R3 71339152Recalls & reported problems

Summary

The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 00885556022443), received between Feb 20, 2018 and Dec 4, 2025 — classified as 13 injuries, 1 malfunction.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (6 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 14 most recent of 14 reports, in the reporter's own words as published by the FDA.

• InjuryDec 4, 2025Fracture; Fracture

  IT WAS REPORTED THAT, AFTER A REVISION SURGERY THAT HAD BEEN PERFORMED ON (B)(6) 2025, THE PATIENT CAME IN FOR A FOLLOW-UP X-RAY, AND IT WAS DETERMINED THAT THE METAL RING IN THE R3 CONST 52MM WAS BROKEN. THIS ADVERSE EVENT WAS TREATED BY A REVISION SURGERY ON (B)(6) 2025 IN WHICH ONE (1) R3 CONST 52MM WAS EXPLANTED. CURRENT HEALTH STATUS OF THE PATIENT IS RECOVERING.

  Patient problems: Insufficient Information

  MAUDE report 23715412 ↗
• InjuryMar 17, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT, AFTER THR SURGERY HAD BEEN PERFORMED IN 2021, THE PATIENT EXPERIENCED A DISLOCATED HIP. THE X-RAYS REVEALED ONE (1) R3 CONST 52MM TO BE DISLOCATED. THIS ADVERSE EVENT WAS SOLVED BY REVISION SURGERY ON (B)(6)2025, IN WHICH THE SURGEON OPENED UP THE JOINT AND PUT IN A NEW CONSTRAINED LINER AND FEMORAL HEAD. PATIENT'S CURRENT HEALTH STATUS IS UNKNOWN. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: Joint Dislocation

  MAUDE report 21627823 ↗
• InjuryJan 3, 2025Adverse 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 ON UNKNOWN DATE, A FIRST REVISION WAS PERFORMED ON (B)(6) 2024 WHERE THE FEMORAL HEAD WAS EXPLANTED DUE HIP DISLOCATION, NOW THE PATIENT EXPERIENCED AN INFECTION. THIS ADVERSE EVENT WAS TREATED BY INCISION AND DRAINAGE. AND ALSO, BY REVISION SURGERY, IN WHICH ONE (1) R3 CONST 52MM AND THE FEMORAL HEAD WERE EXPLANTED. PATIENT'S CURRENT HEALTH STATUS IS STABLE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: Medical device site infection

  MAUDE report 21072594 ↗
• MalfunctionOct 18, 2022Improper or Incorrect Procedure or Method; Device Dislodged or Dislocated; Improper or Incorrect Procedure or Method; Device Dislodged or Dislocated

  IT WAS REPORTED THAT, DURING A REVISION TOTAL HIP REPLACEMENT ON THE LEFT SIDE, THE 52MM R3 CONSTRAINED LINER DID NOT WORK: THE HIP KEPT DISLOCATING. THE SURGEON ASKED FOR ANOTHER EQUIVALENT IMPLANT, WHICH WAS NOT IMMEDIATELY AVAILABLE. AS CONSEQUENCE, THE SURGERY WAS DELAYED, WHICH RESULTED IN UNNECESSARY PROLONGED ANESTHESIA. THERE WAS NOT ANY ADVERSE EVENT ON THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15629222 ↗
• InjuryJul 22, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT, DURING A THA REVISION SURGERY, THE DOCTOR STRUGGLED TO REDUCE THE HIP AND DURING ONE OF THE ATTEMPTS TO DO IT, THE NON-SPLIT METAL RING OF AN R3 CONSTRAINED ACETABULAR LINER 52MM COMPLETELY CAME OFF. AFTER A DELAY OF 5-10 MINUTES, THE DOCTOR DECIDED IT WOULD DO MORE HARM TO THE PATIENT IF HE DISLOCATED AND RELOCATED THE HIP WITH A BACK-UP LINER THAN TO LEAVE IT AS WAS, SO HE CLOSED THE CASE WITH THE SAME DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12211563 ↗
• InjuryMay 6, 2021Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT, DURING A HIP REVISION SURGERY, THE R3 CONST 52 MM LINER FELL OUT OF R3 SHELL. THE PROCEDURE WAS COMPLETED, WITH A DELAY GRATER THAN 30 MIN, USING COMPETITOR DEVICES BECAUSE SURGEON HAD TO COMPLETELY REMOVE LINER, SHELL, AND HEAD. THE CONDITION OF THE PATIENT IS UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11783506 ↗
• InjuryOct 22, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A REVISION SURGERY WAS PERFORMED ON (B)(6) 2018 DUE TO DISLOCATION AND INSTABILITY OF THE REDAPT CEMENTED XLPE LINER. THIS IMPLANT WAS REPLACED WITH A R3 CONSTRAINED LINER. ON (B)(6) 2018, THE R3 CONSTRAINED LINER FAILED AND WAS REPLACED WITH BIOMET DUAL MOBILITY 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 10719280 ↗
• InjurySep 16, 2019Fracture; Fracture

  IT WAS REPORTED A REVISION SURGERY TO REPLACE CRACKED CUP AND REMOVE THE BROKEN CONSTRAINED LINER.

  Patient problems: Injury

  MAUDE report 9073622 ↗
• InjuryFeb 1, 2019Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT REVISION SURGERY WAS PERFORMED ON THE PATIENT DUE TO A DISLOCATION. NO ADDITIONAL INFORMATION SPECIFIED.

  Patient problems: Injury

  MAUDE report 8298455 ↗
• InjuryNov 15, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT A REVISION SURGERY WAS PERFORMED DUE TO DISLOCATION IN SPASTIC PATIENT. THERE WERE REVISED LINER AND FEMORAL HEAD.

  Patient problems: Joint Dislocation; Muscle Spasm(s)

  MAUDE report 8074222 ↗
• InjuryNov 15, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT A REVISION SURGERY WAS PERFORMED DUE TO DISLOCATION IN SPASTIC PATIENT. THERE WERE REVISED LINER AND FEMORAL HEAD.

  Patient problems: Joint Dislocation; Muscle Spasm(s)

  MAUDE report 8073772 ↗
• InjuryOct 24, 2018Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT A REVISION SURGERY OF CONSTRAINED LINER WAS PERFORMED TO A PATIENT DUE TO A DISLOCATION.

  Patient problems: Injury; Joint Dislocation

  MAUDE report 8002989 ↗
• InjuryMay 3, 2018Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IN (B)(6) 2017 PATIENT WENT WITH A NEW DISLOCATION (RX SUGGESTED A BREAKAGE OF THE LOCKING MECHANISM) AFTER A CLOSED REDUCTION PERFORMED IN (B)(6) 2017 ((B)(4)) A NEW SURGICAL REVISION WAS UNDERTAKEN ON (B)(6) 2017 IMPLANTING A NEW CONSTRAINED LINER

  Patient problems: Joint Dislocation

  MAUDE report 7485439 ↗
• InjuryFeb 20, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

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

  Patient problems: Unspecified Infection

  MAUDE report 7282562 ↗

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-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-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-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-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-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
• 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
• 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