BIOLOX® delta Modular Ceramic Head 650-1162Recalls & reported problems
Biomet Uk Ltd · Class 2 · Implant
All models of BIOLOX delta Modular Ceramic Head (10)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 16
- Deaths reported
- 0
- Injuries reported
- 14
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 16 adverse event reports that list this exact device (DI 00887868271564), received between Oct 2, 2021 and Sep 14, 2026 — classified as 14 injuries, 2 malfunctions.
The most frequently reported specific device problem is “Device Dislodged or Dislocated” (7 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, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.
Reports received per month
Most reported problems
Device problems
- Device Dislodged or Dislocated7
- Adverse Event Without Identified Device or Use Problem3
- Fracture3
- Inaccurate Information1
- Mechanical Problem1
- Migration1
- Unintended Movement1
- Unstable1
Patient problems
- Joint Dislocation5
- Pain5
- Subluxation3
- Ambulation or Postural Difficulties2
- Failure of Implant2
- No Clinical Signs, Symptoms or Conditions2
- Balance Problems1
- Bruise/Contusion1
Recent adverse event reports
The 16 most recent of 16 reports, in the reporter's own words as published by the FDA.
InjurySep 14, 2026Fracture
It was reported that the patient underwent hip revision surgery due to a fractured femoral head. No known trauma or other contributing factors were identified. A revision procedure involving replacement of the femoral head only has already been performed.Attempts have been made, and all additional information received has been included in this report.
Patient problems: Insufficient Information
MAUDE report 50753246 ↗InjuryJan 26, 2026Device Dislodged or Dislocated
IT WAS REPORTED THAT THE PATIENT UNDERWENT AN INITIAL HIP PROCEDURE. SUBSEQUENTLY, THE PATIENT WAS REVISED APPROXIMATELY 19 MONTHS POST-IMPLANTATION DUE TO DISLOCATION. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.
Patient problems: Joint Dislocation
MAUDE report 24176377 ↗MalfunctionOct 15, 2025Fracture; Fracture
NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23277334 ↗InjuryJul 16, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated
IT WAS REPORTED THAT THE PATIENT UNDERWENT A REVISION SURGERY ONE YEAR POST IMPLANTATION DUE TO DISLOCATION. THE HEAD AND LINER WERE EXPLANTED. NO FURTHER INFORMATION WAS REQUESTED.
Patient problems: Joint Dislocation
MAUDE report 22517453 ↗InjuryJul 8, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated
NO FURTHER EVENT INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: Joint Dislocation
MAUDE report 22435098 ↗MalfunctionNov 20, 2024Inaccurate Information; Inaccurate Information
IT WAS REPORTED THAT DURING PROCEDURE, WAS NOTED, A WRONG SIZE HEAD WAS IN THE PACKAGING. ON THE BOX IT SAID SIZE 32MM, BUT INSIDE THERE WAS A 36MM HEAD. THE HEAD WAS NOT IMPLANTED. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20734150 ↗InjuryJun 11, 2024Migration; Migration
IT WAS REPORTED THAT APPROXIMATELY TEN DAYS POST IMPLANTATION OF A TOTAL HIP ARTHROPLASTY, THE PATIENT FELL. AFTER THE FALL, THE PATIENT HAD PAIN, AND AN X-RAY SHOWED THAT THE FEMORAL IMPLANT HAD SUBSIDED. THE PATIENT¿S PAIN REPORTEDLY DID NOT RESOLVE, SO THE PATIENT HAD A REVISION SURGERY TWO MONTHS LATER. THE STEM AND HEAD WERE EXPLANTED, AND THE CUP AND LINER WERE RETAINED. NO ADDITIONAL INFORMATION AVAILABLE.
Patient problems: Fall; Pain
MAUDE report 19508801 ↗InjuryMar 18, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated
NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: Pain; Subluxation
MAUDE report 18922324 ↗InjuryMar 18, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT A PATIENT WAS DIAGNOSED WITH TENDINITIS AND BURSITIS APPROXIMATELY SIX MONTHS POST IMPLANTATION AND AGAIN AT TWENTY MONTHS POST IMPLANTATION. THE PATIENT WAS EXPERIENCING PAIN AND INFLAMMATION AND WAS PRESCRIBED MEDICATION. THE PATIENT HAS SINCE RECOVERED AND HIS HAPPY WITH THE OUTCOME. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION IS AVAILABLE.
