE 5500-36-000Recalls & reported problems
Depuy (Ireland) · INHANCE SHOULDER SYSTEM REVERSE LINER X-LINKED VITAMIN E PE Ø36+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 shoulder system implant is a reverse liner used in shoulder replacement. Most of the 59 reports describe the shoulder joint coming apart or dislocating after surgery, with the liner slipping out of place, along with infections and pain that led to revision operations. There were 59 injuries and no deaths. 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
- 64
- Deaths reported
- 0
- Injuries reported
- 64
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 64 adverse event reports that list this exact device (DI 10603295546771), received between Jan 6, 2023 and Sep 30, 2026 — classified as 64 injuries.
The most frequently reported specific device problem is “Device Dislodged or Dislocated” (19 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 Problem42
- Device Dislodged or Dislocated19
- Noise, Audible3
- No Apparent Adverse Event2
Patient problems
- Joint Laxity22
- Joint Dislocation19
- Unspecified Infection16
- Pain6
- Unspecified Tissue Injury3
- Adhesion(s)2
- Unspecified Musculoskeletal problem2
- Bone Notching1
Recent adverse event reports
The 25 most recent of 64 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 50944899 ↗InjurySep 16, 2026Noise, Audible
Patient problems: Adhesion(s); Bone Notching
MAUDE report 50791964 ↗InjurySep 16, 2026Noise, Audible
It was reported that the patient was returned to surgery to upsize liner thickness, and remove a bone spur and scar tissue. Patient reported clicking to surgeon and they decided to upsize liner thickness. No loosening, no issues with implants reported.Affected Side: Left.
Patient problems: Adhesion(s); Unspecified Musculoskeletal problem
MAUDE report 50786798 ↗InjurySep 10, 2026Adverse Event Without Identified Device or Use Problem
It was reported that the revision and washout was completed due to surgeon suspicion of infection. The glenosphere and poly liner were exchanged during the washout. The original surgery was completed by the doctor on (b)(6) 2026. There was no other information was known.DOI: (b)(6) 2026.DOR: (b)(6) 2026.Affected side: Left Shoulder.
Patient problems: Unspecified Infection
MAUDE report 50712854 ↗InjuryJul 27, 2026Device Dislodged or Dislocated
It was reported that patient was revised due to dislocatingDOI: (b)(6) 2026DOR: (b)(6) 2026Affected side: Right shoulder.
Patient problems: Joint Dislocation
MAUDE report 50026426 ↗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 25395190 ↗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 25317279 ↗InjuryMay 28, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE PATIENT WAS DUE TO BE REVISED DUE TO INFECTION. AFFECTED SIDE-LEFT SHOULDER.
Patient problems: Unspecified Infection
MAUDE report 25317078 ↗InjuryMay 22, 2026Device Dislodged or Dislocated
IT WAS REPORTED THAT PATIENT DISLOCATED, AND REVISION OCCURRED TO SWITCH TO RETENTIVE LINER. DOI: (B)(6) 2024. DOR: (B)(6) 2026. AFFECTED SIDE: UNKNOWN.
Patient problems: Joint Dislocation
MAUDE report 25255900 ↗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 25116239 ↗InjuryApr 21, 2026Device Dislodged or Dislocated
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: Joint Dislocation
MAUDE report 24945449 ↗InjuryApr 7, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT PATIENT WAS REVISED DUE TO INSTABILITY. AFFECTED SIDE: LEFT SHOULDER.
Patient problems: Joint Laxity
MAUDE report 24800355 ↗InjuryMar 23, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT PATIENT HAD INJURED DURING PHYSICAL THERAPY. NO ADDITIONAL INFORMATION WAS GIVEN.
Patient problems: Unspecified Tissue Injury
MAUDE report 24665173 ↗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 24568454 ↗InjuryMar 5, 2026Adverse Event Without Identified Device or Use Problem
PATIENT WAS REVISED DUE TO PAIN. DOI: (B)(6) 2025. DOR: (B)(6) 2026. AFFECTED SIDE: RIGHT SHOULDER.
Patient problems: Pain
MAUDE report 24524258 ↗InjuryFeb 20, 2026Device Dislodged or Dislocated
IT WAS REPORTED THAT THERE WAS REOCCURRING DISLOCATION, ROTATOR CUFF REPAIR COMPROMISED. AFFECTED SIDE: RIGHT SHOULDER.
