Mectacer Biolox Delta Femoral Ball Head 01.29.209Recalls & reported problems

Summary

The FDA's MAUDE database contains 109 adverse event reports that list this exact device (DI 07630030809200), received between Jul 31, 2017 and Sep 9, 2026 — classified as 108 injuries, 1 malfunction.

The most frequently reported specific device problem is “Device Appears to Trigger Rejection” (32 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 109 reports, in the reporter's own words as published by the FDA.

• InjurySep 9, 2026Device Dislodged or Dislocated

  At about 3 days after the primary, the patient came in presenting pain due to dislocation of the head from the liner and the cause is unknown. The surgeon revised theFlat PE HC linerD 36/Eto a Hooded PE HC liner D 36/E and theMECTACER Head Biolox Delta D 36 12/14-Mto a Biolox head L. The surgery was completed successfully.

  Patient problems: Implant Pain; Joint Dislocation

  MAUDE report 50692300 ↗
• InjurySep 1, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: Implant Pain; Joint Laxity

  MAUDE report 50543241 ↗
• InjuryJul 8, 2026Device Appears to Trigger Rejection

  REVISION SURGERY AFTER 2 MONTHS FROM PRIMARY DUE TOINFECTION, AND THE PATHOGEN IS UNKNOWN. THE SURGEON PERFORMED A WASHOUT AND REVISED THE LINER AND THE HEAD AND THE SURGERY WAS SUCCESSFULLY COMPLETED.

  Patient problems: Medical device site infection

  MAUDE report 25747751 ↗
• InjuryJul 8, 2026Device Appears to Trigger Rejection

  THE PATIENT HAD AN INFECTION AND THE PATHOGEN IS UNKNOWN. AT ABOUT 9 YEARS AND 6 MONTHS POST PRIMARY THE SURGEON PERFORMED A WASHOUT, REVISED THE 36/G FLAT PE HC LINER TO A 40/G FLAT PE HC LINER, AND REVISED 36MM BIOLOX DELTA HEAD M TO A 40MM BIOLOX OPTION HEAD WITH SLEEVE. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Medical device site infection

  MAUDE report 25747744 ↗
• InjuryJul 6, 2026Device Appears to Trigger Rejection

  AT ABOUT 1 MONTH FROM THE PRIMARY,THE PATIENT CAME IN DUE TO SIGNS OF INFECTION AND THE PATHOGEN IS UNKNOWN. THE SURGEON OBSERVED WOUND WEEPING AND PERFORMED A WASHOUT. DURING THE PROCEDURE, THE HEAD WAS REVISED TO A HEAD WITH A SLEEVE, AND THE LINER WAS REVISED TO A SAME-SIZE LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Medical device site infection

  MAUDE report 25714724 ↗
• InjuryMay 26, 2026Device Appears to Trigger Rejection

  REVISION SURGERY DUE TO INFECTION AFTER ABOUT 1 MONTH FROM PRIMARY. THE SURGEON PERFORMED AN I&D AND REVISED THE 36MM BIOLOX HEAD TO A 36MM BIOLOX OPTION HEAD WITH SLEEVE AND REVISED THE FLAT PE HC LINER D 36/E TO A SAME SIZE LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Medical device site infection

  MAUDE report 25275472 ↗
• InjuryMay 25, 2026Device Appears to Trigger Rejection

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

  Patient problems: Medical device site infection

  MAUDE report 25268625 ↗
• InjuryApr 20, 2026Device Appears to Trigger Rejection

  AT ABOUT 4 MONTHS AFTER THE PRIMARY, THE PATIENT CAME IN PRESENTING SIGNS OF INFECTION AND THE PATHOGEN IS UNKNOWN. THE SURGEON PERFORMED AN INCISION AND DRAINAGE AND REVISED THE HEAD AND LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Medical device site infection

