Shoulder System 04.01.0110Recalls & reported problems

Summary

The FDA's MAUDE database contains 64 adverse event reports that list this exact device (DI 07630040706179), received between Apr 12, 2019 and Jul 8, 2026 — classified as 59 injuries, 5 malfunctions.

The most frequently reported specific device problem is “Device Appears to Trigger Rejection” (20 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 64 reports, in the reporter's own words as published by the FDA.

• InjuryJul 8, 2026Adverse Event Without Identified Device or Use Problem

  THE PATIENT CAME IN PRESENTING CHRONIC PAIN AND THE CAUSE IS UNKNOWN. THERE WERE NO INDICATIONS OF TRAUMA. ABOUT 4 YEARS AND 7 MONTHS AFTER THE PRIMARY SURGERY, THE SURGEON REVISED ALL COMPONENTS EXCEPT THE DIAPHYSIS.

  Patient problems: Implant Pain

  MAUDE report 25747718 ↗
• InjuryMay 27, 2026Adverse Event Without Identified Device or Use Problem

  THE PATIENT CAME IN PRESENTING PAIN AND DISCOMFORT AND THE CAUSE IS UNKNOWN. REVISION SURGERY AT ABOUT 1 YEAR AFTER PRIMARY THERE WERE NO INDICATIONS OF TRAUMA. THE SURGEON REVISED THE REVERSE METAPHYSIS +0MM/0° TO A SAME SIZE METAPHYSIS AND REVISED THE REVERSE HC LINER D 32/+0MM TO A REVISION CONSTRAINED LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Implant Pain

  MAUDE report 25297691 ↗
• InjuryMay 5, 2026Adverse Event Without Identified Device or Use Problem

  AT ABOUT 8 MONTHS FROM THE PRIMARY, THE PATIENT CAME IN PRESENTING INSTABILITY AND THE CAUSE IS UNKNOWN. THERE WERE NO INDICATIONS OF TRAUMA OR BONE QUALITY ISSUES. THE SURGEON REVISED THE METAPHYSIS, THE GLENOSPHERE AND THE LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Joint Laxity

  MAUDE report 25077228 ↗
• InjuryApr 15, 2026Adverse Event Without Identified Device or Use Problem

  AT ABOUT 1 YEAR AND 11 MONTHS FROM THE PRIMARY, THE PATIENT CAME IN PRESENTING SHOULDER INSTABILITY AND THE CAUSE IS UNKNOWN. THERE WAS NO REPORTED TRAUMA. THE SURGEON REVISED THE METAPHYSIS TO THE SAME SIZE AND UPSIZED BOTH THE LINER AND THE GLENOSPHERE. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Joint Laxity

  MAUDE report 24882483 ↗
• InjuryApr 9, 2026Device Appears to Trigger Rejection

  REVISION SURGERY DUE TO INFECTION ABOUT 2 YEARS AND 10 MONTHS AFTER PRIMARY SURGERY. THE SURGEON REVISED THE REVERSE SHOULDER TO ANATOMICAL WITH ANTIBIOTIC SPACERS. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Medical device site infection

  MAUDE report 24826102 ↗
• InjuryFeb 26, 2026Adverse Event Without Identified Device or Use Problem

  REVISION SURGERY WAS PERFORMED ABOUT 8 MONTHS AFTER PRIMARY SURGERY DUE TO INFECTION, AND THE PATHOGEN IS UNKNOWN. THE SURGEON PERFORMED A WASHOUT, THEN REVISED THE METAPHYSIS, LINER, AND GLENOSPHERE TO IMPLANTS OF THE SAME SIZE. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Medical device site infection

  MAUDE report 24454893 ↗
• InjuryFeb 18, 2026Adverse Event Without Identified Device or Use Problem

