Mectacer Biolox Delta Femoral Ball Head 01.29.212Recalls & reported problems

Summary

The FDA's MAUDE database contains 18 adverse event reports that list this exact device (DI 07630030809231), received between Apr 9, 2019 and Jun 30, 2026 — classified as 18 injuries.

The most frequently reported specific device problem is “Device Appears to Trigger Rejection” (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.

Most reported problems

Recent adverse event reports

The 18 most recent of 18 reports, in the reporter's own words as published by the FDA.

• InjuryJun 30, 2026Device Dislodged or Dislocated

  REVISION SURGERY DUE TO JOINT LUXATION AFTER ABOUT 8 MONTHS FROM PRIMARY SURGERY. THE SURGEON REVISED THE 40MM BIOLOX DELTA HEAD S TO A 28MM BIOLOX DELTA HEAD M AND REVISED THE FLAT PE HC LINER D 40/F TO A CONSTRAINED 10° PE LINER D 28/F. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Joint Dislocation

  MAUDE report 25663306 ↗
• InjuryMay 27, 2026Device Dislodged or Dislocated

  REVISION SURGERY DUE TO JOINT LUXATION AFTER 8 DAYS FROM PRIMARY. THE CERAMIC HEAD DISLOCATED FROM THE LINER. THE SURGEON REVISED THE 40MM BIOLOX S HEAD WITH A SAME SIZE HEAD, AND REVISED THE FLAT PE HC D 40/F LINER TO A SAME SIZE LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Joint Dislocation

  MAUDE report 25297695 ↗
• InjuryMay 12, 2026Adverse Event Without Identified Device or Use Problem

  AT ABOUT 2 YEARS 9 MONTHS AFTER THE PRIMARY, THE PATIENT CAME IN PRESENTING ANTERIOR INSTABILITY AND THE CAUSE IS UNKNOWN. THERE WERE NO INDICATIONS OF TRAUMA. THE SURGEON REVISED THE HEAD AND LINER TO A DOUBLE MOBILITY SYSTEM WITH DM CONVERTER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Joint Laxity

  MAUDE report 25148961 ↗
• InjuryFeb 26, 2026Device Appears to Trigger Rejection

  THE PATIENT CAME IN PRESENTING PAIN WITH SIGNS OF INFECTION AND THE PATHOGEN IS UNKNOWN. ABOUT 2 YEARS AND 4 MONTHS AFTER THE PRIMARY SURGERY, THE SURGEON PERFORMED A WASHOUT, THEN REVISED THE LINER AND HEAD TO IMPLANTS OF THE SAME SIZE. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Medical device site infection

  MAUDE report 24454903 ↗
• InjuryNov 10, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  AT ABOUT 2 MONTHS AFTER THE PRIMARY, THE PATIENT CAME IN DUE TO AN INFECTION AND THE PATHOGEN IS UNKNOWN. THE SURGEON PERFORMED A WASHOUT AND REVISED THE LINER AND HEAD. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Medical device site infection

  MAUDE report 23510675 ↗
• InjuryJul 1, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  AT ABOUT 6 YEARS AND 3 MONTHS 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 22371287 ↗
• InjuryMar 7, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  AFTER THE PRIMARY HIP SURGERY, THE PATIENT DISLOCATED ANTERIOR AND SUPERIOR IN THE POST OP RECOVERY AREA. ON THE SAME DAY, THE PATIENT WAS BROUGHT BACK AND THE HEAD AND LINER WERE REVISED. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Joint Dislocation

  MAUDE report 21548761 ↗
• InjuryOct 31, 2024Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  THE PATIENT HAD A PRIMARY HIP SURGERY ON (B)(6) 2024. ON (B)(6) 2024, 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. ON (B)(6) 2024, 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. ON (B)(6) 2024 THE PATIENT CAME IN DUE TO SIGNS OF AN INFECTION AND THE PATHOGEN IS UNKNOWN. THE SURGEON REMOVED ALL IMPLANTS AND IMPLANTED AN ANTIBIOTIC SPACER. THE SURGERY WAS COMPLETED SUCCESSFULLY. ON (B)(6) 2024, ANTIBIOTIC SPACER WAS REMOVED AND FINAL IMPLANTS WERE IMPLANTED. ON (B)(6) 2024, REVISION 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; Unspecified Infection

