Shoulder System 04.01.0155Recalls & reported problems

Summary

The FDA's MAUDE database contains 19 adverse event reports that list this exact device (DI 07630040706421), received between Jul 26, 2019 and Mar 25, 2026 — classified as 18 injuries, 1 malfunction.

The most frequently reported specific device problem is “Fracture” (5 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 19 most recent of 19 reports, in the reporter's own words as published by the FDA.

• InjuryMar 25, 2026Adverse Event Without Identified Device or Use Problem

  ACROMIAL FRACTURE OCCURRED THREE MONTHS POST-PRIMARY AND WAS TREATED CONSERVATIVELY WITH IMMOBILIZATION AND PHYSIOTHERAPY.

  Patient problems: Bone Fracture(s)

  MAUDE report 24684871 ↗
• MalfunctionDec 5, 2025Malposition of Device; Malposition of Device

  THE 6 WEEK POST-OPERATIVE X-RAYS SHOW A MALPOSITIONING OF THE BASEPLATE; IT IS POSITIONED TOO HIGH. THE PATIENT IS CURRENTLY PAIN-FREE AND DEMONSTRATES ACCEPTABLE MOBILITY. OVERALL, THE PATIENT IS PLEASED WITH THE SURGICAL OUTCOME. THE PRIMARY PROCEDURE WAS PERFORMED USING NEXTAR, AND NO ISSUES OR DISCREPANCIES WERE OBSERVED DURING BASEPLATE POSITIONING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23725619 ↗
• InjuryNov 12, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT HAD A PRIMARY SHOULDER SURGERY ON (B)(6) 2024. ON (B)(6) 2024, THE PATIENT CAME IN REPORTING TIGHTNESS. THE SURGEON CHOSE TO DECREASE LATERALIZATION, BY REVISING THE LATERALIZED GLENOSPHERE TO A STANDARD GLENOSPHERE. THE SURGEON ALSO REVISED THE LINER AND THE SURGERY WAS COMPLETED SUCCESSFULLY. MDR 3005180920-2024-00640. ON (B)(6) 2024, THE PATIENT CAME IN DUE TO SIGNS OF INFECTION AND THE PATHOGEN IS UNKNOWN. THE SURGEON REVISED ALL MEDACTA HARDWARE AND REIMPLANTED PERMANENT PRODUCT. THE SURGERY WAS COMPLETED SUCCESSFULLY. MDR 3005180920-2024-00885. ON (B)(6) 2025, THE PATIENT CAME IN REPORTING PAIN AND THE CAUSE IS UNKNOWN. THE SURGEON OBSERVED THAT THE BASEPLATE, AND CONSEQUENTLY THE GLENOSPHERE, WERE MALPOSITIONED AND THE CAUSE IS UNKNOWN. THE SURGEON REVISED THE MEDACTA METAPHYSIS AND LINER TO MEDACTA COMPONENTS AND REVISED THE MEDACTA BASEPLATE AND GLENOSPHERE TO COMPETITOR COMPONENTS. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Implant Pain

  MAUDE report 23532109 ↗
• InjuryJul 28, 2025Fracture; Osseointegration Problem; Fracture; Osseointegration Problem

  REVISION SURGERY CASE AT ABOUT 1 YEAR AND 3 MONTHS POST PRIMARY. THE GLENOID COMPONENT WAS MOBILIZED. THE BASEPLATE, SCREWS AND GLENOSPHERE ALTOGETHER WERE DETACHED FROM THE GLENOID, BUT ASSEMBLED TO EACH OTHER. ONE OF THE 2 SCREWS (UNKNOWN WITH OF THE 2 REPORTED) WAS BROKEN. SOME METALLOSIS WAS DETECTED ON THE SURFACE OF THE GLENOID. THE GLENOID COMPONENTS WERE REMOVED AND THE REVERSE METAPHYSIS AND HUMERAL PE LINER WERE REMOVED AS WELL. A SAFETY ENDOPROSTHESIS WAS IMPLANTED WITH AN ANATOMICAL METAPHYSIS (142), DOUBLE ECCENTER AND HUMERAL HEAD. THE PRIMARY WAS PERFORMED WITH A BONE GRAFT FOR GLENOID LATERALIZATION. THE ISSUE IS DUE TO A FAILURE OF THE BONE GRAFT LEADING TO ANOMALOUS SCREW LOADING AND BASEPLATE MOBILIZATION.

