Mectacer Biolox Delta Femoral Ball Head 01.29.210Recalls & reported problems
Medacta International SA · Femoral Head Ø 36 Size L · Class 2 · Implant
All models of Mectacer Biolox Delta Femoral Ball Head (15)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
Quick summary
This Medacta Biolox Delta ceramic femoral head is the ball-and-socket component used in hip replacement surgery. The reports mostly describe infection around the implant, along with the ball coming out of its socket (dislocation), pain, and one case of a leg length mismatch, several needing revision surgery to clean out or swap parts. There are 48 reports, all describing injuries, and no deaths. No recalls name this device.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 48
- Deaths reported
- 0
- Injuries reported
- 48
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 48 adverse event reports that list this exact device (DI 07630030809217), received between Apr 5, 2018 and May 22, 2026 — classified as 48 injuries.
The most frequently reported specific device problem is “Device Appears to Trigger Rejection” (22 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 Appears to Trigger Rejection22
- Device Dislodged or Dislocated11
- Adverse Event Without Identified Device or Use Problem5
- Appropriate Device Problem Term/Code Not Available5
- Break1
- Difficult to Remove1
- Loosening of Implant Not Related to Bone-Ingrowth1
- Microbial Contamination of Device1
Patient problems
- Unspecified Infection16
- Medical device site infection13
- Joint Dislocation7
- Pain4
- Implant Pain3
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available1
- Bacterial Infection1
- Hematoma1
Recent adverse event reports
The 25 most recent of 48 reports, in the reporter's own words as published by the FDA.
InjuryMay 22, 2026Device Appears to Trigger Rejection
REVISION SURGERY DUE TO INFECTION AFTER ABOUT 1 MONTH AND A HALF FROM PRIMARY. THE SURGEON PERFORMED A WASHOUT, THEN REVISED THE 36MM BIOLOX L HEAD TO A 36MM BIOLOX OPTION HEAD WITH SLEEVE, AND REVISED THE FLAT PE HC LINER D 36/E TO A SAME SIZE LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY.
Patient problems: Medical device site infection
MAUDE report 25253488 ↗InjuryMay 5, 2026Device Appears to Trigger Rejection
REVISION SURGERY DUE TO INFECTION AFTER 6 MONTHS FROM PRIMARY SURGERY. THE SURGEON UPSIZED THE MPACT 3D METAL SHELL, MPACT LINER AND HEAD. THE SURGERY WAS COMPLETED SUCCESSFULLY.
Patient problems: Medical device site infection
MAUDE report 25077220 ↗InjuryApr 23, 2026Device Appears to Trigger Rejection
REVISION SURGERY DUE TO INFECTION ABOUT 8 YEARS AFTER PRIMARY SURGERY AND THE CAUSE IS UNKNOWN. THE SURGEON PERFORMED A WASHOUT AND REVISED THE HEAD, THE ACETABULAR SHELL, LINER AND THE STEM. THE SURGERY WAS COMPLETED SUCCESSFULLY.
Patient problems: Medical device site infection
MAUDE report 24964781 ↗InjuryMar 26, 2026Device Appears to Trigger Rejection
AT ABOUT 3 YEARS AND 3 MONTHS FROM THE PRIMARY, THE PATIENT CAME IN DUE TO SIGNS OF INFECTION AND THE PATHOGEN IS UNKNOWN. THE SURGEON PERFORMED A WASHOUT AND REVISED THE 36 MM BIOLOX HEAD TO A SAME SIZE BIOLOX HEAD AND REVISED THE D 36 HOODED LINER TO A FLAT PE HC LINER D 36 LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY.
Patient problems: Medical device site infection
MAUDE report 24700711 ↗InjuryMar 10, 2026Device Appears to Trigger Rejection
REVISION SURGERY DUE TO INFECTION 20 DAYS AFTER THE PRIMARY SURGERY. THE SURGEON PERFORMED A WASHOUT AND REVISED THE HEAD AND LINER TO A SAME SIZE HEAD AND LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY.
