EXPLORRecalls & reported problems across all models
Biomet Orthopedics, LLC · 15 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 42
- Deaths reported
- 0
- Injuries reported
- 42
- Recalls
- 1
We found 15 models of EXPLOR by Biomet Orthopedics, LLC in the FDA's device registry (GUDID). Together they are named in 42 adverse event reports in the FDA's MAUDE database, received between Sep 13, 2019 and Mar 30, 2026 — classified as 42 injuries.
The most frequently reported specific device problem is “Detachment of Device or Device Component” (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
EXPLOR 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.
- Jun 16, 2017Terminated
Zimmer Biomet is conducting a medical device recall for the ExploR 6x24mm Implantable Stem with Screw due to a complaint alleging that the Modular Radial HD lock screw was not included in the package for the stem.
Z-0269-2018 · Root cause: Packaging change control · Recall details · FDA record ↗
Most reported EXPLOR problems
Device problems
- Adverse Event Without Identified Device or Use Problem15
- Detachment of Device or Device Component9
- Loosening of Implant Not Related to Bone-Ingrowth8
- Corroded4
- Device Dislodged or Dislocated4
- Patient Device Interaction Problem4
- Fracture2
- Insufficient Device Problem Information2
Patient problems
- Pain21
- Failure of Implant16
- Loss of Range of Motion14
- Metal Related Pathology8
- Extraskeletal ossification5
- Scar Tissue5
- Aseptic loosening4
- Swelling/ Edema4
EXPLOR models
15 models, most reported first. Each model has its own page with its reports, recalls and device details.
- EXPLOR 11-210061PROSTHESIS, ELBOW, HEMI-, RADIAL, POLYMER1 recall1 report
- EXPLOR 11-210063PROSTHESIS, ELBOW, HEMI-, RADIAL, POLYMER9 reports
- EXPLOR 11-210042PROSTHESIS, ELBOW, HEMI-, RADIAL, POLYMER6 reports
- EXPLOR 11-210062PROSTHESIS, ELBOW, HEMI-, RADIAL, POLYMER5 reports
- EXPLOR 11-210064PROSTHESIS, ELBOW, HEMI-, RADIAL, POLYMER5 reports
- EXPLOR 11-210032PROSTHESIS, ELBOW, HEMI-, RADIAL, POLYMER3 reports
- ExploR® 11-210099PROSTHESIS, ELBOW, HEMI-, RADIAL, POLYMER3 reports
- EXPLOR 11-210033PROSTHESIS, ELBOW, HEMI-, RADIAL, POLYMER2 reports
- EXPLOR 11-210041PROSTHESIS, ELBOW, HEMI-, RADIAL, POLYMER2 reports
- EXPLOR 11-210022PROSTHESIS, ELBOW, HEMI-, RADIAL, POLYMER1 report
- EXPLOR 11-210023PROSTHESIS, ELBOW, HEMI-, RADIAL, POLYMER1 report
- EXPLOR 11-210031PROSTHESIS, ELBOW, HEMI-, RADIAL, POLYMER1 report
- EXPLOR 11-210034PROSTHESIS, ELBOW, HEMI-, RADIAL, POLYMER1 report
- EXPLOR 11-210044PROSTHESIS, ELBOW, HEMI-, RADIAL, POLYMER1 report
- EXPLOR 11-210043PROSTHESIS, ELBOW, HEMI-, RADIAL, POLYMER1 report
Recent EXPLOR adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
InjuryMar 30, 2026Inadequacy of Device Shape and/or Size
IT WAS REPORTED THAT A PATIENT UNDERWENT AN INITIAL LEFT ELBOW ARTHROPLASTY. SUBSEQUENTLY THE PATIENT WAS REVISED APPROXIMATELY 4 MONTHS AND 16 DAYS POST IMPLANTATION DUE TO LOOSENING, ECTOPIC BONE FORMATION, ARTHROLYSIS, AND PAIN. DURING THE REVISION NOTED SCAR TISSUE, IMPLANT ¿CATCHING¿ AND WEAR. THE HEAD WAS EXCHANGED FOR A SMALLER SIZE WITHOUT COMPLICATIONS.ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.
Patient problems: Aseptic loosening; Extraskeletal ossification; Joint Contracture; Loss of Range of Motion; Pain; Scar Tissue
MAUDE report 24716380 ↗InjuryAug 6, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
NO FURTHER EVENT INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: Insufficient Information; Loss of Range of Motion; Pain
MAUDE report 22729529 ↗InjuryAug 6, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.
Patient problems: Insufficient Information; Loss of Range of Motion; Pain
MAUDE report 22729528 ↗InjuryAug 1, 2025Corroded; Corroded
IT WAS REPORTED THAT THE PATIENT UNDERWENT AN INITIAL ELBOW ARTHROPLASTY APPROXIMATELY FOUR (4) YEARS AND SIX (6) MONTHS AGO. SUBSEQUENTLY, THE PATIENT UNDERWENT A REVISION SURGERY DUE TO SOFT TISSUE METALLOSIS AND DESTRUCTION OF THE CAPITULUM HUMERI SURFACE.
Patient problems: Metal Related Pathology
MAUDE report 22689113 ↗InjuryAug 1, 2025Corroded; Corroded
IT WAS REPORTED THAT THE PATIENT UNDERWENT AN INITIAL ELBOW ARTHROPLASTY APPROXIMATELY FOUR (4) YEARS AND SIX (6) MONTHS AGO. SUBSEQUENTLY, THE PATIENT UNDERWENT A REVISION SURGERY DUE TO SOFT TISSUE METALLOSIS AND DESTRUCTION OF THE CAPITULUM HUMERI SURFACE.
