Mectacer Biolox Option Heads 01.29.230HRecalls & reported problems

Summary

The FDA's MAUDE database contains 16 adverse event reports that list this exact device (DI 07630030809323), received between Jul 30, 2019 and Sep 9, 2026 — classified as 16 injuries.

The most frequently reported specific device problem is “Device Appears to Trigger Rejection” (8 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 16 most recent of 16 reports, in the reporter's own words as published by the FDA.

• InjurySep 9, 2026Device Appears to Trigger Rejection

  The patient had primary right hip surgery on (b)(6)2026. On (b)(6)2026, the patient came in due to signs of infection and the pathogen is unknown. The surgeon performed a washout and revised the 28mm BIOLOX Delta Head M to a 28mm BIOLOX Option Head with Option Sleeve M, and revised the Double Mobility HC Liner D 28/DMG to a same size liner. The surgery was completed successfully. Presently, the patient came in due to continued signs of infection and the pathogen is unknown. The surgeon revised all components (stem, head, liner, cup) to antibiotic spacers until the infection clears. The surgery was completed successfully.

  Patient problems: Medical device site infection

  MAUDE report 50692320 ↗
• InjuryJul 1, 2026Device Appears to Trigger Rejection

  THE PATIENT HAD PRIMARY RIGHT HIP SURGERY ON (B)(6), 2020. ON (B)(6), 2025, THE PATIENT CAME IN WITH PAIN LOCATED IN THE PELVIC REGION AND THE CAUSE IS UNKNOWN. THE PATIENT BELIEVED THE PAIN WAS DUE TO SCREW PLACEMENT DURING PRIMARY SURGERY. THE SURGEON REMOVED THE 15MM AND 20MM SCREWS IMPLANTED DURING THE PRIMARY. THE SURGEON ALSO REVISED THE 36MM BIOLOX HEAD TO A 28MM BIOLOX HEAD, REVISED THE FLAT D 36 LINER TO A D 28 DOUBLE MOBILITY LINER, AND IMPLANTED A DM CONVERTER AND BIOLOX OPTION SLEEVE. THE SURGERY WAS COMPLETED SUCCESSFULLY (MDR 2025-01329). ON (B)(6), 2026, THE PATIENT HAD HIP INFECTION AND THE PATHOGEN IS UNKNOWN. THE SURGEON PERFORMED A WASHOUT, I&D, AND REVISED THE D 28/DMC LINER TO A SAME SIZE LINER, AND REVISED THE 28MM BIOLOX OPTION HEAD AND M SLEEVE TO A SAME SIZE HEAD AND SLEEVE. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Medical device site infection

  MAUDE report 25677109 ↗
• InjuryMay 8, 2026Device Appears to Trigger Rejection

  PRIMARY SURGERY (DATE UNKNOWN) THE PATIENT INITIALLY UNDERWENT PRIMARY HIP ARTHROPLASTY WITH COMPETITOR IMPLANTS. ON (B)(6) 2024, THE PATIENT PRESENTED WITH SIGNS OF INFECTION (UNKNOWN PATHOGEN). ALL COMPONENTS WERE REMOVED AND ANTIBIOTIC SPACERS WERE IMPLANTED. SURGERY WAS COMPLETED SUCCESSFULLY. ON (B)(6) 2024, THE PATIENT UNDERWENT REVISION SURGERY WITH REPLACEMENT OF ANTIBIOTIC SPACERS. ON (B)(6) 2024, THE SPACERS WERE REMOVED WITH IMPLANTATION OF A MEDACTA DISTAL STEM AND PROXIMAL BODY. ON (B)(6) 2024 (MDR: (B)(4), THE PATIENT CAME IN DUE TO SIGNS OF AN INFECTION AND THE PATHOGEN IS UNKNOWN. THE SURGEON PERFORMED A WASHOUT AND REVISED THE PROXIMAL BODY. ON (B)(6) 2025 (MDR: (B)(4), THE PATIENT CAME IN DUE TO SIGNS OF AN INFECTION AND THE PATHOGEN IS UNKNOWN. THE SURGEON REVISED THE PROXIMAL BODY. ON (B)(6) 2026, THE PATIENT CAME IN DUE TO AN ACUTE INFECTION. THE SURGEON PERFORMED WASH-OUT AND IMPLANTED A PERMANENT MEDACTA HEAD WITH SLEEVE AND REVISED THE PROXIMAL BODY. ON (B)(6) 2026, THE PATIENT CAME IN DUE TO CHRONIC INFECTION, ALL MEDACTA AND COMPETITOR COMPONENTS WERE REMOVED AND ANTIBIOTIC SPACERS WERE IMPLANTED. SURGERY WAS COMPLETED SUCCESSFULLY. ON (B)(6) 2026, THE PAT

