R3 ACETABULAR 71338954Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 00885556021927), received between Apr 26, 2017 and Feb 1, 2021 — classified as 9 injuries.

The most frequently reported specific device problem is “Break” (4 reports).

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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 1, 2021Break; Break

  IT WAS REPORTED THAT, PATIENT UNDERWENT BILATERAL THR ((B)(6) 2011). UNDERWENT REVISION OF RIGHT SIDE ((B)(6) 2014) FOR FAILED CERAMIC LINER NOTED AFTER FELT UNUSUAL MOVEMENT WHILE PLAYING TENNIS AND, WHILE NOT APPARENT ON X-RAYS, WAS CONFIRMED BY ARTHROGRAM CT. THE FRACTURED LINER WAS REPLACED WITH SMITH & NEPHEW BACK UP DEVICES. IT IS UNKNOWN IF THERE WAS A SURGICAL DELAY. NO OTHER COMPLICATIONS WHERE REPORTED. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: Failure of Implant

  MAUDE report 11256854 ↗
• InjuryMar 20, 2020Break; Break

  IT WAS REPORTED THAT THE BIOLOX FORTE CERAMIC LINER WAS BROKEN. A REVISION SURGERY WAS PERFORMED TO REMOVE THIS DEVICE.

  Patient problems: Injury

  MAUDE report 9861827 ↗
• InjuryJun 10, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT A REVISION SURGERY WAS PERFORMED ON THE PATIENT FOR UNSPECIFIED REASONS. CUP, LINER AND HEAD EXCHANGED. NO PROCEDURE DETAILS AVAILABLE.

  Patient problems: Injury

  MAUDE report 8683219 ↗
• InjuryApr 28, 2019Fracture; Fracture

  IT WAS REPORTED THAT A REVISION SURGERY WAS PERFORMED DUE TO LINER FRACTURE.

  Patient problems: Injury

  MAUDE report 8559561 ↗
• InjurySep 26, 2018Noise, Audible

  IT WAS REPORTED THAT DR. (B)(6) SAW A PATIENT IN HIS OFFICE BECAUSE OF A CERAMIC-ON-CERAMIC HIP REPLACEMENT THAT WAS DONE ON (B)(6) 2010. NOW THE PATIENT HAS CAME IN WITH AN AUDIBLE SQUEAK AND AUDIBLE CLUNK. DR. (B)(6) IS LOOKING TO REVISE THIS PATIENT IN MID (B)(6) 2018.

  Patient problems: No Code Available

  MAUDE report 7912485 ↗
• InjuryJun 1, 2018Fracture; Fracture

  IT WAS REPORTED THAT A REVISION SURGERY WAS PERFORMED DUE TO FRACTURED LINER. HEAD AND LINER WERE EXPLANTED.

  Patient problems: Injury

  MAUDE report 7563203 ↗
• InjuryFeb 17, 2018Break; Break

  LINER AND HEAD WERE REMOVED AND REPLACED IN A REVISION SURGERY. CERAMIC LINER BROKE INTO 3 PIECES.

  Patient problems: No Information

  MAUDE report 7279442 ↗
• InjuryJan 3, 2018Break; Break

  IT WAS REPORTED A REVISION SURGERY WAS PERFORMED DUE TO A BROKEN R3 LINER.

  Patient problems: Injury

  MAUDE report 7162677 ↗
• InjuryApr 26, 2017Fracture

  IT WAS REPORTED THAT REVISION SURGERY OCCURED DUE TO PAIN SECONDARY TO FRACTURES OF THE LINER. CUP, LINER AND FEMORAL HEAD HAVE BEEN REPLACED.

  Patient problems: Injury; Pain

  MAUDE report 6521576 ↗

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-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-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-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-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