Echo Bi-Metric Hip SystemRecalls & reported problems across all models
Biomet Orthopedics, LLC · 35 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 50
- Deaths reported
- 0
- Injuries reported
- 27
- Recalls
- 1
We found 35 models of Echo Bi-Metric Hip System by Biomet Orthopedics, LLC in the FDA's device registry (GUDID). Together they are named in 50 adverse event reports in the FDA's MAUDE database, received between Nov 18, 2019 and Mar 18, 2026 — classified as 27 injuries, 23 malfunctions.
The most frequently reported specific device problem is “Positioning Failure” (12 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
Echo Bi-Metric Hip 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.
- Jun 8, 2018Terminated
Two lots of the Echo BI-Metric Hip Stem and ARCOS Modular Revision Hip Stem may have been comingled. Potential health consequences include extension of surgery time to find a replacement component.
Z-2821-2018 · Root cause: Process control · Recall details · FDA record ↗
Most reported Echo Bi-Metric Hip System problems
Device problems
- Adverse Event Without Identified Device or Use Problem21
- Positioning Failure12
- Packaging Problem5
- Inadequacy of Device Shape and/or Size4
- Migration3
- Delivered as Unsterile Product2
- Difficult to Insert2
- Positioning Problem2
Patient problems
- No Clinical Signs, Symptoms or Conditions13
- Pain9
- Bone Fracture(s)8
- No Known Impact Or Consequence To Patient7
- Impaired Healing3
- No Patient Involvement3
- Failure of Implant2
- Patient Problem/Medical Problem2
Echo Bi-Metric Hip System models
35 models, most reported first. Each model has its own page with its reports, recalls and device details.
- ECHO BI-METRIC HIP SYSTEM 192414Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented1 recall0 reports
- Echo® Bi-Metric® Hip System 192113Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous cemented, osteophilic finish4 reports
- Echo® Bi-Metric® Hip System 192413PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED4 reports
- Echo® Bi-Metric® Hip System 192014Prosthesis, hip, semi-constrained, uncemented, metal / polymer, non-porous, calcium phosphate3 reports
- ECHO BI-METRIC HIP SYSTEM 192109Prosthesis, hip, constrained, cemented or uncemented, metal/polymer2 reports
- Echo® Bi-Metric® Hip System 192009Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous cemented, osteophilic finish2 reports
- Echo® Bi-Metric® Hip System 192010Prosthesis, hip, semi-constrained, metal/polymer, cemented2 reports
- Echo® Bi-Metric® Hip System 192011Prosthesis, hip, semi-constrained, uncemented, metal / polymer, non-porous, calcium phosphate2 reports
- Echo® Bi-Metric® Hip System 192012Prosthesis, hip, semi-constrained, uncemented, metal / polymer, non-porous, calcium phosphate2 reports
- Echo® Bi-Metric® Hip System 192112Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented2 reports
- Echo® Bi-Metric® Hip System 192409Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous cemented, osteophilic finish2 reports
- Echo® Bi-Metric® Hip System 192410Prosthesis, hip, semi-constrained, uncemented, metal / polymer, non-porous, calcium phosphate2 reports
- ECHO BI-METRIC HIP SYSTEM 192511Prosthesis, hip, semi-constrained, metal/polymer, uncemented1 report
- ECHO BI-METRIC HIP SYSTEM 192508Prosthesis, hip, hemi-, femoral, metal/polymer, cemented or uncemented1 report
- ECHO BI-METRIC HIP SYSTEM 192113Prosthesis, hip, semi-constrained, metal/polymer, uncemented1 report
- ECHO BI-METRIC HIP SYSTEM 192010Prosthesis, hip, semi-constrained, metal/polymer, cemented1 report
- ECHO BI-METRIC HIP SYSTEM 192008Prosthesis, hip, semi-constrained, metal/polymer, uncemented1 report
- ECHO BI-METRIC HIP SYSTEM 192115Prosthesis, hip, semi-constrained, metal/polymer, uncemented1 report
- ECHO BI-METRIC HIP SYSTEM 192515Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous cemented, osteophilic finish1 report
- ECHO BI-METRIC HIP SYSTEM 192112PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED1 report
- ECHO BI-METRIC HIP SYSTEM 192411Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous cemented, osteophilic finish1 report
- Echo® Bi-Metric® Hip System 192013PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED1 report
- Echo® Bi-Metric® Hip System 192018Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented1 report