  Patient problems: Medical device site infection

  MAUDE report 25123172 ↗
• InjuryDec 30, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CORRECTED DESCRIPTION: ONE WEEK AFTER PRIMARY, THE PATIENT CAME IN REPORTING PAIN DUE TO A LUXATION OF THE DOUBLE MOBILITY LINER FROM THE DM CONVERTER (METALLIC LINER). THE SURGEON REVISED HEAD, LINER AND DM CONVERTER. BIOLOX OPTION WAS USED DURING PRIMARY TO ACHIEVE AN XL LENGTH WHILE STILL RETAINING THE WEAR CHARACTERISTICS OF A CERAMIC HEAD FOR A SIZE 28MM DIAMETER. THE CAUSE OF THE DISLOCATION IS UNKNOWN. THE SURGERY WAS COMPLETED SUCCESSFULLY. THE PATIENT CAME BACK ON THE (B)(6) WITH SIGNS OF AN INFECTION, (B)(4) WAS FILED.

  Patient problems: Implant Pain; Joint Dislocation

  MAUDE report 21033632 ↗
• InjuryNov 19, 2024Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  AT ABOUT 2 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 20723146 ↗
• InjuryAug 20, 2024Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  THE PATIENT HAD A PRIMARY HIP SURGERY ON (B)(6) 2014. ON (B)(6) 2024 SHELL, HEAD AND LINER WERE REVISED SUCCESSFULLY. THE PATIENT LUXATED HIS HIP AND SUSTAINED A CLOSED REDUCTION, BUT AFTER THIS, IN THE X-RAYS DONE IN THE ER, IT WAS NOTICED THAT THE SHELL WAS OUT OF THE ACETABULUM BONE. IT IS UNKNOWN IF THE LUXATION WAS DUE TO THE CUP FAILURE OR IF THE CUP FAILURE WAS GENERATED DURING THE CLOSED REDUCTION. PRESENTLY, THE PATIENT CAME IN DUE TO SIGNS OF INFECTION AND THE PATHOGEN IS UNKNOWN. THE SURGEON PERFORMED A WASHOUT, EXPLANTED ALL IMPLANTS AND PLACED AN ANTIBIOTIC SPACER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Medical device site infection

  MAUDE report 20005705 ↗
• InjuryDec 15, 2023Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  AT ABOUT 2 MONTHS AFTER PRIMARY, THE PATIENT CAME IN DUE TO SIGNS OF INFECTION AND THE PATHOGEN IS UNKNOWN. THE SURGEON PERFORMED A WASHOUT AND REVISED THE HEAD, LINER AND OPTION SLEEVE. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Medical device site infection

  MAUDE report 18334851 ↗
• InjuryJun 12, 2023Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  THE PATIENT HAD A PRIMARY HIP SURGERY ON (B)(6) 2023. ON (B)(6) 2023, THE PATIENT CAME IN REPORTING PAIN DUE TO A A DISLOCATION OF THE MEDACTA HEAD FROM A COMPETITOR LINER AND THE CAUSE IS UNKNOWN. THE SURGEON REVISED COMPETITOR CUP AND LINER AND MEDACTA HEAD. THE SURGERY WAS COMPLETED SUCCESSFULLY. PRESENTLY, ON (B)(6) 2023, THE PATIENT CAME 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 17105641 ↗
• InjuryNov 30, 2022Device Dislodged or Dislocated; Device Dislodged or Dislocated

