Mectacer Biolox Delta Femoral Ball Head 01.29.215Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 07630030809262), received between Oct 20, 2022 and Apr 14, 2026 — classified as 7 injuries, 1 malfunction.

The most frequently reported specific device problem is “Device Appears to Trigger Rejection” (4 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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• InjuryApr 14, 2026Adverse Event Without Identified Device or Use Problem

  ABOUT 7 MONTHS AFTER THE PRIMARY SURGERY, THE PATIENT CAME IN REPORTING PAIN AGAIN AND THE CAUSE IS UNKNOWN. THE LABS FOR INFECTION WERE NEGATIVE AND THERE WERE NO INDICATIONS OF TRAUMA. THE SURGEON REVISED THE 40MM BIOLOX XL HEAD TO A 28MM BIOLOX M HEAD, THE D 40 FLAT PE HC LINER TO A D 28 DOUBLE MOBILITY HC LINER, AND IMPLANTED A DC CONVERTER. THE SURGERY WAS COMPLETED SUCCESSFULLY. THE PATIENT HAD PREVIOUSLY PRESENTED COMPLAINING OF PAIN AND THE SURGEON HAD DRAINED FLUID FROM THE HIP, BUT THE CAUSE HAD NOT BEEN IDENTIFIED IN THAT INSTANCE EITHER.

  Patient problems: Implant Pain

  MAUDE report 24871704 ↗
• InjuryFeb 12, 2026Device Appears to Trigger Rejection

  AT ABOUT 1 MONTH 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. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Medical device site infection

  MAUDE report 24321121 ↗
• MalfunctionSep 30, 2025Fracture; Fracture

  THE ANTIROTATIONAL INSERT OF THE TRIAL OFFSET 5MM BROKE. BROKEN PART RETRIEVED AND SURGERY COMPLETED SUCCESSFULLY. APPROXIMATELY 45 MINUTES OF DELAY OCCURRED TO REMOVE THE BROKEN PART. THE SURGEON HAD TO BURR AROUND THE SITE TO GET ACCESS WITH A TRAUMA-THREADED REMOVAL TOOL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23179116 ↗
• InjuryDec 30, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  THE PATIENT HAD A PRIMARY HIP SURGERY ON (B)(6) 2023. ON (B)(6) 2024, THE PATIENT CAME IN REPORTING PAIN DUE TO AN ANTEVERTED CUP. THE SURGEON REVISED THE MEDACTA CUP AND LINER WITH COMPETITOR COMPONENTS AND REVISED THE MEDACTA HEAD WITH A MEDACTA HEAD. THE SURGERY WAS COMPLETED SUCCESSFULLY. PRESENTLY, ON (B)(6) 2024, THE PATIENT CAME IN REPORTING PAIN DUE TO A HIP SUBLUXATION (BETWEEN MEDACTA HEAD AND COMPETITOR LINER) AND THE CAUSE IS UNKNOWN. THE SURGEON REVISED MEDACTA HEAD AND COMPETITOR'S LINER AND CUP AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Subluxation

  MAUDE report 21033591 ↗
• InjuryOct 28, 2024Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  AT ABOUT 3 WEEKS 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 AND LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Unspecified Infection

  MAUDE report 20543357 ↗
• InjuryNov 22, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated

  THE PATIENT HAD A PRIMARY HIP SURGERY ON (B)(6) 2019. SUBSEQUENTLY, THE HEAD DISLOCATED FROM THE LINER. ON (B)(6) 2022, THE SURGEON REVISED THE HEAD AND LINER. SUBSEQUENTLY, THE PATIENT CAME IN DUE TO SIGNS OF INFECTION AND THE PATHOGEN WAS UNKNOWN. ON (B)(6) 2022, THE SURGEON PERFORMED A WASHOUT AND REVISED THE HEAD AND LINER. SUBSEQUENTLY, THE PATIENT CAME IN DUE TO SIGNS OF INFECTION AND THE PATHOGEN WAS UNKNOWN. ON (B)(6) 2023, THE SURGEON PERFORMED A WASHOUT, REVISED ALL IMPLANTS. SUBSEQUENTLY, THE PATIENT CAME IN SUE TO SIGNS OF INFECTION AND THE PATHOGEN WAS UNKNOWN. ON (B)(6) 2023, THE SURGEON PERFORMED A WASHOUT, REVISED ALL IMPLANTS. PRESENTLY, THE PATIENT CAME IN DUE TO A DISLOCATION OF THE HEAD FROM THE LINER. ON (B)(6)2023, THE SURGEON REVISED THE HEAD AND LINER AND IMPLANTED A DM CONVERTER.

  Patient problems: Pain

  MAUDE report 18191308 ↗
• InjurySep 19, 2023Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  THE PATIENT CAME IN DUE TO SIGNS OF AN INFECTION AND THE PATHOGEN IS UNKNOWN. AT ABOUT 1 YEAR FROM THE PRIMARY THE SURGEON PERFORMED A WASHOUT, REMOVED ALL IMPLANTS, AND IMPLANTED NEW IMPLANTS. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Unspecified Infection

  MAUDE report 17773625 ↗
• InjuryOct 20, 2022Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  THE PATIENT CAME IN DUE TO SIGNS OF AN INFECTION AND THE PATHOGEN IS UNKNOWN. AT ABOUT 1 MONTH FROM 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 15637257 ↗