Mectacer Biolox Option HeadsRecalls & reported problems across all models

We found 5 models of Mectacer Biolox Option Heads by Medacta International SA in the FDA's device registry (GUDID). Together they are named in 37 adverse event reports in the FDA's MAUDE database, received between Jul 14, 2017 and Sep 9, 2026 — classified as 37 injuries.

The most frequently reported specific device problem is “Device Appears to Trigger Rejection” (17 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

Most reported Mectacer Biolox Option Heads problems

Mectacer Biolox Option Heads models

5 models, most reported first. Each model has its own page with its reports, recalls and device details.

• Mectacer Biolox Option Heads 01.29.230H

  Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented
  16 reports
• Mectacer Biolox Option Heads 01.29.232H

  Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented
  12 reports
• Mectacer Biolox Option Heads 01.29.231H

  Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented
  4 reports
• Mectacer Biolox Option Heads 01.29.233H

  Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented
  4 reports
• Mectacer Biolox Option Heads 01.29.241A

  Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented
  1 report

Recent Mectacer Biolox Option Heads adverse event reports

The 15 most recent reports across all models, 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 9, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  AT ABOUT 1 YEAR FROM THE PRIMARY, THE PATIENT CAME IN DUE TO SIGNS OF AN INFECTION AND THE PATHOGEN IS UNKNOWN. THE SURGEON PERFORMED A WASHOUT, REMOVED ALL IMPLANTS, AND IMPLANTED NEW HARDWARE. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Medical device site infection

  MAUDE report 23758549 ↗
• 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 ↗
• 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 ↗
• InjuryOct 28, 2024Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  THE PATIENT HAD A PRIMARY HIP SURGERY ON (B)(6) 2021. ON (B)(6) 2022, 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 THE SURGERY WAS COMPLETED SUCCESSFULLY. ON (B)(6) 2023, THE PATIENT CAME IN DUE TO SIGNS OF AN INFECTION AND THE PATHOGEN IS UNKNOWN. THE SURGEON REVISED THE HEAD, SLEEVE AND LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY. PRESENTLY, 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; Unspecified Infection

  MAUDE report 20544237 ↗
• 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 ↗
• 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 ↗
• 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 ↗
• InjuryFeb 6, 2024Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  AT ABOUT 1 MONTH 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 STEM, HEAD AND LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Medical device site infection

  MAUDE report 18648765 ↗

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