Mectacer Biolox Option Heads 01.29.232HRecalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 07630030809347), received between Jul 14, 2017 and Aug 13, 2025 — classified as 12 injuries.

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 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• InjuryAug 13, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  THE PATIENT HAD A PRIMARY HIP SURGERY ON (B)(6) 2018. ON (B)(6) 2025, THE PATIENT CAME IN REPORTING PAIN AND INSTABILITY DUE TO A LEG LENGTH DISCREPANCY AND LACK OF OFFSET. THE SURGEON REVISED THE HEAD AND LINER AND THE SURGERY WAS COMPLETED SUCCESSFULLY. PRESENTLY, ON (B)(6) 2025, THE PATIENT PRESENTED TO ER WITH A DISLOCATION OF THE HEAD FROM THE LINER AND THE CAUSE IS UNKNOWN. THE SURGEON REVISED THE MEDACTA HEAD TO A NEW MEDACTA COCR HEAD AND REVISED THE MEDACTA LINER TO A STRYKER SEMI-CONSTRAINED LINER TO PREVENT FUTURE DISLOCATION. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Joint Dislocation

  MAUDE report 22792527 ↗
• InjuryJul 14, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  THE PATIENT HAD PRIMARY SURGERY ON (B)(6) 2025. SUBSEQUENTLY THE PATIENT HAD REVISION SURGERY ON (B)(6) 2025 DUE TO AN INFECTION. THE SURGEON PERFORMED A WASHOUT AND REVISED THE HEAD AND LINER (MDR 2025-00650). PRESENTLY THE PATIENT CAME IN DUE TO SIGNS OF 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 22493701 ↗
• InjuryFeb 6, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  THE PATIENT HAD SIGNS OF INFECTION AND THE PATHOGEN IS UNKNOWN. AT 2 YEARS AND 3 MONTHS POST PRIMARY THE SURGEON REMOVED ALL COMPONENTS AND IMPLANTED AN ANTIBIOTIC SPACER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Medical device site infection

  MAUDE report 21320170 ↗
• InjurySep 18, 2024Malposition of Device; Device Dislodged or Dislocated; Malposition of Device; Device Dislodged or Dislocated

  THE PATIENT HAD A PRIMARY HIP SURGERY ON (B)(6) 2019. ON (B)(6) 2021, 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 HEAD AND LINER AND THE SURGERY WAS COMPLETED SUCCESSFULLY. ON THE (B)(6) 2024 (2 YEARS AND 10 MONTHS POST PRIMARY) THE PATIENT HAD PAIN DUE TO A DISLOCATION OF THE HEAD FROM THE LINER AND THE CAUSE IS UNKNOWN. THE SURGEON REVISED THE HEAD, CUP AND LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY. THE PRIMARY SURGEON USES A POSTERIOR APPROACH. THE REVISION SURGEON MENTIONED THAT THE CUP APPEARED TO HAVE TOO MUCH ANTEVERSION.

  Patient problems: Joint Dislocation

  MAUDE report 20244170 ↗
• InjuryJul 1, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT HAD A PRIMARY HIP SURGERY ON (B)(6) 2020. ON (B)(6) 2021, THE PATIENT CAME IN REPORTING PAIN DUE TO A LEG LENGTH DISCREPANCY. THE SURGEON REVISED THE HEAD AND LINER AND THE SURGERY WAS COMPLETED SUCCESSFULLY. ON (B)(6) 2022, THE PATIENT CAME IN REPORTING INSTABILITY AND LOOSENESS AND THE CAUSE IS UNKNOWN. DURING THE SURGERY, THE SURGEON DETERMINED THAT THE STEM WAS SOLID AND WELL FIXED, SO HE DECIDED TO REVISE THE CUP AND LINER WITH COMPETITOR COMPONENTS AND REVISE THE HEAD WITH A MEDACTA HEAD. THE SURGERY WAS COMPLETED SUCCESSFULLY. PRESENTLY, ON (B)(6) 2024, THE PATIENT CAME IN REPORTING PAIN DUE TO A LOOSE CUP AND UNSTABLE HIP AND THE CAUSE IS UNKNOWN. THE SURGEON REVISED THE HEAD, CUP AND LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Joint Laxity