Patient problems: Bursitis; Inflammation; Pain
MAUDE report 18922081 ↗InjuryMar 18, 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; Bruise/Contusion; Pain
MAUDE report 18921487 ↗InjuryDec 19, 2023Fracture; Fracture
NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: Extraskeletal ossification; Failure of Implant
MAUDE report 18354932 ↗InjuryOct 3, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated
IT WAS REPORTED AS INITIAL RIGHT TOTAL HIP ARTHROPLASTY. SUBSEQUENTLY REVISED DUE TO SUBLUXATION AND INSTABILITY. DURING THE REVISION POSTERIOR IMPINGEMENT, ACETABULAR COMPONENT NOT IN A FUNCTIONAL POSITION, AND JOINT LAXITY. THE STEM WAS WELL FIXED AND REMAINED IMPLANTED. THE ACETABULAR SHELL, LINER, AND HEAD WERE EXCHANGED WITHOUT COMPLICATION. APPROXIMATELY 85 DAYS POST-IMPLANTATION. ATTEMPTS HAVE BEEN MADE AND ALL ADDITIONAL INFORMATION RECEIVED HAS BEEN INCLUDED IN THIS REPORT.
Patient problems: Joint Impingement; Joint Laxity; Subluxation
MAUDE report 17860117 ↗InjuryJul 19, 2023Unstable; Unstable
NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: Failure of Implant; Unspecified Infection
MAUDE report 17349242 ↗InjuryJul 1, 2022Device Dislodged or Dislocated; Device Dislodged or Dislocated
IT WAS REPORTED THE PATIENT UNDERWENT A HIP REVISION DUE TO DISLOCATION APPROXIMATELY TWO DAYS POST IMPLANTATION . DUE DILIGENCE IS IN PROGRESS FOR THIS COMPLAINT; TO DATE NO ADDITIONAL INFORMATION OR PRODUCT HAS BEEN RECEIVED.
Patient problems: Joint Dislocation
MAUDE report 14884486 ↗InjuryApr 12, 2022Mechanical Problem; Device Dislodged or Dislocated; Unintended Movement; Mechanical Problem; Device Dislodged or Dislocated; Unintended Movement
IT WAS REPORTED, THAT: THE PATIENT UNDERWENT AN INITIAL RIGHT TOTAL HIP ARTHROPLASTY ON (B)(6) 2016. SUBSEQUENTLY, HE HAD A MANIPULATION UNDER ANAESTHESIA (MUA) ON (B)(6) 2021 DUE TO DISLOCATION AND SUBLUXATION. COMPONENTS REMAINED IMPLANTED.
Patient problems: Joint Dislocation; Subluxation
MAUDE report 14083377 ↗InjuryOct 2, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT PATIENT IS EXPERIENCING PAIN, LOSS OF BALANCE, DIZZINESS, DIFFICULTY WALKING AND UPSET STOMACH. PATIENT ALSO ALLEGES ELEVATED SERUM CHROMIUM AND COBALT LEVELS, METALLOSIS, TISSUE DEHISCENCE, TISSUE NECROSIS, BONE NECROSIS, HYPERTROPHIC SCARRING, ANTALGIA, LUMBAR STRAIN, CHRONIC FATIGUE AND SEVERE DISTRESS RELATED TO PAIN AND SUFFERING AFTER AN UNKNOWN AMOUNT OF TIME POST TOTAL HIP ARTHROPLASTY. NO REVISION SURGERY HAS BEEN REPORTED TO DATE.
Patient problems: Ambulation or Postural Difficulties; Balance Problems; Dizziness; Fatigue; Necrosis; Pain
MAUDE report 12566349 ↗
Other PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED devices
- PINNACLE 1217-25-500Depuy Orthopaedics, Inc. · PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED735 reports
- NA 1365-52-000Depuy (Ireland) · PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED683 reports
- APEX 1246-03-000Depuy (Ireland) · PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED3 deaths613 reports
- PINNACLE 1217-20-500Depuy Orthopaedics, Inc. · PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED2 deaths590 reports
- PINNACLE 1217-30-500Depuy Orthopaedics, Inc. · PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED1 death484 reports
- NA 1365-53-000Depuy (Ireland) · PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED404 reports
- PINNACLE ALTRX 1221-36-054Depuy Orthopaedics, Inc. · PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED388 reports
- PINNACLE ALTRX 1221-32-050Depuy Orthopaedics, Inc. · PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED386 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- 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.
How reports and recalls are matched · Editorial policy · Report an error on this page