R3 71339160Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00885556021330), received between Jun 21, 2017 and Feb 13, 2025 — classified as 4 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 18, 2026.

Most reported problems

Recent adverse event reports

The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 13, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT A PATIENT HAD A PREVIOUS THR REVISION SURGERY BEEN PERFORMED ON (B)(6) 2024, WHERE AN R3 20 DEGREE LINER HAD BEEN REVISED FOR A CONSTRAINED LINER. AFTER THAT SURGERY THE PATIENT EXPERIENCED A HIP DISLOCATION. THE PATIENT REPORTED THAT IT HAD BEEN BENDING DOWN IN THE GARDEN AND HEARD/FELT A ¿POP¿. X-RAYS SHOWED THE HIP HAD BEEN DISLOCATED. THIS ADVERSE EVENT WAS ADDRESSED BY A REVISION SURGERY ON (B)(6) 2025, IN WHICH THE CONSTRAINED LINER, ACETABULAR SHELL, AND FEMORAL HEAD WERE REMOVED AND REPLACED. THE CURRENT HEALTH STATUS OF THE PATIENT IS UNKNOWN.

  Patient problems: Joint Dislocation

  MAUDE report 21379021 ↗
• InjuryMar 10, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A REVISION SURGERY TOOK PLACE TO REPLACE THE CONSTRAINED LINER WEAR, ALSO WAS NOTICED THAT THE INSERT AS WELL AS THE MECHANISM OF DUAL MOBILITY IS DIFFICULT TO ACHIEVE AS THE LINER HAS BEGUN TO SEIZE. THE INITIAL CONSTRUCT INCLUDED A SYNERGY STEM (UNSURE OF SIZE) 60MM R3 CUP, 28/60 CONSTRAINED LINER, 28 +8 COCR HEAD. THIS CONSTRUCT WAS PLACED IN (B)(6) OF 2019, A FALL OUT OF WHEELCHAIR OCCURRED AND A CLOSED REDUCTION WAS ATTEMPTED IN (B)(6) 2021.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11449961 ↗
• InjuryAug 14, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT REVISION SURGERY WAS PERFORMED DUE TO DRAINING POSTOPERATIVE HEMATOMA. THE LINER AND THE HEAD WERE REMOVED AND REPLACED. THE PATIENT OUTCOME IS UNKNOWN.

  Patient problems: Hematoma; Injury

  MAUDE report 10405972 ↗
• MalfunctionJan 28, 2019Connection Problem; Connection Problem

  IT WAS REPORTED THAT DURING REVISION THE CONSTRAINED LINER WON'T ENGAGE SHELL. LESS THAN TWO HOURS OF DELAY WAS REPORTED AND A BACKUP DEVICE WAS AVAILABLE.

  Patient problems: No Information

  MAUDE report 8283238 ↗
• InjuryJun 21, 2017Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED A REVISION OF THE CONSTRAINED LINER WAS PERFORMED DUE TO DISLOCATION.

  Patient problems: No Information

  MAUDE report 6658322 ↗

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-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-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-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-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-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-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-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