  MAUDE report 24924646 ↗
• InjuryMar 10, 2026Device Appears to Trigger Rejection

  AT ABOUT 1 MONTH AFTER THE PRIMARY, THE PATIENT CAME DUE TO SIGNS OF INFECTION AND THE PATHOGEN IS UNKNOWN. THE SURGEON PERFORMED A WASHOUT, THEN REVISED THE MEDACTA 36MM BIOLOX HEAD AND D 36 LINER TO A SAME SIZE MEDACTA BIOLOX HEAD AND LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Medical device site infection

  MAUDE report 24558217 ↗
• InjuryMar 3, 2026Adverse Event Without Identified Device or Use Problem

  REVISION SURGERY DUE TO LEG LENGTH DISCREPANCY, WHICH CAUSED INSTABILITY, AT 3 YEARS AND 10 MONTHS. NO TRAUMA WAS REPORTED, AND BONE QUALITY WAS NOT OBSERVED TO BE A CONTRIBUTING FACTOR. THE SURGEON REVISED THE D 36MM BIOLOX M HEAD TO A 28MM BIOLOX OPTION HEAD WITH AN OPTION SLEEVE. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Unequal Limb Length

  MAUDE report 24494909 ↗
• InjuryFeb 16, 2026Device Appears to Trigger Rejection

  AT 4 MONTHS FROM PRIMARY, THE PATIENT CAME DUE TO SIGNS OF AN INFECTION AFTER LABS REVEALED AN ELEVATED WHITE BLOOD CELL COUNT. THE CAUSE OF THE INFECTION IS UNKNOWN. THE SURGEON PERFORMED AN I&D AND REVISED THE HEAD AND INSERT. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Medical device site infection

  MAUDE report 24343899 ↗
• InjuryDec 30, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AT ABOUT 1 YEAR AND 9 MONTHS FROM PRIMARY THE PATIENT REPORTED INSTABILITY DUE TO LEG LENGTH DISCREPANCY. THE SURGEON REVISED THE HEAD AND LINER TO XXL HEAD AND DM LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Unequal Limb Length

  MAUDE report 23920166 ↗
• InjuryDec 9, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  AT ABOUT 4 MONTHS FROM PRIMARY, THE PATIENT CAME IN DUE TO SIGNS OF AN 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 23758546 ↗
• InjuryNov 26, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  AT ABOUT 4 MONTHS FROM THE PRIMARY, THE PATIENT CAME IN REPORTING PAIN DUE TO DISLOCATION OF THE LINER FROM THE HEAD AND THE CAUSE IS UNKNOWN. THE SURGEON REVISED THE HEAD AND LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Joint Dislocation

  MAUDE report 23655148 ↗
• InjuryNov 26, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  AT ABOUT 1 MONTH 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: Joint Dislocation

  MAUDE report 23655147 ↗
• InjuryNov 18, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT REPORTED INSTABILITY DUE TO LEG LENGTH DISCREPANCY. THE CURRENT IMPLANT IS A 36 MM (0)MECTACER HEAD BIOLOX DELTA, AND THE SURGEON REQUESTED A CUSTOM 36 MM (–6) COCR HEAD TO CORRECT THE ISSUE. FURTHER DETAILS WILL BE PROVIDED AFTER SURGERY. REVISION SURGERY NOT YET SCHEDULED.

  Patient problems: Unequal Limb Length

  MAUDE report 23583071 ↗
• InjuryOct 22, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  THE PATIENT HAD PRIMARY LEFT HIP SURGERY USING A COMPETITOR'S TOTAL HIP. ON (B)(6) 2025, THE PATIENT WAS REVISED TO MEDACTA MVIZION STEM DUE TO ASCEPTIC LOOSENING OF THE COMPETITOR STEM. THE SURGEON ALSO REVISED THE HEAD. ON (B)(6) 2025, THE PATIENT CAME IN DUE TO AN INFECTION AND THE PATHOGEN IS UNKNOWN. THE SURGEON PERFORMED A WASHOUT AND REVISED THE HEAD (MDR 2025-00506). PRESENTLY, ON (B)(6) 2025, THE PATIENT CAME IN DUE TO AN INFECTION AND THE PATHOGEN IS UNKNOWN. THE SURGEON PERFORMED AN IRRIGATION AND DEBRIDEMENT, THEN REVISED THE HEAD. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Medical device site infection

