BIOLOX DELTARecalls & reported problems across all models
Depuy Orthopaedics, Inc. · 40 models in the FDA device registry
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 4,995
- Deaths reported
- 4
- Injuries reported
- 4,878
- Recalls
- 1
We found 40 models of BIOLOX DELTA by Depuy Orthopaedics, Inc. in the FDA's device registry (GUDID). Together they are named in 4,995 adverse event reports in the FDA's MAUDE database, received between Mar 6, 2014 and Sep 30, 2026 — classified as 4 deaths, 4,878 injuries, 113 malfunctions.
The most frequently reported specific device problem is “Device Dislodged or Dislocated” (1,936 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
BIOLOX DELTA 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.
- Nov 7, 2014Class IITerminated
Two complaints reported that the BIOLOX delta TS Ceramic Femoral Articul/eze12/14 36mm +12 Head (product code 1365-36-740) did not fit like the trial; the definite hip construct felt loose. The loosening refers to tissue tension and not the taper connection between the femoral head and stem. The investigations found that the small size sleeve (+1.5 femoral head offset) was incorrectly used in the
Z-0825-2015 · Root cause: Mixed-up of materials/components · Recall details · FDA record ↗
Most reported BIOLOX DELTA problems
Device problems
- Adverse Event Without Identified Device or Use Problem2,513
- Device Dislodged or Dislocated1,936
- Insufficient Device Problem Information222
- Naturally Worn118
- Noise, Audible117
- Fracture64
- Appropriate Device Problem Term/Code Not Available50
- Biocompatibility20
Patient problems
- Joint Dislocation1,928
- Unspecified Infection1,429
- No Code Available1,140
- Pain828
- Joint Laxity359
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available174
- Test Result173
- Not Applicable160
BIOLOX DELTA models
40 models, most reported first. Each model has its own page with its reports, recalls and device details.
- BIOLOX DELTA 1365-36-310Prosthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncemented839 reports
- BIOLOX DELTA 1365-36-320Prosthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncemented643 reports
- BIOLOX DELTA 1365-32-310Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented551 reports
- BIOLOX DELTA 1365-32-320Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented1 death314 reports
- BIOLOX DELTA 1365-36-330Prosthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncemented255 reports
- BIOLOX DELTA 1365-36-710PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED206 reports
- BIOLOX DELTA 1365-36-720Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented1 death189 reports
- BIOLOX DELTA 1365-40-710Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented170 reports
- BIOLOX DELTA 1365-28-310Prosthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncemented169 reports
- BIOLOX DELTA 1365-40-720Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented145 reports
- BIOLOX DELTA 1365-36-740PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED1 recall93 reports
- BIOLOX DELTA 1365-36-730PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED1 death140 reports
- BIOLOX DELTA 1365-32-330Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented1 death131 reports
- BIOLOX DELTA 1365-40-730Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented117 reports
- BIOLOX DELTA 1365-32-720Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented105 reports
- BIOLOX DELTA 1365-32-710Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented100 reports
- BIOLOX DELTA 1365-32-730Prosthesis, hip, semi-constrained (metal uncemented acetabular component)93 reports
- BIOLOX DELTA 1365-28-320Prosthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncemented76 reports
- BIOLOX DELTA 1365-36-340Prosthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncemented70 reports
- BIOLOX DELTA 1365-36-210Prosthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncemented62 reports
- BIOLOX DELTA 1365-28-720PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED60 reports
- BIOLOX DELTA 1365-40-740Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented58 reports
- BIOLOX DELTA 1365-36-220Prosthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncemented51 reports
- BIOLOX DELTA 1365-36-230Prosthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncemented48 reports
- BIOLOX DELTA 1365-28-330Prosthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncemented46 reports
- BIOLOX DELTA 1365-28-710Prosthesis, hip, semi-constrained (metal uncemented acetabular component)43 reports
- BIOLOX DELTA 1365-28-730PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED40 reports
- BIOLOX DELTA 1365-28-740PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED38 reports
- BIOLOX DELTA 1365-32-210Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented31 reports
- BIOLOX DELTA 1365-28-210Prosthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncemented19 reports
- BIOLOX DELTA 1365-32-220Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented17 reports
- BIOLOX DELTA 1365-32-230Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented17 reports
- BIOLOX DELTA 1365-36-240Prosthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncemented15 reports
- BIOLOX DELTA 1365-28-220Prosthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncemented11 reports
- BIOLOX DELTA 1365-28-230Prosthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncemented9 reports
- BIOLOX DELTA 1365-36-250Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented7 reports
- BIOLOX DELTA 1365-44-720Prosthesis, hip, semi-constrained (metal uncemented acetabular component)6 reports
- BIOLOX DELTA 1365-44-730Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented6 reports
- BIOLOX DELTA 1365-44-710Prosthesis, hip, semi-constrained (metal uncemented acetabular component)3 reports
- BIOLOX DELTA 1365-44-740PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED2 reports
Recent BIOLOX DELTA adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
InjurySep 30, 2026Device Dislodged or Dislocated
It was reported that the patient was revised to constrained liner due to dislocation. DOI: Unknown .DOR: (b)(6)2026.Affected side: Left hip.
