BIOLOX Delta Hip SystemRecalls & reported problems across all models
Biomet Orthopedics, LLC · 22 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
- 50
- Recalls
- 0
We found 22 models of BIOLOX Delta 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 Apr 25, 2019 and Jun 19, 2026 — classified as 50 injuries.
The most frequently reported specific device problem is “Device Dislodged or Dislocated” (13 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 BIOLOX Delta Hip System problems
Device problems
- Adverse Event Without Identified Device or Use Problem20
- Device Dislodged or Dislocated13
- Insufficient Device Problem Information9
- Fracture3
- Patient Device Interaction Problem3
- Noise, Audible2
- Break1
- Detachment of Device or Device Component1
Patient problems
- Pain18
- Joint Dislocation12
- Failure of Implant6
- Unspecified Infection6
- Inflammation5
- Metal Related Pathology4
- Ambulation or Postural Difficulties3
- No Code Available3
BIOLOX Delta Hip System models
22 models, most reported first. Each model has its own page with its reports, recalls and device details.
- BIOLOX DELTA HIP SYSTEM 650-1057Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented10 reports
- BIOLOX® Delta Hip System 12-115120Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented5 reports
- BIOLOX® Delta Hip System 12-115121Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented4 reports
- BIOLOX® Delta Hip System 650-1057Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented4 reports
- BIOLOX® Delta Hip System 650-1058Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented4 reports
- BIOLOX® Delta Hip System 12-115122Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented3 reports
- BIOLOX DELTA HIP SYSTEM 650-1058Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented2 reports
- BIOLOX® Delta Hip System 12-115109Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented2 reports
- BIOLOX® Delta Hip System 12-115123Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented2 reports
- BIOLOX® Delta Hip System 650-1056Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented2 reports
- BIOLOX DELTA HIP SYSTEM 12-115116Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented1 report
- BIOLOX DELTA HIP SYSTEM 12-115115Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented1 report
- BIOLOX DELTA HIP SYSTEM 650-1056Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented1 report
- BIOLOX DELTA HIP SYSTEM 12-115120Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented1 report
- BIOLOX DELTA HIP SYSTEM 12-115123Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented1 report
- BIOLOX® Delta Hip System 12-115110Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented1 report
- BIOLOX® Delta Hip System 12-115111Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented1 report
- BIOLOX® Delta Hip System 12-115114Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented1 report
- BIOLOX® Delta Hip System 12-115116Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented1 report
- BIOLOX® Delta Hip System 12-115117Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented1 report
- BIOLOX DELTA HIP SYSTEM 12-115130Hip Prosthesis, semi-constrained, cemented, metal/polymer, + additive, porous, uncemented1 report
- BIOLOX DELTA HIP SYSTEM 12-115134Hip Prosthesis, semi-constrained, cemented, metal/polymer, + additive, porous, uncemented1 report
Recent BIOLOX Delta Hip System adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
InjuryJun 19, 2026Device Dislodged or Dislocated
IT WAS REPORTED THAT THE PATIENT UNDERWENT A HIP REVISION APPROXIMATELY 2.5 MONTHS POST-IMPLANTATION DUE TO DISLOCATION. THE LINER AND HEAD WERE REPLACED. ATTEMPTS HAVE BEEN MADE, AND NO FURTHER INFORMATION HAS BEEN PROVIDED.
Patient problems: Joint Dislocation
MAUDE report 25557887 ↗InjuryDec 29, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated
NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: Joint Dislocation
MAUDE report 23906675 ↗InjuryDec 29, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated
NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: Aseptic loosening; Joint Dislocation; Metal Related Pathology; Periprosthetic fracture; Synovitis
MAUDE report 23904916 ↗InjuryDec 5, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE PATIENT HAS BEEN EXPERIENCING RIGHT HIP ISSUES AND PAIN SINCE HIS INITIAL IMPLANTATION. IT IS NOW APPROXIMATELY 11 (ELEVEN) YEARS POST-SURGERY. THE PATIENT REPORTS THE SURGEON IS CONCERNED FOR TRUNNIONOSIS AND METALLOSIS. AN MRI WAS PERFORMED THAT DISPLAYED SMALL CHRONIC BONE FRAGMENTS AT THE GREATER TROCHANTER; OTHERWISE, UNREMARKABLE WITHOUT EVIDENCE OF OSSEOUS ABNORMALITY OR OSTEOLYSIS. ALL PRODUCTS REMAIN IMPLANTED.