  MAUDE report 20577539 ↗
• InjuryAug 28, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  THE PATIENT HAS BEEN REVISED BECAUSE OF A JOINT LUXATION OCCURRED IN POST-OP RECOVERY, AND THE CAUSE IS UNKNOWN. THE SURGEON REVISED SUCCESSFULLY THE HEAD, STEM AND LINER.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 20088915 ↗
• InjuryMay 14, 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 2 MONTHS 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 19309998 ↗
• InjuryApr 2, 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 19018523 ↗
• InjuryJun 1, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated

  AFTER THE PRIMARY HIP SURGERY, IN POST-OP RECOVERY, THE PATIENT SUFFERED A JOINT LUXATION. THE SURGEON REVISED THE CUP, LINER, AND HEAD. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 17036591 ↗
• InjuryOct 5, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT CAME IN REPORTING THIGH PAIN AND THE CAUSE IS UNKNOWN. ABOUT 1 YEAR AND 5 MONTHS AFTER THE PRIMARY SURGERY, THE SURGEON REVISED THE MEDACTA HEAD AND COMPETITOR LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Pain

  MAUDE report 15542030 ↗
• InjuryMay 6, 2022Appropriate Device Problem Term/Code Not Available

  THE PATIENT CAME IN DUE TO SIGNS OF AN INFECTION AND THE PATHOGEN IS UNKNOWN. THE SURGEON PERFORMED A WASHOUT AND REVISED THE HEAD ABOUT 1 MONTH AND 1 WEEK AFTER PRIMARY. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Unspecified Infection

  MAUDE report 14300828 ↗
• InjurySep 15, 2021Fracture; Inadequacy of Device Shape and/or Size; Appropriate Device Problem Term/Code Not Available

  THE PATIENT HAD A PRIMARY HIP SURGERY ON (B)(6) 2021. ON (B)(6) 2021, THE PATIENT CAME IN REPORTING PAIN DUE TO A PERIPROSTHETIC FRACTURE THAT WAS CAUSED FROM FALLING. THE SURGEON CABLED THE FRACTURE AND REVISED THE STEM AND HEAD. THE SURGERY WAS COMPLETED SUCCESSFULLY. PRESENTLY, ON (B)(6) 2021, THE PATIENT CAME IN REPORTING PAIN DUE TO A LEG LENGTH DISCREPANCY AND THE CAUSE OF THE LEG LENGTH DISCREPANCY IS UNKNOWN. THE SURGEON REVISED THE HEAD WITH A COMPETITOR HEAD. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Pain

  MAUDE report 12473173 ↗
• InjurySep 14, 2021Adverse Event Without Identified Device or Use Problem

  THE PATIENT CAME IN DUE TO SIGNS OF AN INFECTION AND THE PATHOGEN IS UNKNOWN. 10 DAYS AFTER PRIMARY THE SURGEON PERFORMED A WASHOUT AND REVISED THE HEAD AND LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Unspecified Infection

  MAUDE report 12467900 ↗
• InjuryAug 26, 2020Device Dislodged or Dislocated; Appropriate Device Problem Term/Code Not Available

  DURING POST-OP RECOVERY, THE PATIENT'S LINER DISLOCATED FROM THE HEAD. THE DAY AFTER PRIMARY SURGERY THE SURGEON REVISED THE HEAD AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Joint Dislocation

  MAUDE report 10452932 ↗
• InjuryApr 9, 2019Adverse Event Without Identified Device or Use Problem

  REVISION SURGERY ABOUT 1 MONTH AFTER PRIMARY FOR HIP INFECTION. THE PATHOGEN IS UNKNOWN. THE SURGEON PERFORMED A WASHOUT AND REVISED THE BALL HEAD AND LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Unspecified Infection

  MAUDE report 8495628 ↗