Mectacer Biolox Delta Femoral Ball Head 01.29.202Recalls & reported problems

Summary

The FDA's MAUDE database contains 36 adverse event reports that list this exact device (DI 07630030809132), received between Nov 15, 2018 and Aug 3, 2026 — classified as 36 injuries.

The most frequently reported specific device problem is “Device Appears to Trigger Rejection” (14 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 36 reports, in the reporter's own words as published by the FDA.

• InjuryAug 3, 2026Device Appears to Trigger Rejection

  Revision surgery at about 20 days from primary due to infection.The surgeon performed a washout and revised the head and liner. The surgery was completed successfully.

  Patient problems: Medical device site infection

  MAUDE report 50114125 ↗
• InjuryApr 15, 2026Device Appears to Trigger Rejection

  REVISION SURGERY WAS PERFORMED 4 DAYS AFTER THE PRIMARY PROCEDURE DUE TO A DISCOLORED AND RASH-LIKE INCISION SITE OF UNKNOWN CAUSE. THE SURGEON PERFORMED AN IRRIGATION AND DEBRIDEMENT (I&D) AND REVISED THE HEAD AND LINER, REPLACING THEM WITH COMPONENTS OF THE SAME SIZE. THE SURGERY WAS SUCCESSFULLY COMPLETED.

  Patient problems: Medical device site infection

  MAUDE report 24882482 ↗
• InjuryDec 20, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  THE PATIENT HAD PRIMARY SURGERY WITH A COMPETITOR. ON (B)(6) 2025 THE PATIENT WAS REVISED FOR AN UNKNOWN REASON AND MEDACTA HARDWARE WAS IMPLANTED. ON (B)(6) 2025 THE PATIENT CAME IN DUE TO SIGNS OF AN INFECTION AND THE PATHOGEN WAS UNKNOWN. THE SURGEON PERFORMED A WASHOUT, REMOVED ALL IMPLANTS, AND IMPLANTED NEW HARDWARE. THE SURGERY WAS COMPLETED SUCCESSFULLY (MDR 2025-01232). PRESENTLY, 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 TO A LINER AND HEAD OF THE SAME SIZE. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Medical device site infection

  MAUDE report 23858477 ↗
• InjuryJul 25, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  AT ABOUT 2 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 COMPETITOR CUP AND LINER AND MEDACTA PROXIMAL BODY AND HEAD. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Medical device site infection

  MAUDE report 22607935 ↗
• InjuryJul 16, 2025Device Appears to Trigger Rejection; Migration; Device Appears to Trigger Rejection; Migration

  AFTER 2 YEARS AND 11 MONTHS, THE PATIENT CAME IN REPORTING PAIN DUE TO A SUBSIDED STEM THAT WAS CAUSED FROM AN INFECTION. THE PATHOGEN IS UNKNOWN. THE SURGEON PERFORMED A WASHOUT AND REVISED THE STEM, HEAD AND LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Medical device site infection

  MAUDE report 22518249 ↗
• InjuryJun 19, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  ON THE (B)(6) 2025, THE PATIENT UNDERWENT A HIP REVISION DUE TO FEMUR FRACTURE. COMPETITOR STEM WAS REMOVED, AMIS-K IMPLANTED AND CONTEXTUALLY MEDACTA DM CONVERTER IMPLANTED. AT ABOUT 1 MONTH FROM PREVIOUS REVISION, THE PATIENT RETURNED TO THE HOSPITAL REPORTING A DISLOCATION. AFTER AN ATTEMPT TO CLOSE-REDUCE THE DISLOCATION WITHOUT SURGERY, THE SURGEON DECIDED TO OPEN THE PATIENT AND FOUND THE HEAD DISLOCATED FROM THE DM LINER AND THE DM LINER DISLOCATED FROM THE DM CONVERTER. IT IS POSSIBLE THAT THE HEAD DISLOCATED FROM THE DM LINER DURING THE CLOSE-REDUCTION MANEUVER BUT THIS CANNOT BE CONFIRMED. SURGEON REVISED THE HEAD, LINER AND ALSO THE DM CONVERTER ALONG WITH THE CUP AS HE WAS NOT SATISFIED WITH ITS POSITION. KERBOUL CAGE AND VERCACEM IMPLANTED.

  Patient problems: Joint Dislocation

  MAUDE report 22288958 ↗
• InjuryMar 25, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  AT ABOUT 3 WEEKS FROM PRIMARY, THE PATIENT CAME IN DUE TO SIGNS OF 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 21687570 ↗
• InjuryMar 5, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  THE PATIENT CAME IN DUE TO SIGNS OF INFECTION AND THE PATHOGEN IS UNKNOWN. ABOUT 1 YEAR AND 9 MONTHS AFTER THE PRIMARY SURGERY, THE SURGEON REVISED THE COMPETITOR CUP AND LINER AND MEDACTA HEAD. THE SURGERY WAS COMPLETED.