Patient problems: Metal Related Pathology; Pain
MAUDE report 23726010 ↗InjuryJul 14, 2025Naturally Worn; Naturally Worn
IT WAS REPORTED BY LEGAL THAT A PATIENT HAD AN INITIAL LEFT TOTAL HIP ARTHROPLASTY. THE PATIENT HAD BEEN DOING WELL FOR 6 YEARS BUT PRESENTED WITH SUDDEN SQUEAKING IN THE HIP AFTER AN ACTIVE DAY. X-RAY AND CT SHOWED EVIDENCE OF A DISSOCIATED POLY INSERT. THE PATIENT RETURNED TO SURGERY 6 YEARS AND 2 MONTHS POST THE INITIAL OPERATION. DURING WHICH, A PSEUDOCAPSULE WAS DEBRIDED FROM THE JOINT WHICH REVEALED A DISLODGED POLY LINER AND A DARK STRIPE WEAR ON THE CERAMIC HEAD. THE HEAD WAS REMOVED FROM THE TAPER SLEEVE, BUT THE SLEEVE WAS COLD WELDED TO THE FEMORAL COMPONENT AND COULD NOT BE REMOVED. WHEN THE LINER WAS REMOVED FROM THE CUP, IT WAS IDENTIFIED THAT THE POLY LOCKING RING HAD SHEARED OFF THE POLY AND WAS STILL PRESENT IN THE LOCKING GROOVE OF THE ACETABULAR COMPONENT. THE INITIAL STEM AND CUP REMAINED INTACT. NO INTRA-OP COMPLICATIONS WERE IDENTIFIED. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED AT THE TIME OF THIS REPORT.
Patient problems: Metal Related Pathology
MAUDE report 22493228 ↗InjuryApr 1, 2025Device Dislodged or Dislocated; Adverse Event Without Identified Device or Use Problem; Device Dislodged or Dislocated; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT APPROXIMATELY 5 YEARS AND 6 MONTHS POST-IMPLANTATION, THE PATIENT INDICATED THAT THEY WILL BE UNDERGOING A PLANNED HIP REVISION SURGERY. REASON FOR THE REVISION IS CURRENTLY UNKNOWN. IT IS ALSO UNKNOWN IF THE REVISION HAS TAKEN PLACE. DUE DILIGENCE IS IN PROGRESS FOR THIS COMPLAINT; NO FURTHER ADDITIONAL INFORMATION OR PRODUCT HAS BEEN RECEIVED AT THE TIME OF THIS REPORT.
Patient problems: Failure of Implant; Insufficient Information; Joint Dislocation
MAUDE report 21737383 ↗InjuryFeb 24, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT SIX YEARS AGO THE PATIENT UNDERWENT INITIAL RIGHT TOTAL HIP ARTHROPLASTY. FOUR YEARS LATER THE PATIENT PRESENTED FOR AN OFFICE VISIT DUE TO SEVERE RIGHT INGUINAL PAIN. THE PATIENT REPORTED SHE HAD STARTED PILATES AND NEW EXERCISES. X-RAYS SHOWED THE IMPLANTS WERE IN SATISFACTORY POSITION WITHOUT COMPLICATIONS. THE PATIENT WAS DIAGNOSED WITH HIP FLEXOR TENDONITIS, INSTRUCTED TO LIMIT EXERCISES FOR TWO WEEKS, AND WAS PRESCRIBED AN ORAL STEROID DOSE PACK. THE PATIENT DID WELL UNTIL A YEAR AGO, WHEN REPORTED TO THE CARE TEAM OF WORSENING GROIN PAIN ALONG WITH DIFFICULTY RAISING LEG. THE PATIENT WAS GIVEN AN ULTRASOUND AND FLUOROSCOPICALLY GUIDED RIGHT PSOAS BURSA INJECTION. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.
Patient problems: Inflammation; Pain
MAUDE report 21444318 ↗InjuryJun 4, 2024Adverse 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: Ambulation or Postural Difficulties; Pain
MAUDE report 19456628 ↗InjuryMay 24, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT APPROXIMATELY SEVEN YEARS AND THREE MONTHS AFTER THE INITIAL SURGERY, THE PATIENT UNDERWENT A REVISION DUE TO INFECTION. DUE DILIGENCE IS IN PROGRESS FOR THIS COMPLAINT; TO DATE NO ADDITIONAL INFORMATION OR PRODUCT HAS BEEN RECEIVED.
Patient problems: Unspecified Infection
MAUDE report 19392125 ↗InjuryJan 10, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated
NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: Joint Dislocation
MAUDE report 18482206 ↗InjuryJan 10, 2024Adverse 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: Inflammation; Loss of Range of Motion; Pain
MAUDE report 18481991 ↗InjuryJan 9, 2024Adverse 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: Ambulation or Postural Difficulties; Pain
MAUDE report 18474588 ↗InjuryDec 8, 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: Bacterial Infection; Impaired Healing; Wound Dehiscence
MAUDE report 18289780 ↗InjuryAug 9, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated
NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: Failure of Implant; Joint Dislocation
MAUDE report 17486858 ↗InjuryJul 31, 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: Inflammation; Pain
MAUDE report 17423161 ↗
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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