INHANCE 5200-44-172Recalls & reported problems
Depuy (Ireland) · INHANCE SHOULDER SYSTEM HUMERAL HEAD diameter 44mm X 17.25mm · Class 2 · Implant
- Adverse event reports
- 6
- Deaths reported
- 0
- Injuries reported
- 6
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 10603295538356), received between Jun 20, 2023 and Jan 27, 2026 — classified as 6 injuries.
The most frequently reported specific device problem is “Device Dislodged or Dislocated” (1 report).
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.
Reports received per month
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem5
- Device Dislodged or Dislocated1
Patient problems
- Unspecified Tissue Injury5
- Joint Dislocation1
- Joint Laxity1
Recent adverse event reports
The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.
InjuryJan 27, 2026Adverse Event Without Identified Device or Use Problem
PATIENT WAS REVISED DUE TO LOST ROTATOR CUFF FUNCTION. INHANCE ANATOMIC WAS CONVERTED TO REVERSE. DOI: (B)(6) 2025. DOR: (B)(6) 2026. AFFECTED SIDE: LEFT SHOULDER.
Patient problems: Unspecified Tissue Injury
MAUDE report 24189711 ↗InjuryDec 11, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE PATIENT UNDERWENT AN INHANCE ANATOMIC PROCEDURE IN JULY. UNFORTUNATELY, PATIENT'S SUBSCAP TENDON WENT ON TO FAILURE. PATIENT WAS REVISED TO A REVERSE INHANCE. DOI: (B)(6) 2025. DOR: (B)(6) 2025. AFFECTED SIDE: RIGHT SHOULDER.
Patient problems: Unspecified Tissue Injury
MAUDE report 23782801 ↗InjuryNov 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 DUE TO A TORE ROTATOR CUFF AND SUBSCAP DURING REHABILITATION. NO FURTHER INFORMATION IS AVAILABLE. DOI: (B)(6) 2025. DOR: (B)(6) 2025. AFFECTED SIDE: UNKNOWN.
Patient problems: Unspecified Tissue Injury
MAUDE report 23646235 ↗InjuryOct 11, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE SUBSCAPULARIS WAS FAILED AND CONVERSION TO REVERSE TOTAL SHOULDER. DOI: (B)(6) 2022. DOR: (B)(6) 2024. AFFECTED SIDE: LEFT SHOULDER.
Patient problems: Unspecified Tissue Injury
MAUDE report 20427595 ↗InjuryJul 25, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
ADDITIONAL INFORMATION WAS RECEIVED AND STATED THAT THERE ARE NO SURGICAL DELAY.
Patient problems: Unspecified Tissue Injury
MAUDE report 19829489 ↗InjuryJun 20, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated
THE PATIENT WAS REVISED DUE TO DISLOCATION/INSTABILITY FOLLOWING TOTAL SHOULDER REPLACEMENT. UNKNOWN SURGICAL DELAY. DOI: (B)(6) 2023. DOR: (B)(6) 2023, AFFECTED SIDE: RIGHT SHOULDER.
Patient problems: Joint Dislocation; Joint Laxity
MAUDE report 17164841 ↗
Other PROSTHESIS, SHOULDER, NON-CONSTRAINED, METAL/POLYMER CEMENTED devices
- Equinoxe 320-38-00Exactech, Inc. · Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented3 recalls107 reports
- Equinoxe 320-42-00Exactech, 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: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.