INHANCE 5200-01-032Recalls & reported problems
Depuy (Ireland) · INHANCE SHOULDER SYSTEM SHORT STEM SMALL diameter 32mm X 70mm · Class 2 · Implant
- Adverse event reports
- 5
- Deaths reported
- 0
- Injuries reported
- 5
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10603295538219), received between Dec 12, 2024 and Sep 22, 2026 — classified as 5 injuries.
The most frequently reported specific device problem is “Loss of or Failure to Bond” (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 Problem3
- Loss of or Failure to Bond1
- Osseointegration Problem1
Patient problems
- Unspecified Infection3
- Bone Fracture(s)1
- Hematoma1
- Inadequate Osseointegration1
- Insufficient Information1
Recent adverse event reports
The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.
InjurySep 22, 2026Adverse Event Without Identified Device or Use Problem
It was reported that infection. No other information was provided.DOI: Unknown.DOR: (b)(6) 2026.Affected Side: Unknown.
Patient problems: Unspecified Infection
MAUDE report 50853926 ↗InjurySep 14, 2026Adverse Event Without Identified Device or Use Problem
It was reported that all In hance reverse implants were explanted due to infection. DOI: (b)(6) 2026. DOR: (b)(6) 2026.
Patient problems: Unspecified Infection
MAUDE report 50751604 ↗InjurySep 15, 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 PERI PROSTHETIC FRACTURE. AFFECTED SIDE: LEFT SHOULDER.
Patient problems: Bone Fracture(s)
MAUDE report 23053002 ↗InjuryJul 31, 2025Osseointegration Problem; Osseointegration Problem
IT WAS REPORTED THAT THE PATIENT DEVELOPED A HEMATOMA. THE SURGEON WAS GOING TO REPLACE THE POLY IN CASE OF INFECTION. WHILE REMOVING THE POLY, THE STEM HAD A LITTLE MOVEMENT. THE SURGEON REMOVED IT AND REPLACED THE STEM, SHELL AND POLY. DOI: (B)(6) 2025, DOR: (B)(6) 2025, AFFECTED SIDE: RIGHT SHOULDER.
Patient problems: Hematoma; Inadequate Osseointegration; Unspecified Infection
MAUDE report 22682676 ↗InjuryDec 12, 2024Loss of or Failure to Bond; Loss of or Failure to Bond
IT WAS REPORTED THAT THE PATIENT WAS REVISED FOR LOOSE GLENOID AND STEM. THERE WAS NO SURGICAL DELAY. DOI: (B)(6) 2024, DOR: (B)(6) 2024 AND AFFECTED SIDE: LEFT SHOULDER.
Patient problems: Insufficient Information
MAUDE report 20920451 ↗
Other prosthesis, shoulder, semi-constrained, metal/polymer + additive, cemented devices
- Comprehensive Reverse Shoulder 115310Biomet Orthopedics, LLC · prosthesis, shoulder, semi-constrained, metal/polymer + additive, cemented1 death99 reports
- INHANCE 5120-00-110Depuy (Ireland) · prosthesis, shoulder, semi-constrained, metal/polymer + additive, cemented75 reports
- Comprehensive® Reverse Shoulder XL-115364Biomet Orthopedics, LLC · prosthesis, shoulder, semi-constrained, metal/polymer + additive, cemented1 recall7 reports
- Comprehensive® Reverse Shoulder XL-115366Biomet Orthopedics, LLC · prosthesis, shoulder, semi-constrained, metal/polymer + additive, cemented1 recall4 reports
- Comprehensive® Reverse Shoulder 180550Biomet Orthopedics, LLC · prosthesis, shoulder, semi-constrained, metal/polymer + additive, cemented2 deaths43 reports
- Comprehensive® Reverse Shoulder 180551Biomet Orthopedics, LLC · prosthesis, shoulder, semi-constrained, metal/polymer + additive, cemented42 reports
- DJO SURGICAL 521-07-246Encore Medical, L.P. · prosthesis, shoulder, semi-constrained, metal/polymer + additive, cemented42 reports
- Comprehensive® 110031399Zimmer, Inc. · prosthesis, shoulder, semi-constrained, metal/polymer + additive, cemented1 death36 reports
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.