Anatomic Shoulder Prosthesis 04.01.0132Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 07630040713276), received between Oct 5, 2018 and Mar 3, 2026 — classified as 6 injuries.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (1 report).

1 other recall cover devices cleared under the same FDA submission (K170910); they may or may not involve this specific model.

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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• InjuryMar 3, 2026Material Deformation

  LEFT SHOULDER REVISION SURGERY DUE TO PAIN AND RESTRICTION OF MOVEMENT ABOUT 6.5 YEARS AFTER THE PRIMARY SURGERY. OSTEOLYSIS WAS ALSO NOTED. REVERSE SYSTEM IMPLANTED; ROTATOR CUFF WAS DEGENERATIVE BUT REPAIRABLE WHEN COMPLETING THE REVERSE. THE PE PEGGED GLENOID WAS FOUND VERY DAMAGED IN THE POSTERIOR INFERIOR SURFACE (DESPITE BEING FOUND WELL FIXED AND NO IMPINGEMENT WAS OBSERVED).

  Patient problems: Implant Pain; Loss of Range of Motion; Osteolysis

  MAUDE report 24494913 ↗
• InjuryMar 31, 2022Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  AT ABUT 2 YEARS AND 9 MONTHS AFTER PRIMARY SURGERY THE SURGEON REVISED THE PATIENT SHOULDER FOR GLENOID IMPLANT LOOSENING. THE SURGERY WAS COMPLETED SUCCESSFULLY, ALL DEVICES SWAPPED.

  Patient problems: Insufficient Information

  MAUDE report 13964412 ↗
• InjurySep 21, 2021Adverse Event Without Identified Device or Use Problem

  8 MONTHS AFTER THE PRIMARY SURGERY THE PATIENT CAME IN DUE TO SIGNS OF AN INFECTION AND THE PATHOGEN IS UNKNOWN. THE SURGEON PERFORMED A WASHOUT, REMOVED ALL COMPONENTS AND IMPLANTED AN ANTIBIOTIC SPACER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Unspecified Infection

  MAUDE report 12506482 ↗
• InjuryMar 16, 2021Device Dislodged or Dislocated

  THE SURGEON REVISED THE PATIENT'S SHOULDER IMPLANTS FOR A DISLOCATION (HEAD FROM LINER) ON (B)(6) 2021. THE PRIMARY SURGERY DATE IS NOT AVAILABLE. THE SHOULDER HAS BEEN DISLOCATED FOR 4 MONTHS.

  Patient problems: Joint Dislocation

  MAUDE report 11494442 ↗
• InjuryAug 9, 2019Appropriate Device Problem Term/Code Not Available

  REVISION SURGERY PERFORMED AFTER 11 MONTHS FROM THE PRIMARY DUE TO PAIN (THE CAUSE OF THE PAIN IS UNKNOWN, THERE WAS NO TRAUMA). THE SURGEON REVISED THE HUMERAL HEAD, DOUBLE ECCENTER, HUMERAL METAPHYSIS, AND HC PEGGED GLENOID SUCCESSFULLY.

  Patient problems: Pain

  MAUDE report 8877722 ↗
• InjuryOct 5, 2018Appropriate Device Problem Term/Code Not Available

  ON SEP 7, 2018 WE WERE INFORMED THAT A REVISION SURGERY WAS PLANNED FOR (B)(6) 2018 DUE TO INFECTION DETECTED 2 WEEKS AFTER A PREVIOUS REVISION DUE TO SHOULDER LUXATION. THE REVISION WAS PERFORMED SUCCESSFULLY. THE PATHOGEN RESULTS ARE NOT AVAILABLE.

  Patient problems: Unspecified Infection

  MAUDE report 7938077 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K170910. One submission often covers many models, so check the product and lot details in each record.

• Z-0775-2020 · Nov 4, 2019 · Terminated
  Medacta Shoulder SYSTEM HUMERAL ANATOMICAL METAPHYSIS, REF 04.01.0023 through 04.01.0055, all sizes - Product Usage: The Medacta Anatomic Shoulder Prosthesis is indicated for treat