Mectacer Biolox Delta Femoral Ball Head 01.29.204Recalls & reported problems

Summary

The FDA's MAUDE database contains 62 adverse event reports that list this exact device (DI 07630030809156), received between Jul 25, 2017 and Sep 9, 2026 — classified as 62 injuries.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (27 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 25 most recent of 62 reports, in the reporter's own words as published by the FDA.

• InjurySep 9, 2026Device Dislodged or Dislocated

  The patient had pain due to joint luxation; the head came off the liner, and the cause is unknown. There was no indication of trauma or fall. At about 1 month and a half post-primary. The surgeon revised the two-hole Acetabular shell to an Mpact DM Acetabular shell D 50, revised the 32mm Biolox Head S to a 28mm Biolox head L, and revised the Flat PE HC liner D 32/D to a Double Mobility HC Liner D 28/DME. The surgery was completed successfully.

  Patient problems: Implant Pain; Joint Dislocation

  MAUDE report 50692309 ↗
• InjuryJun 17, 2026Device Appears to Trigger Rejection

  ON (B)(6) 2026, THE PATIENT HAD PRIMARY RIGHT HIP SURGERY WITH MEDACTA PRODUCTS. ON (B)(6) 2026, THE PATIENT CAME IN DUE TO SIGNS OF INFECTION AND THE PATHOGEN IS UNKNOWN. THE SURGEON PERFORMED A WASHOUT, I&D, AND REVISED THE 32 MM BIOLOX S HEAD AND D 32/D LINER TO A SAME SIZE HEAD AND LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY [MDR (B)(4)]. PRESENTLY, ON (B)(6) 2026, THE PATIENT CAME IN DUE TO CONTINUED SIGNS OF INFECTION AND THE PATHOGEN IS UNKNOWN. THE SURGEON REMOVED THE CUP, LINER, HEAD, AND STEM AND REPLACED THEM WITH ANTIBIOTIC SPACERS TO TREAT THE INFECTION. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Medical device site infection

  MAUDE report 25528760 ↗
• InjuryMay 26, 2026Adverse Event Without Identified Device or Use Problem

  THE PATIENT CAME IN PRESENTING INSTABILITY AND THE CAUSE IS UNKNOWN. ABOUT 9 YEARS AFTER THE PRIMARY SURGERY, THE SURGEON REVISED THE 32MM BIOLOX HEAD S TO A 28MM BIOLOX OPTION HEAD WITH SLEEVE SIZE M. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Joint Laxity

  MAUDE report 25275468 ↗
• InjuryMay 8, 2026Device Dislodged or Dislocated

  REVISION SURGERY DUE TO IMPLANT DISLOCATION AFTER ABOUT 2 MONTHS FROM THE PRIMARY SURGERY. DURING THE SURGERY THE HEAD WAS CHANGED FROM SIZE S TO SIZE M.

  Patient problems: Joint Dislocation

  MAUDE report 25123205 ↗
• InjuryApr 30, 2026Device Appears to Trigger Rejection

  AT ABOUT 2 WEEKS AFTER THE PRIMARY, THE PATIENT CAME IN DUE TO SIGNS OF INFECTION AND THE PATHOGEN IS UNKNOWN. THE SURGEON PERFORMED A WASHOUT, I&D, AND REVISED THE 32MM BIOLOX S HEAD AND D 32/D LINER TO A SAME SIZE HEAD AND LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Medical device site infection

  MAUDE report 25039923 ↗
• InjuryApr 23, 2026Device Dislodged or Dislocated

  THE PATIENT CAME IN DUE TO A DISLOCATION OF THE HEAD FROM THE LINERAFTER ABOUT 20 DAYS FROM THE PRIMARY. THERE WAS NO INDICATION OF A FALL THAT CONTRIBUTED TO THE DISLOCATION. THE SURGEON REVISED THE MEDACTA CUP AND LINER TO A COMPETITOR CUP AND LINER AND REVISED THE HEAD TO AN OPTION HEAD WITH SLEEVE. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Joint Dislocation

  MAUDE report 24964778 ↗
• InjuryFeb 18, 2026Device Appears to Trigger Rejection

  AT ABOUT 9 MONTHS FROM THE PRIMARY, THE PATIENT CAME IN DUE TO SIGNS OF INFECTION AND MRSA AND THE CAUSE IS UNKNOWN. THE SURGEON PERFORMED A WASHOUT AND REMOVED ALL PRIMARY IMPLANTS FOR ANTIBIOTIC SPACERS. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Medical device site infection

  MAUDE report 24376301 ↗
• InjuryJan 23, 2026Device Dislodged or Dislocated

  AT ABOUT 1 MONTH FROM THE PRIMARY, THE PATIENT CAME IN DUE TO PAIN AS THE RESULT OF A DISLOCATION OF THE HEAD AND LINER AND THE CAUSE IS UNKNOWN. THE SURGEON REVISED THE MEDACTA CUP AND LINER TO A COMPETITOR CUP AND LINER, AND REVISED THE MEDACTA D 32MM BIOLOX HEAD S WITH A MEDACTA COCR 12/14 D 28MM XXL HEAD. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Joint Dislocation

  MAUDE report 24162755 ↗
• InjuryJan 9, 2026Device Dislodged or Dislocated

  AT 3 WEEKS FROM PRIMARY, THE PATIENT CAME IN REPORTING PAIN DUE TO A DISLOCATION OF THE HEAD FROM THE LINER AND THE CAUSE IS UNKNOWN. THE SURGEON REVISED HEAD. THE SURGERY WAS COMPLETED SUCCESSFULLY. THE REP IS UNSURE IF TRAUMA OCCURRED.

