R3 71339154Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 00885556020227), received between Oct 9, 2017 and Aug 22, 2025 — classified as 10 injuries, 1 malfunction.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (2 reports).

14 other recalls cover devices cleared under the same FDA submission (K083566, K111635, K122139, K211176); 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 16, 2026.

Most reported problems

Recent adverse event reports

The 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• InjuryAug 22, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER A SECOND THR REVISION SURGERY HAD BEEN PERFORMED ON (B)(6) 2025, THE PATIENT EXPERIENCED RECURRENT DISLOCATIONS. THIS ADVERSE EVENT WAS SOLVED BY A THIRD REVISION SURGERY ON (B)(6) 2025, IN WHICH ONE (1) R3 CONST 54MM AND ONE (1) OXINIUM FEM HD 12/14 22 MM +0 WERE EXPLANTED. THE PATIENT'S CURRENT HEALTH STATUS IS UNKNOWN. NO FURTHER DETAILS OF THE EVENT WERE PROVIDED.

  Patient problems: Joint Dislocation

  MAUDE report 22870229 ↗
• InjuryNov 28, 2023Migration; Migration

  IT WAS REPORTED THAT, AFTER A THR PERFORMED ON (B)(6) 2021, THE PATIENT FELT HER HIP "STUCK" AFTER STANDING UP FROM A CHAIR. X-RAYS AND CT CONFIRMED METAL RING DISLOCATION FROM THE CONSTRAINED LINER. THE RING IS CURRENTLY HANGING AROUND THE NECK OF STEM. PATIENT IS FULLY WEIGHT BEARING UNAIDED BUT COMPLAINING OF PAIN AND FEAR THAT HER HIP MAY "STICK" AGAIN. PATIENT IS A HIGH RISK OF DISLOCATION DUE TO MEDICAL CONDITIONS AND A CONSTRAINED LINER IS REQUIRED. A SUBSEQUENT SURGERY TO REMOVE THE RING AND REPLACE THE LINER IS BEING CONSIDERED, BUT HAS NOT BEEN SCHEDULED YET.

  Patient problems: Arthralgia; Failure of Implant

  MAUDE report 18223222 ↗
• InjuryMar 17, 2022Fracture; Fracture

  IT WAS REPORTED THAT, AFTER A THA HAD BEEN PERFORMED ON AN UNSPECIFIED DATE, THE SYSTEM LUXATED ON (B)(6) 2022. UPON REVISION SURGERY TO ADDRESS THIS EVENT ON (B)(6) 2022, IT WAS NOTICED THAT THE R3 CONST 54MM LINER IS FRACTURED. CURRENT HEALTH STATUS OF PATIENT IS UNKNOWN.

  Patient problems: Failure of Implant; Joint Dislocation

  MAUDE report 13794788 ↗
• InjuryMar 10, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THR SURGERY WAS PERFORMED. REVISION SURGERY WAS COMPLETED AFTERWARD TO REVISED AN R3 CONST 54MM. NO FURTHER INFORMATION IS AVAILABLE. THE CURRENT STATUS OF THE PATIENT IS UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13720699 ↗
• InjuryJul 2, 2021Adverse 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 ON (B)(6) 2021, THE PATIENT EXPERIENCED A DISLOCATION WHILE STANDING AND PIVOTED. A REVISION SURGERY WAS CONDUCTED ON (B)(6) 2021 TO EXCHANGE THE OXINIUM FEMORAL HEAD 12/14 22 MM +0 (CASE (B)(4)) AND THE R3 CONST 54MM (CASE (B)(4)). PATIENT OUTCOME IS UNKNOWN.

  Patient problems: Joint Dislocation

  MAUDE report 12112154 ↗
• InjuryDec 30, 2020Connection Problem; Connection Problem

  IT WAS REPORTED THAT, THE CONSTRAINED LINER DISASSOCIATED FROM THE R3 SHELL SO A REVISION SURGERY WAS PERFORMED. PATIENT WAS REVISED TO OR30 SMITH AND NEPHEW DUAL MOBILITY SYSTEM. NO DELAY WAS REPORTED. NO OTHER COMPLICATIONS WERE REPORTED. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: Joint Dislocation

  MAUDE report 11096094 ↗
• InjuryApr 23, 2020Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT A REVISION SURGERY WAS PERFORMED DUE TO A DISLOCATION OF THE R3 CONSTRAINED LINER AFTER THE ORIGINAL CASE. THE SURGEON TRIED TO RELOCATE IT BUT WAS UNABLE TO GET THE HEAD TO STAY CONSTRAINED IN THE LINER SO THE CUP WAS REPLACED AND NEW LINER WAS LOCKED IN. NO DELAY INVOLVED. A BACK UP WAS AVAILABLE.

  Patient problems: Injury

  MAUDE report 9990795 ↗
• InjuryMay 20, 2019Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT A REVISION SURGERY WAS NEEDED DUE TO A DISLOCATION.

  Patient problems: Injury

  MAUDE report 8624623 ↗
• InjuryNov 16, 2018Break; Break

  IT WAS REPORTED THAT A REVISION WAS PERFORMED DUE TO METAL RING HOLDING R-3 CONSTRAINED LINER BROKE WHEN PATIENT FELL, CAUSING CONSTRAINED LINER TO COME APART. NO DELAY OR BACK UP REPORTED.

