Mectacer Biolox Delta Femoral Ball Head 01.29.206Recalls & reported problems

Summary

The FDA's MAUDE database contains 32 adverse event reports that list this exact device (DI 07630030809170), received between Oct 4, 2018 and May 26, 2026 — classified as 32 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 32 reports, in the reporter's own words as published by the FDA.

• InjuryMay 26, 2026Device Appears to Trigger Rejection

  THE PATIENT HAD HIP INFECTION AND THE PATHOGEN IS UNKNOWN. AT ABOUT 1 MONTH AND A HALF POST PRIMARY THE SURGEON PERFORMED A WASHOUT AND REVISED THE 32MM BIOLOX HEAD L TO A 32MM BIOLOX HEAD XL, AND REVISED THE HC LINER D 32/D TO A SAME SIZE LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Medical device site infection

  MAUDE report 25275476 ↗
• InjuryDec 10, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  AT ABOUT 2 MONTHS FROM THE PRIMARY, THE PATIENT CAME IN REPORTING PAIN DUE TO A DISLOCATION OF THE HEAD FROM THE LINER. SHE WAS DISLOCATING AND INCREASED HER ISSUE DUE TO IMPINGEMENT BETWEEN THE ISCHIUM AND THE LESSER TROCHANTER. THE SURGEON REVISED HEAD, LINER AND CUP, HE PUT IN A DOUBLE MOBILITY LITTLE BIT BIGGER AND ADDED THE 3.5 TO THE HEAD OFFSET. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Joint Dislocation

  MAUDE report 23768146 ↗
• InjuryDec 2, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  THE PATIENT HAD PRIMARY LEFT HIP SURGERY ON (B)(6) 2016. ON (B)(6) 2024, 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 (MDR (B)(4)). ON (B)(6) 2025, 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 BIOLOX HEAD AND HOODED LINER TO A COCR HEAD AND CONTRAINED LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Joint Dislocation

  MAUDE report 23694043 ↗
• InjurySep 12, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AT 2 YEARS 6 MONTHS FROM PRIMARY, THE PATIENT CAME IN REPORTING PAIN. THE SURGEON REVISED THE HEAD, CITING LOSS OF OFFSET AND IMPINGEMENT. THE IMPINGEMENT STRUCTURES INVOLVED WERE THE "ANTERIOR CAPSULE". THE SURGEON ONLY REVISED THE HEAD AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Joint Impingement

  MAUDE report 23036817 ↗
• InjuryJun 10, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

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

  Patient problems: Unequal Limb Length

  MAUDE report 22175048 ↗
• InjuryApr 17, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  ON THE (B)(6) 2024 THE PATIENT UNDERWENT HIP SURGERY. ON THE (B)(6) 2024 THE SURGEON REVISED THE HEAD DUE TO DISLOCATION OF THE HEAD FROM THE LINER. ON, (B)(6) 2025 THE PATIENT CAME IN REPORTING INSTABILITY AND DISLOCATION. THE SURGEON REVISED CUP, HEAD AND LINER. SURGERY WAS COMPLETED SUCCESSFULLY USING A DOUBLE MOBILITY OPTION.

  Patient problems: Joint Dislocation; Joint Laxity

  MAUDE report 21855296 ↗
• InjuryJan 8, 2025Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  THE PATIENT CAME IN REPORTING PAIN DUE TO AN UNDERSIZED STEM. HIP INSTABILITY WAS ALSO PRESENT. NEITHER LOOSENING OR SUBSIDENCE WERE REPORTED. THE CAUSE OF THE UNDERSIZED STEM IS UNKNOWN. AT ABOUT 6 MONTHS POST PRIMARY THE SURGEON REVISED THE HEAD FROM L TO AN XL ONE AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Joint Laxity

  MAUDE report 21101922 ↗
• InjurySep 27, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  REVISION SURGERY DUE TO HIP LUXATION AT ABOUT 5 MONTHS POST PRIMARY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20320101 ↗
• InjuryJul 16, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  AT ABOUT 1 YEAR 9 MONTHS AFTER THE PRIMARY, THE PATIENT CAME IN REPORTING PAIN DUE TO A DISLOCATION OF THE HEAD FROM THE LINER. THE SURGEON REVISED THE CUP, HEAD, AND LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Joint Dislocation

  MAUDE report 19749510 ↗
• InjuryJul 1, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  AT ABOUT 10 DAYS AFTER 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 HEAD AND LINER AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Joint Dislocation

  MAUDE report 19642080 ↗
• InjuryJun 25, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  AT ABOUT 2 YEARS 4 MONTHS AFTER 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 HEAD AND LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Joint Dislocation

  MAUDE report 19605555 ↗
• InjuryMar 23, 2024Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  REVISION SURGERY FOR LEG LENGTH DISCREPANCY AT ABOUT 1 YEAR AND 2 MONTHS FROM PRIMARY. HEAD AND LINER REVISED SUCCESSFULLY.

