Anatomic Shoulder ProsthesisRecalls & reported problems across all models
Medacta International SA · 29 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 59
- Deaths reported
- 1
- Injuries reported
- 58
- Recalls
- 1
We found 29 models of Anatomic Shoulder Prosthesis by Medacta International SA in the FDA's device registry (GUDID). Together they are named in 59 adverse event reports in the FDA's MAUDE database, received between Feb 22, 2018 and Jul 10, 2026 — classified as 1 death, 58 injuries.
The most frequently reported specific device problem is “Device Appears to Trigger Rejection” (9 reports).
1 FDA recall record name at least one of these models by its device identifier.
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
Anatomic Shoulder Prosthesis recalls
FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.
- Nov 4, 2019Terminated
Certain lot numbers of the Medacta Humeral Anatomical Cementless Metaphysis have a dimensional condition that could limit insertion of the screw used to lock the metaphysis to the humeral diaphysis.
Z-0775-2020 · Root cause: Device Design · Recall details · FDA record ↗
Most reported Anatomic Shoulder Prosthesis problems
Device problems
- Adverse Event Without Identified Device or Use Problem17
- Appropriate Device Problem Term/Code Not Available9
- Device Appears to Trigger Rejection9
- Device Dislodged or Dislocated6
- Osseointegration Problem4
- Loosening of Implant Not Related to Bone-Ingrowth3
- Malposition of Device2
- Unstable2
Patient problems
- Medical device site infection10
- Pain10
- Implant Pain6
- Loss of Range of Motion6
- Joint Laxity5
- Unspecified Infection5
- Inadequate Osseointegration4
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available3
Anatomic Shoulder Prosthesis models
29 models, most reported first. Each model has its own page with its reports, recalls and device details.
- Anatomic Shoulder Prosthesis 04.01.0023Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented1 recall0 reports
- Anatomic Shoulder Prosthesis 04.01.0132Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented6 reports
- Anatomic Shoulder Prosthesis 04.01.0004Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented5 reports
- Anatomic Shoulder Prosthesis 04.01.0024Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented4 reports
- Anatomic Shoulder Prosthesis 04.01.0093Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented4 reports
- Anatomic Shoulder Prosthesis 04.01.0129Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented4 reports
- Anatomic Shoulder Prosthesis 04.01.0003Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented3 reports
- Anatomic Shoulder Prosthesis 04.01.0006Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented1 death3 reports
- Anatomic Shoulder Prosthesis 04.01.0089Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented3 reports
- Anatomic Shoulder Prosthesis 04.01.0130Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented3 reports
- Anatomic Shoulder Prosthesis 04.01.0001Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented2 reports
- Anatomic Shoulder Prosthesis 04.01.0005Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented2 reports
- Anatomic Shoulder Prosthesis 04.01.0026Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented2 reports
- Anatomic Shoulder Prosthesis 04.01.0027Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented2 reports
- Anatomic Shoulder Prosthesis 04.01.0131Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented2 reports
- Anatomic Shoulder Prosthesis 04.01.0002Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented1 report
- Anatomic Shoulder Prosthesis 04.01.0007Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented1 report
- Anatomic Shoulder Prosthesis 04.01.0008Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented1 report
- Anatomic Shoulder Prosthesis 04.01.0009Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented1 report
- Anatomic Shoulder Prosthesis 04.01.0025Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented1 report
- Anatomic Shoulder Prosthesis 04.01.0028Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented1 report
- Anatomic Shoulder Prosthesis 04.01.0029Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented1 report
- Anatomic Shoulder Prosthesis 04.01.0090Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented1 report
- Anatomic Shoulder Prosthesis 04.01.0091Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented1 report
- Anatomic Shoulder Prosthesis 04.01.0092Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented1 report
- Anatomic Shoulder Prosthesis 04.01.0095Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented1 report
- Anatomic Shoulder Prosthesis 04.01.0096Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented1 report
- Anatomic Shoulder Prosthesis 04.01.0134Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented1 report
- Anatomic Shoulder Prosthesis 04.01.0135Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented1 report
Recent Anatomic Shoulder Prosthesis adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
InjuryJul 10, 2026Device Appears to Trigger Rejection
THE PATIENT HAD PRIMARY LEFT SHOULDER SURGERY ON (B)(6) 2023. ON (B)(6) 2026, THE PATIENT CAME IN DUE TO INSTABILITY AS THE RESULT OF A LOOSE BASEPLATE. THE CONFIRMED CAUSE IS INFECTION WITH THE PATHOGEN UNKNOWN. THE SURGEON TOOK CULTURES FOR TESTING AND REVISED THE REVERSE SHOULDER TO ANATOMICAL WITH ANTIBIOTIC SPACERS. THE SURGERY WAS COMPLETED SUCCESSFULLY. PRESENTLY, ON (B)(6) 2026, THE PATIENT CAME IN DUE TO CONTINUED SIGNS OF INFECTION WITH THE PATHOGEN UNKNOWN. THE SURGEON PERFORMED A WASHOUT AND CONVERTED THE PATIENT BACK TO A REVERSE SHOULDER SYSTEM. THE SURGERY WAS COMPLETED SUCCESSFULLY.
