Shoulder System 04.01.0125Recalls & reported problems
Medacta International SA · Humeral Reverse HC Liner Ø42/+0mm · Class 2 · Implant
All models of Shoulder System (63)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 15
- Deaths reported
- 0
- Injuries reported
- 15
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 15 adverse event reports that list this exact device (DI 07630040706322), received between May 16, 2019 and Jul 8, 2026 — classified as 15 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 16, 2026.
Reports received per month
Most reported problems
Device problems
- Device Dislodged or Dislocated9
- Device Appears to Trigger Rejection3
- Adverse Event Without Identified Device or Use Problem2
- Appropriate Device Problem Term/Code Not Available1
Patient problems
- Joint Dislocation6
- Medical device site infection3
- Pain3
- Joint Laxity2
- Bone Fracture(s)1
- Implant Pain1
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 15 most recent of 15 reports, in the reporter's own words as published by the FDA.
InjuryJul 8, 2026Device Appears to Trigger Rejection
THE PATIENT HAD PRIMARY LEFT REVERSE SHOULDER SURGERY ON (B)(6) 2026. ON (B)(6) 2026, THE PATIENT CAME IN DUE TO SIGNS OF INFECTION AND THE PATHOGEN IS UNKNOWN. THE SURGEON PERFORMED A WASHOUT AND REVISED THE D 42/+0MM REVERSE HC LINER WITH A SAME SIZE LINER. DURING THE PROCEDURE THE SURGEON ALSO REMOVED THE GLENOSPHERE AND REATTACHED IT WITH NEW GLENOSPHERE SCREWS. THE SURGERY WAS COMPLETED SUCCESSFULLY. PRESENTLY ON (B)(6) 2026, THE PATIENT RETURNED DUE TO SIGNS OF INFECTION AND THE PATHOGEN IS UNKNOWN. THE SURGEON PERFORMED A WASHOUT AND REVISED THE HUMERAL REVERSE HC LINER D 42/+0MM TO A CONSTRAINED E-CROSS LINER D 42/+0, AND REVISED THE SENSITIN LAT. GLENOSPHERE 42XD 24.5 TO A SAME SIZE GLENOSPHERE. THE SURGERY WAS COMPLETED SUCCESSFULLY.
Patient problems: Medical device site infection
MAUDE report 25747730 ↗InjuryJul 6, 2026Device Appears to Trigger Rejection
AT ABOUT 1 MONTH AFTER THE PRIMARY, THE PATIENT CAME IN DUE TO SIGNS OF INFECTION AND THE PATHOGEN IS UNKNOWN. THE SURGEON PERFORMED A WASHOUT AND REVISED THE LINER AND THE GLENOSPHERE. THE SURGERY WAS COMPLETED SUCCESSFULLY.
Patient problems: Medical device site infection
MAUDE report 25714725 ↗InjuryDec 18, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated
AT ABOUT 1 YEAR 1 MONTH AFTER THE PRIMARY, THE PATIENT CAME IN DUE TO PAIN DUE TO A FRACTURED ACROMIUM AND IT IS UNKNOWN HOW THIS OCCURED. DURING SURGERY, IT WAS DETERMINED THAT THE LINER HAD ALSO DISLOCATED FROM THE GLENOSPHERE. THE SURGEON UPSIZED THE POLY TO PREVENT FUTURE DISLOCATION WITH PLANS FOR A FUTURE SURGERY TO CORRECT THE ACROMIUM. THE SURGERY WAS COMPLETED SUCCESSFULLY.
