Shoulder System 04.01.0122Recalls & reported problems

Summary

The FDA's MAUDE database contains 61 adverse event reports that list this exact device (DI 07630040706292), received between Jul 29, 2019 and Apr 14, 2026 — classified as 61 injuries.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (42 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.

Most reported problems

Recent adverse event reports

The 25 most recent of 61 reports, in the reporter's own words as published by the FDA.

• InjuryApr 14, 2026Device Appears to Trigger Rejection

  THE PATIENT HAD A SHOULDER INFECTION AND THE PATHOGEN IS UNKNOWN. AT ABOUT 1 MONTH FROM PRIMARY THE SURGEON PERFORMED A WASHOUT AND DEBRIDEMENT. THE SURGEON ALSO REVISED THE D 39 LINER TO A SAME SIZE LINER AND REVISED THE D 39X24.5 GLENOSPHERE TO A SAME SIZE GLENOSPHERE. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Medical device site infection

  MAUDE report 24871722 ↗
• InjuryMar 31, 2026Device Dislodged or Dislocated

  AT ABOUT 1 WEEK FROM THE PRIMARY, THE PATIENT CAME IN PRESENTING PAIN AS THE RESULT OF A DISLOCATION OF THE HUMERUS AND THE GLENOID AND THE CAUSE IS UNKNOWN. THERE WAS NO TRAUMA REPORTED. THE SURGEON REVISED THE D 39/+0MM LINER WITH A CONSTRAINED D 39/+3MM LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Joint Dislocation

  MAUDE report 24738823 ↗
• InjuryMar 3, 2026Device Dislodged or Dislocated

  THE PATIENT HAD A LUXATION OF THE GLENOSPHERE AND THE LINER. THE CAUSE OF DISLOCATION IS UNKNOWN. AT ABOUT 1 MONTH FROM THE PRIMARY THE SURGEON REVISED THE LINER TO A CONSTRAINED LINER WHILE ALSO INCREASING THE SIZE FROM A D 39/+0 TO D 39/+3. THE SURGEON OBSERVED THAT ALL IMPLANTS WERE WELL FIXED. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Joint Dislocation

  MAUDE report 24494897 ↗
• InjuryFeb 16, 2026Adverse Event Without Identified Device or Use Problem

  AT ABOUT 2 MONTHS FROM PRIMARY, THE PATIENT CAME IN DUE TO PAIN ASSOCIATED WITH A DISLOCATION OF THE GLENOSPHERE FROM THE LINER. THE SURGEON UPSIZED THE GLENOSPHERE AND LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Joint Dislocation

  MAUDE report 24343893 ↗
• InjuryDec 24, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  AT ABOUT 2 WEEKS FROM THE PRIMARY, THE PATIENT CAME IN PRESENTING PAIN DUE TO A DISLOCATION OF THE GLENOSHERE FROM THE LINER AND THE CAUSE IS UNKNOWN. THE SURGEON REVISED THE METAPHYSIS, AND GLENOSPHERE TO PRODUCTS WITH THE SAME SIZE, THE LINER (FROM +0MM TO +6MM) AND THE SHORT DIAPHYSIS (FROM 8 TO 12 SIZE). THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Joint Dislocation

  MAUDE report 23886576 ↗
• InjuryNov 21, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AFTER 5 MONTHS FROM THE PRIMARY SURGERY, THE PATIENT REPORTED PAIN DUE TO SHOULDER INSTABILITY. THE SURGEON UPSIZED THE LINER FROMD 39/+0MM TOD 39/6 MM TO ADDRESS THE ISSUE. THE SURGERY WAS SUCCESSFULLY COMPLETED.

  Patient problems: Joint Laxity

  MAUDE report 23615345 ↗
• InjuryOct 29, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  REVISION SURGERY AT ABOUT 1 YEAR 11 MONTHS DUE TO JOINT LUXATION. THE CAUSE OF LUXATION WAS UNKNOWN. THE SURGERY WAS COMPLETED SUCCESSFULLY. THE LINER, GLENOSPHERE AND METAPHYSIS WERE REVISED.

