INHANCE 5500-32-004Recalls & reported problems
Depuy (Ireland) · INHANCE SHOULDER SYSTEM REVERSE LINER X-LINKED VITAMIN E PE Ø32+4mm · Class 2 · Implant
All models of INHANCE (202)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 13
- Deaths reported
- 0
- Injuries reported
- 13
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 10603295546757), received between Jul 10, 2024 and Sep 14, 2026 — classified as 13 injuries.
The most frequently reported specific device problem is “Device Dislodged or Dislocated” (9 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
- Device Dislodged or Dislocated9
- Adverse Event Without Identified Device or Use Problem4
Patient problems
- Joint Dislocation9
- Joint Laxity3
- Unspecified Infection2
Recent adverse event reports
The 13 most recent of 13 reports, in the reporter's own words as published by the FDA.
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) 2026.DOR: (b)(6) 2026.
Patient problems: Unspecified Infection
MAUDE report 50751665 ↗InjuryDec 15, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated
IT WAS REPORTED THAT THE SHOULDER WAS DISLOCATED.
Patient problems: Joint Dislocation
MAUDE report 23804661 ↗InjuryDec 2, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated
IT WAS REPORTED THAT PATIENT HAD A DISLOCATING OF SHOULDER. DOI: UNKNOWN. DOR: (B)(6) 2025. AFFECTED SIDE: RIGHT SHOULDER.
Patient problems: Joint Dislocation
MAUDE report 23695212 ↗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 23545208 ↗InjuryNov 5, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated
IT WAS REPORTED THAT THE PATIENT WAS REVISED DUE TO DISLOCATING.
Patient problems: Joint Dislocation
MAUDE report 23480631 ↗InjuryNov 5, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated
IT WAS REPORTED THAT THE PATIENT WAS REVISED DUE TO DISLOCATING.
Patient problems: Joint Dislocation
MAUDE report 23480630 ↗InjuryAug 13, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated
IT WAS REPORTED THAT THE PATIENT WAS REVISED DUE TO DISLOCATION. AFFECTED SIDE: RIGHT SHOULDER.
Patient problems: Joint Dislocation
MAUDE report 22795243 ↗InjuryAug 7, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated
IT WAS REPORTED THAT THE PATIENT HAD INITIAL SURGERY DONE ON (B)(6) 2025. THE PATIENT UNFORTUNATELY SUFFERED TWO DISLOCATIONS OF THEIR SHOULDER POST OPERATIVELY. THE SURGEON SAID BOTH DISLOCATIONS HAPPENED WHEN THE PATIENT ADDUCTED ARM. THE SURGEON FELT THE PATIENT WOULD BENEFIT FROM INCREASING THE GLENOSPHERE DIAMETER AS WELL AS THE LATERALIZATION. THE SURGEON WENT FROM A 32+4 TO A 36+8 GLENOSPHERE. THE SHELL AND POLY WERE REMOVED AND WAS REPLACED WITH A NEW +0 MEDIUM SHELL AND A 36+4 RETENTIVE POLY. THE SHOULDER WAS THEN REDUCED AND STABILITY WAS CONFIRMED. THERE WAS NO ADVERSE EVENTS OR DELAYS TOOK PLACE. ACTIVITY LEVEL - YES. DOI: (B)(6) 2025. DOR: (B)(6) 2025. AFFECTED SIDE: LEFT SHOULDER.
Patient problems: Joint Dislocation
MAUDE report 22736520 ↗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 22594452 ↗InjuryMay 15, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated
IT WAS REPORTED THAT PATIENT WAS REVISED DUE TO DISLOCATION. SURGEON IMPLANTED A RETENTIVE LINER. AFFECTED SIDE: LEFT SHOULDER.
Patient problems: Joint Dislocation
MAUDE report 22027932 ↗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. 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 21873131 ↗InjuryFeb 6, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated
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 Dislocation; Joint Laxity
MAUDE report 21324984 ↗InjuryJul 10, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated
PATIENT DISLOCATED AND WAS REVISED TO +8 METAL AND 0 RETENTIVE POLY. DOI: (B)(6) 2024. DOR: (B)(6) 2024; AFFECTED SIDE: RIGHT SHOULDER.
Patient problems: Joint Dislocation
MAUDE report 19710596 ↗
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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