Patient problems: Medical device site infection
MAUDE report 25778115 ↗InjuryMay 15, 2026Device Appears to Trigger Rejection
REVISION SURGERY DUE TO INFECTION AFTER ABOUT 1 YEAR AND MONTH AFTER LAST REVISION SURGERY. THE PATIENT HAD PRIMARY SURGERY ON (B)(6) 2024, FOLLOWED BY THREE REVISION SURGERIES PRIOR TO THE CURRENT PROCEDURE. THE SURGEON REMOVED ALL IMPLANTS AND PLACED ANTIBIOTIC SPACERS. THE SURGERY WAS COMPLETED SUCCESSFULLY.
Patient problems: Medical device site infection
MAUDE report 25185342 ↗InjuryMay 12, 2026Adverse Event Without Identified Device or Use Problem
AT ABOUT 5 YEARS 10 MONTHS AFTER THE PRIMARY, THE PATIENT CAME IN PRESENTING PERSISTENT PAIN AND THE CAUSE IS UNKNOWN. THERE WERE NO INDICATIONS OF TRAUMA OR BONE QUALITY ISSUES. THE SURGEON REVISED THE ANATOMICAL SHOULDER TO A REVERSE SHOULDER SYSTEM, LEAVING THE DIAPHYSIS IMPLANTED FROM THE PRIMARY SURGERY. THE SURGERY WAS COMPLETED SUCCESSFULLY.
Patient problems: Implant Pain
MAUDE report 25148957 ↗InjuryApr 23, 2026Device Appears to Trigger Rejection
AT ABOUT 1 YEAR AND 10 MONTHS FROM THE PRIMARY, THE PATIENT CAME IN DUE TO SIGNS OF INFECTION AND THE PATHOGEN IS UNKNOWN. THE SURGEON REVISED THE ANATOMICAL SHOULDER TO A REVERSE SHOULDER. THE SURGERY WAS COMPLETED SUCCESSFULLY.
Patient problems: Medical device site infection
MAUDE report 24964780 ↗InjuryMar 3, 2026Material Deformation
LEFT SHOULDER REVISION SURGERY DUE TO PAIN AND RESTRICTION OF MOVEMENT ABOUT 6.5 YEARS AFTER THE PRIMARY SURGERY. OSTEOLYSIS WAS ALSO NOTED. REVERSE SYSTEM IMPLANTED; ROTATOR CUFF WAS DEGENERATIVE BUT REPAIRABLE WHEN COMPLETING THE REVERSE. THE PE PEGGED GLENOID WAS FOUND VERY DAMAGED IN THE POSTERIOR INFERIOR SURFACE (DESPITE BEING FOUND WELL FIXED AND NO IMPINGEMENT WAS OBSERVED).
Patient problems: Implant Pain; Loss of Range of Motion; Osteolysis
MAUDE report 24494913 ↗InjuryMar 3, 2026Adverse Event Without Identified Device or Use Problem
AT ABOUT 3 YEARS AND 9 MONTHS FROM THE PRIMARY, THE PATIENT CAME IN PRESENTING LEFT SHOULDER PAIN AND INSTABILITY AND THE CAUSE IS UNKNOWN. NO TRAUMA WAS INDICATED AS A CONTRIBUTING FACTOR. THE SURGEON REVISED THE SHOULDER FROM ANATOMICAL TO A REVERSE SHOULDER SYSTEM. NO X-RAYS ARE AVAILABLE. THE SURGERY WAS COMPLETED SUCCESSFULLY.
Patient problems: Joint Laxity
MAUDE report 24494910 ↗InjuryFeb 26, 2026Device Appears to Trigger Rejection
AT ABOUT 1 YEAR AND 6 MONTHS FROM THE PRIMARY, THE PATIENT CAME IN DUE TO SIGNS OF INFECTION AND THE PATHOGEN IS UNKNOWN. THE SURGEON REMOVED ALL MEDACTA COMPONENTS AND IMPLANTED ANTIBIOTIC CEMENT SPACERS. THE SURGERY WAS COMPLETED SUCCESSFULLY.
Patient problems: Medical device site infection
MAUDE report 24454884 ↗InjuryFeb 16, 2026Device Appears to Trigger Rejection
AT ABOUT 1 YEAR AND 6 MONTHS FROM THE PRIMARY, THE PATIENT CAME IN DUE TO SIGNS OF INFECTION AND THE CAUSE IS UNKNOWN. THE SURGEON REMOVED THE IMPLANTS AND PLACED AN ANTIBIOTIC SPACER. THE SURGERY WAS COMPLETED SUCCESSFULLY.
