POLARCUP 75018956Recalls & reported problems

Summary

The FDA's MAUDE database contains 16 adverse event reports that list this exact device (DI 07611996111460), received between Oct 11, 2018 and Sep 17, 2024 — classified as 16 injuries.

The most frequently reported specific device problem is “Device Appears to Trigger Rejection” (1 report).

1 other recall cover devices cleared under the same FDA submission (K110135, 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 16 most recent of 16 reports, in the reporter's own words as published by the FDA.

• InjurySep 17, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER UNDERGOING THR ON (B)(6) 2024, THE PATIENT PRESENTED A HEMATOMA DUE TO THIS A REVISION SURGERY WAS PERFORMED ON (B)(6) 2024 TO REMOVED AND REPLACED THE LINER (POLARCUP XLPE INSERT 49/28 NON-CEM) AND HEAD (OXINIUM FEM HD 12/14 28MM +0) WITH NEW IMPLANTS DURING THE WASHOUT. THE CURRENT HEALTH STATUS OF PATIENT IS UNKNOWN.

  Patient problems: Hematoma

  MAUDE report 20241875 ↗
• InjurySep 16, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A REVISION SURGERY OF THE RIGHT HIP ON MAR-2022, DUE TO (1) INSTABILITY AND FAILED CONSTRAINED LINER FOLLOWING RIGHT TOTAL HIP ARTHROPLASTY REVISION, AND (2) PELVIC DISCONTINUITY. DURING THE REVISION SURGERY, THE PRIMARY THA SYSTEM WAS EXPLANTED AND REPLACED WITH A THA ACETABULAR REDAPT SYSTEM AND A FEMORAL HEAD FROM A COMPETITOR. THE FEMORAL COMPONENT WAS NOT EXPLANTED. THE IDENTITY OF THE PRIMARY THA SYSTEM IS UNKNOWN. AS REPORTED, THE PATIENT SUFFERED FROM INFECTION AND INFLAMMATORY REACTION AND UNDERWENT A REVISION SURGERY ON (B)(6) 2022. THE FEMORAL HEAD, SLEEVE AND ACETABULAR INSERT WERE EXPLANTED. THERE IS NO FURTHER INFORMATION AT THIS TIME. THE CURRENT STATE OF HEALTH OF THE PATIENT IS UNKNOWN.

  Patient problems: Medical device site infection

  MAUDE report 20233699 ↗
• InjuryAug 31, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AFTER UNDERGOING A THR ON AN UNKNOWN DATE, PATIENT EXPERIENCED INFECTION. THIS ADVERSE EVENT WAS ADDRESSED BY DOING A REVISION SURGERY ON (B)(6) 2024, IN WHICH, THE POLARCUP XLPE INSERT 49/28 NON-CEM WAS EXCHANGED. PATIENT'S CURRENT HEALTH STATUS IS UNKNOWN.

  Patient problems: Medical device site infection

  MAUDE report 20114310 ↗
• InjuryJul 22, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER A THA SURGERY WAS PERFORMED ON (B)(6) 2013, THE PATIENT EXPERIENCED AN UNSPECIFIED INFECTION. THIS ADVERSE EVENT WAS SOLVED BY A REVISION SURGERY ON (B)(6) 2013, WHERE THE POLARCUP XLPE INSERT 49/28 NON-CEM WAS EXPLANTED AND REPLACED. CURRENT HEALTH STATUS OF PATIENT IS UNKNOWN. THIS INFORMATION WAS PROVIDED BY THE NATIONAL JOINT REGISTRY OF THE UNITED KINGDOM, AS PART OF A RETROSPECTIVE DATA COLLECTION OF PATIENTS WHO UNDERWENT EITHER A REVISION OR RE-REVISION SURGERY WHERE A POLARCUP SHELL WAS PART OF THE HIP CONSTRUCT. AS SUCH, NO FURTHER INFORMATION WILL BE AVAILABLE.

