NA 71303604Recalls & reported problems

Summary

The FDA's MAUDE database contains 15 adverse event reports that list this exact device (DI 03596010479990), received between Feb 26, 2019 and Apr 15, 2025 — classified as 13 injuries, 2 malfunctions.

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

1 other recall cover devices cleared under the same FDA submission (K022902, 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 15 most recent of 15 reports, in the reporter's own words as published by the FDA.

• InjuryApr 15, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT, AFTER A FIRST REVISION THR SURGERY HAD BEEN PERFORMED ON (B)(6) 2023, THE PATIENT WAS ADMITTED ON (B)(6) 2025 FOR RELOCATION OF DISLOCATED HIP, IT WAS TREATED BY A CLOSED REDUCTION WITH ANESTHESIA, NOW THE PATIENT EXPERIENCED A SECOND HIP DISLOCATION. THIS ADVERSE EVENT WAS SOLVED BY THR REVISION SURGERY ON (B)(6) 2025, IN WHICH ONE (1) R3 ANTE XLPE LNR 36MM X 50MM +4 AND ONE (1) COCR 12/14 FEM HEAD 36MM +4 WERE REVISED. THE LIP OF THE ANTEVERTED LINER APPEARED DAMAGED, FROM THE DISLOCATION/RELOCATION OF THE FEMORAL HEAD. PATIENT'S CURRENT HEALTH STATUS IS UNKNOWN. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: Joint Dislocation

  MAUDE report 21845648 ↗
• InjuryJun 11, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT, AFTER A THR PERFORMED ON A UNSPECIFIED DATE, THE PATIENT HAD EXPERIENCED SEVERE PAIN FOR THE PAST 4 YEARS AND SUFFERED A HIP DISLOCATION. A REVISION SURGERY WAS PERFORMED ON (B)(6) 2023 IN ORDER TO EXCHANGE THE IMPLANTS, BUT SHE STILL HAS BEEN EXPERIENCING SYMPTOMS LIKE SEVERE PAIN WHEN WALKING AND EVEN RIDING IN CAR. PATIENT ALSO HAS ELEVATED LEVELS OF COBALT (5.5) AND CHROMIUM (8.1) AND SIGNIFICANT DAMAGE TO GLUTEUS MEDIUS, WITH RISK OF FURTHER DISLOCATION. IT IS UNKNOWN HOW THIS ISSUE IS BEING ADDRESSED AT THE MOMENT.

  Patient problems: High metal ion levels; Joint Dislocation; Pain

  MAUDE report 19512717 ↗
• InjuryJan 10, 2023Biocompatibility; Biocompatibility

  IT WAS REPORTED THAT, AFTER A RIGHT THR WAS PERFORMED ON (B)(6) 2013 DUE TO AVASCULAR NECROSIS, THE PATIENT EXPERIENCED UNEXPLAINED PAIN ALONG WITH ADVERSE SOFT TISSUE REACTION TO PARTICULATE DEBRIS. THIS ADVERSE EVENT WAS TREATED BY PERFORMING A REVISION SURGERY ON (B)(6) 2014. DURING THIS PROCEDURE, THE FEMORAL HEAD WAS REMOVED AND REPLACED WITH A COMPETITOR'S (MERETE MEDICAL) DEVICE. 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 STEM WITH AN R3 ACETABULAR CUP AND THAT REQUIRED A REVISION SURGERY DUE TO SPECIFIC REASONS. AS SUCH, NO FURTHER INFORMATION WILL BE AVAILABLE.

  Patient problems: Foreign Body Reaction; Pain

  MAUDE report 16135021 ↗
• InjuryDec 22, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER A RIGHT THR INDEX SURGERY PERFORMED ON (B)(6) 2018 TO ADDRESS OSTEOARTHRITIS SYMPTOMS, THE PATIENT SUSTAINED AN UNSPECIFIED INFECTION THAT MADE NECESSARY A REVISION SURGERY ON (B)(6) 2018. DURING THIS PROCEDURE, THE MODULAR HEAD AND THE ACETABULAR LINER WERE EXPLANTED AND REPLACED WITH A SMITH AND NEPHEW BEARING COMBINATION. 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 STEM WITH AN R3 ACETABULAR CUP AND THAT REQUIRED A REVISION SURGERY DUE TO SPECIFIC REASONS. AS SUCH, NO FURTHER INFORMATION WILL BE AVAILABLE.

