Anatomical Shoulder™ 01.04223.036Recalls & reported problems
Zimmer GmbH · Class 2
All models of Anatomical Shoulder (33)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 16
- Deaths reported
- 0
- Injuries reported
- 16
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 16 adverse event reports that list this exact device (DI 00889024483040), received between Oct 4, 2019 and Sep 2, 2025 — classified as 16 injuries.
The most frequently reported specific device problem is “Loosening of Implant Not Related to Bone-Ingrowth” (5 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
- Adverse Event Without Identified Device or Use Problem7
- Loosening of Implant Not Related to Bone-Ingrowth5
- Fracture4
- Insufficient Device Problem Information3
- Patient Device Interaction Problem2
- Biocompatibility1
- Contamination /Decontamination Problem1
- Material Integrity Problem1
Patient problems
- Pain7
- Unspecified Infection7
- Failure of Implant3
- Insufficient Information3
- Bacterial Infection2
- Bone Fracture(s)1
- Fall1
- Hematoma1
Recent adverse event reports
The 16 most recent of 16 reports, in the reporter's own words as published by the FDA.
InjurySep 2, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryMay 14, 2025Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth
IT WAS REPORTED THAT THE PATIENT UNDERWENT A REVISION APPROXIMATELY 6 YEARS POST-IMPLANTATION DUE TO PAIN AND TMR LOOSENING. ATTEMPTS HAVE BEEN MADE AND ALL AVAILABLE INFORMATION HAS BEEN PROVIDED.
Patient problems: Failure of Implant; Pain
MAUDE report 22020005 ↗InjuryDec 2, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
NO ADDITIONAL INFORMATION AT THIS TIME.
Patient problems: Unspecified Infection
MAUDE report 18253318 ↗InjurySep 5, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT A PATIENT IS EXPERIENCING PAIN AFTER THE IMPLANTATION OF A PRIMARY SHOULDER APPROXIMATELY 6 MONTHS AGO. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.
Patient problems: Pain
MAUDE report 15355220 ↗InjurySep 5, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT A PATIENT IS EXPERIENCING PAIN AFTER THE IMPLANTATION OF A PRIMARY SHOULDER APPROXIMATELY 6 MONTHS AGO. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.
Patient problems: Pain
MAUDE report 15355204 ↗InjuryMar 14, 2022Patient Device Interaction Problem; Patient Device Interaction Problem
NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: Unspecified Infection
MAUDE report 13759494 ↗InjuryNov 11, 2021Fracture; Insufficient Device Problem Information; Fracture; Insufficient Device Problem Information
PATIENT EXPERIENCED HEMATOMA, RADIOGRAPHIC NOTCHING, GENERAL MATERIAL FAILURE AND POSSIBLE SCREW BREAKAGE OF THE MOST CAUDAL SCREW, DEFINABLE BENDING OF THE MOST CAUDAL SCREW.
Patient problems: Hematoma
MAUDE report 12795848 ↗InjuryAug 25, 2021Insufficient Device Problem Information; Loosening of Implant Not Related to Bone-Ingrowth; Insufficient Device Problem Information; Loosening of Implant Not Related to Bone-Ingrowth
PATIENT WAS IMPLANTED ON THE RIGHT SIDE AND UNDERWENT REVISION SURGERY DUE TO LOOSENING.
Patient problems: Inadequate Osseointegration; Insufficient Information
MAUDE report 12364405 ↗InjuryAug 13, 2021Fracture; Fracture
NO EVENT UPDATE. INVESTIGATION RESULTS ARE NOW AVAILABLE.
Patient problems: Failure of Implant; Insufficient Information
MAUDE report 12317960 ↗InjuryJun 16, 2021Adverse Event Without Identified Device or Use Problem; Patient-Device Incompatibility; Adverse Event Without Identified Device or Use Problem
NO EVENT UPDATE. INVESTIGATION RESULTS ARE NOW AVAILABLE.
Patient problems: Bacterial Infection; Pain; Unspecified Infection
MAUDE report 12007874 ↗InjuryApr 20, 2021Fracture; Material Integrity Problem; Patient Device Interaction Problem; Loosening of Implant Not Related to Bone-Ingrowth; Fracture; Material Integrity Problem; Patient Device Interaction Problem; Loosening of Implant Not Related to Bone-Ingrowth
PATIENT WAS IMPLANTED ON THE RIGHT SIDE AND UNDERWENT REVISION SURGERY DUE TO PAIN, LOOSENING AND IMPLANT FRACTURE.
Patient problems: Failure of Implant; Pain
MAUDE report 11691721 ↗InjuryFeb 23, 2021Mechanical Problem; Loosening of Implant Not Related to Bone-Ingrowth; Mechanical Problem; Loosening of Implant Not Related to Bone-Ingrowth
NO CHANGE TO PREVIOUSLY REPORTED EVENT.
Patient problems: Fall; Insufficient Information
MAUDE report 11364018 ↗InjuryDec 30, 2020Fracture; Biocompatibility; Fracture; Biocompatibility
NO CHANGE TO PREVIOUSLY REPORTED EVENT.
Patient problems: Implant Pain; Inflammation; Pain; Unspecified Infection
MAUDE report 11093830 ↗InjuryDec 21, 2020Contamination /Decontamination Problem; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Contamination /Decontamination Problem; Insufficient Device Problem Information
INVESTIGATION RESULTS ARE NOW AVAILABLE.
Patient problems: Pain; Swelling; Swelling/ Edema; Unspecified Infection
MAUDE report 11045672 ↗InjuryJul 30, 2020Adverse Event Without Identified Device or Use Problem; Loosening of Implant Not Related to Bone-Ingrowth; Adverse Event Without Identified Device or Use Problem; Loosening of Implant Not Related to Bone-Ingrowth
INVESTIGATION HAS BEEN COMPLETED.
Patient problems: Bacterial Infection; Unspecified Infection
MAUDE report 10343302 ↗InjuryOct 4, 2019No Apparent Adverse Event; No Apparent Adverse Event
IT WAS REPORTED THAT THE PATIENT UNDERWENT A REVISION SURGERY DUE TO INFECTION. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Unspecified Infection
MAUDE report 9154947 ↗
Other PROSTHESIS, SHOULDER, NON-CONSTRAINED, METAL/POLYMER CEMENTED devices
- Equinoxe 320-42-00Exactech, Inc. · Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented3 recalls107 reports
- Equinoxe 320-38-00Exactech, Inc. · Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented3 recalls107 reports
- Equinoxe 320-42-03Exactech, Inc. · Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented2 recalls87 reports
- Equinoxe 320-38-03Exactech, Inc. · Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented2 recalls43 reports
- Equinoxe 320-42-13Exactech, Inc. · Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented2 recalls41 reports
- Equinoxe 320-10-00Exactech, Inc. · Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented132 reports
- Equinoxe 320-36-00Exactech, Inc. · Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented2 recalls27 reports
- Equinoxe 320-42-10Exactech, Inc. · Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented2 recalls14 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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