R3 71339158Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 00885556020876), received between Sep 14, 2017 and Apr 21, 2025 — classified as 8 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (5 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 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• InjuryApr 21, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT, AFTER A THR SURGERY HAD BEEN PERFORMED ON AN UNKNOWN DATE WHERE A R3 CONST 58MM WAS IMPLANTED, THE PATIENT EXPERIENCED A DISLOCATION. THIS ADVERSE EVENT WAS SOLVED BY A REVISION SURGERY ON (B)(6) 2025, IN WHICH PATIENT WAS REVISED TO AN R3 58MMX36MM ANTEVERTED + 4 LINER. PATIENT'S CURRENT HEALTH STATUS IS UNKNOWN.

  Patient problems: Joint Dislocation

  MAUDE report 21875801 ↗
• InjuryMay 26, 2023Device Dislodged or Dislocated; Adverse Event Without Identified Device or Use Problem; Device Dislodged or Dislocated; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AFTER A REVISION THR HAD BEEN PERFORMED ON (B)(6) 2021, THE HIP STARTED LUXATING SPONTANEOUSLY. THE LOCKING SYSTEM OF THE R3 CONST 58MM DEVICE APPEARS TO HAVE MALFUNCTIONED. AFTER TWO (2) TIMES VERY EASY, FULLY-SEATED CLOSED REDUCTIONS, IT WAS DECIDED THAT THE EVENT ADVERSE WILL BE RESOLVED VIA REVISION SURGERY. A REVISION SURGERY WAS PERFORMED ON (B)(6) 2023. THE CURRENT HEALTH STATUS OF THE PATIENT IS OKAY.

  Patient problems: Failure of Implant; Joint Dislocation; Joint Laxity; Subluxation

  MAUDE report 17008433 ↗
• MalfunctionJan 9, 2023Positioning Failure; Positioning Failure

  IT WAS REPORTED THAT, DURING A THR REVISION SURGERY, AN R3 CONST 58MM DID NOT ENGAGE WITH THE REDAPT SHELL, BUT THE FEMORAL HEAD DID ENGAGE, THEN ANOTHER R3 CONST 58MM ENGAGED WITH THE SHELL, BUT NOT WITH THE FEMORAL HEAD. SURGERY WAS PERFORMED WITH A DELAY GREATER THAN 30 MINUTES, USING A S+N BACK-UP DEVICE. PATIENT WAS NOT HARMED AS CONSEQUENCE OF THIS PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16126289 ↗
• InjuryAug 9, 2022Adverse 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) 2022, THE OXINIUM FEMORAL HEAD 12/14 22 MM +4 DISSOCIATED FROM THE R3 CONSTRAINED LINER 58MM. THIS EVENT WAS ADDRESSED VIA REVISION SURGERY TO EXCHANGE FOR COMPETITOR DEVICES. PATIENT CURRENT HEALTH STATUS IS UNKNOWN.

  Patient problems: Joint Dislocation

  MAUDE report 15192786 ↗
• InjuryJul 29, 2021Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT, AFTER A THR SURGERY HAD BEEN PERFORMED ON (B)(6) 2021, THE PATIENT EXPERIENCED A DISLOCATION OF THE HEAD FROM THE CONSTRAINED LINER. THIS ADVERSE EVENT WAS TREATED BY AN INTERVENTION ON (B)(6) 2021. CURRENT HEALTH STATUS OF PATIENT IS UNKNOWN.

  Patient problems: Joint Dislocation

  MAUDE report 12250171 ↗
• MalfunctionJan 18, 2019Fitting Problem; Fitting Problem

  IT WAS REPORTED THAT DURING REVISION THE LINER WOULD NOT ENGAGE INTO CUP. A DELAY OF OVER 2 HOURS WAS REPORTED. NO INJURY REPORTED. A BACK UP DEVICE WAS AVAILABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8260642 ↗
• InjuryDec 6, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT AN OPEN REDUCTION WAS PERFORMED DUE TO DISLOCATION. NO DELAY OR ADDITIONAL INJURIES REPORTED.

  Patient problems: Injury; Joint Dislocation

  MAUDE report 8137538 ↗
• InjuryDec 21, 2017Device Dislodged or Dislocated; Device Dislodged or Dislocated

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

  Patient problems: Joint Dislocation

  MAUDE report 7140014 ↗
• InjuryDec 1, 2017Device Dislodged or Dislocated; Device Dislodged or Dislocated

  PATIENT WAS PUTTING ON CLOTHES AND DISLOCATED. THIS WAS ORIGINALLY PUT IN (B)(6) 2017. HE SAID THE CUP WAS ABOUT 15 DEGREES RETROVERTED AND SLIGHTLY VERTICAL. HE ALSO SAID HE HAS NEVER SEEN A HEAD COME OUT OF A CONSTRAINED LINER WITHOUT CATASTROPHIC FAILURE, WHICH THIS DID NOT HAVE, MEANING LINER BECAME DISLODGED OR SCREW AND CUP PULL OUT.

  Patient problems: Joint Dislocation

  MAUDE report 7077044 ↗
• InjurySep 14, 2017Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT A REVISION SURGERY WAS PERFORMED DUE TO A FAILED RIGHT HIP CONSTRAINED ACETABULAR LINER.

  Patient problems: Failure of Implant; Injury

  MAUDE report 6865853 ↗

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-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-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-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-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-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-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-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-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