BIOLOX® Option 650-1066Recalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 00887868271489), received between Oct 21, 2021 and Jun 11, 2025 — classified as 9 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Component or Accessory Incompatibility” (2 reports).

1 FDA recall record name this device's identifier, 1 still open.

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 16, 2026.

Recalls naming this device

1. Aug 8, 2024Open, Classified

   Mislabeled: Incorrect sleeve in the packaging. The outer packaging is labeled as a standard neck sleeve, however, the product within the box is a -6mm neck sleeve, and vice versa. The neck of the sleeve can be identified by the device etching as either STD or -6

   Z-3132-2024 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• InjuryJun 11, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED IN A CLINICAL STUDY THAT APPROXIMATELY TWO YEARS POST-IMPLANTATION, THE PATIENT UNDERWENT A HIP REVISION DUE TO SEVERE PAIN AND FAILED IMPLANTS. PATIENT EXPERIENCED PAIN, WEAKNESS, TROCHANTERIC BURSITIS, AND POSSIBLE ILIOPSOAS TENDINITIS. THE SHELL WAS RETAINED AND ALL OTHER IMPLANTS REVISED. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: Bursitis; Failure of Implant; Inflammation; Muscle Weakness/Atrophy; Pain

  MAUDE report 22182204 ↗
• MalfunctionOct 17, 2024Device Markings/Labelling Problem; Device Markings/Labelling Problem

  IT WAS REPORTED THAT DUE TO A LABELING ISSUE A WRONG ITEM IN BOX WAS RECEIVED AND LATER IMPLANTED. THE SURGEON STATED THAT THEY IMPLANTED WHAT THEY THOUGHT WAS A STANDARD 0MM AS STANDS IN PACKAGE, BUT IT LOOKS FROM POST-OP X-RAY THAT A 6MM WAS IMPLANTED INSTEAD. DILIGENCE IS COMPLETED AND NO FURTHER INFORMATION ON THE REPORTED EVENT HAS BEEN PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20470801 ↗
• InjuryMar 11, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

  Patient problems: Insufficient Information; Unequal Limb Length

  MAUDE report 18873113 ↗
• InjuryJan 9, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

  Patient problems: Fall; Osteopenia/ Osteoporosis

  MAUDE report 18474445 ↗
• InjuryDec 4, 2023Naturally Worn; Naturally Worn

  IT WAS REPORTED A PATIENT UNDERWENT A LEFT HIP REVISION APPROXIMATELY TWO YEARS POST IMPLANTATION DUE TO AN INFECTION. DURING THE REVISION, A PSEUDO MEMBRANE, METALLIC FRAGMENTS, AND ABNORMAL TISSUE INCLUDING NECROSIS WAS NOTED. ALL THE IMPLANTS WERE REMOVED AND REPLACED WITH SPACERS. APPROXIMATELY FOUR MONTHS LATER, THE SPACERS WERE REMOVED AND REPLACED WITH ZB IMPLANTS WITHOUT COMPLICATIONS. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Bacterial Infection; Failure of Implant; Metal Related Pathology; Necrosis

  MAUDE report 18254616 ↗
• InjuryFeb 27, 2023Adverse Event Without Identified Device or Use Problem; Patient Device Interaction Problem; Adverse Event Without Identified Device or Use Problem; Patient Device Interaction Problem

  NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

  Patient problems: Bacterial Infection; Fungal Infection

  MAUDE report 16442314 ↗
• MalfunctionJan 9, 2023Component Incompatible; Component or Accessory Incompatibility; Component Incompatible; Component or Accessory Incompatibility

  UPON REASSESSMENT OF THE REPORTED EVENT, IT WAS DETERMINED A MEDWATCH REPORT SHOULD NOT HAVE BEEN FILED BECAUSE ITEM AND LOT NUMBER OF RETURNED PRODUCTS ETCHING IS NOT THAT OF THE REPORTED PRODUCTS WITHIN THE COMPLAINT. FURTHERMORE, THE ITEM NUMBERS ETCHED ONTO THE PARTS ARE NOT RECOGNIZED AS ZIMMER BIOMET PRODUCT NUMBERS.   GIVEN THIS INFORMATION, THIS MEDWATCH WILL BE VOIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16120217 ↗
• MalfunctionJan 9, 2023Component or Accessory Incompatibility; Component or Accessory Incompatibility

  NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16120213 ↗
• InjuryNov 30, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT UNDERWENT REVISION DUE TO HEAD AND SLEEVE BEING LOST IN PATIENT BODY DURING INITIAL SURGERY. IT WAS CONCLUDED THAT PRODUCT MAY HAVE TRAVELED UP INTO THE ABDOMEN. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: Foreign Body In Patient

  MAUDE report 15884334 ↗
• InjuryJan 14, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED, THAT: A PATIENT UNDERWENT AN INITIAL RIGHT HIP ARTHROPLASTY ON AN UNKNOWN DATE. PATIENT TOTAL HIP WAS FINE. SUBSEQUENTLY, PATIENT EXPERIENCED ACUTE ONSET OF PAIN AND SQUEAKING. PAIN BECAME SEVERE OVER A WEEK OR SO, HAD TO GO TO CRUTCHES. PATIENT INVOLVEMENT- REVISION SURGERY.

  Patient problems: Pain

  MAUDE report 13257615 ↗
• InjuryNov 18, 2021Collapse; Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED, THAT: THE PATIENT UNDERWENT A LEFT HIP PROCEDURE IN 2021. SUBSEQUENTLY, THE PATIENT STATES HE IS HAVING SEVERE PAIN, UNABLE TO WALK AND HAS ISSUES WITH THE HIP COLLAPSING AND HAS FALLEN SEVERAL TIMES. PATIENT STATED HE WAS HIT BY DRUNK DRIVER (B)(6), 2019 AND HAS NEEDED SEVERAL SURGERIES OVER HIS WHOLE BODY DUE TO THE ACCIDENT.

  Patient problems: Ambulation or Postural Difficulties; Fall; Pain

  MAUDE report 12834465 ↗
• InjuryOct 21, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT UNDERWENT LEFT THA DUE TO FEMORAL NECK FRACTURE ON (B)(6) 2021. PATIENT WAS REVISED TWO DAYS LATER DUE TO AN IATROGENIC ACETABULAR FRACTURE. THE PATIENT UNDERWENT A SECOND REVISION ON (B)(6) 2021 DUE TO PAIN AND INSTABILITY WITH PLACEMENT OF A CUSTOM CAGE AND CONSTRAINED LINER. DURING THE REVISION, SIGNIFICANT SCARRING WAS NOTED WHICH PROMPTED THE REMOVAL OF THE FEMORAL COMPONENT. THE ACETABULAR COMPONENT WAS FOUND WELL FIXED AND INGROWN. THE CEMENTED LINER WAS REMOVED AS WELL AS THE CUP. BACKING OUT THE SCREWS WAS NOT POSSIBLE, SO THE SURGEON CUT THEM WITH A BUR SO THAT THE CUSTOM CAGE COULD BE PLACED. DUE TO INTRAOPERATIVE COMPLICATIONS (SEE NEW COMPLAINT), ONLY THE CUSTOM CAGE, LINER, AND SCREWS WERE PLACED. THE WOUND WAS CLOSED WITHOUT FEMORAL COMPONENTS IN PLACE, AND THE PATIENT WAS TRANSFERRED TO THE CRITICAL CARE UNIT.

  Patient problems: Pain; Scar Tissue; Swelling/ Edema

  MAUDE report 12670796 ↗