Anatomical Shoulder DomelockRecalls & reported problems across all models
Zimmer GmbH · 10 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 28
- Deaths reported
- 0
- Injuries reported
- 28
- Recalls
- 0
We found 10 models of Anatomical Shoulder Domelock by Zimmer GmbH in the FDA's device registry (GUDID). Together they are named in 28 adverse event reports in the FDA's MAUDE database, received between Dec 19, 2019 and Feb 18, 2025 — classified as 28 injuries.
The most frequently reported specific device problem is “Patient Device Interaction Problem” (8 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 Domelock problems
Device problems
- Adverse Event Without Identified Device or Use Problem12
- Patient Device Interaction Problem8
- Appropriate Device Problem Term/Code Not Available5
- Device Dislodged or Dislocated5
- Material Integrity Problem2
- Physical Resistance/Sticking2
- Material Erosion1
Patient problems
- Pain17
- Loss of Range of Motion12
- Extraskeletal ossification6
- Muscle/Tendon Damage6
- Osteolysis6
- Failure of Implant5
- Radiolucent Lines4
- Scar Tissue4
Anatomical Shoulder Domelock models
10 models, most reported first. Each model has its own page with its reports, recalls and device details.
- Anatomical Shoulder™ Domelock® 01.04227.005prosthesis, shoulder, semi-constrained, metal/polymer + additive, cemented9 reports
- Anatomical Shoulder™ Domelock® 01.04212.465prosthesis, shoulder, semi-constrained, metal/polymer + additive, cemented4 reports
- Anatomical Shoulder™ Domelock® 01.04212.465PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED3 reports
- Anatomical Shoulder™ Domelock® 01.04212.505prosthesis, shoulder, semi-constrained, metal/polymer + additive, cemented3 reports
- Anatomical Shoulder™ Domelock® 01.04227.005PROSTHESIS, SHOULDER, NON-CONSTRAINED, METAL/POLYMER CEMENTED2 reports
- Anatomical Shoulder™ Domelock® 01.04212.445prosthesis, shoulder, semi-constrained, metal/polymer + additive, cemented2 reports
- Anatomical Shoulder™ Domelock® 01.04212.485prosthesis, shoulder, semi-constrained, metal/polymer + additive, cemented2 reports
- Anatomical Shoulder™ Domelock® 01.04213.505prosthesis, shoulder, semi-constrained, metal/polymer + additive, cemented1 report
- Anatomical Shoulder™ Domelock® 01.04212.525prosthesis, shoulder, semi-constrained, metal/polymer + additive, cemented1 report
- Anatomical Shoulder™ Domelock® 01.04227.222prosthesis, shoulder, semi-constrained, metal/polymer + additive, cemented1 report
Recent Anatomical Shoulder Domelock adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
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 21399311 ↗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 21392502 ↗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 18397568 ↗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 18397566 ↗InjurySep 15, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated
IT WAS REPORTED THAT THE PATIENT UNDERWENT AN INITIAL SHOULDER ARTHROPLASTY. SUBSEQUENTLY, THE PATIENT UNDERWENT AN OPEN ROTATOR CUFF REPAIR DUE TO A RUPTURE OF THE CRANIAL FIBERS OF THE SUBSCAPULARIS AND EXTENSIVE INTERSTITIAL CLEAVAGE TEAR OF THE SUPRASPINATUS; NO DEVICE WAS REVISED DURING THE PROCEDURE. APPROXIMATELY 2 YEARS LATER A REVISION SURGERY WAS PERFORMED DUE TO INSTABILITY AND LUXATION OF THE SHOULDER. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.
Patient problems: Failure of Implant; Subluxation
MAUDE report 17754524 ↗InjurySep 15, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated
IT WAS REPORTED THAT THE PATIENT UNDERWENT AN INITIAL SHOULDER ARTHROPLASTY. SUBSEQUENTLY, THE PATIENT UNDERWENT AN OPEN ROTATOR CUFF REPAIR DUE TO A RUPTURE OF THE CRANIAL FIBERS OF THE SUBSCAPULARIS AND EXTENSIVE INTERSTITIAL CLEAVAGE TEAR OF THE SUPRASPINATUS; NO DEVICE WAS REVISED DURING THE PROCEDURE. APPROXIMATELY 2 YEARS LATER A REVISION SURGERY WAS PERFORMED DUE TO INSTABILITY AND LUXATION OF THE SHOULDER. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.
Patient problems: Failure of Implant; Subluxation
MAUDE report 17754521 ↗InjuryJun 21, 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 17168619 ↗InjuryJun 20, 2023Adverse 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: Extravasation; Joint Impingement; Loss of Range of Motion; Pain; Scar Tissue
MAUDE report 17161684 ↗InjuryJun 15, 2023Physical Resistance/Sticking; Physical Resistance/Sticking
NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: Loss of Range of Motion; Muscle/Tendon Damage; Pain
MAUDE report 17133940 ↗InjuryJun 15, 2023Physical Resistance/Sticking; Physical Resistance/Sticking
NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: Loss of Range of Motion; Muscle/Tendon Damage; Pain
MAUDE report 17133931 ↗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 17115130 ↗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 17115123 ↗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 17037628 ↗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 17037623 ↗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 17018238 ↗
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
- Anatomical Shoulder33 models · 102 reports
- Sidus Stem-Free Shoulder9 models · 30 reports · 1 recall
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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