Anatomical Shoulder™ 01.04214.340Recalls & 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
- 3
- Deaths reported
- 0
- Injuries reported
- 3
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00889024481015), received between Dec 11, 2018 and Jun 13, 2023 — classified as 3 injuries.
The most frequently reported specific device problem is “Migration or Expulsion of Device” (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
Device problems
- Adverse Event Without Identified Device or Use Problem1
- Migration or Expulsion of Device1
- Patient Device Interaction Problem1
Patient problems
- Loss of Range of Motion2
- Insufficient Information1
- Muscle Weakness/Atrophy1
- Muscle/Tendon Damage1
- No Information1
- Pain1
- Scar Tissue1
- Subluxation1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
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 17115127 ↗InjuryMar 23, 2021Patient Device Interaction Problem; Patient Device Interaction Problem
PATIENT WAS IMPLANTED ON AN UNKNOWN SIDE AND UNDERWENT A REVISION SURGERY DUE TO ROTATOR CUFF INSUFFICIENCY. THE PATIENT WAS DIAGNOSED WITH AVASCULAR NECROSIS OF THE HUMERUS AND HAD A PREVIOUS IPSILATERAL PROXIMAL HUMERUS FRACTURE. THE ROTATOR CUFF WAS FUNCTIONAL. DURING SURGERY, THE SUBSCAPULARIS TENDON WAS RELEASED FOLLOWING THE ¿LESSER TUBEROSITY OSTEOTOMY¿ APPROACH.
Patient problems: Insufficient Information; Loss of Range of Motion; Muscle Weakness/Atrophy; Muscle/Tendon Damage
MAUDE report 11555176 ↗InjuryDec 11, 2018Migration or Expulsion of Device; Migration or Expulsion of Device
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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