R3 71337654Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 03596010598509), received between Jun 5, 2017 and Nov 10, 2023 — classified as 6 injuries, 4 malfunctions.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (2 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 18, 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.

• InjuryNov 10, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER A TKA SURGERY WAS PERFORMED, THE PATIENT EXPERIENCED RECURRENT DISLOCATIONS. THIS ADVERSE EVENT WAS TREATED BY A REVISION SURGERY ON (B)(6) 2023, IN WHICH A R3 20 DEG XLPE ACET LNR 32MM X 54MM AND A COCR 12/14 FEM HEAD 32 + 4 WERE EXCHANGED. BOTH LINER AND HEAD LOOKED IN GOOD CONDITION. PATIENT'S CURRENT HEALTH STATUS IS UNKNOWN.

  Patient problems: Joint Dislocation

  MAUDE report 18115937 ↗
• InjuryDec 14, 2021Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  IT WAS REPORTED THAT, AFTER THR SURGERY HAD BEEN PERFORMED ON (B)(6) 2021, THE PATIENT EXPERIENCED HIP DISLOCATION. THIS ADVERSE EVENT WAS SOLVED BY REVISION SURGERY IN WHICH WAS FOUND AFTER REMOVAL OF THE LINER, IT WAS DISCOVERED THAT A LINER FOR A 32 MM HEAD WAS USED, WHILST THE HEAD SIZE WAS 36 MM. ON (B)(6) 2021, CORRECT SIZE LINER TO FIT THE CUP AND THE HEAD WAS INSERTED. CURRENT HEALTH STATUS OF PATIENT IS UNKNOWN.

  Patient problems: Joint Dislocation

  MAUDE report 13005286 ↗
• InjuryFeb 12, 2021Difficult to Insert; Difficult to Insert

  IT WAS REPORTED THAT, DURING AN UNKNOWN PROCEDURE, SURGEON ATTEMPTED TO INSERT A 32MM ID 54MM OD LINER BUT FOUND THE LINER DID NOT ENGAGE AT ALL WITH THE CUP. PROCEDURE WAS COMPLETED WITH A 36MM ID 54 OD LINER AND THIS ENGAGED WITH THE SHELL WITHOUT ANY ISSUES OR CONCERNS. THERE WAS NO DELAY OR FURTHER COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11325728 ↗
• MalfunctionDec 23, 2020Incomplete or Inadequate Connection; Incomplete or Inadequate Connection

  IT WAS REPORTED THAT A NORMAL TOTAL HIP ARTHROPLASTY SURGERY WAS PERFORMED. THE LINER DID NOT ENGAGE IN THE R3 SHELL, EVEN AFTER SEVERAL ATTEMPTS. A NEW LINER WAS OPENED (SAME PART NUMBER AND SAME LOT NUMBER). THE NEW LINER LOCKED IN PLACE IMMEDIATELY, AS INTENDED. A PROCEDURAL DELAY OF BETWEEN 0-30 MIN OCCURRED. NO PATIENT INJURY.

  Patient problems: Failure of Implant

  MAUDE report 11069500 ↗
• MalfunctionJul 27, 2020Connection Problem; Connection Problem

  IT WAS REPORTED THAT DURING A THR PROCEDURE, THE R3 20 DEGREES XLPE ACETABULAR LINER COULDN'T BE IMPLANTED. ANOTHER SAME SIZED INSERT WAS USED TO COMPLETE THE SURGERY. IT IS UNKNOWN IF THERE WAS ANY DELAY DUE TO THIS ISSUE. NO OTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10324884 ↗
• MalfunctionJun 26, 2020Unstable; Appropriate Device Problem Term/Code Not Available; Unstable; Appropriate Device Problem Term/Code Not Available

  DURING HIP JOINT REPLACEMENT OPERATION THE SURGEON IMPLANTED R3 CUP. THE SURGEONS WERE INTENDED TO INSERT THE LINER. THE FIRST LINER WAS NOT INSERTED INTO R3 CUP AS THE LINER MECHANISM DID NOT LOCK IN PLACE. THE SURGEONS DECIDED TO REPLACE IT WITH ANOTHER ONE AND DURING ITS INSERTING (THEY BEAT IT STRONGLY INTO THE CUP) THEY SAW THAT THE LINER CRUSHED. IT WAS PUTTED OUT AND REPLACED WITH THE THIRD LINER WHICH WAS EASILY AND QUICKLY IMPLANTED. A DELAY GREATER THAN 30 MIN WAS REPORTED. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

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

  MAUDE report 10203511 ↗
• MalfunctionJun 26, 2020Unstable; Appropriate Device Problem Term/Code Not Available; Unstable; Appropriate Device Problem Term/Code Not Available

  DURING HIP JOINT REPLACEMENT OPERATION THE SURGEON IMPLANTED R3 CUP. THE SURGEONS WERE INTENDED TO INSERT THE LINER. THE FIRST LINER WAS NOT INSERTED INTO R3 CUP AS THE LINER MECHANISM DID NOT LOCK IN PLACE. THE SURGEONS DECIDED TO REPLACE IT WITH ANOTHER ONE AND DURING ITS INSERTING (THEY BEAT IT STRONGLY INTO THE CUP) THEY SAW THAT THE LINER CRUSHED. IT WAS PUTTED OUT AND REPLACED WITH THE THIRD LINER WHICH WAS EASILY AND QUICKLY IMPLANTED. A DELAY GREATER THAN 30 MIN WAS REPORTED. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

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

  MAUDE report 10203472 ↗
• InjuryOct 29, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT, AFTER A RIGHT THR INDEX SURGERY PERFORMED ON (B)(6) 2019 TO ADDRESS OSTEOARTHRITIS SYMPTOMS, THE PATIENT SUSTAINED AN UNSPECIFIED INFECTION THAT MADE NECESSARY A REVISION SURGERY ON (B)(6) 2020. DURING THIS PROCEDURE, ALL PRIMARY COMPONENTS WERE EXPLANTED AND REPLACED WITH A THR SYSTEM FROM A COMPETITOR MANUFACTURER.

  Patient problems: Unspecified Infection

  MAUDE report 9253226 ↗
• InjuryOct 7, 2019Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PATIENT PRESENTED A HIP DISLOCATION. THIS WAS RESOLVED VIA CLOSED REDUCTION.

  Patient problems: Injury

  MAUDE report 9164261 ↗
• InjuryJun 5, 2017Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED A REVISION HIP SURGERY WAS PERFORMED DUE TO DISLOCATION.

  Patient problems: Joint Dislocation

  MAUDE report 6612938 ↗

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.