BIOLOX delta Modular Ceramic HeadRecalls & reported problems across all models
Biomet Uk Ltd · 10 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 159
- Deaths reported
- 0
- Injuries reported
- 139
- Recalls
- 0
We found 10 models of BIOLOX delta Modular Ceramic Head by Biomet Uk Ltd in the FDA's device registry (GUDID). Together they are named in 159 adverse event reports in the FDA's MAUDE database, received between Apr 2, 2020 and Sep 14, 2026 — classified as 139 injuries, 20 malfunctions.
The most frequently reported specific device problem is “Device Dislodged or Dislocated” (49 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 Modular Ceramic Head problems
Device problems
- Adverse Event Without Identified Device or Use Problem54
- Device Dislodged or Dislocated49
- Fracture39
- Material Integrity Problem6
- Mechanical Problem6
- Unintended Movement5
- Break4
- Malposition of Device4
Patient problems
- Joint Dislocation49
- Pain36
- Failure of Implant33
- No Clinical Signs, Symptoms or Conditions17
- Unspecified Infection11
- Insufficient Information10
- Bone Fracture(s)9
- Ambulation or Postural Difficulties8
BIOLOX delta Modular Ceramic Head models
10 models, most reported first. Each model has its own page with its reports, recalls and device details.
- BIOLOX® delta Modular Ceramic Head 650-0661PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED29 reports
- BIOLOX® delta Modular Ceramic Head 650-0662PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED27 reports
- BIOLOX® delta Modular Ceramic Head 650-1159PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED22 reports
- BIOLOX® delta Modular Ceramic Head 650-1158PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED16 reports
- BIOLOX® delta Modular Ceramic Head 650-1162PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED16 reports
- BIOLOX® delta Modular Ceramic Head 650-0660PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED15 reports
- BIOLOX® delta Modular Ceramic Head 650-1161PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED12 reports
- BIOLOX® delta Modular Ceramic Head 650-0663PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED10 reports
- BIOLOX® delta Modular Ceramic Head 650-1157PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED8 reports
- BIOLOX® delta Modular Ceramic Head 650-1160PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED4 reports
Recent BIOLOX delta Modular Ceramic Head adverse event reports
The 15 most recent reports across all models, 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 ↗InjuryAug 28, 2026Malposition of Device; Device Dislodged or Dislocated
It was reported that the patient underwent an initial hip procedure. The patient was revised approximately three and a half months post-implantation due to dislocation and malposition of the cup. Attempts have been made and no further information has been provided.
Patient problems: Joint Dislocation
MAUDE report 50493614 ↗InjuryMar 24, 2026Fracture
IT WAS REPORTED THAT THE PATIENT UNDERWENT REVISION SURGERY APPROXIMATELY FOUR MONTHS AND ONE WEEK POST IMPLANTATION DUE TO FEMORAL HEAD FRACTURE. PATIENT STATED HE DID NOT FALL THOUGH HAD A MISSTEP WHICH WAS JARRING WHERE HE CAUGHT HIS BODY WEIGHT ON THE SIDE WHERE THE DAMAGED COMPONENT. THEN, THE PATIENT HEARD A POP AND FELL TO THE GROUND AT THE TIME THE IMPLANT BROKE. DUE DILIGENCE IS IN PROGRESS FOR THIS COMPLAINT; TO DATE NO ADDITIONAL INFORMATION OR PRODUCT HAS BEEN RECEIVED.
Patient problems: Insufficient Information
MAUDE report 24679356 ↗InjuryMar 20, 2026Inadequacy of Device Shape and/or Size
IT WAS REPORTED THAT APPROXIMATELY TWO WEEKS POST-IMPLANTATION, THE PATIENT UNDERWENT A HIP REVISION DUE TO LEG LENGTH DISCREPANCY. THE LEG OF THE PATIENT WAS CONSIDERABLY LONGER, APPROXIMATELY TWENTY MM, SO THE SURGEON DECIDED TO REMOVE THE PROXIMAL BODY OF THE STEM AND REDUCE THE LEG LENGTH DISCREPANCY BY TEN MM. NO FURTHER INFORMATION IS AVAILABLE.
Patient problems: Unequal Limb Length
MAUDE report 24648269 ↗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 ↗InjuryJan 14, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT APPROXIMATELY SEVEN MONTHS POST LEFT HIP IMPLANTATION, THE PATIENT RECEIVED TREATMENT FOR PAIN IN THEIR LEFT THIGH. FOLLOWING LONG WALKS, THERE IS RADIATING STABBING PAIN FROM BUTTOCKS DOWN THE THIGH AND KNEE. THE PATIENT HAS RECEIVED A CORTISONE INJECTION FOR PAIN IN THE LEFT BURSA. THE PATIENT UNDERGOES WEEKLY PHYSICAL THERAPY, MASSAGE, AND EXERCISES. SIX MONTHS LATER, THE PATIENT REPORTED MILD PAIN WITH LITTLE DIFFICULTIES AND NO REQUIRED PAIN MEDICATION. ATTEMPTS HAVE BEEN MADE, AND NO FURTHER INFORMATION HAS BEEN PROVIDED.
