Mectacer Biolox Option Heads 01.29.231HRecalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 07630030809330), received between Apr 2, 2019 and Jan 5, 2024 — classified as 4 injuries.

The most frequently reported specific device problem is “Device Appears to Trigger Rejection” (1 report).

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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryJan 5, 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 HEAD AND LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Unspecified Infection

  MAUDE report 18452389 ↗
• InjurySep 22, 2020Appropriate Device Problem Term/Code Not Available

  THE PATIENT CAME IN, 2 MONTHS AFTER PRIMARY SURGERY, DUE TO SIGNS OF AN INFECTION AND THE PATHOGEN IS UNKNOWN. THE SURGEON PERFORMED A WASHOUT AND REVISED THE HEAD AND LINER AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Unspecified Infection

  MAUDE report 10566032 ↗
• InjuryFeb 21, 2020Appropriate Device Problem Term/Code Not Available

  THE PATIENT HAD A PRIMARY HIP SURGERY ON (B)(6) 2019. ON (B)(6) 2020, THE PATIENT CAME IN FOR A POST-OP APPOINTMENT. IT WAS OBSERVED THAT THE PATIENT HAD SUPERFICIAL WOUND DRAINAGE. THE SURGEON PERFORMED AN I&D AND REVISED THE HEAD AND LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY. ON (B)(6) 2020, THE PATIENT CAME IN DUE TO SIGNS OF AN INFECTION AND THE PATHOGEN IS UNKNOWN. THE SURGEON REMOVED ALL COMPONENTS AND IMPLANTED AN ANTIBIOTIC SPACER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Unspecified Infection

  MAUDE report 9738114 ↗
• InjuryApr 2, 2019Device Dislodged or Dislocated

  THE PATIENT HAD A PRIMARY HIP SURGERY ON (B)(6) 2016. ON (B)(6) 2019, THE PATIENT CAME IN COMPLAINING OF ANTERIOR HIP PAIN CAUSED BY THE IMPINGEMENT OF THE CUP ON SOFT TISSUE AND THE SURGEON SUBSEQUENTLY REVISED THE CUP, LINER AND HEAD (COMPLAINT (B)(4); MDR 2019-00112). PRESENTLY, ONE MONTH AFTER THE PREVIOUS REVISION SURGERY, THE PATIENT CAME IN COMPLAINING OF PAIN CAUSED BY A DISLOCATION OF THE HEAD FROM THE LINER. THE DISLOCATION ONLY OCCURS WHEN THE PATIENT IS AT 90 DEGREES AND THE SURGEON IS STILL INVESTIGATING WHAT IS CAUSING THE DISLOCATION TO OCCUR. THE SURGEON REVISED THE HEAD AND OPTION SLEEVE AND THE SURGERY WAS COMPLETED SUCCESSFULLY. A DIRECT ANTERIOR APPROACH WAS USED IN THE PRIMARY SURGERY.

  Patient problems: Joint Dislocation

  MAUDE report 8473640 ↗