R3 71339156Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 00885556020470), received between Aug 17, 2017 and May 16, 2024 — classified as 11 injuries.

The most frequently reported specific device problem is “Break” (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 18, 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.

• InjuryMay 16, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER A REVISION THR PROCEDURE WAS PERFORMED ON (B)(6) 2024, THE PATIENT SAT ON ARM OF A COUCH AND FELT 2 POPS IN HIS HIP. SINCE THEN THE PATIENT HAS EXPERIENCED SWELLING AND PAIN WITH AMBULATION OR LAYING IN CERTAIN POSITIONS. ALSO COMPLAINING OF INSTABILITY IN HIS LEFT HIP. THIS ADVERSE EVENT WAS TREATED BY A REVISION SURGERY ON (B)(6) 2024, IN WHICH A R3 CONST 56MM AND A OXINIUM FEM HD 12/14 22 MM +8 WERE EXCHANGED. PATIENT'S CURRENT HEALTH STATUS IS UNKNOWN.

  Patient problems: Joint Laxity; Loss of Range of Motion; Pain; Swelling/ Edema

  MAUDE report 19337330 ↗
• InjuryAug 21, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER THR SURGERY HAD BEEN PERFORMED IN 2006 AND REVISED IN 2017, THE PATIENT EXPERIENCED INFECTION. THIS ADVERSE EVENT WAS SOLVED BY REVISION SURGERY ON (B)(6) 2023, IN WHICH CONSTRAINED LINER AND HEAD WAS REMOVED, WASHOUT AND DEBRIDEMENT TOOK PLACE AND A NEW CONSTRAINED LINER AND HEAD WAS PUT IN. CURRENT HEALTH STATUS OF PATIENT IS UNKNOWN.

  Patient problems: Unspecified Infection

  MAUDE report 17585027 ↗
• InjuryMar 3, 2023Fracture; Material Deformation; Fracture; Material Deformation

  IT WAS REPORTED THAT, AFTER A REVISION SURGERY WAS PERFORMED IN 2017, A PATIENT EXPERIENCED FRACTURE OF THE R3 CONST 56MM. THIS EVENT WAS SOLVED BY A SECONDARY REVISION SURGERY ON (B)(6) 2023 IN WHICH THE R3 CONST 56MM AND FEMORAL HEAD WERE EXPLANTED AND EXCHANGED. CURRENT HEALTH STATUS OF PATIENT IS UNKNOWN.

  Patient problems: Failure of Implant

  MAUDE report 16481046 ↗
• InjuryMay 21, 2022Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT, AFTER THR PROCEDURE HAD BEEN PERFORMED ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED DISLOCATION. THIS ADVERSE EVENT WAS ADDRESSED BY REVISION SURGERY ON (B)(6) 2022 TO EXCHANGE THE R3 3 HOLE ACET SHELL 56MM, R3 CONST 56MM AND COCR 12/14 FEM HEAD 22 + 8. CURRENT HEALTH STATUS OF PATIENT IS UNKNOWN.

  Patient problems: Joint Dislocation

  MAUDE report 14467035 ↗
• InjuryMar 24, 2022Break; Device Dislodged or Dislocated; Break; Device Dislodged or Dislocated

  IT WAS REPORTED THAT, AFTER TOTAL HIP REPLACEMENT WAS PERFORMED ON (B)(6) 2021, THE PATIENT EXPERIENCED DISCOMFORT AND A GRINDING FEELING IN THE HIP JOINT. UPON INVESTIGATION, IT WAS DISCOVERED THAT THE R3 CONSTRAINED ACETABULAR LINER 56MM HAD BROKEN. THE PLASTIC CLIP THAT HOLDS THE SMALL HEAD IN HAD BEEN DAMAGED AND WAS NO LONGER KEEPING THE HEAD INSIDE THE LINER. IT WAS TWISTED AND FLOATING AROUND INSIDE THE JOINT, WITH THE SMALL WIRE COMPLETELY DISENGAGED. THIS ADVERSE EVENT WAS TREATED WITH A REVISION SURGERY ON (B)(6) 2022. THIS WAS THE PATIENT¿S SECOND REVISION (THE FIRST ONE DUE TO DISLOCATION CONDUCTED ON (B)(6) 2021 DUE TO DISLOCATION), FOR WHICH ALL THR COMPONENTS WERE REVISED AND THE ANGLE OF THE ACETABULAR CUP AND THE FEMORAL NECK WAS CHANGED. CURRENT PATIENT'S HEALTH STATUS IS UNKNOWN.

