Biolox deltaRecalls & reported problems across all models
Zimmer GmbH · 16 models in the FDA device registry
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 343
- Deaths reported
- 0
- Injuries reported
- 318
- Recalls
- 0
We found 16 models of Biolox delta by Zimmer GmbH in the FDA's device registry (GUDID). Together they are named in 343 adverse event reports in the FDA's MAUDE database, received between Nov 2, 2018 and Sep 29, 2026 — classified as 318 injuries, 25 malfunctions.
The most frequently reported specific device problem is “Device Dislodged or Dislocated” (135 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 problems
Device problems
- Device Dislodged or Dislocated135
- Adverse Event Without Identified Device or Use Problem85
- Insufficient Device Problem Information34
- Appropriate Device Problem Term/Code Not Available18
- Fracture14
- Patient Device Interaction Problem12
- Unstable9
- Noise, Audible7
Patient problems
- Joint Dislocation110
- Pain91
- Failure of Implant45
- Unspecified Infection31
- No Clinical Signs, Symptoms or Conditions21
- Ambulation or Postural Difficulties18
- No Information17
- No Code Available16
Biolox delta models
16 models, most reported first. Each model has its own page with its reports, recalls and device details.
- Biolox® delta 00-8775-036-02Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented69 reports
- Biolox® delta 00-8775-032-02Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented56 reports
- Biolox® delta 00-8775-028-02Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented37 reports
- Biolox® delta 00-8775-036-01Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented35 reports
- Biolox® delta 00-8775-036-03Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented30 reports
- Biolox® delta 00-8775-028-01Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented18 reports
- Biolox® delta 00-8775-032-01Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented17 reports
- Biolox® delta 00-8775-032-03Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented17 reports
- Biolox® delta 00-8775-040-02Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented16 reports
- Biolox® delta 00-8775-028-03Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented13 reports
- Biolox® delta 00-8775-036-04Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented11 reports
- Biolox® delta 00-8775-040-03Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented11 reports
- Biolox® delta 00-8775-032-04Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented7 reports
- Biolox® delta 00-8775-040-01Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented3 reports
- Biolox® delta 00-8775-040-04Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented2 reports
- Biolox® delta 00-8775-032-02Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented1 report
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 29, 2026Naturally Worn
Patient problems: Insufficient Information
MAUDE report 50932266 ↗InjurySep 10, 2026Adverse Event Without Identified Device or Use Problem
Patient problems: Bursitis; Fall; Pain
MAUDE report 50723278 ↗InjurySep 10, 2026Adverse Event Without Identified Device or Use Problem
Patient problems: Bursitis; Fall; Pain
MAUDE report 50722920 ↗InjuryAug 10, 2026Adverse Event Without Identified Device or Use Problem
It was reported that the patient underwent a hip revision. During the procedure the Head and Liner were revised.It was confirmed that no further information could be provided.
Patient problems: Insufficient Information
MAUDE report 50190502 ↗MalfunctionJul 8, 2026Fracture
IT WAS REPORTED THAT THE 28 MM CERAMIC INNER HEAD BROKE WHEN THE DM HEAD WAS FORCED INTO THE STEM. THE SURGERY WAS SUCCESSFULLY COMPLETED USING A DIFFERENT BEARING AND HEAD. THERE WERE NO CONSEQUENCES OR IMPACT TO THE PATIENT. DILIGENCE IS COMPLETED AND NO FURTHER INFORMATION ON THE REPORTED EVENT HAS BEEN PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25748638 ↗InjuryJun 30, 2026Device Dislodged or Dislocated
IT WAS REPORTED THAT THE PATIENT UNDERWENT A HIP REVISION APPROXIMATELY 4 MONTHS POST-IMPLANTATION DUE TO INSTABILITY. PRIOR TO REVISION, THE PATIENT SUSTAINED A FALL AND EXPERIENCED SUBLUXATION OF THE JOINT. THE REVISION WAS PERFORMED USING A DIRECT ANTERIOR APPROACH TECHNIQUE. DILIGENCE IS COMPLETED AND NO FURTHER INFORMATION ON THE REPORTED EVENT HAS BEEN PROVIDED.
