Anatomical ShoulderRecalls & reported problems across all models
Zimmer GmbH · 33 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 102
- Deaths reported
- 0
- Injuries reported
- 96
- Recalls
- 0
We found 33 models of Anatomical Shoulder by Zimmer GmbH in the FDA's device registry (GUDID). Together they are named in 102 adverse event reports in the FDA's MAUDE database, received between Nov 26, 2018 and Jul 8, 2026 — classified as 96 injuries, 6 malfunctions.
The most frequently reported specific device problem is “Loosening of Implant Not Related to Bone-Ingrowth” (20 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
Most reported Anatomical Shoulder problems
Device problems
- Adverse Event Without Identified Device or Use Problem38
- Loosening of Implant Not Related to Bone-Ingrowth20
- Fracture18
- Device Dislodged or Dislocated16
- Insufficient Device Problem Information13
- Patient Device Interaction Problem13
- Contamination /Decontamination Problem6
- Appropriate Device Problem Term/Code Not Available5
Patient problems
- Pain35
- Unspecified Infection26
- Failure of Implant23
- Insufficient Information14
- Joint Dislocation13
- Loss of Range of Motion11
- Bacterial Infection10
- No Clinical Signs, Symptoms or Conditions7
Anatomical Shoulder models
33 models, most reported first. Each model has its own page with its reports, recalls and device details.
- Anatomical Shoulder™ 01.04223.036PROSTHESIS, SHOULDER, NON-CONSTRAINED, METAL/POLYMER CEMENTED16 reports
- Anatomical Shoulder™ 01.04223.042PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED8 reports
- Anatomical Shoulder™ 01.04201.103PROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED7 reports
- Anatomical Shoulder™ 01.04214.370PROSTHESIS, SHOULDER, NON-CONSTRAINED, METAL/POLYMER CEMENTED6 reports
- Anatomical Shoulder™ 01.04223.030PROSTHESIS, SHOULDER, NON-CONSTRAINED, METAL/POLYMER CEMENTED6 reports
- Anatomical Shoulder™ 01.04223.406PROSTHESIS, SHOULDER, NON-CONSTRAINED, METAL/POLYMER CEMENTED5 reports
- Anatomical Shoulder™ 01.04223.033PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED5 reports
- Anatomical Shoulder™ 01.04223.360PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED4 reports
- Anatomical Shoulder™ 01.04211.123PROSTHESIS, SHOULDER, NON-CONSTRAINED, METAL/POLYMER CEMENTED4 reports
- Anatomical Shoulder™ 01.04201.143shoulder prosthesis, reverse configuration4 reports
- Anatomical Shoulder™ 01.04223.100PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED3 reports
- Anatomical Shoulder™ 01.04223.106PROSTHESIS, SHOULDER, NON-CONSTRAINED, METAL/POLYMER CEMENTED3 reports
- Anatomical Shoulder™ 01.04214.340PROSTHESIS, SHOULDER, NON-CONSTRAINED, METAL/POLYMER CEMENTED3 reports
- Anatomical Shoulder™ 01.04223.363PROSTHESIS, SHOULDER, NON-CONSTRAINED, METAL/POLYMER CEMENTED3 reports
- Anatomical Shoulder™ 01.04223.048PROSTHESIS, SHOULDER, NON-CONSTRAINED, METAL/POLYMER CEMENTED3 reports
- Anatomical Shoulder™ 01.04211.093PROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED3 reports
- Anatomical Shoulder™ 01.04223.018PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED2 reports
- Anatomical Shoulder™ 01.04201.123shoulder prosthesis, reverse configuration2 reports
- Anatomical Shoulder™ 01.04201.092PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED1 report
- Anatomical Shoulder™ 01.04201.102PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED1 report
- Anatomical Shoulder™ 01.04211.142PROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED1 report
- Anatomical Shoulder™ 01.04213.520PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED1 report
- Anatomical Shoulder# 01.04227.102PROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED1 report
- Anatomical Shoulder™ 01.04233.000PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED1 report
- Anatomical Shoulder™ 01.04239.140PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED1 report
- Anatomical Shoulder™ 01.04239.700PROSTHESIS, SHOULDER, NON-CONSTRAINED, METAL/POLYMER CEMENTED1 report
- Anatomical Shoulder™ 01.04239.720PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED1 report
- Anatomical Shoulder™ 01.04223.190PROSTHESIS, SHOULDER, NON-CONSTRAINED, METAL/POLYMER CEMENTED1 report
- Anatomical Shoulder™ 01.04207.103PROSTHESIS, SHOULDER, NON-CONSTRAINED, METAL/POLYMER CEMENTED1 report
- Anatomical Shoulder™ 01.04207.073PROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED1 report
- Anatomical Shoulder™ 01.04207.083PROSTHESIS, SHOULDER, NON-CONSTRAINED, METAL/POLYMER CEMENTED1 report
- Anatomical Shoulder™ 01.04227.448PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED1 report
- Anatomical Shoulder™ 01.04223.366PROSTHESIS, SHOULDER, NON-CONSTRAINED, METAL/POLYMER CEMENTED1 report
Recent Anatomical Shoulder adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
InjuryJul 8, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE PATIENT UNDERWENT A REVISION DUE TO UNKNOWN REASONS. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.
