Anatomical Shoulder™ 01.04201.103Recalls & 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
- 7
- Deaths reported
- 0
- Injuries reported
- 6
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00889024484917), received between Jul 4, 2019 and Dec 27, 2023 — classified as 6 injuries, 1 malfunction.
The most frequently reported specific device problem is “Inadequacy of Device Shape and/or Size” (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
- Adverse Event Without Identified Device or Use Problem3
- Inadequacy of Device Shape and/or Size3
- Insufficient Device Problem Information1
Patient problems
- Bone Fracture(s)2
- No Clinical Signs, Symptoms or Conditions2
- Extravasation1
- Failure of Implant1
- Joint Impingement1
- Loss of Range of Motion1
- No Code Available1
- No Information1
Recent adverse event reports
The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.
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 ↗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 ↗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 17161713 ↗MalfunctionJul 21, 2020Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size
NO EVENT UPDATE. INVESTIGATION RESULTS ARE NOW AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions; No Information
MAUDE report 10304842 ↗InjuryJul 14, 2020Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size
NO EVENT UPDATE. INVESTIGATION RESULTS ARE NOW AVAILABLE.
Patient problems: Failure of Implant; No Clinical Signs, Symptoms or Conditions
MAUDE report 10272298 ↗InjuryFeb 21, 2020Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size
InjuryJul 4, 2019Insufficient Device Problem Information; Insufficient Device Problem Information
PLEASE REFER TO REPORT 0009613350-2019-00418.
Patient problems: Bone Fracture(s)
MAUDE report 8762012 ↗
Other PROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED devices
- DJO SURGICAL 509-02-032Encore Medical, L.P. · PROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED364 reports
- DELTA XTEND 130790036Depuy (Ireland) · PROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED171 reports
- DELTA XTEND 130770018Depuy (Ireland) · PROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED159 reports
- TRIGEN 71118200Smith & Nephew, Inc. · PROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED123 reports
- DJO SURGICAL 509-02-432Encore Medical, L.P. · PROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED119 reports
- DELTA XTEND 130738206Depuy (Ireland) · PROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED116 reports
- COMPREHENSIVE SHOULDER SYSTEM 113633Biomet Orthopedics, LLC · PROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED2 recalls4 reports
- DELTA XTEND 130742206Depuy (Ireland) · PROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED99 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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