Alliance™ Trabecular Metal™ SAGP0002Recalls & reported problems

Summary

The FDA's MAUDE database contains 16 adverse event reports that list this exact device (DI 00889024574496), received between Apr 4, 2022 and Aug 14, 2026 — classified as 15 injuries, 1 malfunction.

The most frequently reported specific device problem is “Degraded” (1 report).

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 18, 2026.

Most reported problems

Recent adverse event reports

The 16 most recent of 16 reports, in the reporter's own words as published by the FDA.

• InjuryAug 14, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that the patient underwent initial right total shoulder arthroplasty approximately 1 year and 8 months ago. Approximately four months later, developed right shoulder pain after working on a fence, which resolved approximately three months later. Several months afterward, the pain recurred, and the patient received a steroid injection to the right shoulder and was prescribed Meloxicam.

  Patient problems: Pain

  MAUDE report 50255856 ↗
• InjuryAug 6, 2026Degraded

  It was reported that during a follow-up examination, radiographs showed the glenoid post and glenoid component had completely dissolved. Attempts have been made and no further information has been provided.

  Patient problems: Insufficient Information

  MAUDE report 50165714 ↗
• MalfunctionMay 21, 2026Detachment of Device or Device Component

  IT WAS REPORTED THAT A POST BECAME DISSOCIATED FROM A GLENOID COMPONENT. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: Insufficient Information

  MAUDE report 25242080 ↗
• InjuryMay 15, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN INITIAL IMPLANTATION APPROXIMATELY FOUR (4) YEARS AND SIX (6) MONTHS AGO. SUBSEQUENTLY, IT WAS NOTED POST-OPERATIVELY THAT THE TM MODULAR PEG OF THE GLENOID PENETRATED THE POLY LINER AND PROTRUDED. THE PATIENT UNDERWENT A REVISION APPROXIMATELY FOUR (4) YEARS AND FIVE (5) MONTHS POST-IMPLANTATION WHERE THE INITIAL PLAN WAS TO CONVERT FROM A TSA TO RTSA; HOWEVER, DUE TO METALLOSIS AND SEVERE BONE RESORPTION, IMPLANTING A GLENOID IMPLANT WAS UNABLE TO OCCUR. THEREFORE, BONE WAS HARVESTED FROM THE ILIUM AND USED FOR A BONE GRAFT AT THE SITE OF THE RESORPTION. IT IS NOTED THE PATIENT WAS VERY ACTIVE, IN WHICH THIS EVENT HAS CAUSED POST-OP MANAGEMENT DIFFICULT. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: Erosion; Metal Related Pathology

  MAUDE report 25184024 ↗
• InjuryMay 9, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THE PATIENT UNDERWENT A TOTAL SHOULDER ARTHROPLASTY. SUBSEQUENTLY, APPROXIMATELY 5 MONTHS POST-IMPLANTATION THE PATIENT WAS REVISED DUE TO UNKNOWN REASONS. ATTEMPTS HAVE BEEN MADE, AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: Insufficient Information

  MAUDE report 21994557 ↗
• InjuryMar 4, 2025Fracture; Adverse Event Without Identified Device or Use Problem; Fracture; Adverse Event Without Identified Device or Use Problem

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

  Patient problems: Insufficient Information

  MAUDE report 21513470 ↗
• InjuryNov 18, 2024Unintended Movement; Unintended Movement

  NO ADDITIONAL INFORMATION IS AVAILABLE REGARDING THE INCIDENT.

  Patient problems: Adhesion(s); Erosion; Joint Dislocation; Joint Impingement; Loss of Range of Motion; Osteopenia/ Osteoporosis; Pain; Subluxation

  MAUDE report 20706326 ↗
• InjuryOct 9, 2024Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN INITIAL SHOULDER ARTHROPLASTY APPROXIMATELY THREE (3) YEARS AND FOUR (MONTHS) AGO. SUBSEQUENTLY, THE PATIENT UNDERWENT A REVISION SURGERY DUE TO WEAR OF THE IMPLANT. UPON REMOVAL OF THE GLENOID, IT WAS FOUND TO BE FRACTURED.