  Patient problems: Joint Dislocation

  MAUDE report 24020875 ↗
• 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 REVISED THE HEAD AND LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Medical device site infection

  MAUDE report 23583099 ↗
• InjuryNov 10, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  AT ABOUT 20 DAYS AFTER THE PRIMARY, 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.

  Patient problems: Joint Dislocation

  MAUDE report 23510651 ↗
• InjuryNov 4, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  AFTER 2 YEARS AND 7 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 23462128 ↗
• InjurySep 10, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT CAME IN REPORTING PAIN AND INSTABILITY DUE TO A LEG LENGTH DISCREPANCY AND THE CAUSE IS UNKNOWN. ABOUT 2 MONTHS AFTER THE PRIMARY SURGERY, THE SURGEON REVISED THE HEAD (32 S TO 32 0) TO GIVE THE PATIENT MORE STABILITY. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Unequal Limb Length

  MAUDE report 23013596 ↗
• InjuryAug 27, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  AFTER 2 MONTHS FROM THE PRIMARY SURGERY, THE PATIENT CAME IN DUE TO SIGNS OF INFECTION, AND THE PATHOGEN IS UNKNOWN. THE SURGEON REMOVED ALL COMPONENTS AND IMPLANTED AN ANTIBIOTIC SPACER. THE SURGERY WAS SUCCESSFULLY COMPLETED.

  Patient problems: Medical device site infection

  MAUDE report 22903493 ↗
• InjuryJul 3, 2025Device Dislodged or Dislocated; Adverse Event Without Identified Device or Use Problem; Device Dislodged or Dislocated; Adverse Event Without Identified Device or Use Problem

  AT ABOUT 4 MONTHS FROM PRIMARY, 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 AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Implant Pain

  MAUDE report 22395930 ↗
• InjuryJul 2, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  AFTER 1 MONTH FROM 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: Medical device site infection

  MAUDE report 22384185 ↗
• InjuryMay 21, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  AT ABOUT 1 MONTH AND HALF 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 LINER, HEAD, SCREW AND CUP. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Implant Pain

  MAUDE report 22060081 ↗
• InjuryMay 5, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AT ABOUT 8 MONTHS AFTER PRIMARY, THE PATIENT CAME IN REPORTING PAIN AND INSTABILITY DUE TO A LEG LENGTH DISCREPANCY AND THE CAUSE IS KNOWN. THE SURGEON REVISED THE HEAD AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Joint Laxity; Pain; Unequal Limb Length

  MAUDE report 21960295 ↗
• InjuryDec 30, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AT ABOUT 8 MONTHS AFTER THE PRIMARY, THE PATIENT CAME IN REPORTING PAIN DUE TO A LEG LENGTH DISCREPANCY. THE SURGEON REVISED THE HEAD AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Implant Pain

  MAUDE report 21033512 ↗
• InjuryOct 25, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  AT ABOUT 2 MONTHS AFTER THE PRIMARY, THE PATIENT CAME IN REPORTING PAIN DUE TO A JOINT LUXATION AND THE CAUSE IS UNKNOWN. THE SURGEON REVISED THE HEAD, CUP AND LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Implant Pain

  MAUDE report 20539547 ↗
• InjuryJul 12, 2024Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  AT 8 MONTHS FROM THE PRIMARY, REVISION SURGERY DUE TO THE PRESENCE OF SCAR TISSUE SEROMA AND SUSPICION OF INFECTION. MOBILE COMPONENTS, INLAY AND HEAD SUCCESSFULLY REVISED.

  Patient problems: Unspecified Infection

  MAUDE report 19731016 ↗
• InjuryMay 24, 2024Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  AT ABOUT 9 MONTHS AFTER 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. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Unspecified Infection

  MAUDE report 19390100 ↗
• InjuryApr 23, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  WHILE IN POST-OP RECOVERY AT THE HOSPITAL, THE PATIENT DISLOCATED THE HIP (THE HEAD DISLOCATED FROM THE LINER). THE SURGEON REVISED THE HEAD AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Joint Dislocation

  MAUDE report 19163665 ↗
• InjuryMar 27, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  REVISION DUE TO A DISLOCATION OF THE HEAD FROM THE LINER AND THE CAUSE IS UNKNOWN. AT ABOUT 1 MONTH POST PRIMARY THE SURGEON REVISED THE HEAD AND LINER AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Joint Dislocation

  MAUDE report 18984913 ↗
• InjuryMar 22, 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 IS UNKNOWN. THE SURGEON REVISED THE CUP AND LINER WITH COMPEITOR CUP AND LINER AND REVISED THE MEDACTA HEAD WITH A MEDACTA HEAD (Ø 32 SIZE S TO Ø22.2 MM SIZE M). THE SURGERY WAS COMPLETED SUCCESSFULLY. ANTERIOR APPROACH USED DURING THE PRIMARY SURGERY.

  Patient problems: Joint Dislocation

  MAUDE report 18959162 ↗