NA 71303608Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 03596010480002), received between Dec 23, 2019 and Nov 4, 2025 — classified as 10 injuries, 1 malfunction.

The most frequently reported specific device problem is “Biocompatibility” (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 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• InjuryNov 4, 2025Biocompatibility; Biocompatibility

  IT WAS REPORTED THAT AFTER A THA SURGERY PERFORMED IN 2017, THE PATIENT EXPERIENCED HIP PAIN. METALLOSIS FROM THE TRUNNION WAS DISCOVERED ALONG WITH A PSEUDOTUMOR. THE ADVERSE EVENT WAS TREATED WITH A REVISION SURGERY ON (B)(6) 2025, DURING WHICH ONE (1) COCR 12/14 FEM HEAD 36MM +8 WAS REPLACED WITH AN OXINIUM +12 HEAD, AND THE POLY LINER WAS REPLACED. THE PATIENT IS DOING WELL.

  Patient problems: Metal Related Pathology; Nodule; Pain

  MAUDE report 23466249 ↗
• MalfunctionFeb 7, 2024Delivered as Unsterile Product; Tear, Rip or Hole in Device Packaging; Delivered as Unsterile Product; Tear, Rip or Hole in Device Packaging

  IT WAS REPORTED THAT DURING THR SURGERY, THE COCR 12/14 FEM HEAD 36MM +8 WAS OPENED AND MOST INNER PLASTIC PACKAGING CONTAINING THE HEAD HAD A SIGNIFICANT CRACK. THE PRODUCT WAS WASTED AS NURSING THOUGHT THIS PRODUCT WAS NOT STERILE DUE TO THE CRACK IN THE PACKAGING. SURGERY WAS RESUMED WITHOUT ANY DELAY WITH A S+N BACK-UP DEVICE. PATIENT WAS NOT HARMED AS CONSEQUENCE OF THE PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18660291 ↗
• 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) 2020 TO ADDRESS OSTEOARTHRITIS SYMPTOMS, THE PATIENT SUSTAINED AN UNSPECIFIED INFECTION THAT MADE NECESSARY A REVISION SURGERY (B)(6) 2020. 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 16040338 ↗
• InjuryOct 30, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER A LEFT THR INDEX SURGERY PERFORMED ON (B)(6) 2017 TO ADDRESS OSTEOARTHRITIS SYMPTOMS AND AN UNSPECIFIED ACUTE TRAUMA INJURY, THE PATIENT EXPERIENCED A DISLOCATION/SUBLUXATION THAT MADE NECESSARY A REVISION SURGERY ON (B)(6) 2017. DURING THIS PROCEDURE, THE 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

  MAUDE report 15697326 ↗
• InjurySep 28, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER SURGERY HAD BEEN PERFORMED , THE PATIENT EXPERIENCED REOCCURRING HIP DISLOCATIONS. THIS ADVERSE EVENT WAS TREATED BY REVISION SURGERY ON (B)(6) 2022. CURRENT HEALTH STATUS OF PATIENT IS UNKNOWN.

  Patient problems: Joint Dislocation

  MAUDE report 15496216 ↗
• InjuryMar 30, 2022Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT, AFTER TOTAL HIP REPLACEMENT WAS PERFORMED ON (B)(6) 2020, THE PATIENT EXPERIENCED LINER AND FEMORAL HEAD DISLOCATION. THIS ADVERSE EVENT WAS TREATED WITH A REVISION SURGERY ON (B)(6) 2022. THIS IS THE SECOND REVISION SURGERY AFTER IMPLANTATION DUE TO THE SAME CAUSE. PATIENT'S CURRENT HEALTH STATUS IS UNKNOWN.

  Patient problems: Failure of Implant

  MAUDE report 13956489 ↗
• InjuryMar 18, 2022Biocompatibility; Biocompatibility

  IT WAS REPORTED THAT, AFTER A PRIMARY RIGHT R3-THA SURGERY IN (B)(6) 2017, THE PLAINTIFF PRESENTED METALLOSIS, SIGNIFICANT PAIN, EDEMA, AND MECHANICAL COMPLICATIONS. AS A RESULT, THE PLAINTIFF UNDERWENT REVISION SURGERY ON (B)(6) 2021. DURING THE REVISION, CORROSION WAS FOUND AT THE NECK AND HEAD JUNCTION. THE FEMORAL COMPONENT AND THE ACETABULAR SHELL WERE WELL FIXED AND WERE LEFT IN PLACE. THE LINER AND THE FEMORAL HEAD WERE EXPLANTED AND REPLACED WITH A THA SYSTEM FROM A COMPETITOR. THE PLAINTIFF TOLERATED THE PROCEDURE WELL.

  Patient problems: Metal Related Pathology

  MAUDE report 13814683 ↗
• InjurySep 22, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER A THR, A REVISION SURGERY WAS PERFORMED IN TWO STAGES, THE FIRST STAGE ON (B)(6) 2021 AND THE SECOND STAGE ON (B)(6) 2021. IN THE SECOND STAGE REVISION SURGERY, NINE (9) DEVICES WERE EXPLANTED, A REF XLPE ALL PLY CUP 36 52, A COCR 12/14 FEM HEAD 36MM +8, A CPCS PRI STD OFFSET 12/14 XSM, A ACC STD 125MM 5 CBL TROCH GRIP, A ACCORD 2.0MM COCR CABLE, AND FOUR (4) ACC 2.0MM COCR CABLES W/CLAMP. THE REASON TO PERFORM THE REVISION SURGERY AND THE PATIENT CURRENT HEALTH STATUS IS UNKNOWN.

  Patient problems: Failure of Implant; Insufficient Information

  MAUDE report 12516531 ↗
• InjuryDec 6, 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 FOR A PSEUDOTUMOR DUE TO TRUNIONOSIS FOUR YEARS AFTER A PRIMARY PROCEDURE WITH A COBALT CHROME FEMORAL HEAD. SURGEON INFORMED A LARGE AMOUNT OF MUSCLE DESTRUCTION AROUND THE HIP JOINT. THE COCR 36MM +8 12/14 TAPER FEMORAL HEAD WAS REMOVED WITH A METAL PUNCH AT WHICH TIME SIGNS OF TRUNION WEAR WAS OBSERVED. STEM FIXATION WAS ASSESSED AND DETERMINED STABLE. OR3O PROSTHESES WAS IMPLANTED. PATIENT OUTCOME IS UNKNOWN. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: Failure of Implant; Metal Related Pathology

  MAUDE report 10955762 ↗
• InjuryFeb 12, 2020Loose or Intermittent Connection; Loose or Intermittent Connection

  IT WAS REPORTED THAT THE ORIGINAL THR WAS PERFORMED AT (B)(6) HOSPITAL (B)(6) ON (B)(6) 2015. REVISION SURGERY WAS PERFORMED ON (B)(6) 2020 DUE TO LOOSENING. THE HEAD WAS EXPLANTED.

  Patient problems: Injury

  MAUDE report 9699383 ↗
• InjuryDec 23, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAS A POLARSTEM DEVICE IN PLACE SINCE 2017 AND WAS EXPERIENCING ELEVATED COBALT LEVELS. REVISION SURGERY WAS PERFORMED AND THE POLY WAS EXPLANTED AND AN OXINIU HEAD WAS USED.

  Patient problems: Injury

  MAUDE report 9513568 ↗

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.