Patient problems: Bone Fracture(s); Joint Dislocation
MAUDE report 23836923 ↗InjuryJul 23, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated
PRIMARY SURGERY PERFORMED ON (B)(6) 2025. 1ST REVISION SURGERY PERFORMED ON (B)(6) 2025 DUE TO JOINT LUXATION; LINER AND GLENOSPHERE REVISED. 2ND REVISION SURGERY PERFORMED ON (B)(6) 2025 DUE TO JOINT LUXATION; LINER AND GLENOSPHERE REVISED. 3RD REVISION SURGERY PERFORMED ON (B)(6) 2025 DUE TO JOINT LUXATION; LINER, GLENOSPHERE, AND METAPHYSIS REVISED. PRESENTLY, ON (B)(6) 2025, THE 4TH REVISION SURGERY HAS BEEN PERFORMED DUE TO JOINT LUXATION; PATIENT CONVERTED TO HEMIARTHROPLASTY - GLENOSPHERE AND BASEPLATE REMOVED, LINER AND METAPHYSIS REPLACED WITH ANATOMICAL COMPONENTS. PATIENT HISTORY: PRIMARY SURGERY PERFORMED ON (B)(6) 2025. 1ST REVISION SURGERY PERFORMED ON (B)(6) 2025 DUE TO JOINT LUXATION; LINER AND GLENOSPHERE REVISED. (MDR 2025-00721). 2ND REVISION SURGERY PERFORMED ON (B)(6) 2025 DUE TO JOINT LUXATION; LINER AND GLENOSPHERE REVISED. (MDR 2025-00720). 3RD REVISION SURGERY PERFORMED ON (B)(6) 2025 DUE TO JOINT LUXATION; LINER, GLENOSPHERE, AND METAPHYSIS REVISED. (MDR 2025-00723). 4TH REVISION SURGERY PERFORMED ON (B)(6) 2025 DUE JOINT LUXATION; PATIENT CONVERTED TO HEMIARTHROPLASTY - GLENOSPHERE AND BASEPLATE REMOVED, LINER AND METAPHYSIS REPLACED WITH ANATOMICAL COMPO
Patient problems: Joint Dislocation
MAUDE report 22573885 ↗InjuryMay 7, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated
AT ABOUT 9 MONTHS AFTER PRIMARY, THE PATIENT CAME IN REPORTING PAIN DUE TO SHOULDER LUXATION AND THE CAUSE IS UNKNOWN. THE SURGEON REVISED THE LINER AND THE SURGERY WAS COMPLETED SUCCESSFULLY.
Patient problems: Joint Dislocation; Pain
MAUDE report 21975206 ↗InjuryFeb 20, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated
AT ABOUT 1 YEAR AND 1 MONTH FROM PRIMARY, THE PATIENT CAME IN REPORTING PAIN DUE TO A DISLOCATION OF THE LINER FOR THE GLENOSPHERE. THE CAUSE OF THE DISLOCATION IS UNKNOWN. THE SURGEON REVISED THE GLENOSPHERE, LINER AND METAPHYSIS. THE SURGERY WAS COMPLETED SUCCESSFULLY.
Patient problems: Joint Dislocation
MAUDE report 21420279 ↗InjuryFeb 6, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
AT ABOUT 9 DAYS AFTER THE PRIMARY, THE PATIENT CAME IN REPORTING PAIN DUE TO A DISLOCATION OF THE LINER FOR THE GLENOSPHERE. THE CAUSE OF THE DISLOCATION IS UNKNOWN. THE SURGEON REVISED THE GLENOSPHERE AND LINER AND THE SURGERY WAS COMPLETED SUCCESSFULLY.
Patient problems: Joint Dislocation
MAUDE report 21322093 ↗InjuryJan 23, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated
AT ABOUT 2 WEEKS AFTER THE PRIMARY, THE PATIENT CAME IN REPORTING PAIN DUE TO A JOINT LUXATION. THE SURGEON REVISED THE LINER AND THE SURGERY WAS COMPLETED SUCCESSFULLY.
Patient problems: Implant Pain
MAUDE report 21217483 ↗InjuryMay 2, 2024Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
REVISION SURGERY PERFORMED ABOUT 1 MONTH AFTER THE PRIMARY SURGERY DUE TO INFECTION. GLENOSPHERE AND LINER REVISED.
Patient problems: Medical device site infection
MAUDE report 19228066 ↗InjuryJun 22, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated
AT ABOUT 2 MONTHS AFTER THE PRIMARY, THE PATIENT CAME IN REPORTING PAIN DUE TO SHOULDER LUXATION AND THE CAUSE IS UNKNOWN. THE SURGEON REVISED THE GLENOSPHERE, LINER, AND METAPHYSIS, LATERALIZING ON THE GLENOID AND HUMERAL SIDE. THE SURGERY WAS COMPLETED SUCCESSFULLY.
Patient problems: Pain
MAUDE report 17181793 ↗InjuryMar 23, 2023Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available
AT ABOUT 12 DAYS AFTER THE PRIMARY SURGERY, THE PATIENT CAME IN REPORTING INSTABILITY AND THE CAUSE IS UNKNOWN. THE SURGEON REVISED THE LINER (+0MM) WITH A THICKER ONE (+3MM) AND THE SURGERY WAS COMPLETED SUCCESSFULLY.