  Patient problems: Unspecified Infection

  MAUDE report 15089784 ↗
• InjuryJul 22, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER A LEFT THA HAD BEEN PERFORMED ON (B)(6) 2018, THE PATIENT EXPERIENCED A DISLOCATION OF THE PROSTHESIS JOINT. A REVISION SURGERY WAS PERFORMED ON (B)(6) 2020 TO TREAT THIS ADVERSE EVENT. DURING THIS PROCEDURE, THE ACETABULAR CUP, THE LINER AND HEAD WERE EXPLANTED. THE PATIENT'S HEALTH STATUS IS NOT KNOWN. THIS INFORMATION WAS PROVIDED BY THE NATIONAL JOINT REGISTRY OF THE UNITED KINGDOM, AS PART OF A RETROSPECTIVE DATA COLLECTION OF PATIENTS WHO UNDERWENT EITHER A REVISION OR RE-REVISION SURGERY WHERE A POLARCUP SHELL WAS PART OF THE HIP CONSTRUCT. AS SUCH, NO FURTHER INFORMATION WILL BE AVAILABLE

  Patient problems: Joint Dislocation

  MAUDE report 15089725 ↗
• InjuryJul 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 REVISION SURGERY WHERE A POLARCUP XLPE INSERT 49/28 NON-CEM WAS IMPLANTED, THE PATIENT UNDERWENT A REVISION SURGERY ON (B)(6) 2018 TO EXPLANT LINER DUE TO DISLOCATION/SUBLUXATION. CURRENT HEALTH STATUS OF THE PATIENT IS UNKNOWN. THIS INFORMATION WAS PROVIDED BY THE NATIONAL JOINT REGISTRY OF THE UNITED KINGDOM, AS PART OF A RETROSPECTIVE DATA COLLECTION OF PATIENTS WHO UNDERWENT EITHER A REVISION OR RE-REVISION SURGERY WHERE A POLARCUP SHELL WAS PART OF THE HIP CONSTRUCT. AS SUCH, NO FURTHER INFORMATION WILL BE AVAILABLE.

  Patient problems: Joint Dislocation

  MAUDE report 15089667 ↗
• InjuryJul 21, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER A THA SURGERY WAS PERFORMED ON (B)(6) 2018, THE PATIENT EXPERIENCED AN UNSPECIFIED ADVERSE EVENT THAT LED TO A REVISION SURGERY ON (B)(6) 2018. THE STEM, FEMORAL HEAD AND LINER WERE EXPLANTED AND REPLACED. CURRENT HEALTH STATUS OF PATIENT IS UNKNOWN. THIS INFORMATION WAS PROVIDED BY THE NATIONAL JOINT REGISTRY OF THE UNITED KINGDOM, AS PART OF A RETROSPECTIVE DATA COLLECTION OF PATIENTS WHO UNDERWENT EITHER A REVISION OR RE-REVISION SURGERY WHERE A POLARCUP SHELL WAS PART OF THE HIP CONSTRUCT. AS SUCH, NO FURTHER INFORMATION WILL BE AVAILABLE.

  Patient problems: Insufficient Information

  MAUDE report 15080884 ↗
• InjuryJul 21, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AFTER A RIGHT THR PERFORMED ON (B)(6) 2015, THE PATIENT PRESENTED INFECTION. THIS WAS ADDRESSED VIA REVISION SURGERY ON (B)(6) 2015 WHERE THE FEMORAL HEAD FROM COMPETITOR'S AND THE POLARCUP XLPE INSERT 49/28 NON-CEM WERE EXPLANTED. THIS INFORMATION WAS PROVIDED BY THE NATIONAL JOINT REGISTRY OF THE UNITED KINGDOM, AS PART OF A RETROSPECTIVE DATA COLLECTION OF PATIENTS WHO UNDERWENT EITHER A REVISION OR RE-REVISION SURGERY WHERE A POLARCUP SHELL WAS PART OF THE HIP CONSTRUCT. AS SUCH, NO FURTHER INFORMATION WILL BE AVAILABLE. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: Unspecified Infection