Patient problems: Joint Dislocation; Unspecified Tissue Injury
MAUDE report 24403212 ↗InjuryFeb 19, 2026Adverse Event Without Identified Device or Use Problem
SUBJECT ID: (B)(6). STUDY NO: (B)(6). CLINICAL ADVERSE EVENT RECEIVED FOR JOINT EFFUSION (POSSIBLE INFECTION OF RIGHT SHOULDER INCISION. PT CALLED OFFICE ON (B)(6) STATES HE WAS ADMITTED TO HOSPITAL IN FLORIDA ON (B)(6) ON IV ANTIBIOTICS) NO RELATIONSHIP TO STUDY DEVICE: NOT RELATED RELATIONSHIP TO PRIMARY STUDY PROCEDURE: POSSIBLE DATE OF EVENT: 29 DEC 2025 DATE OF IMPLANT: (B)(6) 2025 DATE OF REVISION: NO INFORMATION PROVIDED DEVICE LOCATION: RIGHT TREATMENT/IMPACT: HOSPITALIZATIONS, DIAGNOSTIC INTERVENTIONS (VNOUS DUPLEX, ULTRASOUND, MRI, XRAY), INJECTED MEDICATIONS (VANCOMYCIN IVPB 2000MG, PIPERACILLIN-TAZOBACTAM IV 4.5MG), ASPIRATIONS, ORAL/TOPICAL MEDICATION (LIDOCAINE 5% PATCH, ACETAMINOPHEN-CODEINE 300-30MG, PO LINEZOLID 600 BID AND AUGMENTIN 875 BID X 1 WEEK), DEBRIDEMENT, ANTIBIOTICS, IMPLANT RETENTION DEPUY SYNTHES PRODUCTS USED: CATALOG NUMBER: 550536008 LOT NUMBER: 354222 COMPONENT TYPE: GLENOSPHERE UNIQUE DEVICE ID: (B)(4). CATALOG NUMBER: 550035600 LOT NUMBER: 233591 COMPONENT TYPE: SCREW UNIQUE DEVICE ID: (B)(4). CATALOG NUMBER: 550300500 LOT NUMBER: 235422 COMPONENT TYPE: SCREW UNIQUE DEVICE ID: (B)(4). CATALOG NUMBER: 550011240 LOT NUMBER: 664506 COMPONENT TYPE: B
Patient problems: Unspecified Infection
MAUDE report 24390007 ↗InjuryFeb 17, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT REVISED POLY FOR INSTABILITY FROM SURGERY EARLIER IN THE DAY. AFFECTED SIDE: RIGHT SHOULDER.
Patient problems: Joint Laxity
MAUDE report 24363998 ↗InjuryFeb 10, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THERE WAS REVISION DUE TO INSTABILITY.
Patient problems: Joint Laxity
MAUDE report 24304309 ↗InjuryJan 30, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT PATIENT HAD INFECTION. DOI: UNKNOWN. DOR: (B)(6) 2026. AFFECTED SIDE: UNKNOWN
Patient problems: Unspecified Infection
MAUDE report 24221754 ↗InjuryJan 14, 2026Adverse Event Without Identified Device or Use Problem
SUBJECT ID: (B)(6). STUDY NO: DSM202108. CLINICAL ADVERSE EVENT RECEIVED FOR POSSIBLE INFECTION OF RIGHT SHOULDER INCISION DEVICE AND PROCEDURE (RELATEDNESS), DEVICE RELATED: NOT RELATED, PROCEDURE RELATED: POSSIBLE, DATE OF EVENT: 29 DEC 2025, DATE OF IMPLANT: (B)(6) 2025, DATE OF REVISION: NO INFORMATION PROVIDED, DEVICE LOCATION: RIGHT. TREATMENT/IMPACT: HOSPITALIZATION, DIAGNOSTIC INTERVENTION (VENOUS DUPLEX, ULTRASOUND, MRI, XRAY), INJECTED MEDICATION (VANCOMYCIN IVPB 2000MG, PIPERACILLIN-TAZOBACTAM IV 4.5MG), ORAL/TOPICAL MEDICATION (LIDOCAINE 5% PATCH, ACETAMINOPHEN-CODEINE 300-30MG, PO LINEZOLID 600 BID AND AUGMENTIN 875 BID X 1 WEEK).
Patient problems: Unspecified Infection
MAUDE report 24073142 ↗InjuryJan 14, 2026Adverse Event Without Identified Device or Use Problem
SUBJECT ID: (B)(6). STUDY NO: (B)(4). CLINICAL ADVERSE EVENT RECEIVED FOR POSSIBLE INFECTION OF LEFT SHOULDER INCISION DEVICE AND PROCEDURE (RELATEDNESS). DEVICE RELATED: NOT RELATED. PROCEDURE RELATED: POSSIBLE. DATE OF EVENT: 29 DEC 2025. DATE OF IMPLANT: ON (B)(6) 2025. DATE OF REVISION: NO INFORMATION PROVIDED. DEVICE LOCATION: RIGHT. TREATMENT/IMPACT: HOSPITALIZATION, INJECTED MEDICATION (PT STATES HE IS ON IV ANTIBIOTICS).
