BIO-MODULAR SHOULDER SYSTEMRecalls & reported problems across all models
Biomet Orthopedics, LLC · 9 models in the FDA device registry
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 6
- Deaths reported
- 0
- Injuries reported
- 6
- Recalls
- 1
We found 9 models of BIO-MODULAR SHOULDER SYSTEM by Biomet Orthopedics, LLC in the FDA's device registry (GUDID). Together they are named in 6 adverse event reports in the FDA's MAUDE database, received between Apr 9, 2020 and Sep 18, 2025 — classified as 6 injuries.
The most frequently reported specific device problem is “Loosening of Implant Not Related to Bone-Ingrowth” (4 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
BIO-MODULAR SHOULDER SYSTEM 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.
- Aug 21, 2019Class IITerminated
Elevated levels of bacterial endotoxin and residual debris remain on the devices due to cleaning issue.
Z-0533-2020 · Root cause: Environmental control · names 3 of these models · Recall details · FDA record ↗
Most reported BIO-MODULAR SHOULDER SYSTEM problems
Device problems
- Loosening of Implant Not Related to Bone-Ingrowth4
- Adverse Event Without Identified Device or Use Problem1
- Detachment of Device or Device Component1
- Device Dislodged or Dislocated1
- Loss of Osseointegration1
- Patient Device Interaction Problem1
Patient problems
- Failure of Implant3
- Joint Dislocation2
- Muscle/Tendon Damage2
- Insufficient Information1
- Loss of Range of Motion1
- Pain1
BIO-MODULAR SHOULDER SYSTEM models
9 models, most reported first. Each model has its own page with its reports, recalls and device details.
- BIO-MODULAR SHOULDER SYSTEM 113867PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER, UNCEMENTED1 recall0 reports
- BIO-MODULAR SHOULDER SYSTEM 113865PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER, UNCEMENTED1 recall0 reports
- BIO-MODULAR SHOULDER SYSTEM 113863PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER, UNCEMENTED1 recall0 reports
- BIO-MODULAR SHOULDER SYSTEM 113851PROSTHESIS, SHOULDER, NON-CONSTRAINED, METAL/POLYMER CEMENTED1 report
- BIO-MODULAR SHOULDER SYSTEM 11-113705PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER, UNCEMENTED1 report
- BIO-MODULAR SHOULDER SYSTEM 113849PROSTHESIS, SHOULDER, NON-CONSTRAINED, METAL/POLYMER CEMENTED1 report
- BIO-MODULAR SHOULDER SYSTEM 113896PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED1 report
- Bio-Modular® Shoulder System 113760PROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED1 report
- Bio-Modular® Shoulder System 113921PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER, UNCEMENTED1 report
Recent BIO-MODULAR SHOULDER SYSTEM adverse event reports
The 6 most recent reports across all models, in the reporter's own words as published by the FDA.
InjurySep 18, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE PATIENT UNDERWENT AN INITIAL LEFT SHOULDER ARTHROPLASTY ON AN UNKNOWN DATE. SUBSEQUENTLY, THE PATIENT IS BEING CONSIDERED FOR A REVISION SURGERY USING A CUSTOM IMPLANT DUE TO AN UNKNOWN REASON.
Patient problems: Insufficient Information
MAUDE report 23088235 ↗InjuryDec 5, 2022Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth
IT WAS REPORTED THAT THE PATIENT UNDERWENT A REVISION SURGERY DUE TO A TEAR OF THE ROTATOR CUFF. FURTHER, THE PATIENT HAD LOOSENING OF THE GLENOID COMPONENT AND DISLOCATION OF THE POLYETHYLENE FROM THE POST IMPLANT.
Patient problems: Failure of Implant; Joint Dislocation; Muscle/Tendon Damage
MAUDE report 15914640 ↗InjuryOct 18, 2022Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth
IT WAS REPORTED THAT THE PATIENT UNDERWENT AN INITIAL LEFT TOTAL SHOULDER ARTHROPLASTY. SUBSEQUENTLY, THE PATIENT WAS REVISED FOR ANATOMIC GLENOID LOOSENING. NO ADDITIONAL PATIENT CONSEQUENCES WERE REPORTED.
Patient problems: Failure of Implant
MAUDE report 15626946 ↗InjuryOct 18, 2022Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth
IT WAS REPORTED THAT THE PATIENT UNDERWENT AN INITIAL LEFT TOTAL SHOULDER ARTHROPLASTY. SUBSEQUENTLY, THE PATIENT WAS REVISED FOR ANATOMIC GLENOID LOOSENING. NO ADDITIONAL PATIENT CONSEQUENCES WERE REPORTED.
Patient problems: Failure of Implant
MAUDE report 15626803 ↗InjuryApr 16, 2020Detachment of Device or Device Component; Device Dislodged or Dislocated; Detachment of Device or Device Component; Device Dislodged or Dislocated
NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: Joint Dislocation
MAUDE report 9967233 ↗InjuryApr 9, 2020Loss of Osseointegration; Patient Device Interaction Problem; Loosening of Implant Not Related to Bone-Ingrowth; Loss of Osseointegration; Patient Device Interaction Problem; Loosening of Implant Not Related to Bone-Ingrowth
NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: Loss of Range of Motion; Muscle/Tendon Damage; Pain
MAUDE report 9943725 ↗
Other Biomet Orthopedics, LLC products
- AFFIXUSHIP FRACTURE NAIL - RIGHT39 models · 6 reports · 37 recalls
- AFFIXUSHIP FRACTURE NAIL - LEFT27 models · 7 reports · 24 recalls
- Compress Device71 models · 99 reports · 22 recalls
- Arcos Modular Revision Hip System71 models · 191 reports · 19 recalls
- Comprehensive Reverse Shoulder57 models · 895 reports · 3 recalls
- Vanguard Knee System147 models · 306 reports · 13 recalls
- STAGEONE17 models · 0 reports · 18 recalls
- StageOne Select15 models · 2 reports · 15 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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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