  Patient problems: Inadequate Osseointegration

  MAUDE report 22630833 ↗
• InjuryDec 3, 2024Positioning Problem; Positioning Problem

  POST-OPERATIVE CTS SHOW THAT THE BASEPLATE SLOPES DOWNWARDS (THERE MAY BE A FRACTURE OF THE GLENOID BUT THAT WAS NOT NOTICEABLE PER-OPERATIVE), DIFFERENTLY FROM THE PLANNING. HOWEVER, NO ISSUE OCCURRED DURING THE SURGERY REGARDING NEXTAR TECHNOLOGY OR THE PLANNING. THE PATIENT IS DOING QUITE WELL. THE SURGEON IS NOT PLANNING ANY REVISION.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 20832757 ↗
• InjuryAug 21, 2024Fracture; Loosening of Implant Not Related to Bone-Ingrowth; Fracture; Loosening of Implant Not Related to Bone-Ingrowth

  THE PATIENT UNDERWENT PRIMARY SHOULDER SURGERY ON (B)(6) 2023. A 27X25 BASEPLATE WAS IMPLANTED ON THE GLENOID WITH THE ADDITION OF A BONE GRAFT APPROXIMATELY 1 CM IN SIZE, WHICH WAS FOUND TO BE PERFECTLY INTEGRATED. AN X-RAY CHECK IN DECEMBER 2023 CONFIRMED THAT THE PROSTHESIS WAS CORRECTLY POSITIONED. THE PATIENT BEGAN EXPERIENCING PAIN AFTER A SUDDEN INTERNAL ROTATION TO CATCH A HEAVY PAN (ABOUT 2 KG) THAT WAS FALLING. THE PATIENT HAS BEEN IN THIS CONDITION SINCE (B)(6) 2024. BOTH SCREWS WERE FOUND TO BE BROKEN, AND THE BASEPLATE HAD COMPLETELY EXITED THE GLENOID. THE GLENOSPHERE AND BASEPLATE WERE PAIRED BUT SEPARATED FROM THE GLENOID. ON (B)(6) 2024, THE SURGEON REVISED THE PROSTHESIS, IMPLANTING A 27X35 BASEPLATE WITH 3 SCREWS AND A 42X27 GLENOSPHERE.

  Patient problems: Pain

  MAUDE report 20019566 ↗
• InjuryJun 19, 2024Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  REVISION SURGERY PERFORMED ABOUT 2 YEARS AND 8 MONTHS AFTER THE PRIMARY SURGERY DUE TO INFECTION (PROPIONI-BACTERIUM). ALL COMPONENTS REVISED.

  Patient problems: Bacterial Infection; Medical device site infection

  MAUDE report 19565507 ↗
• InjuryApr 10, 2024Fracture; Failure to Osseointegrate; Fracture; Failure to Osseointegrate

  REVISION SURGERY PERFORMED ABOUT 1 YEAR AND 4 MONTHS AFTER THE PRIMARY SURGERY. THE GLENOID BASEPLATE WAS MOBILIZED BECAUSE THE BONE GRAFT HAD NOT OSSEOINTEGRATED. TWO GLENOID POLYAXIAL LOCKING SCREWS WERE FOUND BROKEN. THE SURGEON GRAFTED THE GLENE WITH SOME ILLIAC CREST BONE AND CONVERTED INTO AN HEMI-ARTHROPLASTY.

  Patient problems: Inadequate Osseointegration

  MAUDE report 19078274 ↗
• InjuryApr 13, 2023Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  AT ABOUT 2 MONTHS AFTER THE PRIMARY, REVISION SURGERY PERFORMED FOLLOWING DEEP INFECTION. THE SURGEON REVISED GLENOSPHERE, LINER AND GLENOID COMPONENTS AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Medical device site infection

  MAUDE report 16731287 ↗
• InjuryApr 5, 2023Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  REVISION SURGERY FOR INFECTION AT ABOUT 2 YEARS AND 1 MONTH AFTER PRIMARY. THE SURGEON REVISED SUCCESSFULLY ALL THE DEVICES.

  Patient problems: Medical device site infection

  MAUDE report 16680117 ↗
• InjuryNov 15, 2022Osseointegration Problem; Osseointegration Problem

  REVISION SURGERY PERFORMED DUE TO MOBILIZATION OF THE BASEPLATE WITH AUTOGRAFT THAT CAUSED THE JOINT LUXATION, 7 MONTHS AFTER THE PRIMARY SURGERY. THE PATIENT HAS POOR BONE QUALITY. THE AUTOGRAFT WAS NOT OF GOOD QUALITY. ALL IMPLANTS, EXCEPT FOR THE HUMERAL SHORT STEM, WERE REVISED.

  Patient problems: Inadequate Osseointegration

  MAUDE report 15796635 ↗
• InjuryNov 8, 2022Osseointegration Problem; Osseointegration Problem

  REVISION SURGERY PERFORMED ABOUT 1 YEAR AND 4 MONTHS AFTER THE PRIMARY SURGERY DUE TO GLENOID COMPONENTS AND GRAFT MOBILIZATION, WITH BREAKAGE OF INFERIOR 42MM NON LOCKING SCREW AND GREAT BONE LOSS AROUND THE PEG. THE SURGEON PUT BONE CHIPS AT GLENOID SIDE AND SWITCH TO A HEMIARTHROPLASTY WITH ANATOMIC CONFIGURATION (142° AND HEAD 48).

