Biolox® delta 00-8775-040-02Recalls & reported problems
Zimmer GmbH · BIOLOX® DELTA, CERAMIC FEMORAL HEAD, M, Ø 40/0, TAPER 12/14 · Class 2 · Implant
All models of Biolox delta (16)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 16
- Deaths reported
- 0
- Injuries reported
- 16
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 16 adverse event reports that list this exact device (DI 00889024430402), received between Dec 11, 2018 and Feb 17, 2026 — classified as 16 injuries.
The most frequently reported specific device problem is “Device Dislodged or Dislocated” (6 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 Dislocated6
- Adverse Event Without Identified Device or Use Problem4
- Appropriate Device Problem Term/Code Not Available2
- Insufficient Device Problem Information2
- Patient Device Interaction Problem2
- No Apparent Adverse Event1
- Noise, Audible1
Patient problems
- Pain12
- Joint Dislocation2
- Unspecified Infection2
- Ambulation or Postural Difficulties1
- Arthralgia1
- Bone Fracture(s)1
- Death1
- Extraskeletal ossification1
Recent adverse event reports
The 16 most recent of 16 reports, in the reporter's own words as published by the FDA.
InjuryFeb 17, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE PATIENT UNDERWENT A RIGHT TOTAL HIP REVISION APPROXIMATELY 7 WEEKS POST-IMPLANTATION DUE TO A PERIPROSTHETIC FRACTURE. DURING THE REVISION, THE HEAD AND STEM WERE EXCHANGED, AND CERCLAGE WIRES WERE APPLIED TO THE FRACTURE AREA; THE SHELL AND LINER REMAINED IMPLANTED. DUE DILIGENCE IS IN PROCESS AND NO FURTHER INFORMATION ON THE REPORTED EVENT HAS BEEN PROVIDED.
Patient problems: Periprosthetic fracture
MAUDE report 24364351 ↗InjuryJun 26, 2025Noise, Audible; Noise, Audible
IT WAS REPORTED THAT A PATIENT UNDERWENT A HIP REVISION APPROXIMATELY ONE YEAR POST-IMPLANTATION DUE TO A STRANGE NOISE INSIDE HIS BODY. THE LINER WAS FOUND TO BE BROKEN, BUT THE FEMORAL HEAD WAS INTACT. BOTH LINER AND HEAD WERE REVISED. 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 22336965 ↗InjuryJan 20, 2022Patient Device Interaction Problem; Patient Device Interaction Problem
InjuryNov 7, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE PATIENT EXPERIENCED SEVERE PAIN AND WAS DIAGNOSED WITH TROCHANTERIC BURSITIS APPROXIMATELY 6 MONTHS POST IMPLANTATION. THE SURGEON RECOMMENDED PHYSICAL THERAPY, REST, AND ICE. THE OUTCOME WAS TOLERATED, AND THE PATIENT SHOWED IMPROVEMENT AT THE 1 YEAR FOLLOW UP WITH MODERATE PAIN.
Patient problems: Implant Pain; Inflammation; Pain
MAUDE report 12758197 ↗InjuryApr 19, 2021Device Dislodged or Dislocated; Patient Device Interaction Problem; Device Dislodged or Dislocated; Patient Device Interaction Problem
NO CHANGE TO PREVIOUSLY REPORTED EVENT.
Patient problems: Arthralgia; Bone Fracture(s); Joint Dislocation; Pain; Unequal Limb Length
MAUDE report 11684103 ↗InjuryMay 29, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryMar 16, 2020Insufficient Device Problem Information; Insufficient Device Problem Information
IT WAS REPORTED THAT PATIENT WAS IMPLANTED ON THE RIGHT SIDE AND UNDERWENT REVISION DUE TO PAIN AND INFECTION.
Patient problems: Pain; Unspecified Infection
MAUDE report 9835396 ↗InjuryNov 7, 2019Device Dislodged or Dislocated; Insufficient Device Problem Information; Device Dislodged or Dislocated; Insufficient Device Problem Information
NO CHANGE TO PREVIOUSLY REPORTED EVENT.
Patient problems: Death; Extraskeletal ossification; Impaired Healing; Joint Dislocation; Paraplegia; Scar Tissue; Sepsis; Swelling/ Edema; Unspecified Infection
MAUDE report 9290820 ↗InjuryAug 30, 2019Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available
InjuryApr 16, 2019No Apparent Adverse Event; No Apparent Adverse Event
InjuryMar 13, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED AT THE SEVEN YEAR VISIT, THAT THE PATIENT IS EXPERIENCING MODERATE PAIN, DIFFICULTY AMBULATING, AND DECREASE IN ROM.
Patient problems: Ambulation or Postural Difficulties; Loss of Range of Motion; Pain
MAUDE report 8417363 ↗InjuryDec 11, 2018Device Dislodged or Dislocated; Device Dislodged or Dislocated
InjuryDec 11, 2018Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available
InjuryDec 11, 2018Device Dislodged or Dislocated; Device Dislodged or Dislocated
InjuryDec 11, 2018Device Dislodged or Dislocated; Device Dislodged or Dislocated
InjuryDec 11, 2018Device Dislodged or Dislocated; Device Dislodged or Dislocated
Other Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented devices
- BIOLOX DELTA 1365-32-310Depuy Orthopaedics, Inc. · Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented551 reports
- PINNACLE ALTRX 1221-36-052Depuy Orthopaedics, Inc. · Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented481 reports
- BIOLOX DELTA 1365-32-320Depuy Orthopaedics, Inc. · Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented1 death314 reports
- BIOLOX DELTA 1365-36-720Depuy Orthopaedics, Inc. · Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented1 death189 reports
- DJO SURGICAL 400-03-362Encore Medical, L.P. · Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented187 reports
- Anthology 71365705Smith & Nephew, Inc. · Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented176 reports
- BIOLOX DELTA 1365-40-710Depuy Orthopaedics, Inc. · Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented170 reports
- PINNACLE GRIPTION 1217-32-054Depuy Orthopaedics, Inc. · Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented169 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