  Patient problems: Injury

  MAUDE report 8078883 ↗
• InjuryOct 9, 2017Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT A REVISION SURGERY WAS PERFORMED DUE TO DISLOCATION.

  Patient problems: Injury; Joint Dislocation

  MAUDE report 6930188 ↗
• MalfunctionOct 9, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT WHILE IMPACTING THE LINER, THE METAL RING POPPED OF THE POLY ETHYLENE. LINER WAS REMOVED AND ANOTHER CUP OPENED TO REPLACE THE LINER.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6930182 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K083566, K111635, K122139, K211176. One submission often covers many models, so check the product and lot details in each record.

• Z-0326-2025 · Oct 15, 2024 · Open, Classified
  Tandem Intl Bipolar Cocr Shell/UHMWPE Liner, TI-6AL-4V Retaining Ring, 28MM I.D. 46 MM O.D., REF 71324046, sterile, femoral head bipolar component of the Tandem Bipolar Hip System.
• Z-1738-2015 · May 6, 2015 · Terminated
  R3(TM) 28 MM I.D., 60 MM O.D. CONSTRAINED LINER, REF 71339160, QTY: (1), STERILE EO, Product Usage: The R3 Constrained liner Acetabular System is a cemented or uncemented prosthe
• Z-1737-2015 · May 6, 2015 · Terminated
  R3(TM) 22 MM I.D., 58 MM O.D. CONSTRAINED LINER, REF 71339158, QTY: (1), STERILE EO. Product Usage: The R3 Constrained liner Acetabular System is a cemented or uncemented prosthes
• Z-1739-2015 · May 6, 2015 · Terminated
  R3(TM) 28 MM I.D., 62 MM O.D. CONSTRAINED LINER, REF 71339162, QTY: (1), STERILE EO. Product Usage: The R3 Constrained liner Acetabular System is a cemented or uncemented prosthes
• Z-1736-2015 · May 6, 2015 · Terminated
  R3(TM) 22 MM I.D., 56 MM O.D. CONSTRAINED LINER, REF 71339156, QTY: (1), STERILE EO. Product Usage: The R3 Constrained liner Acetabular System is a cemented or uncemented prosthes
• Z-1735-2015 · May 6, 2015 · Terminated
  R3(TM) 22 MM I.D., 52 MM O.D. CONSTRAINED LINER, REF 71339152, QTY: (1), STERILE EO. Product Usage: The R3 Constrained liner Acetabular System is a cemented or uncemented prosthes
• Z-0083-2011 · Aug 13, 2010 · Terminated
  R3 (TM) 28 MM I.D., 60 MM O.D., CONSTRAINED LINER, UHMWPE, CO-CR, TI-6AL-4V, REF 71339160, STERILE EO, QTY 1, Smith & Nephew, Inc., Hip prosthesis acetabular component. Acetabular
• Z-0085-2011 · Aug 13, 2010 · Terminated
  R3 (TM) 28 MM I.D., 64 MM O.D., CONSTRAINED LINER, UHMWPE, CO-CR, TI-6AL-4V, REF 71339164, STERILE EO, QTY 1, Smith & Nephew, Inc., Hip prosthesis acetabular component. Acetabular
• Z-0079-2011 · Aug 13, 2010 · Terminated
  R3 (TM) 22 MM I.D., 52 MM O.D., CONSTRAINED LINER, UHMWPE, CO-CR, TI-6AL-4V, REF 71339152, STERILE EO, QTY 1, Smith & Nephew, Inc., Hip prosthesis acetabular component. Acetabular
• Z-0081-2011 · Aug 13, 2010 · Terminated
  R3 (TM) 22 MM I.D., 56 MM O.D., CONSTRAINED LINER, UHMWPE, CO-CR, TI-6AL-4V, REF 71339156, STERILE EO, QTY 1, Smith & Nephew, Inc., Hip prosthesis acetabular component. Acetabular
• Z-0084-2011 · Aug 13, 2010 · Terminated
  R3 (TM) 28 MM I.D., 62 MM O.D., CONSTRAINED LINER, UHMWPE, CO-CR, TI-6AL-4V, REF 71339162, STERILE EO, QTY 1, Smith & Nephew, Inc., Hip prosthesis acetabular component. Acetabular
• Z-0082-2011 · Aug 13, 2010 · Terminated
  R3 (TM) 22 MM I.D., 58 MM O.D., CONSTRAINED LINER, UHMWPE, CO-CR, TI-6AL-4V, REF 71339158, STERILE EO, QTY 1, Smith & Nephew, Inc., Hip prosthesis acetabular component. Acetabular
• Z-0086-2011 · Aug 13, 2010 · Terminated
  R3 (TM) 28 MM I.D., 66/70 MM O.D., CONSTRAINED LINER, UHMWPE, CO-CR, TI-6AL-4V, REF 71339166, STERILE EO, QTY 1, Smith & Nephew, Inc., Hip prosthesis acetabular component. Acetabul
• Z-0080-2011 · Aug 13, 2010 · Terminated
  R3 (TM) 22 MM I.D., 54 MM O.D., CONSTRAINED LINER, UHMWPE, CO-CR, TI-6AL-4V, REF 71339154, STERILE EO, QTY 1, Smith & Nephew, Inc., Hip prosthesis acetabular component. Acetabular