Shoulder System 04.01.0211Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 07630040728102), received between Jan 5, 2021 and May 13, 2026 — classified as 9 injuries.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (3 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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• InjuryMay 13, 2026Adverse Event Without Identified Device or Use Problem

  POST-OPERATIVE ACROMION FRACTURE WAS OBSERVED ABOUT 2 MONTHS AFTER PRIMARY SURGERY. THE FRACTURE WAS IDENTIFIED AFTER THE PATIENT REPORTED PAIN, WHICH LED TO A CONSULTATION AND SUBSEQUENT CT IMAGING. THE FRACTURE WILL BE TREATED CONSERVATIVELY; NO ADDITIONAL/REVISION SURGERY PLANNED. NO BONE GRAFT WAS USED. NEXTAR WAS NOT USED FOR THIS SURGERY.

  Patient problems: Bone Fracture(s)

  MAUDE report 25161498 ↗
• InjurySep 17, 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 DUE TO INSTABILITY WITH THE CAUSE UNKNOWN. THE SURGEON UPSIZED THE GLENOSPHERE, LINER AND METAPHASIS. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Implant Pain; Joint Laxity

  MAUDE report 23070934 ↗
• InjuryJan 9, 2025Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  THE GLENOSPHERE SCREW COULD NOT BE FULLY INSERTED AND TIGHTENED. THE BASEPLATE (REF. (B)(4) ) AND POLYAXIAL SCREWS WERE REMOVED AND REINSERTED, BUT THE GLENOSPHERE SCREW DID NOT LOCK. ANOTHER GLENOSPHERE (REF. (B)(4) ) WAS USED. THE SURGERY WAS COMPLETED SUCCESSFULLY. TOTAL SURGERY TIME WAS 1 HOUR AND 36 MINUTES, THE DELAY TIME WAS 20 MINUTES. THE 20 MINUTES DELAY OCCURRED BECAUSE THE POLYAXIAL SCREWS AND GLENOSPHERE WERE REMOVED AND NEW ONES USED, AND ALSO THE BASEPLATE WAS REMOVED AND REINSTALLED (POLYAXIAL SCREWS CHANGED).

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

  MAUDE report 21111329 ↗
• InjuryDec 30, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING A CLINICAL STUDY, ACROMION STRESS FRACTURE DISCOVERED AT ABOUT 9 MONTHS FROM THE PRIMARY. NO REVISION SURGERY PLANNED, ONLY PHYSIOTHERAPY PRESCRIBED.

  Patient problems: Bone Fracture(s)

  MAUDE report 21033588 ↗
• InjuryMar 26, 2024Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  REVERSE SHOULDER REVISION SURGERY ON THE LEFT SIDE ABOUT 11 MONTHS AFTER THE PRIMARY SURGERY. EXPLANTATION OF ALL REVERSE SHOULDER IMPLANTS FROM THE PRIMARY SURGERY. MELTED BONE GRAFT AND PRESENCE OF MACROSCOPICALLY INFECTED TISSUE. IMPLANTATION OF NEW REVERSE SHOULDER COMPONENTS.

  Patient problems: Unspecified Infection

  MAUDE report 18977238 ↗
• InjuryMay 27, 2021Device Dislodged or Dislocated

  THE PATIENT HAD SEVERAL WOUND CLEANING ( 2 OR 3) DUE TO DIFFICULT HEALING. AFTER THE SURGERY, THE WOUND NEVER HEALED AND THE SURGEON SUPPOSES AN INFECTION, BUT IT WAS NOT CONFIRMED. FINALLY, 1,5 MONTHS AFTER THE PRIMARY SURGERY THE SURGEON REVISED ALL IMPLANTS AND DID NOT IMPLANT ANYTHING. DURING THE REVISION SURGERY IT WAS OBSERVED THAT THE SUBSCAPULARIS WAS DAMAGED (IT WASN'T ATTACHED) A DISLOCATION OF THE GLENOSPHERE FROM THE LINER WAS VISIBLE ON THE X-RAYS (PROBABLY DUE TO THE SUBSCAPULARIS DAMAGE). NO TRAUMA REPORTED.

  Patient problems: Joint Dislocation

  MAUDE report 11893146 ↗
• InjuryApr 13, 2021Device Dislodged or Dislocated

  2 MONTHS AFTER THE PREVIOUS REVISION SURGERY (THE PATIENT DISLOCATED MULTIPLE TIMES AND WAS TREATED WITH CLOSED REDUCTION AND FINALLY THE LINER AND GLENOSPHERE WERE REVISED TO GIVE LESS OFFSET) THE PATIENT CAME IN DUE TO ANOTHER DISLOCATION OF THE GLENOSPHERE FROM THE LINER (THE PATIENT BROKE INTO A PARKINSON'S ATTACK AND DISLOCATED HIS SHOULDER): THE FOLLOWING IMPLANTS WERE REMOVED: GLENOSPHERE, SCREWS, BASEPLATE AND HUMERAL METAPHYSIS. THE PRIMARY SURGERY WAS PERFORMED ON (B)(6) 2021.

  Patient problems: Joint Dislocation

  MAUDE report 11654731 ↗
• InjuryMar 17, 2021Device Dislodged or Dislocated

  REVISION SURGERY PERFORMED DUE TO RECURRENT SHOULDER LUXATION (GLENOSPHERE FROM THE LINER) 1 MONTH AFTER THE PRIMARY SURGERY. THE PATIENT WAS TREATED, PREVIOUSLY, WITH A CLOSE REDUCTION BUT THE SHOULDER DISLOCATED AGAIN.

  Patient problems: Joint Dislocation

  MAUDE report 11504347 ↗
• InjuryJan 5, 2021Appropriate Device Problem Term/Code Not Available

  A REVISION SURGERY OF THE SHOULDER WAS PERFORMED ON DEC 7TH, DUE TO AN INFECTION 2 MOTNHS AFTER PRIMARY. AFTER A BLOOD TEST, THE FINDING OF A SUBCUTANEOUS ABSCESS AND INTRA-JOINT SEROUS COLLECTION, THE SEPSIS WAS FOUND AND THE SURGEON HAD TO REMOVE THE SHOULDER LAT. GLENOSPHERE AND HUMERAL REVERSE HC LINER. THE AREA HAS BEEN DISINFECTED WITH AN ANTISEPTIC POVIDONE IODINE AND NEW IMPLANT WAS PLACED. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Unspecified Infection

  MAUDE report 11115737 ↗