Mectacer Biolox Delta Femoral Ball Head 01.29.205Recalls & reported problems

Summary

The FDA's MAUDE database contains 40 adverse event reports that list this exact device (DI 07630030809163), received between Sep 15, 2017 and Sep 9, 2026 — classified as 40 injuries.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (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 40 reports, in the reporter's own words as published by the FDA.

• InjurySep 9, 2026Device Dislodged or Dislocated

  The patient underwent primary hip surgery on (b)(6) 2024. Prior to the primary surgery, the patient had sustained a pelvic fracture, which had already healed.Two years and four months after the primary surgery, the patient experienced an anterior dislocation. An open revision was considered but was ultimately deemed unnecessary, as the surgeon successfully performed a closed reduction. No implant components were exchanged. To date, no further dislocation or other related event has been reported.

  Patient problems: Implant Pain; Joint Dislocation

  MAUDE report 50692267 ↗
• InjuryOct 31, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  AT ABOUT 20 DAYS AFTER THE PRIMARY, THE PATIENT CAME IN DUE TO PAIN RELATED TO DISLOCATION. THE SURGEON DETERMINED LOWER MUSCLE TONE ON RIGHT SIDE CONTRIBUTED TO THE DISLOCATION. THE SURGEON REVISED THE HEAD, LINER AND CUP. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Joint Dislocation

  MAUDE report 23436206 ↗
• InjuryAug 13, 2025Adverse Event Without Identified Device or Use Problem; Osseointegration Problem; Adverse Event Without Identified Device or Use Problem; Osseointegration Problem

  AT 3 YEARS 2 MONTHS FROM PRIMARY, THE PATIENT CAME IN DUE TO INSTABILITY WITH UNKNOWN CAUSE. THE SURGEON UPSIZED THE HEAD. ADDITIONALLY, THE SURGEON BELIEVED THE CUP WAS LOOSE, SO HE REVISED THE CUP AND LINER WITH COMPETITOR DEVICES. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Inadequate Osseointegration; Joint Laxity

  MAUDE report 22792530 ↗
• InjuryJul 1, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  AT 10 YEARS AND 2 MONTHS FROM THE PRIMARY, THE PAIN CAME IN REPORTING PAIN DUE TO A DISLOCATION OF THE HEAD FROM THE LINER. THE SURGEON REVISED THE HEAD AND LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY. THE CABLES VISIBLE FROM THE X-RAYS WERE INSERTED TO AVOID A POTENTIAL FRACTURE.

  Patient problems: Joint Dislocation

  MAUDE report 22371304 ↗
• InjuryMay 7, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AT ABOUT 7 YEARS AND 4 MONTHS AFTER PRIMARY, THE PATIENT CAME IN REPORTING PAIN AND THE CAUSE IS UNKNOWN. THE SURGEON REVISED THE MEDACTA STEM AND HEAD WITH A COMPETITOR STEM AND HEAD AND REVISED THE MEDACTA LINER WITH A MEDACTA LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Implant Pain

  MAUDE report 21974794 ↗
• InjuryJan 28, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  AT ABOUT 1 MONTH AFTER PRIMARY, THE PATIENT CAME IN DUE TO SIGNS OF AN INFECTION AND THE PATHOGEN IS UNKNOWN. THE SURGEON PERFORMED A WASHOUT AND REVISED THE CUP, HEAD AND LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Unspecified Infection

  MAUDE report 21251763 ↗
• InjuryJan 24, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  THE PATIENT DISLOCATED (HEAD FROM COMPETITOR LINER) AND THE CAUSE IS UNKNOWN. THE SURGEON AT ABOUT 1 YEAR AND 4 MONTHS FROM PRIMARY REVISED THE COMPETITOR LINER AND MEDACTA HEAD. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Joint Dislocation

  MAUDE report 21228878 ↗
• InjuryJan 22, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  AT ABOUT 2 MONTHS AFTER PRIMARY, THE PATIENT CAME IN REPORTING PAIN DUE TO JOINT LUXATION. THE SURGEON REVISED THE CERAMIC BALL HEAD AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Implant Pain

  MAUDE report 21208115 ↗
• InjuryOct 23, 2024Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  AT ABOUT 1 MONTH POST PRIMARY THE SURGEON DECIDED TO CHANGE THE MOBILE PARTS (HEAD AND LINER) DUE TO AN INFECTION CAUSED BY STREPTOCOCCUS. THE STEM AND CUP REMAIN IN PLACE.

  Patient problems: Bacterial Infection; Medical device site infection

  MAUDE report 20512682 ↗
• InjurySep 5, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  AT ABOUT 4 MONTHS AFTER PRIMARY, THE PATIENT HAS BEEN REVISED BECAUSE OF JOINT LUXATION CAUSED BY INSTABILITY. LINER, BALL HEAD AND CUP REVISED SUCCESSFULLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20143061 ↗
• InjuryAug 21, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AT ABOUT 5 MONTHS FROM THE PRIMARY, THE PATIENT CAME IN REPORTING PAIN AND DISCOMFORT DUE TO A LEG LENGTH DISCREPANCY. THE SURGEON REVISED THE HEAD AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Unequal Limb Length

  MAUDE report 20021833 ↗
• InjuryAug 8, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  THE PATIENT HAD A PRIMARY HIP SURGERY ON (B)(6) 2024 AND WHILE IN POST-OPERATIVE RECOVERY, THE HEAD DISLOCATED FROM THE LINER. THE SURGEON REVISED THE 32MM BIOLOX DELTA HEAD WITH A 32MM BIOLOX OPTION HEAD AND ADDED AN OPTION SLEEVE. THE SURGERY WAS COMPLETED SUCCESSFULLY. AN AMIS APPROACH WAS USED IN THE PRIMARY SURGERY