Patient problems: Metal Related Pathology
MAUDE report 22689111 ↗InjuryAug 1, 2025Corroded; Corroded
IT WAS REPORTED THAT THE PATIENT UNDERWENT AN INITIAL ELBOW ARTHROPLASTY APPROXIMATELY FOUR (4) YEARS AGO. SUBSEQUENTLY, THE PATIENT THE PATIENT UNDERWENT A REVISION SURGERY ON AN UNKNOWN DATE DUE TO SOFT TISSUE METALLOSIS AND DESTRUCTION OF THE CAPITULUM HUMERI SURFACE.
Patient problems: Metal Related Pathology
MAUDE report 22687266 ↗InjuryAug 1, 2025Corroded; Corroded
IT WAS REPORTED THAT THE PATIENT UNDERWENT AN INITIAL ELBOW ARTHROPLASTY APPROXIMATELY FOUR (4) YEARS AGO. SUBSEQUENTLY, THE PATIENT THE PATIENT UNDERWENT A REVISION SURGERY ON AN UNKNOWN DATE DUE TO SOFT TISSUE METALLOSIS AND DESTRUCTION OF THE CAPITULUM HUMERI SURFACE.
Patient problems: Metal Related Pathology
MAUDE report 22687256 ↗InjuryJul 17, 2025Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth
NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: Aseptic loosening; Loss of Range of Motion; Pain
MAUDE report 22538414 ↗InjuryJul 17, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
NO FURTHER EVENT INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: Aseptic loosening; Loss of Range of Motion; Pain
MAUDE report 22538413 ↗InjuryApr 17, 2025Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth
IT WAS REPORTED THAT THE PATIENT UNDERWENT AN INITIAL ELBOW IMPLANTATION APPROXIMATELY ONE (1) YEAR AGO AFTER EXPERIENCING AN ISOLATED, COMMINUTED FRACTURE OF THE RADIAL HEAD TWO (2) DAYS PRIOR. SUBSEQUENTLY, THE PATIENT UNDERWENT A REVISION APPROXIMATELY ELEVEN (11) MONTHS POST-IMPLANTATION DUE TO LOOSENING OF THE RADIAL HEAD PROSTHESIS. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.
Patient problems: Failure of Implant; Scar Tissue
MAUDE report 21860662 ↗InjuryApr 4, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE PATIENT EXPERIENCED PAIN IN THE WRIST APPROXIMATELY TWO MONTHS POST IMPLANTATION. THE PATIENT UNDERWENT ULNA SHORTENING OSTEOTOMY PROCEDURE AS A TREATMENT FOR PAIN. NO FURTHER INFORMATION IS AVAILABLE.
Patient problems: Pain
MAUDE report 21772993 ↗InjuryApr 4, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE PATIENT EXPERIENCED PAIN IN THE WRIST APPROXIMATELY TWO MONTHS POST IMPLANTATION. THE PATIENT UNDERWENT ULNA SHORTENING OSTEOTOMY PROCEDURE AS A TREATMENT FOR PAIN. NO FURTHER INFORMATION IS AVAILABLE.
Patient problems: Pain
MAUDE report 21772977 ↗InjuryMar 17, 2025Fracture; Loosening of Implant Not Related to Bone-Ingrowth; Fracture; Loosening of Implant Not Related to Bone-Ingrowth
IT WAS REPORTED THAT THE PATIENT WAS IMPLANTED WITH A PROSTHESIS. SUBSEQUENTLY, THE PATIENT SUFFERED A FRACTURE AND THE IMPLANT BECAME LOOSE. THERE WAS HARM TO THE PATIENT AS THE PATIENT HAD TO UNDERGO ADDITIONAL SURGICAL/MEDICAL PROCEDURE. DUE DILIGENCE IS COMPLETE. NO ADDITIONAL INFORMATION IS AVAILABLE.
Patient problems: Aseptic loosening; Failure of Implant
MAUDE report 21625577 ↗InjuryMar 17, 2025Fracture; Fracture
IT WAS REPORTED THAT THE PATIENT WAS IMPLANTED WITH A PROSTHESIS. SUBSEQUENTLY, THE PATIENT SUFFERED A FRACTURE AND THE IMPLANT BECAME LOOSE. THERE WAS HARM TO THE PATIENT AS THE PATIENT HAD TO UNDERGO ADDITIONAL SURGICAL/MEDICAL PROCEDURE. DUE DILIGENCE IS COMPLETE. NO ADDITIONAL INFORMATION IS AVAILABLE.
Patient problems: Failure of Implant
MAUDE report 21625567 ↗InjuryMar 12, 2025Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth
IT WAS REPORTED THAT THE PATIENT UNDERWENT AN INITIAL ELBOW IMPLANTATION APPROXIMATELY ONE (1) YEAR AGO AFTER EXPERIENCING AN ISOLATED, COMMINUTED FRACTURE OF THE RADIAL HEAD TWO (2) DAYS PRIOR. SUBSEQUENTLY, THE PATIENT UNDERWENT A REVISION APPROXIMATELY ELEVEN (11) MONTHS POST-IMPLANTATION DUE TO LOOSENING OF THE RADIAL HEAD PROSTHESIS. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.
Patient problems: Failure of Implant; Scar Tissue
MAUDE report 21584250 ↗
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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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