Patient problems: Unspecified Infection
MAUDE report 24071867 ↗InjuryJan 7, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE PATIENT WAS NOT STABLE. DOI: (B)(6) 2025. DOR: (B)(6) 2025. AFFECTED SIDE: LEFT SHOULDER.
Patient problems: Joint Laxity
MAUDE report 23991186 ↗InjuryJan 7, 2026Device Dislodged or Dislocated; No Apparent Adverse Event; Noise, Audible
SUBJECT ID: (B)(6). STUDY NO: (B)(4). CLINICAL ADVERSE EVENT RECEIVED FOR POSSIBLE COMPONENT DISLOCATION, PT CALLED OFFICE STATING HE WAS CARRYING AN ITEM DOWN THE HALL AND GOT CAUGHT ON THE CORNER AND HEARD A POP AND NOTICES A CLEAR BULGE IN HIS ARM. PT IS HEADED TO THE ED AND SCHEDULED MONDAY WITH DR. DEVICE AND PROCEDURE (RELATEDNESS). DEVICE RELATED: PROBABLE. PROCEDURE RELATED: CAUSAL RELATIONSHIP. DATE OF EVENT: 12 DEC 2025. DATE OF IMPLANT: (B)(6) 2025. DATE OF REVISION: NO INFORMATION PROVIDED. DEVICE LOCATION: LEFT. TREATMENT/IMPACT: DIAGNOSTIC INTERVENTION: YES (SPECIFY: XRAYS). DEPUY SYNTHES PRODUCTS USED: CATALOG NUMBER: 550011240. LOT NUMBER: 664507. COMPONENT TYPE: BASEPLATE. DESCRIPTION: INHANCE SHOULDER SYSTEM MODULAR UNITI PLATFORM BASEPLATE SMALL Ø24MM CEMENTLESS. CATALOG NUMBER: 550300500. LOT NUMBER: 235422. COMPONENT TYPE: SCREW. DESCRIPTION: INHANCE SHOULDER SYSTEM SELF-DRILLING & LOCKING SCREW 4 PACK 20MM & 25MM. CATALOG NUMBER: 550035600. LOT NUMBER: 232001. COMPONENT TYPE: SCREW. DESCRIPTION: INHANCE SHOULDER SYSTEM CENTRAL SCREW Ø6.0 X 35MM. CATALOG NUMBER: 550536008. LOT NUMBER: 354226. COMPONENT TYPE: GLENOSPHERE. DESCRIPTION: INHANCE SHOULDER SYSTEM GLE
Patient problems: Joint Dislocation
MAUDE report 23988438 ↗InjuryDec 23, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated
IT WAS REPORTED THAT THE PATIENT HAD INITIAL SHOULDER SURGERY DONE. POSTOPERATIVELY, PATIENT SUFFERED A SHOULDER DISLOCATION. DOCTOR STATED THAT PATIENT HAD EHLERS-DANLOS SYNDROME AND THAT WAS THE REASON FOR THEIR DISLOCATION. DOCTOR OPTED TO REVISE THEIR SHOULDER AND INCREASE THE POLY THICKNESS TO REGAIN STABILITY OF THE SHOULDER. A 36+4 RETENTIVE POLY WAS TRIALED AND FOUND TO BE STABLE. THE REAL POLY WAS OPENED AND IMPLANTED AND STABILITY WAS CONFIRMED. NO DELAYS OR ADVERSE EVENTS TOOK PLACE. THE CLOSING PROCESS BEGAN. DOI: (B)(6) 2025, DOR: UNKNOWN, AFFECTED SIDE: RIGHT SHOULDER.
Patient problems: Joint Dislocation
MAUDE report 23881319 ↗
Other PROSTHESIS, SHOULDER, NON-CONSTRAINED, METAL/POLYMER CEMENTED devices
- Equinoxe 320-42-00Exactech, Inc. · Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented3 recalls107 reports
- Equinoxe 320-38-00Exactech, Inc. · Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented3 recalls107 reports
- Equinoxe 320-42-03Exactech, Inc. · Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented2 recalls87 reports
- Equinoxe 320-38-03Exactech, Inc. · Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented2 recalls43 reports
- Equinoxe 320-42-13Exactech, Inc. · Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented2 recalls41 reports
- Equinoxe 320-10-00Exactech, Inc. · Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented132 reports
- Equinoxe 320-36-00Exactech, Inc. · Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented2 recalls27 reports
- Equinoxe 320-42-10Exactech, Inc. · Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented2 recalls14 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.
How reports and recalls are matched · Editorial policy · Report an error on this page