Patient problems: Insufficient Information
MAUDE report 25746503 ↗InjurySep 2, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
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 ↗InjuryFeb 18, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: Extraskeletal ossification; Osteolysis; Pain
MAUDE report 21396169 ↗InjuryNov 12, 2024Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth
IT WAS REPORTED THAT A PATIENT SUFFERED A SHOULDER DISLOCATION APPROXIMATELY 3 DAYS POST IMPLANTATION AND UNDERWENT A REVISION SURGERY APPROXIMATELY 2 WEEKS LATER. DURING THE SURGERY, IT WAS FOUND THAT THE CEMENTED BASEPLATE HAD FALLEN OUT OF THE GLENOID. ALL IMPLANTS EXCEPT THE STEM WERE REMOVED AND REPLACED. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.
Patient problems: Failure of Implant; Joint Dislocation
MAUDE report 20663774 ↗InjuryNov 12, 2024Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth
IT WAS REPORTED THAT A PATIENT SUFFERED A SHOULDER DISLOCATION APPROXIMATELY 3 DAYS POST IMPLANTATION AND UNDERWENT A REVISION SURGERY APPROXIMATELY 2 WEEKS LATER. DURING THE SURGERY, IT WAS FOUND THAT THE CEMENTED BASEPLATE HAD FALLEN OUT OF THE GLENOID. ALL IMPLANTS EXCEPT THE STEM WERE REMOVED AND REPLACED. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.
Patient problems: Failure of Implant; Joint Dislocation
MAUDE report 20663697 ↗InjuryApr 18, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryDec 29, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
NO ADDITIONAL INFORMATION AT THIS TIME.
Patient problems: Insufficient Information
MAUDE report 18418441 ↗InjuryDec 29, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
NO ADDITIONAL INFORMATION AT THIS TIME.
Patient problems: Insufficient Information
MAUDE report 18418438 ↗InjuryDec 27, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED ACCORDING TO A CLINICAL STUDY THAT THE PATIENT WAS IMPLANTED WITH AN ANATOMIC TOTAL SHOULDER IMPLANT ON THE RIGHT SIDE. A CONVERSION TO A REVERSE SHOULDER ARTHROPLASTY HAS BEEN PERFORMED APPROXIMATELY 3 AND A HALF YEARS POST IMPLANTATION DUE TO A ROTATOR CUFF INSUFFICIENCY. DILIGENCE IS COMPLETED AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.
Patient problems: Tissue Breakdown
MAUDE report 18397561 ↗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 ↗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 18253317 ↗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 18253316 ↗InjurySep 14, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT PATIENT UNDERWENT A REVERSE LEFT SHOULDER ARTHROPLASTY. DURING SURGERY THE HUMERAL BONE FRACTURED WHILE THE SURGEON WAS IMPLANTING THE STEM. NO KNOWN IMPACT OR CONSEQUENCE TO THE PATIENT. THE FRACTURE WAS TREATED CONSERVATIVELY. DUE DILIGENCE IS IN PROGRESS FOR THIS COMPLAINT; TO DATE NO ADDITIONAL INFORMATION OR PRODUCT HAS BEEN RECEIVED.
Patient problems: Bone Fracture(s)
MAUDE report 17743081 ↗
Other Zimmer GmbH products
- Affixus Natural Nail55 models · 612 reports
- Biolox delta16 models · 343 reports
- NCB78 models · 200 reports
- Zimmer Natural Nail System57 models · 187 reports
- Biolox Option16 models · 68 reports · 2 recalls
- Avenir24 models · 57 reports · 1 recall
- Sidus Stem-Free Shoulder9 models · 30 reports · 1 recall
- Wagner SL Revision33 models · 66 reports
Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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