  MAUDE report 15080826 ↗
• InjuryMar 29, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER A THR SURGERY WAS PERFORMED ON (B)(6) 2022, THE PATIENT EXPERIENCED AN INFECTION. THIS ADVERSE EVENT WAS TREATED WITH A REVISION SURGERY ON (B)(6) 2022, IN WHICH A POLARCUP XLPE INSERT 49/28 NON-CEM WAS EXPLANTED. MOREOVER, A KNEE FUSION FAN L 11.5MM X 75CM ALONG TWO (2) TRIGEN LOW PROFILE SCREW 5.0MM X 27.5MM WERE USED AS AN ANTIBIOTIC SPACER, AND A TEMPORARY IMPLANT WAS USED TO COUNTERACT INFECTION. PATIENT IS CURRENTLY HOSPITALIZED OVERCOMING PREVIOUS INFECTION.

  Patient problems: Unspecified Infection

  MAUDE report 13938826 ↗
• InjuryMar 14, 2021Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  IT WAS REPORTED THAT, A REVISION SURGERY WAS PERFORMED WITH A ROUTINE WASH-OUT AND COMPONENT EXCHANGE DUE TO INFECTION. PATIENT OUTCOME IS UNKNOWN.

  Patient problems: Unspecified Infection

  MAUDE report 11478998 ↗
• InjurySep 3, 2020Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT, AFTER A THA SURGERY HAD BEEN PERFORMED, THE PATIENT EXPERIENCED A MECHANICAL DISLOCATION OF THE CERAMIC CERAMIC BALL HEAD DELTA 28 M AND POLARCUP XLPE INSERT 49/28 NON-CEM. A REVISION SURGERY WAS PERFORMED TO REPLACE SUCH DEVICES. THE PATIENT OUTCOME IS UNKNOWN.

  Patient problems: Injury

  MAUDE report 10490832 ↗
• InjuryMar 5, 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 DUE TO INFECTION. PATIENT HAD DIABETIC REFLUX AND HYPERTENSION. SURGEON USED PREVIOUS INCISION TO OPEN JOINT AND DISLOCATED THE HIP. HEAD AND LINER WAS REMOVED VIA PUNCH. STEM WAS REMOVED VIA FLEXIBLE OSTEOTOMES AND REMOVAL TOOL. CUP REMOVED BY EXPLANT.

  Patient problems: Unspecified Infection

  MAUDE report 9794025 ↗
• InjuryMar 5, 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 DUE TO INFECTION. PATIENT HAD DIABETIC REFLUX AND HYPERTENSION. SURGEON USED PREVIOUS INCISION TO OPEN JOINT AND DISLOCATED THE HIP. HEAD AND LINER WAS REMOVED VIA PUNCH. STEM WAS REMOVED VIA FLEXIBLE OSTEOTOMES AND REMOVAL TOOL. CUP REMOVED BY EXPLANT.

  Patient problems: Unspecified Infection

  MAUDE report 9793988 ↗
• InjuryFeb 10, 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, 4 WEEKS AFTER THR. DUE TO INFECTION, HEAD AND LINER WERE EXCHANGED.

  Patient problems: Unspecified Infection

  MAUDE report 9687340 ↗
• InjuryNov 5, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT REVISION SURGERY WAS PERFORMED DUE TO INFECTION. ALL IMPLANTS WERE REMOVED.

  Patient problems: Unspecified Infection

  MAUDE report 9280207 ↗
• InjuryOct 11, 2018Misconnection; Misconnection

  IT WAS REPORTED THAT THE FEMORAL HEAD DISLOCATED FROM THE POLAR XLPE LINER. HEAD REMAINED ATTACHED TO THE STEM TAPER. REVISION OF FEMORAL HEAD AND THEREFORE LINER AND CEMENTED POLAR SHELL WAS ALSO CHANGED.

  Patient problems: Joint Dislocation

  MAUDE report 7958917 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K110135, 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.