  THE PATIENT CAME IN FOR A PRIMARY HIP SURGERY ON (B)(6) 2022. ON (B)(6) 2022, THE PATIENT CAME IN REPORTING PAIN DUE TO A DISLOCATION OF THE HEAD FROM THE LINER AND THE CAUSE WAS UNKNOWN. THE SURGEON REVISED THE HEAD AND LINER AND SURGERY WAS COMPLETED SUCCESSFULLY. PRESENTLY, ON (B)(6) 2022, 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 SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Pain

  MAUDE report 15885751 ↗
• InjuryOct 18, 2022Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  THE PATIENT HAD A PRIMARY HIP SURGERY ON (B)(6) 2022. ON (B)(6) 2022, 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. ON (B)(6) 2022, 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 15624382 ↗
• InjuryMay 6, 2021Appropriate Device Problem Term/Code Not Available

  SIGNS OF INFECTION 2 YEARS AFTER FIRST REVISION SURGERY DUE TO INFECTION. WASHOUT PERFORMED AND HEAD REVISED.

  Patient problems: Unspecified Infection

  MAUDE report 11782890 ↗
• InjuryNov 3, 2020Device Dislodged or Dislocated; Appropriate Device Problem Term/Code Not Available

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

  Patient problems: Joint Dislocation

  MAUDE report 10776751 ↗
• InjuryJul 20, 2020Device Dislodged or Dislocated

  THE PATIENT HAD A PRIMARY HIP SURGERY ON (B)(6) 2015. SUBSEQUENTLY, THE PATIENT CAME IN REPORTING PAIN AND ON (B)(6) 2020, THE SURGEON REVISED THE MEDACTA CUP AND LINER WITH ANOTHER COMPANY'S PRODUCT AND REVISED THE MEDACTA HEAD WITH A MEDACTA HEAD. PRESENTLY (4 MONTHS AFTER PREVIOUS SURGERY), THE PATIENT CAME IN REPORTING PAIN DUE TO A DISLOCATION OF THE MEDACTA HEAD FROM THE COMPETITOR'S LINER. THE SURGEON REVISED ALL IMPLANTS WITH ANOTHER COMPANY'S PRODUCT AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Joint Disorder

  MAUDE report 10294912 ↗
• InjuryFeb 6, 2020Device Dislodged or Dislocated

  THE PATIENT CAME IN REPORTING PAIN DUE TO A DISLOCATION. THE CAUSE OF THE DISLOCATION IS UNKNOWN. THE SURGEON INITIALLY PLANNED TO REVISE THE CUP, BUT AFTER OPENING THE PATIENT DECIDED TO ONLY REVISE THE SLEEVE AND HEAD DUE TO THE PATIENT HAVING POOR BONE QUALITY AND AGE. THE SURGERY WAS COMPLETED SUCCESSFULLY ALMOST 5 MONTHS AFTER PRIMARY.

  Patient problems: Joint Dislocation

  MAUDE report 9675276 ↗
• InjurySep 10, 2019Appropriate Device Problem Term/Code Not Available

  THE PATIENT CAME IN, 3 WEEKS AFTER PRIMARY SURGERY, DUE TO SIGNS OF AN INFECTION AND THE PATHOGEN IS UNKNOWN. THE SURGEON REVISED THE MEDACTA 28MM BIOLOX OPTION HEAD WITH A 28MM BIOLOX OPTION HEAD, A MEDACTA BIOLOX OPTION SLEEVE XL WITH A BIOLOX OPTION SLEEVE XL AND A MEDACTA VERSAFITCUP DM LINER HC 54/28 WITH A VERSAFITCUP DM LINER HC 54/28. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Unspecified Infection

  MAUDE report 8979021 ↗
• InjuryJul 30, 2019Appropriate Device Problem Term/Code Not Available

  REVISION SURGERY PERFORMED 15 DAYS FROM THE PRIMARY DUE TO AN INFECTION (THE PATHOGEN IS UNKNOWN). THE SURGEON PERFORMED AN I&D AND REVISED THE HEAD, LINER, AND SLEEVE AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Unspecified Infection

  MAUDE report 8841135 ↗