R3 71339162Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00885556021668), received between Aug 31, 2017 and Oct 17, 2023 — classified as 3 injuries.

The most frequently reported specific device problem is “Break” (1 report).

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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryOct 17, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER A THR REVISION PERFORMED ON (B)(6) 2015, DUE TO A HISTORY OF PROSTHETIC HIP DISLOCATIONS, THE PATIENT BEGAN TO DEVELOP CHRONIC PAIN. AFTER A THOROUGH WORKUP THEY WERE DIAGNOSED WITH A PROSTHETIC JOINT BORDETELLA HOLMESII INFECTION, FOR WHICH A TWO-STAGE REVISION WAS CARRIED OUT. STAGE ONE OF THE REVISION WAS PERFORMED ON (B)(6) 2021; WHEN THE PATIENT¿S HIP WAS ASPIRATED GROSS PURULENT FLUID WAS NOTED, THE POSTERIOR CAPSULE WAS EXTREMELY INFLAMED, AND FOCAL OSTEOLYSIS WAS FOUND IN THE ACETABULUM. PATIENT HAD A SYNOVECTOMY, WAS IRRIGATED WITH ANTIBIOTICS, HAD R3 AND SYNERGY HAD COMPONENTS EXPLANTED, AND A DE PUY PROSTALAC SPACER IMPLANTED. SECOND STAGE REVISION WAS PERFORMED ON (B)(6) 2021, DURING WHICH NO EVIDENCE OF INFECTION WAS FOUND, AND A STRYKER REVISION SYSTEM WAS IMPLANTED. THE PATIENT WAS TAKEN TO THE RECOVERY ROOM IN STABLE CONDITION.

  Patient problems: Medical device site infection; Osteolysis

  MAUDE report 17951017 ↗
• InjuryApr 29, 2021Break; Break

  IT WAS REPORTED THAT A PATIENT WENT THROUGH PRIMARY THR IN (B)(6) 2020. LAST WEEK THE PATIENT FELL IN THE BATHROOM AND HAD PAIN IN HIS HIP, THEREFORE, A REVISION SURGERY WAS PERFORMED. INTRAOPERATIVELY, THE LINER WAS NOTICED TO LOOKS TILTED AND THE INNER LINER RING WAS FOUND BROKEN. THE R3 INSERT CONSTRAINED 62 MM HAD TO BE DISASSEMBLED DUE TO THE COMPLEX REVISION SURGERY TO ALLOW DISLOCATION OF THE HIP. IT WAS NOT POSSIBLE TO REINSERT A NEW 62MM CONSTRAINED INLAY, SO AN ANTEVERTED INLAY WAS INSERTED. THE OUTCOME OF THE PATIENT IS UNKNOWN.

  Patient problems: Failure of Implant; Fall

  MAUDE report 11745721 ↗
• InjuryAug 31, 2017Insufficient Device Problem Information; Insufficient Device Problem Information

  PATIENT PRESENTED TO EMERGENCY DEPARTMENT WITH DISLOCATED HIP. EMERGENCY DEPARTMENT RELOCATED HIP UNDER SEDATION. NO OPERATION NEEDED.

  Patient problems: Injury; Joint Dislocation

  MAUDE report 6833815 ↗

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-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-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-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-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-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-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-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-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-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-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-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-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