  Patient problems: Joint Dislocation

  MAUDE report 19936761 ↗
• InjuryJun 27, 2024Device Dislodged or Dislocated; Osseointegration Problem; Device Dislodged or Dislocated; Osseointegration Problem

  HIP REVISION AT ABOUT 1 MONTH POST PRIMARY. DISLOCATION OF THE HEAD FROM THE LINER AND THE CUP MOVED FROM THE ACETABULUM. THE PATIENT DID NOT FOLLOW THE SURGEON'S RECOMMENDATIONS BECAUSE HE HAD NO PAIN AND MOVED WITHOUT CANES DIRECTLY AFTER SURGERY. NO LOOSENING OF THE STEM. NO INFECTION. ACETABULAR COMPONENTS AND FEMORAL HEAD REVISED SUCCESSFULLY.

  Patient problems: Inadequate Osseointegration; Joint Dislocation

  MAUDE report 19623415 ↗
• InjuryApr 25, 2024Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  AT ABOUT 2 MONTHS AFTER 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 19178637 ↗
• InjuryNov 7, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated

  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. PRESENTLY, ON (B)(6) 2023, THE PATIENT CAME IN REPORTING PAIN DUE TO A DISLOCATION OF THE HEAD FROM THE LINER. THE SURGEON REVISED THE HEAD AND LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Joint Dislocation

  MAUDE report 18083904 ↗
• InjuryJun 9, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated

  THE PATIENT HAD A PRIMARY HIP SURGERY ON (B)(6) 2021. ON (B)(6) 2023, THE PATIENT CAME IN REPORTING INSTABILITY AND THE CAUSE OF THE INSTABILITY IS UNKNOWN. THE SURGEON REVISED THE HEAD AND LINER AND THE SURGERY WAS COMPLETED SUCCESSFULLY. PRESENTLY, ON (B)(6)2023, THE PATIENT CAME IN REPORTING PAIN AFTER DISLOCATING ANTERIORLY AND THE CAUSE IS UNKNOWN. THE SURGEON REVISED THE MEDACTA CUP AND LINER WITH A COMPETITOR CUP AND LINER AND REVISED THE MEDACTA HEAD WITH A MEDACTA HEAD. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Implant Pain

  MAUDE report 17097351 ↗
• InjuryApr 26, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT HAD A RIGHT PRIMARY HIP SURGERY ON (B)(6) 2022 AND A LEFT PRIMARY HIP SURGERY ON 21 MARCH 2022. ON (B)(6) 2022, THE PATIENT CAME IN REPORTING INSTABILITY IN BOTH HIPS AND THE CAUSE IS UNKNOWN. THE SURGEON REVISED THE HEAD AND LINER ON BOTH THE RIGHT AND LEFT HIP. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Joint Laxity

  MAUDE report 16813626 ↗
• InjuryApr 20, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT CAME IN REPORTING INSTABILITY AND THE CAUSE OF THE INSTABILITY IS UNKNOWN. AT 1 YEAR AND 11 MONTHS POST PRIMARY THE SURGEON REVISED THE HEAD AND LINER AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Joint Laxity

  MAUDE report 16774618 ↗
• InjuryApr 14, 2023Off-Label Use; Off-Label Use

  DURING TOTAL HIP REPLACEMENT SURGERY ON (B)(6) 2021, WRONG SIZE OF THE HEAD, Ø32 INSTEAD OF Ø36 HAS BEEN IMPLANTED (LINER G MUST BE USED WITH HEAD Ø36). THE PATIENT UNDERWENT TO A REVISION SURGERY TO REPLACE THAT COMPONENT. THE REVISION SURGERY DATE IS UNKNOWN.

  Patient problems: Insufficient Information

  MAUDE report 16741093 ↗
• InjuryMar 31, 2023Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  REVISION SURGERY FOR INFECTION. AT ABOUT 1 MONTH POST PRIMARY SURGERY ONLY THE CERAMIC HEAD WAS REVISED. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Unspecified Infection

  MAUDE report 16655292 ↗
• InjuryFeb 28, 2023Device 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 16451654 ↗
• InjuryFeb 21, 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. ABOUT 5 YEARS 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 16408290 ↗
• InjuryJan 4, 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. ABOUT 9 MONTHS AFTER THE PRIMARY SURGERY, THE SURGEON PERFORMED A WASHOUT AND REVISED THE HEAD AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Unspecified Infection

  MAUDE report 16093803 ↗
• InjuryAug 29, 2022Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  THE PATIENT CAME IN DUE TO SIGNS OF INFECTION AND THE PATHOGEN IS UNKNOWN. AT 2 WEEKS AFTER THE PRIMARY SURGERY, THE SURGEON REVISED ALL IMPLANTS AND RE-IMPLANTED PERMANENT HARDWARE. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Unspecified Infection

  MAUDE report 15310353 ↗
• InjuryAug 5, 2022Inadequacy of Device Shape and/or Size; Appropriate Device Problem Term/Code Not Available

  THE PATIENT CAME IN REPORTING PAIN AND INSTABILITY DUE TO A LEG LENGTH DISCREPANCY. ABOUT 1 YEAR AFTER THE PRIMARY SURGERY, THE SURGEON REVISED THE HEAD AND LINER AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Pain

  MAUDE report 15174134 ↗