Patient problems: Pain
MAUDE report 24065742 ↗InjuryJan 8, 2026Adverse Event Without Identified Device or Use Problem
NO FURTHER EVENT INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: Pain
MAUDE report 24000810 ↗InjuryDec 9, 2025Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size
NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: Joint Contracture; Unequal Limb Length
MAUDE report 23756984 ↗InjuryDec 3, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THE PATIENT UNDERWENT A PRIMARY TOTAL HIP REPLACEMENT AND SUBSEQUENTLY DEVELOPED ONGOING PAIN DURING HIP FLEXION AND EXTERNAL ROTATION, WITH SUSPECTED ILIOPSOAS INVOLVEMENT/IMPINGEMENT. THE PATIENT¿S JOINT WAS LATER REOPENED, AND A SUBSEQUENT PROCEDURE WAS PERFORMED APPROXIMATELY 19 MONTHS POST-IMPLANTATION. DETAILS REGARDING SPECIFIC COMPONENT CHANGES OR INTRA-OPERATIVE FINDINGS WERE NOT PROVIDED. NO ENVIRONMENTAL FACTORS WERE REPORTED. THE PATIENT WAS REVISED; NO FURTHER DETAILS REGARDING THE PATIENT¿S OUTCOME WERE PROVIDED. ATTEMPTS HAVE BEEN MADE, AND NO FURTHER INFORMATION HAS BEEN PROVIDED.
Patient problems: Pain
MAUDE report 23704860 ↗InjuryNov 13, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated
IT WAS REPORTED THE PATIENT UNDERWENT REVISION SURGERY APPROXIMATELY ONE-YEAR POST-IMPLANTATION DUE TO HIP DISLOCATION AND INSTABILITY. A CONSTRAINED LINER WAS IMPLANTED TO ADDRESS THE INSTABILITY. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.
Patient problems: Joint Dislocation
MAUDE report 23542334 ↗InjuryOct 29, 2025Adverse 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: Bone Fracture(s)
MAUDE report 23413212 ↗InjuryOct 22, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED BY LEGAL THAT A PATIENT HAD AN INITIAL RIGHT TOTAL HIP ARTHROPLASTY PERFORMED APPROXIMATELY FOUR YEARS AND THREE MONTHS AGO. THE PATIENT DID WELL UNTIL TWO YEARS POSTOP WHEN HE WAS MOVING A BOX AND LEANING FORWARD AND FELT SOMETHING POP IN HIS HIP. IMMEDIATE X-RAYS DID NOT SHOW ANY ACUTE FINDINGS. THREE WEEKS LATER, THE PATIENT PRESENTED WITH PROGRESSIVE PAIN, SQUEAKING, SWELLING, AND REDNESS IN THE HIP. X-RAYS SHOWED THE FEMORAL HEAD ARTICULATING AGAINST THE CUP WITH POLY LINER DISSOCIATION AND SUBSIDENCE. ELEVATED CRP LEVELS INCREASED CONCERN FOR INFECTION, SO THE PATIENT UNDERWENT IRRIGATION AND DEBRIDEMENT WITH HEAD AND LINER EXCHANGE APPROXIMATELY RWO YEARS AGO. DURING THE REVISION, SIGNIFICANT METALLOSIS WAS IDENTIFIED THROUGH A TEAR IN THE FASCIA WHICH TRACKED DOWN INTO THE HIP. NECROTIC TISSUE AND PIECES OF LOOSE POLY WERE REMOVED FROM THE HIP. THE HIP WAS THOROUGHLY IRRIGATED, AND A NEW HEAD AND LINER WERE PLACED WITHOUT COMPLICATIONS. THE INITIAL STEM AND SHELL WERE WELL POSITIONED AND REMAINED INTACT. FOLLOW UP SIX MONTHS POST-REVISION DEMONSTRATED FULL RECOVERY WITHOUT COMPLICATIONS. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.
Patient problems: Erythema; Hemorrhage/Blood Loss/Bleeding; Inflammation; Metal Related Pathology; Necrosis; Pain; Subluxation; Swelling/ Edema
MAUDE report 23356500 ↗MalfunctionOct 20, 2025Fracture; Fracture
IT WAS REPORTED THAT DURING A PROCEDURE, THE CERAMIC FEMORAL HEAD FRACTURED UPON IMPACTION WITH THE MALLET. THE SURGEON CONFIRMED THAT APPROPRIATE TECHNIQUE AND FORCE WERE USED, AND NO EXCESSIVE FORCE WAS APPLIED. NO FRAGMENTS FELL OR WERE RETAINED IN THE PATIENT. THERE WERE NO REPORTED CONSEQUENCES OR HEALTH IMPACTS TO THE PATIENT. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED AT THE TIME OF THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23334484 ↗InjuryOct 16, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
NO FURTHER EVENT INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: Insufficient Information
MAUDE report 23311572 ↗InjuryOct 15, 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 23279914 ↗
Other Biomet Uk Ltd products
All Biomet Uk Ltd 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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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