BIOLOX FORTE CERAMIC 71330284Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00885556019726), received between Jun 28, 2021 and Aug 13, 2025 — classified as 2 injuries.

The most frequently reported specific device problem is “Fracture” (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 18, 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.

• InjuryAug 13, 2025Fracture; Fracture

  IT WAS REPORTED THAT, AFTER A THR SURGERY HAD BEEN PERFORMED ON (B)(6) 2003, THE PATIENT EXPERIENCED A FRACTURED OF ONE (1) BIOLOX FORTE CER 28 HD 12/14 +4. THIS ADVERSE EVENT WAS SOLVED BY REVISION SURGERY ON (B)(6) 2025. CURRENT HEALTH STATUS OF PATIENT IS UNKNOWN.

  Patient problems: Failure of Implant

  MAUDE report 22801399 ↗
• InjuryJun 28, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER A RIGHT THA PERFORMED IN 2000 (SPECIFIC DATE IS UNKNOWN), THE PATIENT EXPERIENCED PAIN AND SQUEAKING SOUND IN THE ARTICULATION. A REVISION SURGERY WAS PERFORMED ON (B)(6) 2021 TO TREAT THESE ADVERSE EVENTS. THE BIOLOX FORTE CER 28 HD 12/14 +4 (CASE-(B)(4)), THE LINER (CASE-(B)(4)) AND THE R3 3 HOLE ACET SHELL 54MM (CASE-(B)(4)) WERE REMOVED DURING THE REVISION SURGERY. MORE DETAILS ABOUT THE SURGERY ARE UNKNOWN. THE PATIENT OUTCOME IS UNKNOWN.

  Patient problems: Pain

  MAUDE report 12076083 ↗

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-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-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
• 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-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