  AT ABOUT 1 YEAR AND 3 MONTHS FROM THE PRIMARY, THE PATIENT CAME IN PRESENTING INSTABILITY AND THE CAUSE IS UNKNOWN. THE SURGEON REVISED THE METAPHYSIS FROM A +0/0° TO A +9/20°R METAPHYSIS AND REVISED THE LINER FROM A D 36/+3MM TO A D 36/+6MM LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Joint Laxity

  MAUDE report 24376291 ↗
• InjuryJan 12, 2026Adverse Event Without Identified Device or Use Problem

  AT ABOUT 6 MONTHS FROM THE PRIMARY, THE PATIENT CAME IN REPORTING SHOULDER INSTABILITY AND THE CAUSE IS UNKNOWN. THE SURGEON REVISED THE INSERT AND METAPHYSIS TO GIVE THE PATIENT MORE STABILITY. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Joint Laxity

  MAUDE report 24031966 ↗
• InjuryJan 9, 2026Adverse Event Without Identified Device or Use Problem

  AT ABOUT 3 MONTHS FROM THE PRIMARY, THE PATIENT CAME IN REPORTING INSTABILITY AND THE CAUSE IS UNKNOWN. THE SURGEON REPLACED MEDACTA METAPHYSIS, LINER, AND DIAPHYSIS WITH COMPETITOR COMPONENTS AND MEDACTA GLENOSPHERE WITH A MEDACTA GLENOSPHERE. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Joint Laxity

  MAUDE report 24020870 ↗
• InjuryDec 30, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  AT 1 MONTH FROM THE PRIMARY, THE PATIENT CAME IN DUE TO SIGNS OF AN INFECTION AND THE PATHOGEN IS UNKNOWN. THE SURGEON PERFORMED A WASHOUT AND REVISED THE LINER AND METAPHYSIS. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Medical device site infection

  MAUDE report 23920102 ↗
• InjuryDec 22, 2025Device Appears to Trigger Rejection; Adverse Event Without Identified Device or Use Problem; Device Appears to Trigger Rejection; Adverse Event Without Identified Device or Use Problem

  THE FIRST SURGERY WAS SUCCESSFULLY PERFORMED ON (B)(6) 2024, FOLLOWING A PRIMARY PERIPROSTHETIC INFECTION. DURING THE PROCEDURE, THE SURGEON IMPLANTED A CUSTOM-MADE GLENOID RECONSTRUCTION. UNFORTUNATELY, ON (B)(6) 2025, THE PATIENT RETURNED WITH A SHOULDER DISLOCATION AND A RECURRENT INFECTION. DUE TO THE RECURRENCE OF THE INFECTION, A SIGNIFICANT AMOUNT OF FLUID ACCUMULATED IN THE SHOULDER JOINT, WHICH CONTRIBUTED TO THE DISLOCATION. ON (B)(6) 2025, A DAIR REVISION SURGERY WAS PERFORMED TO CLEAN THE SHOULDER. DURING THIS PROCEDURE, THE HUMERAL METAPHYSIS AND THE POLYETHYLENE COMPONENT WERE REPLACED IN ORDER TO RESOLVE THE DISLOCATION AND RESTORE SHOULDER STABILITY.

  Patient problems: Medical device site infection

  MAUDE report 23864307 ↗
• InjuryDec 20, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AT ABOUT 11 MONTHS FROM PRIMARY THE PATIENT REPORTED INSTABILITY. THE SURGEON UPSIZED THE METAPHYSIS AND LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Joint Laxity

  MAUDE report 23858630 ↗
• InjuryDec 20, 2025Device Appears to Trigger Rejection; Loosening of Implant Not Related to Bone-Ingrowth; Migration; Device Appears to Trigger Rejection; Loosening of Implant Not Related to Bone-Ingrowth; Migration