Patient problems: Medical device site infection
MAUDE report 24558229 ↗InjurySep 17, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
THE PATIENT UNDERWENT PRIMARY SURGERY ON (B)(6) 2025. ON (B)(6) 2025, THE PATIENT PRESENTED WITH DRAINAGE AT THE INCISION SITE AND A HEMATOMA. THE SURGEON PERFORMED AN I&D AND EXCHANGED THE HEAD AND POLYETHYLENE. RECENTLY, THE PATIENT PRESENTED AGAIN DUE TO INFECTION OF UNKNOWN PATHOGEN. THE SURGEON PERFORMED A WASHOUT AND EXCHANGED THE HEAD. THE SURGERY WAS SUCCESSFULLY COMPLETED.
Patient problems: Medical device site infection
MAUDE report 23070935 ↗InjuryJul 31, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
THE PATIENT CAME IN REPORTING INSTABILITY DUE TO A LEG LENGTH DISCREPANCY, AND THE CAUSE IS UNKNOWN. THE SURGEON DOWNSIZED THE HEAD TO GIVE THE PATIENT MORE STABILITY. THE SURGERY WAS COMPLETED SUCCESSFULLY. HEAD SIZE WAS DECREASED BECAUSE LEG WAS TOO LONG. X-RAYS NOT AVAILABLE.
Patient problems: Unequal Limb Length
MAUDE report 22673490 ↗InjuryJul 8, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated
THE PATIENT CAME HAD PAIN DUE TO A DISLOCATION OF THE HEAD FROM THE LINER. AT ABOUT 2 MONTHS FROM PRIMARY THE SURGEON REVISED THE HEAD AND LINER AND THE SURGERY WAS COMPLETED SUCCESSFULLY.
Patient problems: Joint Dislocation
MAUDE report 22436992 ↗InjuryMay 23, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
AT ABOUT THREE WEEKS FROM PRIMARY, THE PATIENT CAME IN DUE TO SIGNS OF AN INFECTION AND THE PATHOGEN IS UNKNOWN. THE SURGEON PERFORMED A WASHOUT AND REVISED THE HEAD AND LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY.
Patient problems: Medical device site infection
MAUDE report 22076616 ↗InjuryMay 16, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
AT 1 MONTH FROM PRIMARY, THE PATIENT CAME IN REPORTING PAIN DUE TO DEVELOPING A HEMATOMA. THE SURGEON PERFORMED ADRENAGE AND REVISED THE HEAD AND LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY.
Patient problems: Hematoma
MAUDE report 22033729 ↗InjuryMar 27, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
THE PATIENT HAD A PRIMARY HIP SURGERY ON (B)(6) 2024. ON (B)(6) 2025, THE PATIENT CAME IN DUE TO SIGNS OF INFECTION AND THE PATHOGEN IS UNKNOWN. THE SURGEON PERFORMED A WASHOUT AND REVISED THE HEAD AND LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY. PRESENTLY, ON (B)(6) 2025, THE PATIENT CAME IN DUE TO SIGNS OF INFECTION AND THE PATHOGEN IS UNKNOWN. THE SURGEON REMOVED ALL MEDACTA HARDWARE AND IMPLANTED AN ANTIBIOTIC SPACER. THE SURGERY WAS COMPLETED SUCCESSFULLY.
Patient problems: Medical device site infection
MAUDE report 21708477 ↗InjuryFeb 19, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
THE PATIENT HAD A HIP INFECTION AND THE PATHOGEN IS UNKNOWN. AT ABOUT 1 MONTH POST PRIMARY THE SURGEON PERFORMED A WASHOUT AND REVISED THE HEAD AND LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY.
Patient problems: Medical device site infection
MAUDE report 21411268 ↗InjuryFeb 11, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
THE PATIENT HAD A HIP INFECTION AND THE PATHOGEN IS UNKNOWN. AT ABOUT 5 YEARS AND 5 MONTHS POST PRIMARY THE SURGEON PERFORMED A WASHOUT AND REVISED THE CUP, HEAD AND LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY.
Patient problems: Medical device site infection
MAUDE report 21353077 ↗InjuryJan 14, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
AT ABOUT 1 YEAR 10 MONTHS AFTER THE PRIMARY, THE PATIENT CAME IN DUE TO SIGNS OF INFECTION AND THE PATHOGEN IS UNKNOWN. THE SURGEON PERFORMED A WASHOUT AND REVISED THE HEAD AND LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY.
