R3 71334946Recalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 03596010598097), received between Oct 8, 2018 and Mar 14, 2026 — classified as 6 injuries, 6 malfunctions.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (4 reports).

3 other recalls cover devices cleared under the same FDA submission (K113848, 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 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 14, 2026Positioning Failure

  IT WAS REPORTED THAT, DURING A POLAR PRIMARY HIP REPLACEMENT SURGERY, ONE (1) R3 20 DEG XLPE ACET LNR 28MM X 46MM DID NOT FIT IN ONE (1) R3 3 HOLE ACET SHELL MM46 THAT WAS PLACED AND SECURED WITH THREE SCREWS. POSSIBLE CAUSES WERE REVIEWED, AND IT WAS IDENTIFIED THAT THE POLYETHYLENE LINER NEVER ADHERED CORRECTLY TO THE CUP. THE DOCTOR DECIDED TO CEMENT THE INSERT TO THE CUP. DUE TO THE PATIENT'S PATHOLOGY AND MORPHOLOGY, THE CUP COULD NOT BE REMOVED. THE PROCEDURE WAS RESUMED, AFTER A NON-SIGNIFICANT DELAY, USING THE SAME DEVICES. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24600334 ↗
• InjuryNov 15, 2022Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT, AFTER A RIGHT THR INDEX SURGERY PERFORMED ON (B)(6) 2015 TO ADDRESS OSTEOARTHRITIS SYMPTOMS, THE PATIENT EXPERIENCED DISSOCIATION OF THE LINER THAT MADE NECESSARY A REVISION SURGERY ON (B)(6) 2015. DURING THIS PROCEDURE, THE ACETABULAR LINER AND FEMORAL HEAD WERE EXPLANTED AND REPLACED WITH SMITH AND NEPHEW COMPONENTS. THIS INFORMATION WAS PROVIDED BY THE NATIONAL JOINT REGISTRY OF THE UNITED KINGDOM, AS PART OF A RETROSPECTIVE DATA COLLECTION OF PATIENTS WHO UNDERWENT A PRIMARY THR SURGERY WITH A HIP PROSTHESIS CONSTRUCT THAT INCLUDED A POLARSTEM AND THAT REQUIRED A REVISION SURGERY DUE TO SPECIFIC REASONS. AS SUCH, NO FURTHER INFORMATION WILL BE AVAILABLE.

  Patient problems: Failure of Implant

  MAUDE report 15798490 ↗
• InjuryJul 28, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER A RIGHT THA HAD BEEN PERFORMED ON (B)(4) 2019, THE PATIENT EXPERIENCED AN INFECTION. A REVISION SURGERY WAS PERFORMED ON 4-SET-2019 WHERE R3 20 DEG XLPE ACET LNR 28MM X 46MM AND OXINIUM FEM HD 12/14 28MM +8 WERE EXPLANTED. PATIENTS CURRENT HEALTH STATUS IS UNKNOWN. THIS INFORMATION WAS PROVIDED BY THE NATIONAL JOINT REGISTRY FOR ENGLAND, WALES, NORTHERN IRELAND AND THE ISLE OF MAN SUPPLIER FEEDBACK; THEREFORE, FURTHER INFORMATION IS NOT AVAILABLE.

  Patient problems: Bacterial Infection; Unspecified Infection

  MAUDE report 12242167 ↗
• MalfunctionJul 6, 2021Fitting Problem; Fitting Problem

  IT WAS REPORTED THAT, DURING A THR SURGERY, THE R3 20 DEG XLPE ACET LNR 28MM X 46MM COME OUT AFTER TRYING SEVERAL TIMES IN THE R3 3 HOLE ACET SHELL MM46. FINALLY, ANOTHER LINER AND CUP WERE USED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH NO SIGNIFICANT DELAY USING A SMITH AND NEPHEW BACK UP DEVICE. PATIENT WAS NOT HARMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12125595 ↗
• MalfunctionApr 21, 2021Incomplete or Inadequate Connection; Incomplete or Inadequate Connection