  Patient problems: Joint Dislocation

  MAUDE report 23412830 ↗
• InjuryAug 26, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  AT ABOUT 1 MONTH AFTER THE PRIMARY, THE PATIENT CAME IN REPORTING PAIN DUE TO A DISLOCATION OF THE LINER FROM THE GLEOSPHERE. THE SURGEON REVISED THE LINER. SURGEON NEEDED TO UPSIZE THE LINER (0 TO 3MM) TO MAKE THE SHOULDER MORE STABLE AND DETER FUTURE DISLOCATION. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Implant Pain

  MAUDE report 22892643 ↗
• InjuryJul 23, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  PRIMARY SURGERY PERFORMED ON (B)(6) 2025. REVISION SURGERY PERFORMED ON (B)(6) 2025 DUE TO JOINT LUXATION; LINER AND GLENOSPHERE REVISED. 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. (B)(4). 2ND REVISION SURGERY PERFORMED ON (B)(6) 2025 DUE TO JOINT LUXATION; LINER AND GLENOSPHERE REVISED. (B)(4). 3RD REVISION SURGERY PERFORMED ON (B)(6) 2025 DUE TO JOINT LUXATION; LINER, GLENOSPHERE, AND METAPHYSIS REVISED. (B)(4). 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 COMPONENTS (B)(4). 5TH REVISION SURGERY PERFORMED ON (B)(6) 2025 DUE TO INTRA-PROSTHETIC DISLOCATION (METAL HUMERAL HEAD AND DOUBLE ECCENTER) - HUMERAL HEAD AND THE DOUBLE ECCENTRIC REVISED AND SURROUNDING BONE TRIMMED USING A RONGEUR. (B)(4).

  Patient problems: Joint Dislocation

  MAUDE report 22573887 ↗
• InjuryJul 23, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  AT ABOUT 2 MONTHS FROM PRIMARY, THE PATIENT CAME IN REPORTING PAIN DUE TO A DISLOCATION. THE CAUSE OF THE DISLOCATION IS UNKNOWN. THE SURGEON REVISED THE LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Joint Dislocation; Pain

  MAUDE report 22573679 ↗
• InjuryJul 21, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  THE PATIENT HAD A PRIMARY SHOULDER SURGERY ON (B)(6) 2025. ON (B)(6) 2025, THE PATIENT CAME IN REPORTING PAIN DUE TO A DISLOCATION OF THE MEDACTA LINER FROM THE COMPETITOR GLENOSPHERE AND THE CAUSE OF THE DISLOCATION IS UNKNOWN. THE SURGEON REVISED THE COMPETITOR GLENOSPHERE AND MEDACTA LINER AND METAPHYSIS. THE SURGERY WAS COMPLETED SUCCESSFULLY. MDR 2025-00605 WAS SENT. ON (B)(6) 2025, THE PATIENT CAME IN REPORTING PAIN DUE TO A DISLOCATION OF THE MEDACTA LINER FROM THE COMPETITOR GLENOSPHERE AND THE CAUSE OF THE DISLOCATION IS UNKNOWN. THE SURGEON REMOVED THE COMPETITOR'S REVERSE BASEPLATE/GLENOSPHERE AND LET THE GLENOID EMPTY. THE SURGEON ALSO PULLED THE REVERSE METAPHYSIS/LINER OUT AND REPLACED IT WITH AN ANATOMIC BODY/DOUBLE ECCENTER/HUMERAL HEAD. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Joint Dislocation

  MAUDE report 22554191 ↗
• InjuryJul 15, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  AT ABOUT 1 MONTH FROM PRIMARY, THE PATIENT CAME IN REPORTING PAIN DUE TO A DISLOCATION. THE CAUSE OF THE DISLOCATION IS UNKNOWN. THE SURGEON REVISED THE POLY AND UPSIZED TO A +3MM LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY. IT SHOULD BE NOTED THAT THE COUPLING OF GRS BASEPLATE FULL WEDGE WITH A LATERALIZED GLENOSPHERE IS NOT REGISTERED FOR USE IN THE USA.