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

  MAUDE report 18965632 ↗
• InjuryMar 7, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  AT 5 DAYS AFTER THE PRIMARY, 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: Implant Pain

  MAUDE report 18854232 ↗
• InjuryJan 19, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  AT ABOUT 1 YEAR AND 11 MONTHS AFTER 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 HEAD AND LINER SUCCESSFULLY. THE SURGERY WAS COMPLETED SUCCESSFULLY.

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

  MAUDE report 18541561 ↗
• InjuryNov 23, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated

  THE PATIENT HAD A PRIMARY HIP SURGERY ON 23 MARCH 2023. ON (B)(6) 2023, 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 LINER AND HEAD. 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 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 18198433 ↗
• InjuryNov 17, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated

  REVISION SURGERY DUE TO JOINT LUXATION, AT ABOUT 1 YEAR FROM THE PRIMARY. THE SURGEON REVISED THE HEAD AND LINER AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Joint Dislocation

  MAUDE report 18158253 ↗
• InjurySep 19, 2023Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  AT ABOUT 7 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 17773092 ↗
• InjuryJul 25, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated

  AT ABOUT 2 DAYS AFTER THE PRIMARY, THE PATIENT REPORTED PAIN DUE TO A DISLOCATION OF THE HEAD FROM THE LINER. THE SURGEON REVISED THE LINER AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

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

  MAUDE report 17387718 ↗
• InjuryDec 14, 2022Device Dislodged or Dislocated; Device Dislodged or Dislocated

  REVISION SURGERY PERFORMED DUE TO JOINT LUXATION 1 YEAR AND 8 MONTHS AFTER THE PRIMARY SURGERY. THE PATIENT DID AN HORMONE THERAPY TO GET PREGNANT WHICH RESULTS IN A SLACKENING OF THE TISSUE.

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

  MAUDE report 15977591 ↗
• InjuryDec 9, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT CAME IN REPORTING PAIN AND INSTABILITY DUE TO A LEG LENGTH DISCREPANCY. ABOUT 7 MONTHS AFTER THE PRIMARY SURGERY, THE SURGEON REVISED THE HEAD AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Pain

  MAUDE report 15950515 ↗
• InjuryFeb 16, 2022Loosening of Implant Not Related to Bone-Ingrowth

  AFTER PRIMARY SURGERY, THE PATIENT'S HIP LUXATED TWO TIMES IN ONE WEEK. THE SURGEON THEN DECIDED TO REVISE THE HEAD AND THE LINER ONE WEEK AFTER PRIMARY. A DM CONVERTER HAS BEEN IMPLANTED. AN ANTERIOR APPROACH WAS USED DURING PRIMARY SURGERY.

  Patient problems: Joint Laxity

  MAUDE report 13541837 ↗
• InjurySep 14, 2021Adverse Event Without Identified Device or Use Problem

  THE PATIENT CAME IN REPORTING PAIN DUE TO A LEG A LENGTH DISCREPANCY AND THE CAUSE OF THE LEG LENGTH DISCREPANCY IS UNKNOWN. 6 MONTHS AFTER PRIMARY THE SURGEON REVISED THE HEAD AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Pain

  MAUDE report 12466361 ↗
• InjurySep 7, 2021Appropriate Device Problem Term/Code Not Available

  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 1 MONTH AND A HALF AFTER THE PRIMARY SURGERY. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Unspecified Infection

  MAUDE report 12431479 ↗
• InjuryJul 6, 2021Use of Device Problem; Use of Device Problem

  REVISION SURGERY 2 DAYS AFTER PRIMARY BECAUSE POST OP, AFTER AGENT INVENTORY, IT WAS RECOGNIZED THAT THE PATIENT WAS IMPLANTED WITH A HEAD 32 IN A LINER 36. THE SCRUB TECH, SALES AGENT AND SURGEON DID NOT NOTICE THAT DURING THE SURGERY. HEAD REVISED SUCCESSFULLY.

  Patient problems: Insufficient Information

  MAUDE report 12121055 ↗
• InjuryJan 13, 2021Adverse Event Without Identified Device or Use Problem

  THE PATIENT CAME IN, 5 MONTHS AFTER PRIMARY SURGERY, DUE TO SIGNS OF 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 11160559 ↗