Patient problems: Medical device site infection
MAUDE report 24343897 ↗InjuryJan 23, 2026Adverse Event Without Identified Device or Use Problem
AT ABOUT 1 YEAR AND 8 MONTHS FROM THE PRIMARY, THE PATIENT CAME IN DUE TO SUSPECTED DISLOCATION, BUT WITH ONLY INSTABILITY AND THE CAUSE IS UNKNOWN. THE SURGEON REVISED THE ANATOMICAL SHOULDER TO A REVERSE TOTAL SHOULDER. THE SURGERY WAS COMPLETED SUCCESSFULLY.
Patient problems: Joint Laxity
MAUDE report 24162764 ↗InjuryJan 8, 2026Device Appears to Trigger Rejection
AT ABOUT 3 WEEKS FROM PRIMARY, THE PATIENT CAME IN DUE TO SIGNS OF AN INFECTION AND THE PATHOGEN IS UNKNOWN. THE SURGEON PERFORMED A WASHOUT AND REVISED THE DOUBLE ECCENTER AND HUMERAL HEAD. THE SURGERY WAS COMPLETED SUCCESSFULLY.
Patient problems: Medical device site infection
MAUDE report 24004371 ↗InjuryDec 9, 2025Device Dislodged or Dislocated; Osseointegration Problem; Device Dislodged or Dislocated; Osseointegration Problem
REVISION SURGERY DUE TO JOINT SUBLUXATION AT ABOUT 5 YEARS 10 MONTHS FROM PRIMARY. NO PAIN REPORTED. IT WAS THEREFORE DECIDED TO PERFORM SURGERY TO INCREASE THE HEIGHT OF THE INLAY IN ORDER TO RESTORE SUFFICIENT STABILITY. DURING THE REVISION SURGERY IT WAS FOUND THAT THE STEM WAS ALSO LOOSE. THE SURGEON DECIDED TO REVISE THE STEM (SAME SIZE, CEMENTLESS TO CEMENTED), METAPHYSIS (+0 TO +9 MM) AND LINER (+3MM TO +6 MM E-CROSS CONSTRAINED) AT 155 DEGREES. THE SURGERY WAS COMPLETED SUCCESSFULLY.
Patient problems: Aseptic loosening; Inadequate Osseointegration; Joint Dislocation
MAUDE report 23758551 ↗DeathSep 9, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
PRIMARY SURGERY WAS PERFORMED ON (B)(6) 2025 (B)(6) MEDICAL CENTER. ON (B)(6) 2025 REVISION SURGERY PERFORMED. THE PATIENT CAME IN REPORTING PAIN AFTER FALLING AND LANDING ON THE SHOULDER, LEADING TO A DISLOCATION OF THE LINER FROM THE GLENOSPHERE. THE SURGEON REVISED ONLY THE LINER (0 MM TO 6 MM). SOMETIME IN MID-(B)(6) 2025, THE PATIENT PASSED AWAY DUE TO HEART FAILURE. NO ISSUE WITH MEDACTA DEVICES.
Patient problems: Heart Failure/Congestive Heart Failure
MAUDE report 23001781 ↗InjurySep 8, 2025Implant subsidence; Implant subsidence
14 DAYS AFTER THE PRIMARY SURGERY, THE PATIENT REPORTED PAIN DUE TO A SUBSIDED STEM OF UNKNOWN CAUSE. THE SURGEON REVISED THE METAPHYSIS AND LINER, AND THE SURGERY WAS COMPLETED SUCCESSFULLY.
Patient problems: Pain
MAUDE report 22991529 ↗InjurySep 2, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
AT ABOUT 2 YEARS 3 MONTHS AFTER THE PRIMARY, THE PATIENT CAME IN DUE TO SIGNS OF AN INFECTION AND THE PATHOGEN IS UNKNOWN. THE SURGEON PERFORMED A WASHOUT, REMOVED ALL IMPLANTS, AND IMPLANTED AN ANTIBIOTIC SPACER. THE SURGERY WAS COMPLETED SUCCESSFULLY.
Patient problems: Medical device site infection
MAUDE report 22931703 ↗InjuryAug 26, 2025Osseointegration Problem; Osseointegration Problem
REVISION SURGERY AT ABOUT 4 YEARS AND 9 MONTHS FROM PRIMARY DUE TO PROXIMAL STEM LOOSENING. THE SURGEON REVISED ALL COMPONENTS TO COMPETITOR COMPONENTS, AND THE SURGERY WAS COMPLETED SUCCESSFULLY.
Patient problems: Aseptic loosening
MAUDE report 22892575 ↗
Other Medacta International SA products
- GMK Sphere Total Knee System209 models · 2,306 reports
- GMK Primary Total Knee System99 models · 876 reports
- Shoulder System63 models · 716 reports
- AMIStem H Femoral Stems20 models · 679 reports
- Mpact Acetabular System68 models · 609 reports
- Mectacer Biolox Delta Femoral Ball Head15 models · 551 reports
- Quadra H femoral stems32 models · 354 reports
- MectaLIF Anterior6 models · 4 reports · 6 recalls
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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