Mectacer Biolox Delta Femoral Ball Head 01.29.211Recalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 07630030809224), received between Nov 9, 2018 and Sep 1, 2026 — classified as 12 injuries.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (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 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• InjurySep 1, 2026Device Appears to Trigger Rejection

  Patient problems: Medical device site infection

  MAUDE report 50543249 ↗
• InjuryJul 7, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  AT ABOUT 7 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. CUP WAS REVISED BECAUSE IT LOOKED LIKE IT WAS VERTICAL AND NOT ANTEVERTED ENOUGH TO THE SURGEON (CAUSE UNKNOWN). THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Joint Dislocation

  MAUDE report 22410970 ↗
• InjuryNov 5, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  AT ABOUT 9 MONTHS FROM THE PRIMARY, THE PATIENT CAME IN REPORTING PAIN DUE TO DISLOCATION OF THE HEAD FROM THE LINER. THE SURGEON REVISED THE HEAD AND LINER AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Implant Pain; Joint Dislocation

  MAUDE report 20609955 ↗
• 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 1 MONTHS POST PRIMARY THE SURGEON REVISED THE HEAD AND LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Implant Pain

  MAUDE report 20485135 ↗
• InjuryMay 8, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  THE PATIENT UNDERWENT PRIMARY SURGERY ON (B)(6) 2022. ON (B)(6) 2022, THE PATIENT HAS BEEN REVISED THE FIRST TIME BECAUSE OF SURGICAL WOUND ISSUES. CERAMIC BALL HEAD Ø36 SIZE XL AND LINER Ø36/E REVISED SUCCESSFULLY AND THE SURGEON IMPLANTED CERAMIC BALL HEAD (Ø36 SIZE XL) AND PE LINER. ON (B)(6) 2022, THE PATIENT UNDERWENT A SECOND REVISION SURGERY DUE TO JOINT LUXATION. BALL HEAD, LINER AND ACETABULAR SHELL HAVE BEEN SUCCESSFULLY REVISED AND VERSAFITCUP DM Ø58MM, LINER DM Ø28/58MM DMI AND COCR BALL HEAD Ø28 SIZE XL (+7) WERE IMPLANTED.

  Patient problems: Joint Dislocation

  MAUDE report 19267220 ↗
• InjuryMay 26, 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 3 MONTHS FROM PRIMARY THE SURGEON REMOVED ALL COMPONENTS AND IMPLANTED AN ANTIBIOTIC SPACER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Medical device site infection

  MAUDE report 17008949 ↗
• InjurySep 12, 2022Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  AT ABOUT 15 DAYS 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 MEDACTA HEAD AND COMPETITOR LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Unspecified Infection

  MAUDE report 15402222 ↗
• InjuryMar 2, 2021Adverse Event Without Identified Device or Use Problem

  THE PATIENT CAME IN REPORTING DISCOMFORT 7 MONTHS AFTER THE PRIMARY SURGERY DUE TO A LEG LENGTH DISCREPANCY. IT WAS DETERMINED THAT THE RIGHT LEG WAS LONGER THAN THE LEFT LEG. THE SURGEON REVISED THE 36MM BIOLOX DELTA HEAD XL WITH A 36MM BIOLOX DELTA HEAD M. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Discomfort; Unequal Limb Length

  MAUDE report 11397760 ↗
• InjuryFeb 3, 2021Inadequacy of Device Shape and/or Size

  THE PATIENT HAD RETURNED FOR A SECOND REVISION AFTER 1 YEAR AND 5 MONTHS FROM THE PREVIOUS REVISION, DUE TO COMPLICATED MUSCULOSKELETAL CONDITION THAT RESULTED IN HIM FEELING SHORTER ON THE LEFT SIDE DESPITE THE PREVIOUS REVISION TO A SIZE +8 HEAD. THE PATIENT HAS COMPLEX SCOLIOSIS AND NEURAL CORD DAMAGE CAUSING SUBSEQUENT MUSCLE WEAKNESS. THE LEG LENGTH AND OFFSET ON XR AND EXAMINATION OF THE PATIENT ARE SATISFACTORY, HOWEVER, THE PATIENT PREFERRED FOR THE LEG TO BE MADE LONGER. THE OPERATION WAS AGAIN VIA A BIKINI INCISION ANTERIOR APPROACH. THE CERAMIC HEAD WAS REMOVED AND A COMPETITOR HEAD AND SLEEVE WERE IMPLANTED.

  Patient problems: Muscle Weakness/Atrophy; Unequal Limb Length

  MAUDE report 11271949 ↗
• InjuryJul 21, 2020Appropriate Device Problem Term/Code Not Available

  THE PATIENT CAME IN 21 DAYS AFTER THE PRIMARY SURGERY DUE TO SIGNS OF 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 10301339 ↗
• InjuryJun 26, 2019Adverse Event Without Identified Device or Use Problem

  PATIENT SUFFERED OF WOUND INFECTION WHICH PASSED INTO THE JOINT. STAPHYLOCOCCUS WAS THE BACTERIAL INFECTION FOUND AFTER 2 HIP WASHOUTS THAT WERE COMPLETED PRIOR TO LINER AND HEAD EXCHANGE. IN THE REVISION SURGERY, 2 MONTHS AFTER PRIMARY, THE HEAD AND LINER WERE EXCHANGED TO PROVIDE NEW BEARING SURFACES. WE BECAME AWARE OF THE EVENT ON MAY 27TH AND THE REVISION SURGERY WAS PERFORMED ON MAY 29TH.

  Patient problems: Unspecified Infection

  MAUDE report 8734389 ↗
• InjuryNov 9, 2018Device Dislodged or Dislocated

  ON (B)(6) 2018 WE WERE INFORMED THAT THE PATIENT HAD COME IN COMPLAINING OF PAIN 2 YEARS AND A HALF AFTER PRIMARY. THE SURGEON DETERMINED THAT THE PATIENT WAS DISLOCATING (THE HEAD DISLOCATED FROM THE LINER). THE SURGEON REVISED THE BALL HEAD ON (B)(6) 2018. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Joint Dislocation

  MAUDE report 8054261 ↗