  IT WAS REPORTED THAT DURING THR SURGERY THE R3 20 DEGREES XLPE ACET LNR 28 MM X 46MM INSERT COULDN'T BE LOCKED. IT WAS USED A SMITH AND NEPHEW BACK UP DEVICE. IT IS UNKN OWN IF THERE WAS ANY INJURY OR A DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11699958 ↗
• MalfunctionMar 11, 2021Fitting Problem; Fitting Problem

  IT WAS REPORTED THAT, DURING A THA PROCEDURE, AFTER IMPLANTING THE SHELL, THE LINER COULD NOT LOCK INTO THE SHELL. MORE THAN 30 MINUTES DELAY. NO FURTHER COMPLICATIONS REPORTED. PROCEDURE WAS COMPLETED WITH THE SAME DEVICES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11458326 ↗
• MalfunctionSep 18, 2020Connection Problem; Connection Problem

  IT WAS REPORTED THAT DURING A THR SURGERY, WHEN IMPLANTING THE 46/28 LINER, THE LINER IS SMALLER THAN THE OUT CUP. FINALLY ANOTHER OF THE SAME SIZE LINER WAS USED TO COMPLETE THE SURGERY. DELAY REPORTED WAS LESS OR EQUAL THAN 30 MINUTES.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10557388 ↗
• InjuryJun 26, 2020Loose or Intermittent Connection; Loosening of Implant Not Related to Bone-Ingrowth; Loose or Intermittent Connection; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT DURING A THA SURGERY, THE LOCKING MECHANISM OF 46MM OUTER CUP AND 46MM LINER CAUSED THE LINER COULD NOT BE IMPLANTED, IT WAS LOOSE, AND IT DIDN'T WORK EVEN AFTER TRYING SEVERAL TIMES. FINALLY A 48MM LINER WAS USED TO COMPLETE THE SURGERY. THERE WAS A DELAY BETWEEN 31-60M MIN.

  Patient problems: Failure of Implant; No Clinical Signs, Symptoms or Conditions

  MAUDE report 10199296 ↗
• MalfunctionFeb 18, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT DURING A THR THE R3 XLPE POLY LINER DID NOT LOCK R3 ACETABULAR CUP AND WHILE SURGEON WAS TRYING TO REMOVE THE ACETABULAR CUP AND THE SCREWS, THE ACETABULUM GOT DAMAGED. DUE TO WHICH WE COULD NOT OPERATE FURTHER.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9720204 ↗
• InjuryJan 14, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT A REVISION SURGERY WAS PERFORMED DUE TO INFECTION. LINER AND HEAD WERE EXPLANTED. SURGEON DOES NOT BLAME THE PRODUCT.

  Patient problems: Injury; Unspecified Infection

  MAUDE report 9586138 ↗
• InjuryDec 26, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A CLOSED REDUCTION DUE TO DISLOCATION.

  Patient problems: Joint Dislocation

  MAUDE report 9520282 ↗
• InjuryOct 8, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT REVISION SURGERY WAS PERFORMED. PATIENT HAD ACUTE INFECTION, SURGEON PERFORMED A LINER AND HEAD EXCHANGE WITH WASHOUT AND DEBRIDEMENT.

  Patient problems: Injury; Unspecified Infection

  MAUDE report 7945397 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K113848, 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-1928-2013 · May 29, 2013 · Terminated
  R3 (TM) XLPE ACETABULAR LINER UHMWPE, 20o OVERHANG, 36 MM ID, 62 MM OD, QTY: (1), STERILE H2O2, REF 71335762. Orthopaedic.
• Z-1929-2013 · May 29, 2013 · Terminated
  R3 (TM) XLPE ACETABULAR LINER UHMWPE, 20o OVERHANG, 36 MM ID, 60 MM OD, QTY: (1), STERILE H2O2, REF 71335760. Orthopaedic.