R3 ACETABULAR 71338950Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00885556020661), received between Aug 10, 2018 and Dec 7, 2021 — classified as 3 injuries.

The most frequently reported specific device problem is “Crack” (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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryDec 7, 2021Crack; Crack

  IT WAS REPORTED THAT, AFTER A THR SURGERY HAD BEEN PERFORMED ON 2013, THE PATIENT EXPERIENCED BURSITIS A FEW TIMES. THIS ADVERSE EVENT WAS SOLVED BY A REVISION SURGERY ON (B)(6) 2021, IN WHICH THE R3 32MM ID US CRMC LINER 50 WAS FOUND CRACKED, AND WAS EXPLANTED AND REPLACED. CURRENT HEALTH STATUS OF PATIENT IS UNKNOWN.

  Patient problems: Inflammation

  MAUDE report 12953723 ↗
• InjuryDec 2, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT A REVISION SURGERY WAS PERFORMED TO REPLACE A CERAMIC LINER WITH A POLY LINER. NO FAILURE SPECIFIED. NO DELAY OR ADDITIONAL INJURIES REPORTED.

  Patient problems: Injury

  MAUDE report 8123194 ↗
• InjuryAug 10, 2018Device Damaged by Another Device; Device Damaged by Another Device

  IT WAS REPORTED A REVISION SURGERY IN WHICH A R3 CERAMIC LINER WAS FRACTURED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7772163 ↗

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-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-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-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-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-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-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