  THE PATIENT HAD PRIMARY RIGHT SHOULDER SURGERY USING COMPETITOR PRODUCTS. ON (B)(6) 2024, THE PATIENT WAS REVISED WITH MEDACTA PRODUCTS. PRESENTLY, ON (B)(6) 2025, THE PATIENT CAME IN DUE TO INSTABILITY. THE SURGEON FOUND ~40-50CC OF GRAY FLUID CONSISTENT WITH METALLOSIS. THE GLENOSPHERE SCREW WAS FOUND TO BE LOOSE, AND ABUNDANT METALLOSIS DEBRIS AT THE GLENOSPHERE/BASEPLATE INTERFACE. THE BASEPLATE WAS FOUND TO BE LOOSE IN THE GLENOID, AND DUE TO THE CAVITY LEFT BEHIND FROM THE BASEPLATE POST, THE CAVITY WAS FILLED WITH CANCELLOUS BONE CHIPS AND DBM PUTTY. THE SURGEON CONVERTED THE PATIENT TO A HEMIARTHROPLASTY WITH PLANS FOR THE PATIENT TO RETURN FOR A REVISION.

  Patient problems: Aseptic loosening; Joint Laxity; Metal Related Pathology

  MAUDE report 23858474 ↗
• InjuryDec 2, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT HAD PRIMARY SHOULDER SURGERY USING A COMPETITOR'S PRODUCTS. ON (B)(6) 2025, THE PATIENT HAD COMPETITOR ANTIBIOTIC SPACERS REMOVED AND MEDACTA PRODUCTS IMPLANTED. PRESENTLY, ON (B)(6) 2025, THE PATIENT CAME IN PRESENTING AN INFECTION AND THE CAUSE IS UNKNOWN. THE SURGEON PERFORMED A WASHOUT AND REVISED THE POLY, GLENOSPHERE, AND METAPHYSIS. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Medical device site infection

  MAUDE report 23696635 ↗
• InjuryDec 2, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT HAD SHOULDER INSTABILITY AND THE CAUSE IS UNKNOWN. AT ABOUT 4 MONTHS POST PRIAMRY THE SURGEON LATERALIZED THE GLENOSPHERE, SWAPPED THE METAPHYSIS, AND UPSIZED THE POLY TO IMPROVE PATIENT STABILITY. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Joint Laxity

  MAUDE report 23694052 ↗
• InjuryNov 18, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  AT ABOUT 1 YEAR AND 5 MONTHS FROM THE PRIMARY, THE PATIENT CAME IN DUE TO AN INFECTION AND THE PATHOGEN IS UNKNOWN. THE SURGEON PERFORMED A WASHOUT AND SWAPPED THE METAPHYSIS, LINER AND GLENOSPHERE. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Medical device site infection

  MAUDE report 23583096 ↗
• InjuryNov 18, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT HAD PRIMARY SHOULDER SURGERY USING A COMPETITOR' S IMPLANTS. ON (B)(6) 2023, THE PATIENT WAS REVISED FOR UNKNOWN REASONS. THE SURGEON REVISED THE STEM, METAPHYSIS, AND LINER TO MEDACTA IMPLANTS. PRESENTLY, ON (B)(6) 2025, THE PATIENT CAME IN DUE TO PAIN RELATED TO SCAPULAR NOTCHING AND THE CAUSE OF THE NOTCHING IS UNKNOWN. THE SURGEON REVISED THE COMPETITOR GLENOSPHERE TO A COMPETITOR GLENOSPHERE AND REVISED THE MEDACTA METAPHYSIS AND LINER TO A MEDACTA METAPHYSIS AND LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Implant Pain

  MAUDE report 23579949 ↗
• InjuryOct 22, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AT ABOUT 9 MONTHS AFTER THE PRIMARY, THE PATIENT CAME IN DUE TO CONTINUOUS PAIN AND THE CAUSE IS UNKNOWN. THE SURGEON REVISED THE SHOULDER FROM A REVERSE SHOULDER TO A HEMI ARTHROPLASTY. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Implant Pain

  MAUDE report 23356473 ↗
• InjuryOct 20, 2025Device Appears to Trigger Rejection; Osseointegration Problem; Device Appears to Trigger Rejection; Osseointegration Problem

