REFLECTION 71338456Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00885556021453), received between Mar 26, 2021 and Mar 26, 2021 — classified as 1 injury.

The most frequently reported specific device problem is “Break” (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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryMar 26, 2021Break; Adverse Event Without Identified Device or Use Problem; Break; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AFTER PRIMARY SURGERY, PATIENT COMPLAINED OF PAIN. REVISION SURGERY WAS PERFORMED, AND IT WAS FOUND THAT THE CERAMIC LINER FAILED AND BROKEN IN MANY PIECES. THE LINER ((B)(4)) AND HEAD ((B)(4)) WERE REMOVED FROM THE PATIENT. THE SHELL WAS KEPT IN PLACE. A COMPETITOR CEMENTED LINER AND S&N OXINIUM HEAD WERE USED FOR REPLACEMENT. LINER AND HEAD WERE UNABLE TO OBTAIN DUE TO FRAGMENTATION, AND THE HOSPITAL DISCARDED THEM. THE OUTCOME OF THE PATIENT IS UNKNOWN.

  Patient problems: Failure of Implant; Pain

  MAUDE report 11573369 ↗

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-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-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-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