  Patient problems: Unspecified Infection

  MAUDE report 16040215 ↗
• InjuryOct 30, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER A RIGHT THR INDEX SURGERY PERFORMED ON (B)(6) 2015 TO ADDRESS OSTEOARTHRITIS SYMPTOMS, THE PATIENT EXPERIENCED A DISLOCATION/SUBLUXATION AND UNEXPLAINED PAIN THAT MADE NECESSARY A REVISION SURGERY ON (B)(6) 2016. DURING THIS PROCEDURE, THE MODULAR FEMORAL HEAD AND THE ACETABULAR LINER WERE EXPLANTED AND REPLACED WITH A SMITH AND NEPHEW BEARING COMBINATION. 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 AN R3 SHELL AND THAT REQUIRED A REVISION SURGERY DUE TO SPECIFIC REASONS. AS SUCH, NO FURTHER INFORMATION WILL BE AVAILABLE.

  Patient problems: Joint Dislocation; Pain

  MAUDE report 15697322 ↗
• MalfunctionFeb 16, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER A THR SURGERY HAD BEEN PERFORMED ON (B)(6) 2021, THE PATIENT REPORTED AN INFECTION. THE ADVERSE EVENT WAS ADDRESSED WITH A REVISION SURGERY ON (B)(6) 2022 TO REPLACE THE COCR 12/14 FEM HEAD 36MM +4. THE CONDITION OF THE PATIENT IS UNKNOWN.

  Patient problems: Unspecified Infection

  MAUDE report 13542151 ↗
• InjuryOct 15, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  US LEGAL. IT WAS REPORTED THAT AFTER A LEFT THA WAS PERFORMED ON (B)(6) 2016, PLAINTIFF EXPERIENCED INCREASING PAIN, EFFUSION ON LEFT HIP, AND HEMATOMA ON THE HIP. AN IRRIGATION AND DEBRIDEMENT OF HEMATOMA, AND DEBRIDEMENT OF LEFT TROCHANTERIC BURSA WAS PERFORMED ON (B)(6) 2019 TO INITIALLY TREAT THESE ADVERSE EVENTS. HOWEVER, PLAINTIFF CONTINUED HAVING ISSUES, INCLUDING HIGH COBALT LEVELS ON BLOOD ( (B)(6) 2019: COBALT 19 MCG/L). DUE TO THIS, A REVISION SURGERY WAS PERFORMED ON (B)(6) 2019. DURING SURGERY ALL THE S+N DEVICES WERE EXPLANTED, AND NEW DEVICES WERE IMPLANTED. AFTER THE REVISION SURGERY, THE PLAINTIFF EXPERIENCED MULTIPLE INTERVENTIONS INCLUDING A SECOND REVISION SURGERY AND OPEN REDUCTION WITH INTERNAL FIXATION OF LEFT PELVIS FRACTURE, HOWEVER SINCE THERE IS NO INFORMATION ABOUT THE MANUFACTURER FOR ALL DEVICES IMPLANTED ON THE FIRST REVISION SURGERY, DETERMINATION IF SOME OF THE DEVICES ARE FROM S+N CANNOT BE CONCLUDED. A CORRELATION BETWEEN THESE EVENTS AND OUR DEVICES CANNOT BE STABLISH. PLAINTIFF OUTCOME IS UNKNOWN.

  Patient problems: Bone Fracture(s); Hematoma; Infiltration into Tissue; Inflammation; Pain; Swelling/ Edema

  MAUDE report 12639027 ↗
• InjuryJun 23, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER TOTAL HIP ARTHROPLASTY HAD BEEN PERFORMED ON (B)(6) 2021, THE PATIENT EXPERIENCED AN INFECTION. THIS ADVERSE EVENT WAS SOLVED BY A REVISION SURGERY ON (B)(6) 2021, WHERE THE 20 DEGREE XLPE ACETABULAR LINER 36MM INNER DIAMETER X OUTER DIAMETER 52MM ((B)(4)) AND THE COBALT CHROME 12/14 TAPER FEMORAL HEAD 36MM +4 ((B)(4)) WERE REPLACED. CURRENT HEALTH STATUS OF PATIENT IS UNKNOWN.