- Echo® Bi-Metric® Hip System 192110Prosthesis, hip, constrained, cemented or uncemented, metal/polymer1 report
- Echo® Bi-Metric® Hip System 192111Prosthesis, hip, semi-constrained, uncemented, metal / polymer, non-porous, calcium phosphate1 report
- Echo® Bi-Metric® Hip System 192115Prosthesis, hip, hemi-, femoral, metal/polymer, cemented or uncemented1 report
- Echo® Bi-Metric® Hip System 192117Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous cemented, osteophilic finish1 report
- Echo® Bi-Metric® Hip System 192408Prosthesis, hip, hemi-, femoral, metal/polymer, cemented or uncemented1 report
- Echo® Bi-Metric® Hip System 192412Prosthesis, hip, hemi-, femoral, metal1 report
- Echo® Bi-Metric® Hip System 192414PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED1 report
- Echo® Bi-Metric® Hip System 192417Prosthesis, hip, hemi-, femoral, metal1 report
- Echo® Bi-Metric® Hip System 192510Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous cemented, osteophilic finish1 report
- Echo® Bi-Metric® Hip System 192511Prosthesis, hip, semi-constrained, uncemented, metal / polymer, non-porous, calcium phosphate1 report
- Echo® Bi-Metric® Hip System 192513Prosthesis, hip, constrained, cemented or uncemented, metal/polymer1 report
- Echo® Bi-Metric® Hip System 192515Prosthesis, hip, semi-constrained, metal/polymer, cemented1 report
Recent Echo Bi-Metric Hip System adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionMar 18, 2026Inadequacy of Device Shape and/or Size
IT WAS REPORTED THE SURGEON BELIEVED THE BROACH DID NOT MATCH THE IMPLANT SIZE, NOTING THE FULL-PROFILE BROACHES APPEARED LARGER THAN THE CORRESPONDING STANDARD FULL-PROFILE STEMS. THERE WAS NO KNOWN IMPACT OR CONSEQUENCES TO THE PATIENT. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24626344 ↗MalfunctionDec 1, 2025Delivered as Unsterile Product; Tear, Rip or Hole in Device Packaging; Delivered as Unsterile Product; Tear, Rip or Hole in Device Packaging
IT WAS REPORTED THAT WHEN THE STEM WAS OPENED, THE INNER AND OUTER PLASTIC PACKAGING WAS FOUND BROKEN AND UNSTERILE. THE PRODUCT COULD NOT BE IMPLANTED IN THE PATIENT. THERE WAS NO KNOWN IMPACT OR CONSEQUENCES TO THE PATIENT. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23681182 ↗MalfunctionAug 28, 2025Positioning Failure; Positioning Failure
NO ADDITIONAL INFORMATION AVAILABLE FOR THE REPORTED EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22911159 ↗MalfunctionAug 28, 2025Positioning Failure; Positioning Failure
NO ADDITIONAL INFORMATION AVAILABLE FOR THE REPORTED EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22911153 ↗InjuryAug 18, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT APPROXIMATELY FIVE WEEKS POST-IMPLANTATION, THE PATIENT UNDERWENT A HIP REVISION DUE TO A FEMORAL FRACTURE. THE FRACTURE WAS NOT NOTED DURING PRIMARY SURGERY OR AT 3-WEEK POS-OP CHECK. A NEW HEAD AND STEM WITH CABLES WERE IMPLANTED. IT WAS REPORTED NO FURTHER INFORMATION HAS BEEN PROVIDED.
Patient problems: Periprosthetic fracture
MAUDE report 22836051 ↗InjuryAug 5, 2025Detachment of Device or Device Component; Adverse Event Without Identified Device or Use Problem; Detachment of Device or Device Component; Adverse Event Without Identified Device or Use Problem
NO FURTHER INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: Medical device site infection; Necrosis; Pain; Scar Tissue
MAUDE report 22722647 ↗InjuryMar 13, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE PATIENT UNDERWENT A REVISION PROCEDURE DUE TO A PERI-PROSTHETIC FRACTURE. THERE IS NO FURTHER INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: Bone Fracture(s)
MAUDE report 21599568 ↗MalfunctionNov 13, 2024Positioning Problem; Positioning Problem
NO ADDITIONAL EVENT INFORMATION TO REPORT AT THIS TIME.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20673709 ↗InjuryNov 5, 2024Adverse Event Without Identified Device or Use Problem; Osseointegration Problem; Adverse Event Without Identified Device or Use Problem; Osseointegration Problem
IT WAS REPORTED A PATIENT UNDERWENT A HIP REVISION APPROXIMATELY SIX MONTHS POST IMPLANTATION AFTER EXPERIENCING A FALL AND EXPERIENCING ONGOING PAIN. IMAGING PROVIDED SUSPICION OF POOR ON-GROWTH OF BONE ONTO THE IMPLANT IS SAID TO CONTRIBUTE. THE STEM WAS REMOVED AND REPLACED. IT WAS REPORTED THAT NO FURTHER INFORMATION IS AVAILABLE.