Patient problems: Joint Laxity
MAUDE report 16596963 ↗InjuryJul 21, 2022Device Dislodged or Dislocated; Device Dislodged or Dislocated
THE PATIENT HAD PRIMARY SURGERY OF MEDACTA PRODUCTS ON (B)(6) 2022. ON (B)(6) 2022, THE PATIENT CAME IN REPORTING PAIN DUE TO A LOOSE HUMERAL COMPONENT AND THE CAUSE IS UNKNOWN. THE SURGEON REVISED THE DIAPHYSIS, METAPHYSIS, AND LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY. THE PATIENT HAD A PREVIOUS REVISION SURGERY OF COMPETITOR'S PRODUCTS: REVERSE 6+ YEARS POST PRIMARY THAT WAS MISSING A LARGE PORTION OF THE PROXIMAL HUMERUS. PRESENTLY, ON (B)(6) 2022, THE PATIENT CAME IN REPORTING PAIN DUE TO A DISLOCATION OF THE LINER FROM THE COMPETITOR GLENOSPHERE AND STEM LOOSENING. THE SURGEON REMOVED THE REVERSE LINER, METAPHYSIS AND STEM AND IMPLANTED AN ANATOMIC METAPHYSIS, DOUBLE ECCENTER AND HUMERAL HEAD. THE SURGERY WAS COMPLETED SUCCESSFULLY.
Patient problems: Pain
MAUDE report 15072646 ↗InjuryMay 3, 2022Adverse Event Without Identified Device or Use Problem
THE PATIENT CAME IN REPORTING INSTABILITY AND THE CAUSE IS UNKNOWN. AT 1 MONTH AFTER THE PRIMARY SURGERY, THE SURGEON REVISED THE METAPHYSIS AND LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY.
Patient problems: Joint Laxity
MAUDE report 14268959 ↗InjuryApr 29, 2022Device Dislodged or Dislocated
THE PATIENT CAME IN REPORTING PAIN DUE TO A DISLOCATION OF THE LINER FOR THE GLENOSPHERE. THE CAUSE OF THE DISLOCATION IS UNKNOWN. THE SURGEON REVISED THE GLENOSPHERE, LINER, AND METAPHYSIS. THE SURGERY WAS COMPLETED SUCCESSFULLY.
Patient problems: Joint Dislocation
MAUDE report 14247701 ↗InjuryMay 16, 2019Device Dislodged or Dislocated; Device Dislodged or Dislocated
ON (B)(6) 2019 WE WERE INFORMED ABOUT A REVISION SURGERY PERFORMED ON THE FOLLOWING DAY DUE TO IMPLANT LUXATION (GLENOSPHERE FROM THE LINER) 2 MONTHS AFTER SURGERY, AND DELTOID DAMAGING: A THICKER INLAY HAS BEEN USED IN THE REVISION. THIS IS THE SECOND REVISION SURGERY FOR THIS PATIENT THAT WAS REVISED FIRSTLY IN (B)(6) 2019 DUE TO AN UNKNOWN REASON. THE PRIMARY SURGERY, THE DATE IS UNKNOWN, HAS BEEN PERFORMED WITH NON-MEDACTA PRODUCTS.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8615710 ↗
Other Shoulder Prosthesis, Reverse Configuration devices
- DJO SURGICAL 508-36-101Encore Medical, L.P. · shoulder prosthesis, reverse configuration508 reports
- DJO SURGICAL 508-32-101Encore Medical, L.P. · shoulder prosthesis, reverse configuration433 reports
- DJO SURGICAL 508-32-103Encore Medical, L.P. · shoulder prosthesis, reverse configuration421 reports
- DJO SURGICAL 509-00-036Encore Medical, L.P. · shoulder prosthesis, reverse configuration1 recall259 reports
- DJO SURGICAL 508-32-104Encore Medical, L.P. · shoulder prosthesis, reverse configuration1 recall203 reports
- DJO SURGICAL 509-00-032Encore Medical, L.P. · shoulder prosthesis, reverse configuration233 reports
- DELTA XTEND 130760000Depuy (Ireland) · shoulder prosthesis, reverse configuration223 reports
- DJO SURGICAL 508-00-032Encore Medical, L.P. · shoulder prosthesis, reverse configuration122 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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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