Alliance™ SAGL2043 (UDI 00889024574373)Recalls & reported problems
Zimmer, Inc. · Class 2 · Implant
All models of Alliance (32)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 6
- Deaths reported
- 0
- Injuries reported
- 6
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00889024574373), received between Jul 6, 2022 and May 18, 2026 — classified as 6 injuries.
The most frequently reported specific device problem is “Naturally Worn” (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 18, 2026.
Reports received per month
Most reported problems
Device problems
- Naturally Worn3
- Fracture2
- Loosening of Implant Not Related to Bone-Ingrowth1
- Malposition of Device1
- Positioning Failure1
- Unintended Movement1
Patient problems
- Insufficient Information3
- Erosion2
- Metal Related Pathology2
- Pain2
- Adhesion(s)1
- Failure of Implant1
- Joint Dislocation1
- Joint Impingement1
Recent adverse event reports
The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.
InjuryMay 18, 2026Positioning Failure; Naturally Worn
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 25201269 ↗InjuryJan 9, 2026Naturally Worn
NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: Insufficient Information; Metal Related Pathology; Pain
MAUDE report 24022594 ↗InjuryNov 19, 2025Fracture; Naturally Worn; Fracture; Naturally Worn
NO FURTHER EVENT INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: Insufficient Information
MAUDE report 23594385 ↗InjuryJul 30, 2025Fracture; Loosening of Implant Not Related to Bone-Ingrowth; Fracture; Loosening of Implant Not Related to Bone-Ingrowth
NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: Insufficient Information
MAUDE report 22668437 ↗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 20706148 ↗InjuryJul 6, 2022Malposition of Device; Malposition of Device
IT WAS REPORTED THAT THE PATIENT UNDERWENT A RIGHT SHOULDER REVISION SURGERY DO TO THE IMPLANTS BEING DISPLACED DUE TO THE MALPOSITIONING OF AND LOSS OF FIXATION OF THE IMPLANTS.
Patient problems: Failure of Implant
MAUDE report 14935950 ↗
Other PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED devices
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- DJO SURGICAL 509-00-432Encore Medical, L.P. · Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented1 recall117 reports
- Alliance® SBGL3007Zimmer, Inc. · PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED162 reports
- DELTA XTEND 130760138Depuy (Ireland) · PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED146 reports
- DELTA XTEND 130790030Depuy (Ireland) · PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED132 reports
- DJO SURGICAL 509-00-436Encore Medical, L.P. · Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented124 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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