  Patient problems: Pain

  MAUDE report 20410069 ↗
• InjurySep 4, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED IN A CLINICAL STUDY THAT A PATIENT DEVELOPED A DVT/PE APPROXIMATELY 2 MONTHS POST IMPLANTATION OF A LEFT SHOULDER ARTHROPLASTY. THE PATIENT WAS HOSPITALIZED AND PLACED ON MEDICATION. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.

  Patient problems: Pulmonary Embolism; Thrombosis/Thrombus

  MAUDE report 20138256 ↗
• InjurySep 4, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED A PATIENT HAD AN INITIAL LEFT ANATOMICAL TOTAL SHOULDER ARTHROPLASTY. ONE MONTH POST-OP, THE PATIENT DEVELOPED SUBCUTANEOUS SWELLING REDNESS AT THE PROXIMAL INCISION, AND A HEMATOMA. THE PATIENT WAS PLACED ON CLINDAMYCIN AND DOXYCYCLINE AND WAS RESOLVED WITHOUT FURTHER COMPLICATIONS. ALL IMPLANTS REMAIN IN PLACE. NO ADDITIONAL PATIENT CONSEQUENCES WERE REPORTED.

  Patient problems: Erythema; Hematoma; Swelling/ Edema

  MAUDE report 20136925 ↗
• InjurySep 4, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED IN A CLINICAL STUDY THAT A PATIENT DEVELOPED DRAINAGE FROM A SURGICAL SITE WOUND APPROXIMATELY 10 DAYS POST IMPLANTATION OF A LEFT SHOULDER ARTHROPLASTY. 15 DAYS POST IMPLANTATION, THE DRAINAGE SITE/HEMATOMA WAS OPENED UP AND A MAJORITY WAS EXPRESSED OUT. A DRESSING WAS APPLIED AND THE PATIENT WAS TREATED WITH ANTIBIOTICS. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.

  Patient problems: Fluid Discharge; Hematoma

  MAUDE report 20136709 ↗
• InjuryAug 14, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

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

  Patient problems: Impaired Healing

  MAUDE report 19986373 ↗
• InjuryAug 30, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT BEGAN TO HAVE SEVERE SHOULDER PAIN, MODERATE DIFFICULTIES COMPLETING DAILY ACTIVITIES, LIMITED RANGE OF MOTION, AND MUSCLE WEAKNESS APPROXIMATELY TEN MONTHS POST OPERATION. THE PATIENT REPORTS SHARP POPPING PAIN IN THE ANTERIOR SHOULDER WITH A TWISTING MOTION. NO ADDITIONAL PATIENT CONSEQUENCES WERE REPORTED. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.

  Patient problems: Loss of Range of Motion; Muscle Weakness/Atrophy; Muscle/Tendon Damage; Numbness; Pain

  MAUDE report 17650381 ↗
• InjuryOct 3, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT WAS FOUND TO HAVE WOUND DEHISCENCE 1 MONTH POST IMPLANTATION OF A LEFT TOTAL SHOULDER ARTHROPLASTY. THE PATIENT WAS PRESCRIBED ORAL ANTIBIOTICS AND IS TO FOLLOW UP AGAIN IN CLINIC. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.

  Patient problems: Wound Dehiscence

  MAUDE report 15527610 ↗
• InjuryMay 5, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A REVISION PROCEDURE APPROXIMATELY 7 MONTHS POSTIMPLANTATION DUE TO UNKNOWN REASONS. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14288467 ↗
• InjuryApr 4, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A REVISION PROCEDURE APPROXIMATELY 13 MONTHS POSTIMPLANTION DUE TO INFECTION AND BONE LOSS. THE IMPLANTS WERE REMOVED AND A CEMENT SPACER WAS PLACED WHILE A CUSTOM IMPLANT IS BEING MANUFACTURED. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.

  Patient problems: Erosion; Unspecified Infection

  MAUDE report 13999150 ↗