BIOLOX FORTE CERAMIC 71332084Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00885556019849), received between Sep 20, 2018 and Jul 16, 2020 — classified as 2 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (1 report).

6 other recalls cover devices cleared under the same FDA submission (P030022); they may or may not involve this specific model.

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.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryJul 16, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER A THA HAD BEEN PERFORMED, THE PATIENT EXPERIENCED PAIN. THE ADVERSE EVENT WAS ADDRESSED BY PERFORMING A REVISION SURGERY. THE PATIENT OUTCOME IS UNKNOWN.

  Patient problems: Arthralgia

  MAUDE report 10284267 ↗
• InjurySep 20, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED A SERIOUS INJURY IN WHICH PATIENT WAS COMPLAINING OF PAIN. IT WAS FOUND THAT THE CERAMIC LINER WAS NOT FRACTURED, IMPLANTS WERE FINE. SURGEON CHANGED LINER TO A POLY LINER AND A NEW FEMORAL HEAD WAS PUT ON. NO ISSUES, NO DELAYS, NO INJURIES.

  Patient problems: Pain

  MAUDE report 7896285 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under P030022. One submission often covers many models, so check the product and lot details in each record.

• Z-2058-2011 · Mar 11, 2011 · Terminated
  R3 TM CERAMIC ACETABULAR LINER, BIOLOX FORTE, 36 MM O.D. 62 MM O.D., REF 71338962, STERILE R, QTY (1), Smith & Nephew, Inc., Memphis, TN 38116, 2017/06
• Z-2056-2011 · Mar 11, 2011 · Terminated
  R3 TM CERAMIC ACETABULAR LINER, BIOLOX FORTE, 36 MM O.D. 54 MM O.D., REF 71338954, STERILE R, QTY (1), Smith & Nephew, Inc., Memphis, TN 38116, 2017/06
• Z-2053-2011 · Mar 11, 2011 · Terminated
  R3 TM CERAMIC ACETABULAR LINER, BIOLOX FORTE, 32 MM I.D. 48 MM O.D., REF 71338948, STERILE R, QTY (1), Smith & Nephew, Inc., Memphis, TN 38116, 2017/06 Usage: Primary total
• Z-2054-2011 · Mar 11, 2011 · Terminated
  R3 TM CERAMIC ACETABULAR LINER, BIOLOX FORTE, 32 MM O.D. 55 MM O.D., REF 71338950, STERILE R, QTY (1), Smith & Nephew, Inc., Memphis, TN 38116, 2017/06
• Z-2055-2011 · Mar 11, 2011 · Terminated
  R3 TM CERAMIC ACETABULAR LINER, BIOLOX FORTE, 36 MM O.D. 52 MM O.D., REF 71338952, STERILE R, QTY (1), Smith & Nephew, Inc., Memphis, TN 38116, 2017/06
• Z-2057-2011 · Mar 11, 2011 · Terminated
  R3 TM CERAMIC ACETABULAR LINER, BIOLOX FORTE, 36 MM O.D. 56 MM O.D., REF 71338956, STERILE R, QTY (1), Smith & Nephew, Inc., Memphis, TN 38116, 2017/06