  Patient problems: Unspecified Infection

  MAUDE report 12053906 ↗
• InjuryJun 7, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, 3 MOTHS AFTER A LEFT REVISION SURGERY PERFORMED IN (B)(6) 2015 (CAPTURED UNDER (B)(4)), THE PATIENT EXPERIENCED PAIN ON THE AREA. THE PHYSICIAN DIAGNOSED TRAUMATIC BURSITIS, WHICH WAS TREATED WITH SOME PHYSICAL THERAPY AND ULTRASOUND TREATMENT. NO OTHER COMPLICATIONS WERE REPORTED.

  Patient problems: Inflammation; Pain

  MAUDE report 11949430 ↗
• MalfunctionMay 31, 2021Problem with Sterilization; Packaging Problem; Problem with Sterilization; Packaging Problem

  IT WAS REPORTED THAT, DURING THR SURGERY THE COCR 12/14 FEM HEAD 36MM +4 STERILITY BARRIER WAS BREACHED BECAUSE THE PACKAGING WAS OPENING. THE PROCEDURE WAS COMPLETED, WITH A MINIMAL DELAY (LESS THAN 30 MINUTES) , USING A S+N BACK-UP DEVICE. NO PATIENT INJURIES AND NO OTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11909330 ↗
• InjuryApr 19, 2021Adverse 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 THE A CPCS COBALT CHROME PRIMARY STANDARD OFFSER 12/14 TAPER SIZE 3 AND COBALT CHROME 12/14 TAPER FEMORAL HEAD 36 MM +4 WERE LOOSE INSIDE THE CEMENT MANTLE.

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

  MAUDE report 11689119 ↗
• InjuryApr 5, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  BILATERAL PATIENT. IT WAS REPORTED THAT A SECOND REVISION SURGERY WAS PERFORMED THE PATIENT LEFT HIP ON (B)(6) 2018. THE REVISION SURGERY WAS PERFORMED DUE TO METALOSIS. THE CUP, HEAD, LINER AND SLEEVE WERE REMOVED, ONLY THE STEM WAS LEFT INSIDE THE PATIENT. DEPUY PARTS WERE IMPLANTED. ALTHOUGH THE PATIENT IS A BILATERAL ONE AND ELEVATED ION LEVELS (METALOSIS) WAS REPORTED THE RIGHT HIP CONSTRUCT CONSIST OF CERAMIC PARTS, THEREFORE THERE IS NO CONTRIBUTION OF THE RIGHT HIP CONSTRUCT TO THE ELEVATED ION LEVELS THAT PROVOKE THE SECOND REVISION SURGERY. THE PATIENT OUTCOME IS UNKNOWN.

  Patient problems: Loss of Vision; Metal Related Pathology; Partial Hearing Loss; Tachycardia

  MAUDE report 11616783 ↗
• InjuryJan 14, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A REVISION SURGERY WAS PERFORMED BECAUSE THE PATIENT PRESENTED A FRANK INFECTION. THE PATIENT WOULD HAVE RECEIVED A COURSE OF ANTIBIOTICS TO COVER THE INFECTION, BUT IT DIDN'T WORK, SO THE SURGEON TOOK FLUID AND TISSUE SAMPLES. THEN SOME SOFT TISSUE DEBRIDEMENT WAS UNDERTAKEN AND THE HIP JOINT SOAKED WITH BETADINE SOLUTION, CHLORHEXIDINE, AND HYDROGEN PEROXIDE. AFTER, THE SURGEON REPLACED THE LINER AND HEAD. THI COMPLAINT IS AGAINST THE HEAD. FINALLY, THE SURGEON CLOSED THE WOUND AND APPLIED A DRESSING.

  Patient problems: Bacterial Infection

  MAUDE report 11169163 ↗
• InjuryFeb 25, 2020Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT REVISION SURGERY TO REMOVE A COCR FEMORAL HEAD, PART OF A 2012 TKR. THE PATIENT PRESENTED METAL WEAR DEBRIS AROUND THE SOFT TISSUE AND THE TAPER JUNCTION FROM THE FEMORAL HEAD APPEARED TO HAVE CORROSION.

  Patient problems: Injury

  MAUDE report 9752061 ↗
• InjuryFeb 26, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

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

  Patient problems: Unspecified Infection

  MAUDE report 8370115 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K022902, 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.