Mectacer Biolox Delta Femoral Ball Head 01.29.213Recalls & reported problems

Summary

The FDA's MAUDE database contains 29 adverse event reports that list this exact device (DI 07630030809248), received between Mar 24, 2020 and Jul 8, 2026 — classified as 29 injuries.

The most frequently reported specific device problem is “Device Appears to Trigger Rejection” (13 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 29 reports, in the reporter's own words as published by the FDA.

• InjuryJul 8, 2026Device Appears to Trigger Rejection

  AT ABOUT 1 MONTHS FROM THE PRIMARY, THE PATIENT CAME IN DUE TO SIGNS OF INFECTION AND THE CAUSE IS UNKNOWN. THE SURGEON PERFORMED A WASHOUT AND REVISED THE FLAT PE HC LINER D 40/F TO A FACE CHANGING 10° PE HC LINER D 40/G AND THE 40MM BIOLOX HEAD M TO A SIZE S. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Medical device site infection

  MAUDE report 25747742 ↗
• InjuryJul 1, 2026Device Appears to Trigger Rejection

  REVISION SURGERY DUE TO INFECTION AFTER ABOUT 2 YEARS AND 6 MONTHS FROM PRIMARY.THE SURGEON PERFORMED A WASHOUT, I&D, AND REVISED THE 40MM BIOLOX HEAD M TO A 40MM BIOLOX OPTION HEAD WITH SLEEVE, AND REVISED THE FLAT PE HC LINER D 40/G TO A SAME SIZE LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Medical device site infection

  MAUDE report 25677104 ↗
• InjuryMar 30, 2026Device Dislodged or Dislocated

  AT ABOUT 3 MONTHS FROM THE PRIMARY,THE PATIENT CAME IN DUE TO A DISLOCATION OF THE HEAD FROM THE LINER AND THE CAUSE IS UNKNOWN. THE SURGEON OBSERVED AN AVULSED RECTUS FEMORIS AND LUMBAR ARTHRITIS, RESULTING IN LIMITED MOBILITY. THE MPACT D 40/G LINER WAS REVISED TO A DOUBLE MOBILITY D 28/DMF LINER, AND THE 40 MM BIOLOX DELTA HEAD (SIZE M) WAS REPLACED WITH A BIOLOX DELTA HEAD OF THE SAME SIZE USING A SENSITIN DM CONVERTER. NO FALL OR TRAUMA WAS REPORTED, AND X-RAYS ARE UNAVAILABLE. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Joint Dislocation

  MAUDE report 24710934 ↗
• InjuryMar 16, 2026Adverse Event Without Identified Device or Use Problem

  REVISION SURGERY DUE TO LEG LENGTH DISCREPANCY, AT 6 MONTHS FROM PRIMARY SURGERY AND THE CAUSE IS UNKNOWN. THE SURGEON ELECTED TO UPSIZE THE 40MM BIOLOX M HEAD TO A 40MM BIOLOX XL HEAD TO ADDRESS THE DISCREPENCY. THE SURGERY WAS COMPLETED SUCCESSFULLY. AI: IMPLANTED - 01.29.215 40MM BIOLOX DELTA HEAD XL 2101468.

  Patient problems: Unequal Limb Length

  MAUDE report 24603557 ↗
• InjuryJan 29, 2026Device Appears to Trigger Rejection

  REVISION SURGERY AFTER 1 MONTH POST-PRIMARY DUE TO INFECTION. THE SURGEON REVISED THE LINER AND THE HEAD TO ADDRESS THE INFECTION.

  Patient problems: Medical device site infection

  MAUDE report 24208591 ↗
• InjuryJan 23, 2026Device Dislodged or Dislocated

  REVISION SURGERY AFTER 1 MONTH AFTER THE PRIMARY DUE TO A DISLOCATION OF THE HEAD AND LINER.THE SURGEON REVISED THE HEAD, LINER, AND CUP TO A DOUBLE MOBILITY SYSTEM TO PREVENT DISLOCATION. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Joint Dislocation

  MAUDE report 24162753 ↗
• InjuryDec 30, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AT 5 MONTHS FROM PRIMARY, THE PATIENT CAME IN PRESENTING PAIN DUE TO IMPINGEMENT BETWEEN THE HEAD AND THE PSOAS TENDON. THE SURGEON DOWNSIZED THE 40MM BIOLOX HEAD M TO A 36MM BIOLOX OPTION HEAD WITH SLEEVE AND DOWNSIZED THE MPACT D 40 LINER TO AN MPACT D 36 LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Joint Impingement

  MAUDE report 23920165 ↗
• InjuryDec 10, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  AT ABOUT 14 DAYS FROM THE PRIMARY, 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 LINER AND HEAD AND IMPLANTED A DM CONVERTER. THE STEM WAS ALSO REVISED TO ADJUST LEG LENGTH. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Joint Dislocation

  MAUDE report 23768144 ↗
• InjuryNov 10, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  AT 1 MONTH FROM PRIMARY, THE PATIENT CAME IN DUE TO 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 23510646 ↗
• InjurySep 17, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  AT ABOUT 1 YEAR AND 3 MONTHS THE PATIENT CAME IN DUE TO SIGNS OF AN INFECTION AND THE CAUSE IS UNKNOWN. THE SURGEON PERFORMED A SWAP OF THE LINER AND HEAD. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Medical device site infection

