Mectacer Biolox Delta Femoral Ball Head 01.29.201Recalls & reported problems

Summary

The FDA's MAUDE database contains 31 adverse event reports that list this exact device (DI 07630030809125), received between Dec 27, 2017 and Dec 20, 2025 — classified as 31 injuries.

The most frequently reported specific device problem is “Device Appears to Trigger Rejection” (12 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 31 reports, in the reporter's own words as published by the FDA.

• InjuryDec 20, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

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

  Patient problems: Medical device site infection

  MAUDE report 23858465 ↗
• InjuryNov 18, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ONE MONTH AFTER THE PRIMARY SURGERY, THE PATIENT RETURNED DUE TO AN EARLY-STAGE INFECTION OF AN UNKNOWN PATHOGEN. THE SURGEON PERFORMED A WASHOUT AND REPLACED THE STEM, LINER, AND HEAD. THE SURGERY WAS COMPLETED.

  Patient problems: Medical device site infection

  MAUDE report 23583103 ↗
• InjuryNov 18, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  ON (B)(6) 2025, THE PATIENT HAD PRIMARY LEFT HIP SURGERY. ON (B)(6) 2025, THE PATIENT CAME IN REPORTING PAIN DUE TO A LOOSE CUP AND THE CAUSE OF THE LOOSE CUP IS UNKNOWN. THE SURGEON REVISED THE CUP, LINER, AND HEAD. THE SURGERY WAS COMPLETED SUCCESSFULLY (MDR (B)(4)). ON (B)(6) 2025, THE PATIENT CAME IN DUE TO SIGNS OF AN INFECTION AND THE PATHOGEN IS UNKNOWN. THE SURGEON REVISED THE CUP, SCREWS, LINER, DM CONVERTER AND HEAD. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Medical device site infection

  MAUDE report 23579953 ↗
• InjuryOct 29, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  NO DISLOCATION WAS OBSERVED DURING THE TRIAL STABILITY TEST (USED BROACH, TRIAL NECK AND TRIAL HEAD WITH TRIAL LINER IN THE FINAL SHELL). HOWEVER, AFTER INSERTING THE HEAD, DISLOCATION OCCURRED IN EXTENSION AND EXTERNAL ROTATION OF THE HIP. BONE IMPINGEMENT AND INTERFERENCE WITH OTHER SOFT TISSUES WERE CHECKED, BUT NO SUCH INFLUENCE WAS IDENTIFIED. THE HEAD SIZE WAS CHANGED FROM S TO M, AND THE SURGERY WAS SUCCESSFULLY COMPLETED. THE DELAY WAS 30 MINUTES, AND THE TOTAL SURGICAL TIME WAS 2 HOURS. DURING THE 30 MINUTES, THE POSITIONING WAS ADJUSTED, AND THE HEAD WAS REMOVED, THOUGH THE REMOVAL WAS SOMEWHAT DIFFICULT. AFTER THAT, A NEW TRIAL WAS PERFORMED, AND THE HEAD WAS REINSERTED.

  Patient problems: Joint Dislocation

  MAUDE report 23412829 ↗
• InjuryJul 16, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  AT ABOUT 3 WEEKS 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 22518025 ↗
• InjuryJul 8, 2025Device 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 3 YEARS AND 7 MONTHS AFTER THE PRIMARY SURGERY, THE SURGEON PERFORMED A WASHOUT AND REVISED THE HEAD AND LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Medical device site infection

  MAUDE report 22434262 ↗
• InjuryJul 7, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  AT ABOUT 10 YEARS 4 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: Medical device site infection

  MAUDE report 22411002 ↗
• InjuryMay 26, 2025Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  AT ABOUT 10 YEARS AND 3 MONTHS FROM PRIMARY, THE PATIENT CAME IN REPORTING PAIN. THE SURGEON REVISED THE DM CUP/LINER TO A COMPETITOR CUP/LINER AND REVISED THE MEDACTA HEAD WITH A MEDACTA HEAD. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Pain

  MAUDE report 22084240 ↗
• InjuryJan 20, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE DAY AFTER THE PRIMARY SURGERY, THE PATIENT CAME REPORTED HIP INSTABILITY DUE TO A LEG LENGTH DISCREPANCY AND THE CAUSE IS REPORTED TO BE DUE TO IMPLANT SIZING.THE SURGEON REVISED THE HEAD AND LINER AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Joint Laxity; Unequal Limb Length

  MAUDE report 21189776 ↗
• InjuryNov 22, 2024Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  AT ABOUT 1 MONTH AFTER 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 20757061 ↗
• InjuryNov 5, 2024Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  AT ABOUT 11 YEARS 6 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 AND LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Unspecified Infection

  MAUDE report 20610086 ↗
• InjuryOct 11, 2024Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  AT ABOUT 7 MONTHS FROM THE PRIMARY, REVISION SURGERY DUE TO INFECTION. THE SURGEON PERFORMED A WASHOUT AND REVISED HEAD AND LINER. SURGERY COMPLETED SUCCESSFULLY.

