Anatomical Shoulder™ Domelock® 01.04227.005 (UDI 00889024485006)Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 00889024485006), received between Feb 3, 2021 and Dec 27, 2023 — classified as 9 injuries.

The most frequently reported specific device problem is “Patient Device Interaction Problem” (4 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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• InjuryDec 27, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED ACCORDING TO A CLINICAL STUDY THAT THE PATIENT WAS IMPLANTED WITH AN ANATOMIC TOTAL SHOULDER IMPLANT ON THE RIGHT SIDE. A CONVERSION TO A REVERSE SHOULDER ARTHROPLASTY HAS BEEN PERFORMED APPROXIMATELY 3 AND A HALF YEARS POST IMPLANTATION DUE TO A ROTATOR CUFF INSUFFICIENCY. DILIGENCE IS COMPLETED AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.

  Patient problems: Tissue Breakdown

  MAUDE report 18397568 ↗
• InjurySep 15, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN INITIAL SHOULDER ARTHROPLASTY. SUBSEQUENTLY, THE PATIENT UNDERWENT AN OPEN ROTATOR CUFF REPAIR DUE TO A RUPTURE OF THE CRANIAL FIBERS OF THE SUBSCAPULARIS AND EXTENSIVE INTERSTITIAL CLEAVAGE TEAR OF THE SUPRASPINATUS; NO DEVICE WAS REVISED DURING THE PROCEDURE. APPROXIMATELY 2 YEARS LATER A REVISION SURGERY WAS PERFORMED DUE TO INSTABILITY AND LUXATION OF THE SHOULDER. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: Failure of Implant; Subluxation

  MAUDE report 17754524 ↗
• InjuryJun 21, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT WITH LEFT TOTAL SHOULDER REPLACEMENT UNDERWENT AN ADDITIONAL SURGERY DUE TO FROZEN SHOULDER, IMPINGEMENT SYNDROME, AND UNKNOWN CEMENT LEAKED INTO THE SPINOGLENOID NOTCH. NO ADDITIONAL COMPLICATIONS HAVE BEEN REPORTED. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: Extravasation; Joint Impingement; Loss of Range of Motion; Pain; Scar Tissue

  MAUDE report 17168619 ↗
• InjuryJun 13, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THROUGH A CLINICAL STUDY THAT A PATIENT UNDERWENT AN INITIAL RIGHT TOTAL SHOULDER ARTHROPLASTY APPROXIMATELY SIX (6) YEARS AGO. APPROXIMATELY SEVEN (7) MONTHS AFTER IMPLANTATION, THE PATIENT HAD DEVELOPED PAIN. ABOUT ONE AND HALF (1,5) YEARS LATER, INFECTION WAS RULED OUT AND COMPONENTS WERE FOUND TO BE STABLE, HOWEVER EXTENSIVE DEBRIDEMENT OF INTRA-AND EXTRA-ARTICULAR SCAR TISSUE WAS REQUIRED. THE HEAD WAS NOTED TO BE SLIGHTLY OVERSTUFFED AND SOMEWHAT SUBLUXATED VENTRALLY. AS OF THE FIVE (5) YEAR STUDY FOLLOW-UP VISIT, THE PATIENT IS SATISFIED AND ABLE TO COMPLETE THE MAJORITY OF DAILY ACTIVITIES WITH MINIMAL PAIN. THERE HAVE BEEN NO OTHER ADVERSE EVENTS OR COMPLICATIONS REPORTED. THE ORIGINAL STUDY COMPONENTS REMAIN IMPLANTED. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: Loss of Range of Motion; Pain; Scar Tissue; Subluxation

  MAUDE report 17115130 ↗
• InjuryJun 1, 2023Patient Device Interaction Problem; Patient Device Interaction Problem

  NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

  Patient problems: Extraskeletal ossification; Failure of Implant; Loss of Range of Motion; Osteolysis; Pain; Radiolucent Lines

  MAUDE report 17037628 ↗
• InjuryMay 30, 2023Patient Device Interaction Problem; Patient Device Interaction Problem

  NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

  Patient problems: Extraskeletal ossification; Loss of Range of Motion; Osteolysis; Pain; Radiolucent Lines

  MAUDE report 17018235 ↗
• InjuryMay 18, 2021Adverse Event Without Identified Device or Use Problem; Patient Device Interaction Problem; Patient Device Interaction Problem

  PATIENT WAS IMPLANTED ON LEFT SIDE AND STARTED EXPERIENCING PAIN WHICH WAS TREATED BY ARTHROSCOPIC ARTHROLYSIS SURGERY. NO REVISION SURGERY IS PLANNED. THE EVENT WAS DEFINED AS RESOLVED ON (B)(6) 2020. DURING THE FOLLOW-UP VISIT, THE PATIENT WAS FOUND TO BE DOING WELL AND HAS BEEN REFERRED TO A PHYSIOTHERAPIST. THIS EVENT IS PART OF A DOMELOCK STUDY - ID (B)(4) AT THE (B)(6) HOSPITAL.

  Patient problems: Pain

  MAUDE report 11840457 ↗
• InjuryMar 24, 2021Patient Device Interaction Problem; Patient Device Interaction Problem

  NO CHANGE TO PREVIOUSLY REPORTED EVENT.

  Patient problems: Failure of Implant; Loss of Range of Motion; Muscle Weakness/Atrophy; Muscle/Tendon Damage

  MAUDE report 11561034 ↗
• InjuryFeb 3, 2021Appropriate Device Problem Term/Code Not Available; Adverse Event Without Identified Device or Use Problem; Appropriate Device Problem Term/Code Not Available

  SEE SECTION H10.

  Patient problems: Muscle/Tendon Damage; Rupture

  MAUDE report 11271130 ↗