  MAUDE report 23070839 ↗
• InjuryJul 8, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  4 MONTHS AFTER THE REVISION SURGERY FOR LOOSENING OF THE CUP AND INSTABILITY, 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 22435819 ↗
• InjuryJul 1, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  AT ABOUT 2 MONTHS FROM PRIMARY, 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 CUP, HEAD AND LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Joint Dislocation

  MAUDE report 22371288 ↗
• InjuryMay 30, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  AT ABOUT 1 MONTH 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 22113330 ↗
• InjuryNov 25, 2024Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  THE PATIENT HAD A PRIMARY HIP SURGERY ON (B)(6) 2024. 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. ON (B)(6) 2024, THE PATIENT CAME IN DUE TO SIGNS OF INFECTION AND THE PATHOGEN IS UNKNOWN. THE SURGEON PERFORMED A WASHOUT AND REVISED THE STEM, HEAD AND LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY. PRESENTLY, ON (B)(6) 2024, THE PATIENT CAME IN DUE TO SIGNS OF 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: Unspecified Infection

  MAUDE report 20769966 ↗
• InjurySep 25, 2024Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  AT ABOUT 3 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 INER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Unspecified Infection

  MAUDE report 20298883 ↗
• InjuryAug 26, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  AT ABOUT 3 MONTHS AFTER THE PRIMARY, THE PATIENT CAME IN REPORTING PAIN DUE TO A JOINT LUXATION. THE SURGEON REVISED THE HEAD AND LINER AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Implant Pain

  MAUDE report 20062473 ↗
• InjuryJun 26, 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. AT 11 DAYS 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 19611929 ↗
• InjuryMay 15, 2024Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  THE PATIENT HAD A PRIMARY HIP SURGERY ON (B)(6) 2020. ON (B)(6) 2021, THE PATIENT CAME IN REPORTING PAIN AND INSTABILITY. POST-OP X-RAYS INDICATED THAT THE STEM HAD SUBSIDED AND A PHYSICAL EXAMINATION REVEALED A LEG LENGTH DISCREPANCY OF GREATER THAN 1 CM. THE SURGEON REVISED THE PROXIMAL BODY Ø20MM L 50MM LAT WITH A 01.22.030 PROXIMAL BODY Ø24MM L 70MM LAT AND REVISED THE 40MM BIOLOX DELTA HEAD XL WITH A 01.29.213 40MM BIOLOX DELTA HEAD M. THE SURGERY WAS COMPLETED SUCCESSFULLY. THE PATIENT HAD GOOD BONE QUALITY. THE SURGEON KEPT IN THE ORIGINAL DISTAL STEM FROM THE PRIMARY. THE DISTAL REAMER USED WAS A SIZE 15MM PRESENTLY, ON (B)(6) 2024, THE PATIENT CAME IN REPORTING THIGH PAIN AND THE CAUSE IS UNKNOWN. THE SURGEON REVISED THE HEAD AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Implant Pain

  MAUDE report 19318552 ↗
• InjuryMay 14, 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 2 MONTHS 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 19310002 ↗
• InjuryDec 22, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated

  AFTER THE PRIMARY HIP SURGERY, IN POST-OP RECOVERY, JOINT LUXATION OCCURRED. THE SAME DAY OF THE PRIMARY SURGERY, THE SURGEON REVISED HEAD (Ø 40 M TO Ø 40 L) AND UPSIZED THE STEM (SIZE 10 TO SIZE 11) TO SIT PROUD AND COMPENSATE FOR LACK OF TENSION. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Joint Dislocation

  MAUDE report 18381849 ↗
• InjuryDec 6, 2023Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  THE PATIENT UNDERWENT REVISION SURGERY DUE TO INFECTION ON (B)(6) 2021, THE PATIENT UNDERWENT REVISION SURGERY DUE TO INFECTION THAT CAUSED LOOSENING OF THE IMPLANTS. THE SURGEON EXPLANTED ALL INSITU IMPLANTS AND WILL REPLACE THEM WITH CEMENTED IMPLANTS ONCE THE INFECTION CLEARS UP.

  Patient problems: Unspecified Infection

  MAUDE report 18272889 ↗
• InjuryJan 16, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AT ABOUT 3 MONTHS AFTER THE PRIMARY SURGERY, THE PATIENT CAME IN REPORTING PAIN AND INSTABILITY DUE TO A LEG LENGTH DISCREPANCY AND THE CAUSE IS UNKNOWN. THE SURGEON REVISED THE HEAD AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Pain

  MAUDE report 16173754 ↗
• InjuryNov 21, 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 1 YEAR FROM PRIMARY THE SURGEON PERFORMED A WASHOUT AND REVISED THE HEAD AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Medical device site infection

  MAUDE report 15832744 ↗
• InjuryAug 18, 2022Adverse Event Without Identified Device or Use Problem

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

  Patient problems: Unspecified Infection

  MAUDE report 15247453 ↗
• InjuryJun 15, 2022Device Dislodged or Dislocated

  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 MEDACTA CUP AND LINER WITH COMPETITOR COMPONENTS AND REVISED THE MEDACTA HEAD WITH A MEDACTA HEAD 1 YEAR AFTER PRIMARY. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Joint Dislocation

  MAUDE report 14698597 ↗