  MAUDE report 23356470 ↗
• InjuryAug 27, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  ABOUT 2 YEARS AND 11 MONTHS AFTER THE PRIMARY SURGERY, THE PATIENT EXPERIENCED JOINT LUXATION IN EXTENSION. DURING REDUCTION ATTEMPTS PERFORMED AT THE EMERGENCY ROOM ON (B)(6) 2025, THE HEAD DISLOCATED FROM THE STEM. REVISION SURGERY WAS THEN CARRIED OUT ON (B)(6) 2025. ONLY LINER AND HEAD REVISED (HEAD DIAMETER 32 WITH SLEEVE AND HOODED LINER). THE SURGEON NOTED THAT THE CUP WAS OVERSIZED AND THAT A FOOTPLATE HAD FORMED DISTALLY IN THE FEMORAL DIAPHYSIS FOLLOWING THE INITIAL IMPLANTATION.

  Patient problems: Joint Dislocation

  MAUDE report 22902789 ↗
• InjuryAug 20, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  AT ABOUT 3 MONTHS FROM 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: Implant Pain

  MAUDE report 22849200 ↗
• InjuryAug 13, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AT 10 YEARS 4 MONTHS FROM PRIMARY, THE PATIENT CAME IN REPORTING INSTABILITY AND THE CAUSE IS UNKNOWN. THE SURGEON REVISED THE HEAD AND LINER (FROM Ø36 TO Ø40) AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Joint Laxity

  MAUDE report 22792532 ↗
• InjuryAug 7, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  APPROXIMATELY 1 MONTH AFTER THE PRIMARY SURGERY, THE PATIENT PRESENTED WITH PAIN DUE TO A DISLOCATION OF THE HEAD FROM THE LINER. THE CAUSE OF THE DISLOCATION IS UNKNOWN. THE SURGEON REVISED ONLY THE HEAD, AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Joint Dislocation

  MAUDE report 22738117 ↗
• InjuryAug 7, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  AT ABOUT 1 YEAR AND 2 MONTHS AFTER THE PRIMARY SURGERY, THE PATIENT PRESENTED WITH HEALING ISSUES. A SCINTIGRAPHY REVEALED A DEFECT IN THE OSSEOINTEGRATION OF THE FEMORAL PIVOT. THE SURGEON DECIDED TO REPLACE THE PROSTHESIS, CONSIDERING THE CASE TO BE A CHRONIC INFECTION, CONFIRMED BY THE SAMPLES.

  Patient problems: Unspecified Infection

  MAUDE report 22737159 ↗
• InjuryJun 18, 2025Device Dislodged or Dislocated; Adverse Event Without Identified Device or Use Problem; Device Dislodged or Dislocated; Adverse Event Without Identified Device or Use Problem

  AT ABOUT 3 MONTHS FROM PRIMARY, THE PATIENT CAME IN REPORTING PAIN DUE TO A DISLOCATION OF THE HEAD FROM THE LINER. THE CAUSE OF THE DISLOCATION IS UNKNOWN. THE SURGEON REVISED THE HEAD AND LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Implant Pain

  MAUDE report 22282513 ↗
• InjuryJun 18, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  THE PATIENT HAD AN INFECTION AND THE PATHOGEN IS UNKNOWN. AT ABOUT 3 MONTHS FROM PRIMARY, THE SURGEON PERFORMED A WASHOUT AND REVISED THE HEAD AND LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Medical device site infection

  MAUDE report 22282502 ↗
• InjuryJun 5, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  THE PATIENT CAME HAD SIGNS OF AN INFECTION AND THE PATHOGEN IS UNKNOWN. AT ABOUT 1 MONTH AND A HALF AFTER PRIMARY THE SURGEON PERFORMED A WASHOUT AND REVISED THE HEAD. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Medical device site infection

  MAUDE report 22149346 ↗