  Patient problems: Medical device site infection

  MAUDE report 21523850 ↗
• InjuryOct 23, 2024Naturally Worn; Naturally Worn

  AT ABOUT 10 YEARS AND 1 MONTH AFTER PRIMARY, THE PATIENT CAME IN FOR A POST-OP APPOINTMENT AND THE HEAD AND LINER SEEMED TO BE WORN. THE CAUSES WERE UNKNOWN. THE SURGEON REVISED THE HEAD AND LINER AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20512204 ↗
• InjuryOct 8, 2024Device 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 1 MONTH AND A HALF 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 20396114 ↗
• InjuryMay 24, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT HAD HIP INSTABILITY DUE TO A LEG LENGTH DISCREPANCY AND THE CAUSE IS UNKNOWN. AT ABOUT 2 YEARS AND 1 MONTH POST PRIMARY THE SURGEON REVISED THE MEDACTA HEAD AND LINER WITH A NEW MEDACTA HEAD AND LINER AND REVISED THE MEDACTA CUP WITH A COMPETITOR CUP. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Pain; Unequal Limb Length

  MAUDE report 19392538 ↗
• InjuryMar 8, 2024Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  REVISION DUE TO SIGNS OF AN INFECTION AND THE PATHOGEN IS UNKNOWN. AT ABOUT 1 MONTH POST PRIMARY THE SURGEON PERFORMED A WASHOUT AND REVISED THE HEAD. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Unspecified Infection

  MAUDE report 18865035 ↗
• InjuryDec 13, 2023Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  AT ABOUT 2 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 18316743 ↗
• InjuryOct 31, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AT ABOUT 6 MONTHS AFTER THE PRIMARY, THE PATIENT CAME IN REPORTING PAIN AND INSTABILITY DUE TO A LEG LENGTH DISCREPANCY. THE SURGEON REVISED THE HEAD AND LINER AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Unequal Limb Length

  MAUDE report 18039859 ↗
• InjurySep 13, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT CAME IN DUE TO SIGNS OF AN INFECTION AND THE PATHOGEN IS UNKNOWN. AT ABOUT 7 MONTHS FROM PRIMARY THE SURGEON PERFORMED A WASHOUT AND REVISED THE HEAD AND LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Medical device site infection

  MAUDE report 17734946 ↗
• InjuryAug 10, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated

  THE PATIENT CAME IN REPORTING PAIN DUE TO A DISLOCATION OF THE HEAD FROM THE LINER AND THE CAUSE IS UNKNOWN. ABOUT 2 WEEKS AFTER THE PRIMARY SURGERY, THE SURGEON REVISED ALL COMPONENTS AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Implant Pain

  MAUDE report 17496768 ↗
• InjuryMay 10, 2023Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  THE PATIENT CAME IN DUE TO SIGNS OF AN INFECTION AND THE PATHOGEN WAS UNKNOWN. AT ABOUT 3 WEEKS POST PRIMARY THE SURGEON PERFORMED A WASHOUT AND REVISED THE HEAD AND LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Unspecified Infection

  MAUDE report 16900765 ↗
• InjuryMay 9, 2023Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  THE PATIENT CAME IN REPORTING ANTERIOR GROIN PAIN AND THE CAUSE IS UNKNOWN. BONE SCAN WAS GOOD AND THE PATIENT WAS NEGATIVE FOR ANY INFECTION. THERE WAS A SOFT TISSUE MASS THAT APPEARED ON ONE OF THE SCANS. ABOUT 9 MONTHS AFTER THE PRIMARY SURGERY, THE SURGEON REVISED THE MEDACTA CUP AND LINER WITH A COMPETITOR CUP AND LINER AND REVISED THE MEDACTA HEAD WITH A MEDACTA HEAD. DURING SURGERY, IT WAS FOUND THAT THE ANTERIOR CAPSULE AND THE SURROUNDING TISSUE WERE VERY THICK AND LEATHERY. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Pain

  MAUDE report 16893408 ↗
• InjuryApr 18, 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 MONTH AFTER 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 16761028 ↗
• InjuryMar 10, 2023Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  AT ABOUT 1 YEAR AND 4 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 SUCCESSFULLY THE HEAD AND LINER.

  Patient problems: Unspecified Infection

  MAUDE report 16521455 ↗
• InjuryDec 15, 2022Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  AT ABOUT 7 YEARS 8 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 15987317 ↗
• InjurySep 16, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AT ABOUT 6 MONTHS AFTER THE PRIMARY SURGERY, THE PATIENT CAME IN REPORTING PAIN AND INSTABILITY DUE TO A LEG LENGTH DISCREPANCY. THE SURGEON REVISED THE HEAD AND LINER AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Joint Laxity

  MAUDE report 15438966 ↗
• InjuryJun 1, 2022Appropriate Device Problem Term/Code Not Available

  THE PATIENT CAME IN REPORTING PAIN DUE TO DEVELOPING A HEMATOMA AND THE CAUSE IS UNKNOWN. AT 1 MONTH AFTER THE PRIMARY SURGERY, THE SURGEON REVISED THE HEAD AND LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Hematoma

  MAUDE report 14560052 ↗
• InjuryApr 6, 2022Appropriate Device Problem Term/Code Not Available

  THE PATIENT CAME IN DUE TO SIGNS OF AN INFECTION AFTER ABOUT 1 MONTH FROM THE PRIMARY SURGERY, 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 14021621 ↗
• InjuryMar 19, 2022Appropriate Device Problem Term/Code Not Available

  THE PATIENT HAD A PRIMARY HIP SURGERY ON (B)(6) 2019. ON (B)(6) 2021, THE PATIENT CAME IN DUE TO SIGNS OF AN INFECTION AND THE PATHOGEN WAS UNKNOWN. THE SURGEON PERFORMED A WASHOUT AND REVISED THE HEAD AND LINER. PRESENTLY, ON (B)(6) 2022, THE PATIENT CAME IN DUE TO SIGNS OF AN INFECTION AND THE PATHOGEN IS UNKNOWN. THE SURGEON REMOVED ALL COMPONENTS, PERFORMED A WASHOUT, AND REIMPLANTED NEW COMPONENTS. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Unspecified Infection

  MAUDE report 13826438 ↗