  Patient problems: Joint Dislocation

  MAUDE report 22506926 ↗
• InjuryJul 14, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  SHOULDER LUXATION DETECTED TWO MONTHS AFTER THE PRIMARY SURGERY DURING FOLLOW-UP. THE PATIENT REPORTED NO PAIN. THE SURGEON REVISED THE REVERSE- TO A HEMI-SHOULDER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Joint Dislocation

  MAUDE report 22493699 ↗
• InjuryJul 14, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  AT ABOUT 1 MONTH FROM PRIMARY, THE PATIENT CAME IN REPORTING PAIN DUE TO A DISLOCATION. THE CAUSE OF THE DISLOCATION IS UNKNOWN. THE SURGEON REVISED THE GLENOSPHERE, METAPHYSIS, AND LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Pain

  MAUDE report 22493615 ↗
• InjuryJun 18, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  THE PATIENT HAD A PRIMARY SHOULDER SURGEON ON (B)(6) 2024. ON (B)(6) 2025, THE PATIENT CAME IN REPORTING PAIN DUE TO A DISLOCATION OF THE LINER FROM THE GLENOSPHERE AND THE CAUSE OF THE DISLOCATION IS UNKNOWN. THE SURGEON REVISED THE GLENOSPHERE AND LINER AND THE SURGERY WAS COMPLETED SUCCESSFULLY. PRESENTLY, ON (B)(6) 2025, THE PATIENT CAME IN REPORTING PAIN DUE TO A DISLOCATION OF THE LINER FROM THE GLENOSPHERE. THE SURGEON REVISED THE LINER AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Implant Pain

  MAUDE report 22269583 ↗
• InjuryJun 17, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  AT ABOUT 1 MONTH FROM PRIMARY, THE PATIENT CAME IN REPORTING PAIN DUE TO A DISLOCATION OF THE LINER FROM THE GLENOSPHERE. THE SURGEON REVISED THE GLENOSPHERE AND LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Joint Dislocation

  MAUDE report 22229179 ↗
• InjuryJun 4, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AT ABOUT 2 YEARS AND 3 MONTHS AFTER PRIMARY, THE PATIENT CAME IN REPORTING PAIN AND IMPINGEMENT, DURING INTERNAL ROTATION, BETWEEN THE LESSER TUBEROSITY AND THE CONJOINT TENDON. THE SURGEON INITIALLY PERFORMED SOME TISSUE RELEASES AND THEN PROCEEDED BY REVISING THE LINER (+0MM) WITH A +3MM LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Implant Pain

  MAUDE report 22138795 ↗
• InjuryMay 27, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  AT ABOUT 3 WEEKS AFTER PRIMARY, THE PATIENT CAME IN REPORTING PAIN DUE TO JOINT LUXATION. THE CAUSE IS UNKNOWN. THE SURGEON REVISED THE LINER AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Pain

  MAUDE report 22087034 ↗
• InjuryMay 13, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  AT ABOUT 4 MONTHS AFTER PRIMARY, THE PATIENT CAME IN REPORTING PAIN DUE TO SHOULDER LUXATION AND THE CAUSE IS UNKNOWN. THE SURGEON REVISED THE GLENOSPHERE AND LINER AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Joint Dislocation; Pain

  MAUDE report 22011825 ↗
• InjuryApr 1, 2025Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  ON (B)(6)2023 PATIENT UNDERGONE REVERSE SHOULDER ARTHROPLASTY. ON THE (B)(6)2024 SURGEON REVISED AL COMPONENTS DUE TO INFECTION (MDR 3005180920-2024-00151). ON (B)(6) 2025 ALL COMPONENTS WERE REVISED FOR METAL ALLERGY ALONG WITH A SUSPICION OF INFECTION (METAL ALLERGY). NO LOOSENING OF THE COMPONENTS. SURGEON IMPLANTED COMPETITOR IPOALLERGENIC DEVICE AND SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Hypersensitivity/Allergic reaction

