Mectacer Biolox Delta Femoral Ball Head 01.29.214Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 07630030809255), received between Jun 16, 2020 and Nov 18, 2025 — classified as 10 injuries.

The most frequently reported specific device problem is “Device Appears to Trigger Rejection” (5 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 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• InjuryNov 18, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  AT ABOUT 1 MONTHS FROM THE PRIMARY, THE PATIENT CAME IN DUE TO AN INFECTION AND THE PATHOGEN IS UNKNOWN. THE SURGEON PERFORMED A WASHOUT AND HEAD AND LINER SWAP. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Medical device site infection

  MAUDE report 23583098 ↗
• InjuryNov 10, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  AT 2 WEEKS FROM THE PRIMARY, THE PATIENT CAME IN DUE TO AN INFECTION AND THE PATHOGEN IS UNKNOWN. THE SURGEON REVISED THE MEDACTA HEAD WITH A MEDACTA HEAD AND REVISED THE COMPETITOR LINER WITH A COMPETITOR LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Medical device site infection

  MAUDE report 23510656 ↗
• InjuryAug 20, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  AT ABOUT 10 MONTHS FROM PRIMARY, THE PATIENT CAME IN DUE TO PAIN THAT WAS DETERMINED BY THE SURGEON TO BE A RESULT OF INFECTION WITH AN UNKNOWN CAUSE. THE SURGEON REVISED THE PROXIMAL BODY, FEMORAL HEAD AND LINER IN ADDITION TO PERFORMING A WASHOUT. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Medical device site infection

  MAUDE report 22849203 ↗
• InjuryApr 24, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  AT ABOUT 3 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 MEDACTA STEM AND HEAD AND COMPETITOR HEAD AND LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Medical device site infection

  MAUDE report 21899448 ↗
• InjuryFeb 12, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  AT ABOUT 1 YEAR AND 5 MONTHS AFTER PRIMARY, 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 21364687 ↗
• InjuryApr 2, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  THE PATIENT HAD A PRIMARY HIP SURGERY ON (B)(6) 2023. ON (B)(6) 2023, THE PATIENT CAME IN REPORTING PAIN DUE TO A DISLOCATION OF THE HEAD FROM THE LINER AND THE CAUSE IS UNKNOWN. THE SURGEON REVISED THE HEAD AND LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY. PRESENTLY, ON (B)(6) 2024, THE PATIENT CAME IN REPORTING PAIN DUE TO A DISLOCATION OF THE HEAD FROM THE LINER. THE SURGEON REVISED THE MEDACTA CUP AND LINER WITH A COMPETITOR CUP AND LINER AND REVISED THE MEDACTA HEAD WITH A MEDACTA HEAD. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Joint Dislocation

  MAUDE report 19018524 ↗
• InjuryJun 14, 2023Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  AT ABOUT 3 MONTHS AFTER THE PRIMARY, THE PATIENT CAME IN REPORTING INSTABILITY DUE TO A LEG LENGTH DISCREPANCY AND THE CAUSE IS UNKNOWN. THE SURGEON REVISED THE HEAD AND LINER AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Joint Laxity

  MAUDE report 17123884 ↗
• InjuryOct 4, 2021Loose or Intermittent Connection; Unstable

  THE PATIENT CAME IN REPORTING INSTABILITY DUE TO LAXITY. THE CAUSE OF LAXITY IS UNKNOWN. ABOUT 7 MONTHS AFTER THE PRIMARY SURGERY, THE SURGEON REVISED THE 40MM BIOLOX DELTA HEAD L TO A 40MM BIOLOX DELTA HEAD XL. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Insufficient Information

  MAUDE report 12568614 ↗
• InjuryMar 24, 2021Device Dislodged or Dislocated

  THE PATIENT CAME IN REPORTING PAIN DUE TO A DISLOCATION OF THE HEAD FROM THE LINER. THE SURGEON REVISED THE HEAD 23 DAYS AFTER THE PRIMARY SURGERY AND THE SURGERY WAS COMPLETED SUCCESSFULLY. THE LINER WAS LEFT IN SITU.

  Patient problems: Joint Dislocation

  MAUDE report 11562515 ↗
• InjuryJun 16, 2020Appropriate Device Problem Term/Code Not Available

  THE PATIENT CAME IN 6 DAYS AFTER THE PRIMARY SURGERY DUE TO SIGNS OF INFECTION AND THE PATHOGEN IS UNKNOWN. THE SURGEON PERFORMED A WASHOUT AND REVISED THE MEDACTA HEAD WITH A MEDACTA HEAD AND ANOTHER COMPANY'S LINER WITH A COMPETITOR'S LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Unspecified Infection

  MAUDE report 10157886 ↗