  Patient problems: Discomfort; Failure of Implant

  MAUDE report 13876743 ↗
• InjuryMar 15, 2021Break; Break

  IT WAS REPORTED THAT A REVISION SURGERY TOOK PLACE ON (B)(6)2021 TO REMOVE THE R3 CONST 56MM DUE TO A BROKEN LOCKING RING. PRIMARY SURGERY WAS PERFORMED ON (B)(6) 2019. AFTER EXPLANTATION OF THE ABOVE, THE REVISION PROCEDURE WAS COMPLETED WITH A ZIMMER CEMENTED CONSTRAINED LINER. 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 11479278 ↗
• InjuryFeb 22, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD PRIMARY THR PERFORMED IN 2013 AND HAS HISTORY OF MULTIPLE DISLOCATIONS. THE SURGEON PERFORMED A REVISION SURGERY DUE TO DISASSOCIATION OF HEAD AND CONSTRAINED LINER, AND DECIDED TO PERFORM HEAD/LINER EXCHANGE (HOWEVER, THE FEMORAL HEAD WAS FROM A COMPETITOR PRODUCT). THE CONSTRAINED LINER WAS REMOVED (IMPLANTED 2017- EXACT DATE UNAVAILABLE) AND REPLACED WITH NEW CONSTRAINED LINER.

  Patient problems: Joint Dislocation

  MAUDE report 11362406 ↗
• InjuryAug 24, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AT SOME POINT IN THE LAST 3 MONTHS, THIS PATIENT HAD A FALL ONTO THEIR THR, WHICH RESULTED IN THE CONSTRAINED R3 LINER LOCKING RING BREAKING, THEREFORE LEADING TO INSTABILITY AND DAMAGE TO THE LINER. THE REVISION SURGERY WAS PERFORMED AND THE LINER AND HEAD WERE EXPLANTED.

  Patient problems: Injury

  MAUDE report 10444622 ↗
• InjuryNov 27, 2019Connection Problem; Connection Problem

  IT WAS REPORTED THAT A REVISION THR OF A PERIPROSTHETIC FRACTURE WAS PERFORMED AROUND AN EXETER STEM AND UNITRAX BIPOLAR HEAD. THE PATIENT HAD A 44MM +0 EXETER STEM AND A 55MM BIPOLAR HEAD. THIS WAS REMOVED ALONG WITH THE CEMENT AND THE FEMORAL FRACTURE WAS REDUCED AND CABLED. THE INTENTION WAS TO USE AN R3 56MM CONSTRAINED LINER AND 22MM HEAD. THE ACETABULUM WAS REAMED 70 55MM AND A 56MM 3 HOLE R# CUP WAS IMPLANTED WITH ONE SCREW. A TRIAL 36MM LINER WAS INSERTED. THE FEMUR WAS PREPARED FOR AN ECHELON 265 X 16MM BOWED STEM. TRIALING WAS DONE USING A COUPLE OF 36MM HEAD LENGTHS. THE TRIAL LINER WAS REMOVED AND THE R3 56MM CONSTRAINED LINER WAS IMPLANTED. THE 22MM +0 OX HEAD WAS IMPLANTED AND THE HIP REDUCED. REDUCTION WAS DIFFICULT AS THE HIP WAS A LITTLE TIGHT. WHEN THE HEAD WAS REDUCED INTO THE LINER THERE WAS NO AUDIBLE CLICK OF THE HEAD LOCKING IN. DURING ROM TESTING IT WAS FOUND THAT WITH THE HIP AT 90DEG OF FLEXION AND 10DEG OF INTERNAL ROTATION THE HEAD WOULD DISLOCATE FROM THE LINER. REDUCTION WAS TRIED A NUMBER OF TIMES. THE SURGEON THEN IMPACTED THE STEM FURTHER TO MAKE THE JOINT LESS TIGHT. REDUCTION WAS DONE AGAIN BUT THE PROBLEM OF DISLOCATION IN THE SAME POSITION PERSI

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9384407 ↗
• InjuryNov 24, 2017Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A SECOND REVISION SURGERY DUE TO DISLOCATION WITH LINER EXCHANGE.

  Patient problems: Failure of Implant

  MAUDE report 7057883 ↗
• InjuryAug 17, 2017Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE PATIENT HAD A FALL AND A REVISION WAS PERFORMED FOR DISASSOCIATION. SURGEON REPLACED THE LINER.

  Patient problems: Injury; Joint Dislocation

  MAUDE report 6800417 ↗

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-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-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-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-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-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-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-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-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-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-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-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
• 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-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