  THE PATIENT CAME IN DUE TO DEVELOPING A LARGE HEMATOMA. ABOUT 9 DAYS AFTER THE PRIMARY SURGERY, THE SURGEON PERFORMED ARTHROTOMY TO TREAT THE HEMATOMA. LINER WAS REVISED BECAUSE THE HEMATOMA WAS VERY DEEP INTO THE JOINT. WHEN REMOVING THE LINER (WITH AN OSTEOTOME), HE TESTED THE STABILITY OF THE DIAPHYSIS (CEMENTLESS). DURING THIS TEST, THE STEM CAME OFF EASILY. THE SURGEON FINALLY REVISED GLENOSPHERE, LINER, METAPHYSIS AND DIAPHYSIS (LONGER METAPHYSIS IMPLANTED).

  Patient problems: Aseptic loosening; Hematoma

  MAUDE report 23334288 ↗
• InjurySep 18, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AT ABOUT 1 YEAR 8 MONTHS AFTER THE PRIMARY, THE PATIENT CAME IN REPORTING INSTABILITY AND THE CAUSE IS UNKNOWN. THE SURGEON UPSIZED THE LINER AND METAPHYSIS TO GIVE THE PATIENT MORE STABILITY. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Implant Pain; Joint Laxity

  MAUDE report 23081976 ↗
• InjuryAug 27, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  THE PATIENT CAME IN REPORTING INSTABILITY AND SIGNS OF AN INFECTION. ABOUT 3 WEEKS AFTER THE PRIMARY SURGERY, THE SURGEON PERFORMED A WASHOUT AND REVISED THE POLY AND UPSIZED THE METAPHYSIS (+9MM) TO ADDRESS THE INSTABILITY. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Medical device site infection

  MAUDE report 22901811 ↗
• InjuryJul 2, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT CAME HAD PAIN DUE TO SHOULDER INSTABILITY AND THE CAUSE IS UNKNOWN. AT ABOUT 1 YEAR FROM THE PRIMARY SURGERY THE SURGEON REVISED THE METAPHYSIS AND LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Joint Laxity

  MAUDE report 22383899 ↗
• InjuryMay 27, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  THE PATIENT HAD A PRIMARY SHOULDER SURGEON ON (B)(6) 2023. ON (B)(6) 2024 THE PATIENT CAME IN REPORTING PAIN DUE TO A TORN ROTATOR CUFF THAT WAS CAUSED FROM FALLING. THE SURGEON CONVERTED THE PATIENT FROM ANATOMIC TO REVERSE. THE SURGERY WAS COMPLETED SUCCESSFULLY. COMPLAINT (B)(4) WAS FILED. PRESENTLY, ON (B)(6) 2025, THE PATIENT CAME IN DUE TO SIGNS OF AN INFECTION AND THE PATHOGEN IS UNKNOWN. THE SURGEON PERFORMED A WASHOUT, REMOVED ALL IMPLANTS, AND IMPLANTED AN ANTIBIOTIC SPACER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Medical device site infection

  MAUDE report 22087863 ↗
• InjuryMay 27, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AT ABOUT 1 MONTH AFTER THE PRIMARY, THE PATIENT CAME IN REPORTING PAIN AND THE CAUSE OF THE PAIN IS UNKNOWN. THE SURGEON REVISED THE METAPHYSIS AND LINER AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Pain

  MAUDE report 22087039 ↗
• InjuryMay 21, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  THE PATIENT CAME IN DUE TO SIGNS OF INFECTION AND THE PATHOGEN IS UNKNOWN. ABOUT 1 YEAR AND 1 MONTH AFTER THE PRIMARY SURGERY, THE SURGEON REVISED ALL MEDACTA HARDWARE AND REIMPLANTED COMPETITOR COMPONENTS. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Medical device site infection

  MAUDE report 22060633 ↗