Patient problems: Joint Dislocation
MAUDE report 50947516 ↗InjurySep 30, 2026Adverse Event Without Identified Device or Use Problem
It was reported that patient was revised due to possible infection liner and head removed.DOI: (b)(6) 20260DOR: (b)(6) 2026. Affected Side: Unknown.
Patient problems: Unspecified Infection
MAUDE report 50945478 ↗InjurySep 30, 2026Improper or Incorrect Procedure or Method
It was reported on (b)(6) 2026, a RTC with ceramic head was performed.During the evaluation carried out post-operatively it was evident that the patient presented with a fall. This was apparently associated with a sciatic nerve injury, as well as a difference in the length of the lower extremities. The operated limb longer than the contralateral. Dr states that during the procedure he used a head 36 +1.5 mm, corresponding to the shortest option available. However, the resident of orthopedics informed him that, when reviewing the surgical expenses, the reference registered and billed corresponds to a 36 +5 mm head.According to the information provided by Dr, an error could have occurred in the delivery of the implant during the procedure. The doctor says that he requested the surgical support, identified as Óscar, the shortest head available. He also comments that the reduction was technically difficult during the surgery, although at that time he did not consider it to be related to the size of the implanted head. Revision surgery has been planned with the aim of making the change to the head of shorter length.
Patient problems: Nerve Damage; Physical Asymmetry
MAUDE report 50945420 ↗InjurySep 30, 2026Device Dislodged or Dislocated
It was reported that replaced original stem with one larger in size and changed out the poly liner and head.DOI-Unknown,DOR-(b)(6)2026,Affected side- Unknown.
Patient problems: Joint Dislocation
MAUDE report 50945288 ↗InjurySep 29, 2026Device Dislodged or Dislocated
It was reported that Due to dislocation, Dr. removed head, cup and liner and replaced with competitor cup and liner and new Depuy head.DOI: on (b)(6) 2026,DOR: on (b)(6) 2026,Affected side: Left.
Patient problems: Joint Dislocation
MAUDE report 50931197 ↗InjurySep 29, 2026Device Dislodged or Dislocated
It was reported that the patient was revised due to dislocation.Affected side: Left hip.
Patient problems: Joint Dislocation
MAUDE report 50931182 ↗InjurySep 29, 2026Adverse Event Without Identified Device or Use Problem
It was reported that the patient required revision of hip implants due to post operative infection. DAIR procedure was carried out.
Patient problems: Unspecified Infection
MAUDE report 50931083 ↗InjurySep 28, 2026Adverse Event Without Identified Device or Use Problem
Patient problems: Unspecified Infection
MAUDE report 50920975 ↗InjurySep 28, 2026Adverse Event Without Identified Device or Use Problem
Patient problems: Unspecified Infection
MAUDE report 50918032 ↗InjurySep 28, 2026Adverse Event Without Identified Device or Use Problem
It was reported that Head and liner were removed and replaced with washout for infection.Affected Side: Unknown.
Patient problems: Unspecified Infection
MAUDE report 50917814 ↗InjurySep 24, 2026Adverse Event Without Identified Device or Use Problem
It was reported that the patient was revised due to instability.DOI: Unknown, DOR: (b)(6) 2026,Affected side: Unknown hip.
Patient problems: Joint Laxity
MAUDE report 50888522 ↗InjurySep 23, 2026Device Dislodged or Dislocated
It was reported that patient had dislocation.DOI: Unknown.DOR: (b)(6) 2026.Affected Side: Unknown.
Patient problems: Joint Dislocation
MAUDE report 50873784 ↗InjurySep 23, 2026Adverse Event Without Identified Device or Use Problem
It was reported that patient had TH 8-3-26. Patient fell and sustained a femur fracture. DOI: (b)(6) 2026.DOR: (b)(6) 2026.Affected side: Unknown.
Patient problems: Fall
MAUDE report 50873602 ↗InjurySep 23, 2026Adverse Event Without Identified Device or Use Problem
It was reported that the patient is unstable. The cup and liner were taken out and their position was changed during a revision procedure.DOI: (b)(6) 2010.DOR:(b)(6) 2026.Affected side: Left hip.
Patient problems: Joint Laxity
MAUDE report 50873114 ↗InjurySep 23, 2026Adverse Event Without Identified Device or Use Problem
It was reported that the I&D poly swap & head exchange. No issues or problems or delays during this case.DOI: on (b)(6) 2026,DOR: on (b)(6) 2026,Affected side: Right Hip.
Patient problems: Insufficient Information
MAUDE report 50872169 ↗
Other Depuy Orthopaedics, Inc. products
All Depuy Orthopaedics, Inc. devices →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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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