R3 STIKTITE 71335546Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 03596010598219), received between Nov 6, 2017 and Jul 6, 2021 — classified as 4 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Connection Problem” (2 reports).

7 other recalls cover devices cleared under the same FDA submission (K070756, 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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• 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 12125594 ↗
• MalfunctionSep 30, 2020Connection Problem; Incomplete or Inadequate Connection; Connection Problem; Incomplete or Inadequate Connection

  IT WAS REPORTED THAT, DURING SURGERY, THE R3 CUP WAS IMPLANTED AND UPON TRYING TO INSERT THE LINER THE SURGEON REALIZED THE LOCKING MECHANISM WAS DEFECTIVE AND THE LINER COULDN'T BE PUT IN PLACE. IT IS UNKNOWN IF THERE WAS A DELAY. NO PATIENT INJURIES REPORTED. AN S&N BACKUP WAS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient

  MAUDE report 10604581 ↗
• InjuryJun 26, 2020Loose or Intermittent Connection; Insufficient Device Problem Information; Loose or Intermittent Connection; Insufficient Device Problem Information

  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 CUP 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 10199321 ↗
• MalfunctionFeb 18, 2020Connection Problem; Connection Problem

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

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9720108 ↗
• InjuryFeb 3, 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, EXCHANGING LINER, CUP AND HEAD DUE TO LOOSENING OF THE CUP. DURING THE PROCEDURE, THE STEM HAD TO BE EXPLANTED SINCE THE HEAD WAS COMPLETELY STUCK ON THE STEM. THIS WAS NOT PLANNED AND THERE WAS ONE HOUR DELAY.

  Patient problems: Injury

  MAUDE report 9659931 ↗
• InjuryMay 4, 2018Loose or Intermittent Connection; Loose or Intermittent Connection

  IT WAS REPORTED THAT A REVISION SURGERY WAS PERFORMED DUE TO A CUP MIGRATION.

  Patient problems: Injury

  MAUDE report 7485980 ↗
• InjuryNov 6, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT UNDERWENT HIP REVISION SURGERY DUE TO INFECTION.

  Patient problems: Injury; Unspecified Infection

  MAUDE report 7003315 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K070756, 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-2336-2020 · Apr 22, 2020 · Open, Classified
  smith&nephew R3 MULTI HOLE HA COATED HEMISPHERICAL STIKTITE COATED SHELL, manufactured in the following sizes: Size REF/product number 48MM 71338733 50MM 71338734 52MM 71338735 54M
• Z-2332-2020 · Apr 22, 2020 · Open, Classified
  smith&nephew R3 ZERO HOLE HA COATED HEMISPHERICAL STIKTITE COATED SHELL, manufactured in the following sizes: Size REF/product number 42MM 71332242 46MM 71332246 48MM 71332248 50MM
• Z-2333-2020 · Apr 22, 2020 · Open, Classified
  smith&nephew R3 THREE HOLE HEMISPHERICAL STIKTITE COATED SHELL, manufactured in the following sizes: Size REF/product number 40MM 71335540 42MM 71335542 44MM 71335544 46MM 71335546
• Z-2334-2020 · Apr 22, 2020 · Open, Classified
  smith&nephew R3 THREE HOLE HA COATED HEMISPHERICAL STIKTITE COATED SHELL, manufactured in the following sizes: Size REF/product number 42MM 71331942 46MM 71331946 48MM 71331948 50M
• Z-2335-2020 · Apr 22, 2020 · Open, Classified
  smith&nephew R3 MULTI HOLE HEMISPHERICAL STIKTITE COATED SHELL, manufactured in the following sizes: Sizes REF/product number 48MM 71338663 50MM 71338664 52MM 71338665 54MM 7133866
• Z-2331-2020 · Apr 22, 2020 · Open, Classified
  smith&nephew R3 NO HOLE HEMISPHERICAL STIKTITE COATED SHELL, manufactured in the following sizes: Size REF/product number 42MM 71331842 48MM 71331848 50MM 71331850 52MM 71331852 5