  Patient problems: Inadequate Osseointegration

  MAUDE report 15750572 ↗
• InjurySep 14, 2021Fracture; Loosening of Implant Not Related to Bone-Ingrowth; Fracture; Loosening of Implant Not Related to Bone-Ingrowth

  REVISION SURGERY WAS PERFORMED DUE TO POLYAXIAL SCREWS BREAKAGE AND BASEPLATE MOBILIZATION 1 YEAR AFTER THE PRIMARY SURGERY, THE PATIENT DEVELOPED PAIN DOING GOLF.

  Patient problems: Pain

  MAUDE report 12467895 ↗
• InjuryJul 16, 2020Fracture; Appropriate Device Problem Term/Code Not Available

  REVISION SURGERY PERFORMED DUE TO BONE FRACTURE AT THE LEVEL OF THE BASEPLATE, POSTERIORLY. IT CAUSED THE SHOULDER LUXATION. THE PRIMARY INTERVENTION WAS WITH B2 GLENOID, BIO RSA WITH ANGLE CORRECTION, WEAK BONE AND VARIOUS SECONDARY DISEASES OF THE PATIENT (B)(6).

  Patient problems: Bone Fracture(s)

  MAUDE report 10282567 ↗
• InjuryMar 11, 2020Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  REVISION SURGERY PERFORMED DUE TO GLENOID BASEPLATE LOOSENING AND POLYAXIAL SCREW BREAKAGE (BODY) AFTER ABOUT 3 YEARS. THE PATIENT IS A RETIRED GYMNAST, HE IS VERY ACTIVE.

  Patient problems: No Code Available

  MAUDE report 9818114 ↗
• InjuryNov 14, 2019Appropriate Device Problem Term/Code Not Available

  REVISION SURGERY 4 MONTHS AFTER PRIMARY FOR INFECTION, ALL HARDWARE REMOVED SUCCESSFULLY. THIS PATIENT COMES FROM A VERY COMPLEX CLINICAL HISTORY WITH MULTIPLE PRECEDENT INTERVENTION ON THE SHOULDER.

  Patient problems: Unspecified Infection

  MAUDE report 9321301 ↗
• InjuryOct 31, 2019Device Dislodged or Dislocated; Loosening of Implant Not Related to Bone-Ingrowth

  ON (B)(6) 2019 THE PATIENT HAD A SHOULDER LUXATION REPOSITIONED UNDER ANAESTHESIA ON (B)(6) THE DAY AFTER LUXATED AGAIN (GLENOSPHERE FROM LINER), THE DISLOCATION WAS TREATED ANATOMICALLY. ON (B)(6) 2019 THE PATIENT WAS REVISED DUE TO GLENOSPHERE DISSOCIATION FROM THE BASEPLATE. LATERALIZED GLENOSPHERE 42 (+5MM OFFSET) AND INLAY 42/+6MM HAVE BEEN USED IN REVISION SURGERY. THE PATIENT SUFFERS FROM SPASTICITY. ALSO, THE PATIENT ALREADY HAD MORE REVISION SURGERIES DUE TO INFECTION AND LUXATION.

  Patient problems: Joint Disorder

  MAUDE report 9260086 ↗
• InjuryOct 30, 2019Microbial Contamination of Device

  ON (B)(6) THE PATIENT REFLUXATED (THE PATIENT HAVE A COMPLEX CLINICAL HISTORY, HE IS SPASTIC). ON (B)(6) ALL THE IMPLANTS HAVE BEEN EXPLANTED DUE TO INFECTION. NEW IMPLANTS HAVE BEEN IMPLANTED ON (B)(6) 2019, 4 MONTHS AFTER PRIMARY SURGERY. REVISION SURGERY COMPLETED SUCCESSFULLY.

  Patient problems: Unspecified Infection

  MAUDE report 9254778 ↗
• InjuryJul 26, 2019Break; Appropriate Device Problem Term/Code Not Available

  AFTER ABOUT 5 MONTHS FROM THE PRIMARY SURGERY, SHOULDER REVISION SURGERY PERFORMED FOR BASEPLATE MOBILIZATION AND POLYAXIAL LOCKING SCREW BREAKAGE. THE SURGEON REVISED SUCCESSFULLY THE BASEPLATE, THE GLENOSPHERE, THE LINER AND THE SCREWS.

  Patient problems: Inadequate Osseointegration

  MAUDE report 8830085 ↗