  MAUDE report 19641455 ↗
• InjuryMar 14, 2024Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  THE PATIENT HAD A PRIMARY HIP SURGERY ON (B)(6) 2021. ON (B)(6) 2023, THE PATIENT CAME IN REPORTING PAIN DUE TO A FRACTURED FEMUR THAT WAS CAUSED FROM FALLING. THE SURGEON REVISED THE HEAD AND STEM AND THE SURGERY WAS COMPLETED SUCCESSFULLY. ON (B)(6) 2024, 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 18902570 ↗
• InjuryOct 27, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated

  THE PATIENT HAD PAIN DUE TO A DISLOCATION OF THE HEAD FROM THE LINER. AT ABOUT 3 WEEKS FROM PRIMARY, THE SURGEON REVISED THE HEAD AND LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Implant Pain

  MAUDE report 18021383 ↗
• InjuryOct 10, 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 DISLOCATION OF THE HEAD FROM THE LINER AND THE CAUSE IS UNKNOWN, THE SURGEON REVISED THE HEAD AND LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY. PRESENTLY, ON (B)(6) 2023, 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 17903327 ↗
• InjuryApr 26, 2023Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  THE PATIENT HAD A RIGHT PRIMARY HIP SURGERY ON (B)(6) 2022 AND A LEFT PRIMARY HIP SURGERY ON (B)(6)2022. ON (B)(6) 2022, THE PATIENT CAME IN REPORTING INSTABILITY IN BOTH HIPS AND THE SURGEON REVISED THE HEAD AND LINER ON BOTH THE RIGHT AND LEFT SIDES. PRESENTLY, ON (B)(6)2023, THE SURGEON DETERMINED THAT THE PATIENT WAS OVER-LENGTHENED IN BOTH HIPS. THE SURGEON REVISED THE HEAD, SLEEVE, AND LINER ON BOTH SIDES OF THE HIP AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

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

  MAUDE report 16813414 ↗
• InjuryAug 5, 2020Appropriate Device Problem Term/Code Not Available

  THE PATIENT HAS DEVELOPED AN INFECTION IN THE HIP FOLLOWING REVISION SURGERY PERFORMED 1 MONTH BEFORE. THE TYPE OF PATHOGEN IS UNKNOWN. THE SURGEON PERFORMED A WASHOUT. THE BALL HEAD WAS REVISED.

  Patient problems: Unspecified Infection

  MAUDE report 10366326 ↗
• InjuryApr 13, 2018Appropriate Device Problem Term/Code Not Available

  THE SALES REPRESENTATIVE HAS BEEN INFORMED BY SURGEON ON 16 MARCH 2018 THAT THE PATIENT CAME IN COMPLAINING OF HIP PAIN. THE SURGEON PLANS TO REVISE THE HIP ON (B)(6) 2018. ON (B)(6) 2018 THE REVISION SURGERY WAS PERFORMED DUE TO CHRONIC DISLOCATION 3 MONTHS AFTER PRIMARY . THE MEDACTA HEAD DISLOCATED ANTERIORLY FROM THE COMPETITOR REVISION HOODED LINER THAT WAS CEMENTED INTO COMPETITOR REVISION ACETABULAR CUP.

  Patient problems: Joint Dislocation

  MAUDE report 7428043 ↗
• InjuryJul 14, 2017Device Dislodged or Dislocated

  THE PATIENT HAD 3 DISLOCATIONS AND THE SURGEON DECIDED TO REVISE THE ACETABULAR COMPONENT.

  Patient problems: Joint Dislocation

  MAUDE report 6714018 ↗