  MAUDE report 21736862 ↗
• InjuryMar 11, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  PRIMARY SURGERY WAS PERFORMED ON (B)(6)2024. ON (B)(6) 2024, THE PATIENT UNDERWENT REVISION SURGERY DUE TO JOINT LUXATION. ONLY THE GLENOSPHERE - Ø39X24.5 WAS REMOVED AND GLENOSPHERE - Ø39X27 WAS IMPLANTED (WRONG COMBINATION AS THE BASEPLATE IS A Ø24.5X25). ON (B)(6) 2025, REVISION SURGERY DUE TO INFECTION. SINCE SCINTIGRAPHY SHOWED NO REACTION UNDER THE STEM OR BASEPLATE, THE GOAL WAS TO RINSE THE ARTICULATION WHILE KEEPING THE STEM AND BASEPLATE IN PLACE. UPON MAKING THE INCISION, THE INNER SCREW OF THE GLENOSPHERE, SURROUNDED BY SIGNIFICANT METALLOSIS, WAS IMMEDIATELY VISIBLE. IT WAS OUT OF THE GLENOSPHERE AND MIGRATED UNDERNEATH THE SKIN. WHEN CUTTING THE CAPSULE, METALLOSIS WAS FOUND THROUGHOUT THE ARTICULATION AND WAS CAREFULLY REMOVED. THE SURGEON PROCEEDED TO REMOVE THE INSERT AND METAPHYSIS. WHEN ATTEMPTING TO EXTRACT THE GLENOSPHERE, IT CAME OUT VERY EASILY. ALTHOUGH IT APPEARED TO BE IN PLACE ON THE BASEPLATE, IT WAS NOT PROPERLY FIXED. THIS LIKELY CONTRIBUTED TO THE LOOSENING OF THE SCREW AND THE DEVELOPMENT OF METALLOSIS. SENSITIN GLENOSPHERE 42XØ24.5 WAS IMPLANTED AS THE PATIENT IS ALLERGIC TO CHROMIUM. DIAPHYSIS AND BASEPLATE NOT REVISED.

  Patient problems: Joint Dislocation; Medical device site infection

  MAUDE report 21570541 ↗
• InjuryFeb 6, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  ON (B)(6) 2018 THE PATIENT HAD A PRIMARY ANATOMIC SHOULDER SURGERY. ON (B)(6) 2024, THE SURGEON CONVERTED THE PATIENT FROM AN ANATOMICAL SHOULDER TO A REVERSE SHOULDER DUE TO THE PATIENT REPORTING PAIN RELATED TO A ROTATOR CUFF FAILURE. ON (B)(6) 2024, THE PATIENT CAME IN REPORTING PAIN DUE TO A DISLOCATION OF THE GLENOSPHERE FROM THE LINER. THE SURGEON CLOSED REDUCED UNDER ANESTHESIA THE PATIENT AND NO IMPLANTS WERE REVISED. THE CASE WAS COMPLETED SUCCESSFULLY. ON (B)(6) 2025, THE PATIENT REPORTED PAIN DUE TO A DISLOCATION OF THE LINER FOR THE GLENOSPHERE AFTER LIFTING HEAVY ITEMS. THE SURGEON REVISED THE LINER, GLENOSPHERE AND METAPHYSIS. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Implant Pain

  MAUDE report 21321671 ↗
• InjuryFeb 3, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  AT ABOUT 2 MONTHS FROM PRIMARY THE PATIENT CAME IN REPORTING PAIN DUE TO A DISLOCATION OF THE LINER FROM THE GLENOSPHERE. THE SURGEON REVISED THE LINER AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Implant Pain

  MAUDE report 21290771 ↗
• InjuryJan 21, 2025Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  REVISION SURGERY 4 YEARS AND 11 MONTHS AFTER THE PRIMARY SURGERY DUE TO NOT MEDACTA BASEPLATE LOOSENING, NOT MEDACTA SCREW BREAKAGE AND OSTEOLYSIS FOUND IN THE GLENOID PART. THE SURGEON CONVERTED THE PATIENT TO AN ANATOMIC SHOULDER. THE SURGERY WAS COMPLETED SUCCESSFULLY. LINER AND METAPHYSIS ARE THE ONLY MEDACTA PRODUCTS.

  Patient problems: Osteolysis

  MAUDE report 21197089 ↗
• InjuryDec 11, 2024Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  AT ABOUT 3 MONTHS AFTER THE PRIMARY THE PATIENT CAME IN REPORTING INSTABILITY. THE SURGEON REVISED THE 39 / +0 LINER WITH A 39 / +6 LINER AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Unspecified Infection

  MAUDE report 20900784 ↗