Patient problems: Inadequate Osseointegration; Pain
MAUDE report 20609817 ↗MalfunctionNov 1, 2024Inadequacy of Device Shape and/or Size; Packaging Problem; Inadequacy of Device Shape and/or Size; Packaging Problem
NO ADDITIONAL EVENT INFORMATION TO REPORT AT THIS TIME.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20588845 ↗InjuryOct 2, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THE PATIENT UNDERWENT A PRIMARY HIP ARTHROPLASTY. SUBSEQUENTLY, THE PATIENT WAS REVISED DUE TO TROCHANTERIC SHAFT FRACTURE JUST AFTER TWO WEEKS POST IMPLANTATION. ATTEMPTS HAVE BEEN MADE AND THERE IS NO ADDITIONAL INFORMATION TO REPORT.
Patient problems: Bone Fracture(s)
MAUDE report 20351949 ↗InjuryAug 29, 2024Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth
InjuryMay 20, 2024Material Erosion; Material Erosion
IT WAS REPORTED THAT AFTER IMPLANTATION, THE PATIENT HAD ONGOING PAIN. PATIENT STARTED HAVING SWOLLEN LYMPH NODES AND HIGH WHITE BLOOD CELL COUNT MORE RECENTLY. PATIENT WAS DIAGNOSED WITH CHRONIC LYMPHOCYTIC LEUKEMIA AND MARGINAL LYMPHOMA IN THE GROIN ONLY. PATIENT IS RECEIVING ONGOING DIAGNOSTICS. PATIENT WAS TOLD HE HAD HEAVY METAL POISONING TO ALUMINUM AND SEVERAL OTHER METALS. THE IMPLANT SURGEON¿S OFFICE INFORMED THE PATIENT TODAY THAT HIS FEMUR DEVICE CONTAINED ALUMINUM. PATIENT WAS INFORMED THAT HE LIKELY WILL REQUIRE A REVISION TO HAVE THE IMPLANTS REMOVED. THERE IS NO ADDITIONAL INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: High White Blood Cell Count; Lymphoma; Metal Related Pathology; Pain; Swollen Lymph Nodes/Glands
MAUDE report 19351828 ↗InjuryMay 1, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED A PATIENT RECEIVED A CORTISONE INJECTION APPROXIMATELY THREE MONTHS POST IMPLANTATION FOR LATERAL HIP PAIN AND TROCHANTERIC BURSITIS. THEN AGAIN ONE YEAR POST IMPLANTATION DUE TO MILD PAIN, MODERATE DIFFICULTIES WITH ADL¿S, SNAPPING SENSATION AND DIFFICULTY SLEEPING. THE PATIENT WAS PRESCRIBED A CORTICOSTEROID INJECTION IN THE RIGHT TROCHANTERIC BURSA, VOLTAREN GEL AND A PRESCRIPTION FOR PT, POSSIBLY DRY NEEDLING. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION IS AVAILABLE.
Patient problems: Bursitis; Pain; Swelling/ Edema
MAUDE report 19222874 ↗InjuryApr 1, 2024Migration; Migration
IT WAS REPORTED THAT THE PATIENT UNDERWENT AN INITIAL HIP PROCEDURE. FIVE DAYS POST OP, THE PATIENT DEVELOPED PAIN AND WAS UNABLE TO BEAR WEIGHT. THE PATIENT HAD NO TRAUMA OR FALLS POST INITIAL SURGERY. A SECONDARY X-RAYS SHOWED THAT THE STEM HAD SUBSIDED. SUBSEQUENTLY, THE PATIENT UNDERWENT A REVISION PROCEDURE APPROXIMATELY 2 WEEKS POST IMPLANTATION. DURING THE SECONDARY PROCEDURE, A FRACTURE WAS FOUND, CABLED AND A BIGGER STEM WAS REAMED, BROACHED, AND INSERTED. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.
Patient problems: Bone Fracture(s); Pain
MAUDE report 19012190 ↗
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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