Patient problems: Medical device site infection
MAUDE report 21146987 ↗InjuryNov 18, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated
AT ABOUT 4 MONTHS AFTER THE PRIMARY, THE PATIENT CAME IN REPORTING PAIN DUE TO A DISLOCATION OF THE HEAD FROM THE LINER AND THE CAUSE OF THE DISLOCATION IS UNKNOWN. THE SURGEON REVISED THE CUP, HEAD AND LINER AND THE SURGERY WAS COMPLETED SUCCESSFULLY.
Patient problems: Joint Dislocation
MAUDE report 20705351 ↗InjuryNov 13, 2024Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
AT ABOUT 1 MONTH AFTER PRIMARY, THE PATIENT CAME IN DUE TO SIGNS OF AN INFECTION AND THE PATHOGEN IS UNKNOWN. THE SURGEON PERFORMED A WASHOUT AND REVISED THE HEAD, CUP AND LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY.
Patient problems: Unspecified Infection
MAUDE report 20674180 ↗InjuryNov 7, 2024Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
REVISION DUE TO SIGNS OF INFECTION AT ABOUT 2 WEEKS FROM PRIMARY AND THE PATHOGEN IS UNKNOWN. THE SURGEON REVISED THE HEAD AND LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY.
Patient problems: Medical device site infection
MAUDE report 20628625 ↗InjuryOct 29, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated
AT ABOUT 10 MONTHS AFTER PRIMARY, THE PATENT CAME IN REPORTING PAIN DUE TO A JOINT LUXATION AND THE CAUSE IS UNKNOWN. THE SURGEON REVISED THE HEAD AND LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY.
Patient problems: Implant Pain
MAUDE report 20554923 ↗InjuryOct 18, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated
THE PATIENT HAD PAIN DUE TO A LUXATION OF THE HEAD FROM THE LINER. AT ABOUT 3 MONTHS POST PRIMARY THE SURGEON REVISED THE HEAD AND LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY.
Patient problems: Implant Pain
MAUDE report 20485051 ↗InjurySep 17, 2024Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
THE PATIENT CAME IN DUE TO SIGNS OF AN INFECTION AND THE PATHOGEN IS UNKNOWN. ABOUT 1 MONTH AFTER THE PRIMARY SURGERY, THE SURGEON PERFORMED A WASHOUT AND REVISED THE HEAD AND LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY.
Patient problems: Unspecified Infection
MAUDE report 20235663 ↗InjuryJun 19, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated
AT ABOUT 1 MONTH AFTER THE PRIMARY, THE PATIENT CAME IN REPORTING PAIN DUE TO A DISLOCATION OF THE HEAD FROM THE LINER AND THE CAUSE OF THE DISLOCATION IS UNKNOWN. THE SURGEON REVISED THE HEAD AND THE SURGERY WAS COMPLETED SUCCESSFULLY. CUP AND LINER WAS COMPETITOR'S.
Patient problems: Implant Pain
MAUDE report 19566132 ↗InjuryApr 9, 2024Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
ABOUT 3 MONTHS AFTER THE PRIMARY SURGERY, THE PATIENT CAME IN DUE TO SIGNS OF AN INFECTION AND THE PATHOGEN IS UNKNOWN. THE SURGEON PERFORMED A WASHOUT AND REVISED THE HEAD AND LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY.
Patient problems: Unspecified Infection
MAUDE report 19070203 ↗InjuryJan 17, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated
IMMEDIATELY AFTER THE PRIMARY HIP SURGERY, THE PATIENT SUSTAINED A DISLOCATION OF THE HEAD FROM THE LINER. THE SURGEON REVISED THE STEM, HEAD AND LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY.
Patient problems: Pain
MAUDE report 18525667 ↗InjurySep 22, 2023Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
AT ABOUT 3 YEARS AND 8 MONTHS FROM THE PRIMARY, THE PATIENT CAME IN DUE TO SIGNS OF AN INFECTION AND THE PATHOGEN IS UNKNOWN. THE SURGEON PERFORMED A WASHOUT AND REVISED THE HEAD AND LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY.
Patient problems: Medical device site infection
MAUDE report 17798546 ↗InjuryJul 26, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated
REVISION FOR JOINT LUXATION AT ABOUT 1 YEAR AND 1 MONTH POST PRIMARY. MECTACER HEAD AND MPACT FLAT LINER CHANGED SUCCESSFULLY.
Patient problems: Pain
MAUDE report 17396945 ↗
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.
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