R3 ACETABULAR 71338952Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00885556021552), received between Sep 21, 2018 and May 22, 2023 — classified as 7 injuries.

The most frequently reported specific device problem is “Fracture” (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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• InjuryMay 22, 2023Fracture; Fracture

  IT WAS REPORTED THAT, AFTER A THR HAD BEEN PERFORMED ON (B)(6) 2010, THE PATIENT SUFFERED A FALL RESULTING IN PAIN IN THE AFFECTED HIP. A REVISION SURGERY WAS PERFORMED ON (B)(6) 2023 TO ADDRESS THIS EVENT. IN ADDITION, THERE DID NOT APPEAR TO BE ANY DAMAGE TO THE FORTE FEMORAL HEAD, HOWEVER THE R3 36MM ID US CRMC LINER 52MM WAS FRACTURED. THE COMPONENTS WERE REPLACED WITH A R3 20 DEGREE XLPE LINER AND A ZIMMER +7MM SLEEVED 36 DELTA HEAD. PATIENT WAS SCHEDULED TO BE DISCHARGED DAY OF SURGERY.

  Patient problems: Failure of Implant; Pain

  MAUDE report 16975971 ↗
• InjuryMar 25, 2021Fracture; Fracture

  US LEGAL. IT WAS REPORTED THAT A PATIENT UNDERWENT MEDICALLY INDICATED REVISION OF THE R3 SYSTEM LEFT HIP ON (B)(6) 2020. THE PATIENT REVISION SURGERY WAS PERFORMED DUE TO A FRACTURED R3 CERAMIC LINER. THE PATIENT OUTCOME IS UNKNOWN.

  Patient problems: Failure of Implant

  MAUDE report 11568083 ↗
• InjuryJan 29, 2021Break; Fracture; Break; Fracture

  IT WAS REPORTED THAT, PATIENT UNDERWENT BILATERAL THR ((B)(6) 2011). ON (B)(6) 2020 A REVISION SURGERY DUE TO PAIN IN THE LEFT HIP AFTER PLAYING GOLF WAS PERFORMED. A CT SCAN SHOWED A FRACTURE OF THE R3 CERAMIC LINER. THE FOLLOWING DEVICES WHERE EXPLANTED: R3 CERAMIC LINER, R3¿ NO HOLE ACETABULAR SHELL, SYNERGY POROUS PLUS STEM , UNKNOWN FEMORAL HEAD INSERT AND R3¿/REFLECTION¿ THREADED HOLE COVER. THE PROCEDURE WAS COMPLETED WITH SMITH & NEPHEW BACK-UP DEVICES. IT IS UNKNOWN IF THERE WAS A SURGICAL DELAY. AFTER SURGERY AND ONCE PATIENT DISCHARGED HOME ((B)(6) 2020), IN DECEMBER THE PATIENT DEVELOPED AN AREA OF CELLULITIS AT THE DISTAL INCISION, TREATED WITH ANTIBIOTICS. AS OF ((B)(6) 2021) OFFICE VISIT, THERE WAS IMPROVEMENT IN THE CELLULITIS; THERE WAS NO OBVIOUS FLUID COLLECTION AND THE SKIN & SUBCUTANEOUS TISSUES FELT NORMAL. 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: Ambulation or Postural Difficulties; Cellulitis; Extraskeletal ossification; Failure of Implant; Pain

  MAUDE report 11250345 ↗
• 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 10284229 ↗
• InjuryJul 14, 2019Fracture; Fracture

  IT WAS REPORTED THAT THE DOCTOR REVISED A SHATTERED AN R3 CERAMIC LINER. THE HEAD AND THE LINER WERE REMOVED. A POLY LINER WAS IMPLANTED. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: Injury

  MAUDE report 8787667 ↗
• InjuryOct 2, 2018Break; Noise, Audible

  IT WAS REPORTED THAT A REVISION SURGERY WAS PERFORMED DUE TO THE CERAMIC LINER WAS SQUEAKING WHEN THE PATIENT WALKED. DURING REMOVAL THE DOCTOR REPORTED THAT THE LINER WAS BROKEN.

  Patient problems: No Code Available

  MAUDE report 7927972 ↗
• InjurySep 21, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT REVISION SURGERY WAS PERFORMED. SURGEON REVISED R3 ALUMINA ON ALUMINA. PATIENT WAS COMPLAINING OF PAIN, THOUGHT CERAMIC LINER MIGHT BE FRACTURED. 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 7899528 ↗

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-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-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