Patient problems: Joint Laxity; Subluxation
MAUDE report 25673245 ↗InjuryJun 3, 2026Device Dislodged or Dislocated
INITIAL LEFT TOTAL HIP ARTHROPLASTY ON AN UNKNOWN DATE IN 2024. SUBSEQUENTLY, THE PATIENT WAS REVISED DUE TO SUSPICION OF INLAY FRACTURE. DURING THE REVISION SIGNIFICANT METALLOSIS WAS NOTED. THE INLAY WAS FOUND DISLOCATED FROM THE BENEATH THE CERAMIC HEAD AND WAS POSITIONED MEDIAL-CAUDALLY. THE STEM AND CUP WERE RETAINED, WHILE THE INLAY AND HEAD WERE REVISED. NO INTRAOPERATIVE COMPLICATIONS WERE REPORTED. DILIGENCE IS COMPLETED AND NO FURTHER INFORMATION ON THE REPORTED EVENT HAS BEEN PROVIDED.
Patient problems: Crepitus; Joint Dislocation; Metal Related Pathology; Pain
MAUDE report 25374001 ↗InjuryMay 15, 2026Detachment of Device or Device Component
IT WAS REPORTED THAT THE PATIENT UNDERWENT A HIP REVISION APPROXIMATELY 19 MONTHS POST-IMPLANTATION DUE TO A DISASSOCIATED DUAL MOBILITY BEARING AND HEAD. NO FURTHER INFORMATION HAS BEEN PROVIDED.
Patient problems: Joint Dislocation
MAUDE report 25179916 ↗InjuryApr 23, 2026Noise, Audible
IT WAS REPORTED THAT APPROXIMATELY THREE YEARS POST-IMPLANTATION, THE PATIENT UNDERWENT A RIGHT HIP REVISION DUE TO REPORTED NOISES AND PREMATURE POLY WEAR. THE PATIENT REPORTED SQUEAKING DURING WALKING AND MOBILIZATION WITHOUT PAINFUL SYMPTOMS, WHICH LIMITED DAILY ACTIVITIES. THE REVISION WAS PERFORMED AND THERE WAS PREMATURE WEAR OF THE POLYETHYLENE. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.
Patient problems: Ambulation or Postural Difficulties
MAUDE report 24964602 ↗InjuryMar 13, 2026Adverse Event Without Identified Device or Use Problem
DILIGENCE IS COMPLETED AND NO FURTHER INFORMATION ON THE REPORTED EVENT HAS BEEN PROVIDED.
Patient problems: Impaired Healing
MAUDE report 24597627 ↗InjuryFeb 19, 2026Device Dislodged or Dislocated
IT WAS REPORTED THAT THE PATIENT UNDERWENT PRIMARY SURGERY, AND SUBSEQUENTLY FELL BACKWARD, RESULTING IN AN ANTERIOR DISLOCATION AND REQUIRING REVISION SURGERY APPROXIMATELY 2 YEARS, 8 MONTHS POST PRIMARY SURGERY. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.
Patient problems: Joint Dislocation
MAUDE report 24386196 ↗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 ↗MalfunctionJan 13, 2026Contamination; Device Contaminated During Manufacture or Shipping
IT WAS REPORTED THAT A HAIR WAS OBSERVED UNDER THE TYVEK LID, ON THE IMPLANT. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24050964 ↗InjuryJan 2, 2026Adverse Event Without Identified Device or Use Problem
THERE IS NO UPDATE TO THE PRIOR EVENT DESCRIPTION PROVIDED.
Patient problems: Unspecified Infection
MAUDE report 23941631 ↗InjuryNov 28, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated
THERE IS NO UPDATE TO THE PRIOR EVENT DESCRIPTION PROVIDED.
Patient problems: Joint Dislocation
MAUDE report 23671142 ↗
Other Zimmer GmbH products
- Affixus Natural Nail55 models · 612 reports
- NCB78 models · 200 reports
- Zimmer Natural Nail System57 models · 187 reports
- Biolox Option16 models · 68 reports · 2 recalls
- Avenir24 models · 57 reports · 1 recall
- Anatomical Shoulder33 models · 102 reports
- Sidus Stem-Free Shoulder9 models · 30 reports · 1 recall
- Wagner SL Revision33 models · 66 reports
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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