Anatomical Shoulder™ 01.04214.370Recalls & reported problems
Zimmer GmbH · Class 2 · Implant
All models of Anatomical Shoulder (33)
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 00889024481008), received between Mar 10, 2019 and Aug 23, 2023 — classified as 6 injuries.
The most frequently reported specific device problem is “Loosening of Implant Not Related to Bone-Ingrowth” (2 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.
Most reported problems
Device problems
- Loosening of Implant Not Related to Bone-Ingrowth2
- Patient Device Interaction Problem2
- Adverse Event Without Identified Device or Use Problem1
- Device Dislodged or Dislocated1
- Fracture1
Patient problems
- Pain5
- Failure of Implant3
- Loss of Range of Motion3
- Extraskeletal ossification2
- Osteolysis2
- Radiolucent Lines2
- Damage to Ligament(s)1
- Extravasation1
Recent adverse event reports
The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.
InjuryAug 23, 2023Fracture; 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: Failure of Implant
MAUDE report 17602121 ↗InjuryJun 20, 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 17161687 ↗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 17037620 ↗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 17018237 ↗InjuryDec 5, 2019Device Dislodged or Dislocated; Device Dislodged or Dislocated
NO CHANGE TO PREVIOUSLY REPORTED EVENT.
Patient problems: Joint Dislocation; Pain
MAUDE report 9415102 ↗InjuryMar 10, 2019Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth
PLEASE REFER TO REPORT.
Patient problems: Damage to Ligament(s); Failure of Implant; Pain
MAUDE report 8406439 ↗
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.
How reports and recalls are matched · Editorial policy · Report an error on this page