  Patient problems: Medical device site infection; Unspecified Infection

  MAUDE report 20426611 ↗
• InjuryAug 8, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AT ABOUT 2 MONTHS AFTER THE PRIMARY, THE PATIENT CAME IN REPORTING A LEG LENGTH DISCREPANCY. THE SURGEON REVISED THE HEAD AND LINER AND ADDED AN OPTION SLEEVE. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Unequal Limb Length

  MAUDE report 19936769 ↗
• InjuryApr 9, 2024Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  REVISION SURGERY DUE TO SIGNS OF AN INFECTION AND THE PATHOGEN IS UNKNOWN. AT ABOUT 8 MONTHS POST PRIMARY THE SURGEON PERFORMED A WASHOUT AND REVISED THE HEAD AND LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Unspecified Infection

  MAUDE report 19070201 ↗
• InjuryMar 15, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AT ABOUT 5 MONTHS AFTER PRIMARY, THE PATIENT HAS BEEN REVISED ON THE RIGHT HIP SIDE BECAUSE OF LEG LENGTH DISCREPANCY. BALL HEAD AND DOUBLE MOBILITY LINER WERE REVISED SUCCESSFULLY.

  Patient problems: Unequal Limb Length

  MAUDE report 18911150 ↗
• InjuryJan 26, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AT ABOUT 1 YEAR AND 4 MONTHS FROM THE PRIMARY, THE PATIENT CAME IN REPORTING PAIN AND THE CAUSE WAS UNKNOWN. DURING THE REVISION SURGERY, A BONE TAMP WAS USED TO REMOVE THE HEAD AND THE DM LINER FROM THE TRUNION. AFTER HITTING ONCE WITH MALLET, THE CERAMIC HEAD BROKE INTO MULTIPLE PIECES WITHIN THE DM LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Pain

  MAUDE report 18585791 ↗
• InjuryJan 25, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AT ABOUT 4 MONTHS AFTER PRIMARY, THE PATIENT CAME IN DUE TO SIGNS OF 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 18578625 ↗
• InjuryJan 17, 2024Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  AT ABOUT 1 MONTH AND HALF 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 BIPOLAR AND FEMORAL HEAD. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Unspecified Infection

  MAUDE report 18525665 ↗
• InjuryDec 19, 2023Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  AT ABOUT 4 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 MEDACTA HEAD AND COMPETITOR LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Medical device site infection

  MAUDE report 18356420 ↗
• InjuryDec 11, 2023Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  AT ABOUT 9 YEARS AND 3 MONTHS AFTER PRIMARY, THE PATIENT CAME IN REPORTING INSTABILITY AND THE CAUSE OF THE INSTABILITY IS UNKNOWN. THE SURGEON REVISED THE MEDACTA HEAD AND LINER WITH A COMPETITOR'S COMPONENTS AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Joint Laxity

  MAUDE report 18301130 ↗
• InjuryAug 23, 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 10 MOTHS FORM PRIMARY THE SURGEON PERFORMED A WASHOUT AND REVISED THE HEAD AND LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Unspecified Infection

  MAUDE report 15275475 ↗
• InjuryJul 20, 2022Insufficient Device Problem Information

  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 AT ABOUT 20 DAYS FROM PRIMARY. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Unspecified Infection

  MAUDE report 15064922 ↗
• InjuryMay 8, 2021Adverse Event Without Identified Device or Use Problem

  2 YEARS AND 6 MONTHS 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 HEAD AND LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Unspecified Infection

  MAUDE report 11795343 ↗
• InjuryDec 3, 2020Unstable

  THE PATIENT CAME IN REPORTING INSTABILITY 1 YEAR AFTER THE PRIMARY SURGERY WHICH WAS CAUSED BY A LEG LENGTH DISCREPANCY. THE SURGEON REVISED THE 28MM BIOLOX DELTA HEAD S WITH A 40MM BIOLOX OPTION HEAD AND ADDED A BIOLOX OPTION SLEEVE M. THE SURGEON ALSO REVISED THE CUP AND LINER WITH COMPETITOR PRODUCTS. THE SURGERY WAS COMPLETED SUCCESSFULLY. THERE WAS NO PROBLEM WITH THE CUP, THE SURGEON REVISES IT IN ORDER TO MAKE IT FIT WITH THE SECOND HIP IMPLANTS.

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

  MAUDE report 10940366 ↗
• InjurySep 7, 2020Adverse Event Without Identified Device or Use Problem

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

  Patient problems: Unspecified Infection

  MAUDE report 10499304 ↗