NA 71302804Recalls & reported problems

Summary

The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 03596010194138), received between Oct 31, 2017 and Oct 31, 2022 — classified as 14 injuries.

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 (K211176, K963509); 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 14 most recent of 14 reports, in the reporter's own words as published by the FDA.

• InjuryOct 31, 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) 2019 TO ADDRESS AN UNSPECIFIED ACUTE TRAUMATIC INJURY, THE PATIENT EXPERIENCED A DISLOCATION/SUBLUXATION THAT MADE NECESSARY A REVISION SURGERY ON (B)(6) 2021. DURING THIS PROCEDURE, THE MODULAR HEAD AND ACETABULAR LINER WERE EXPLANTED AND REPLACED WITH COMPETITORS DEVICES. 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 15697858 ↗
• InjuryJul 21, 2022No Apparent Adverse Event; No Apparent Adverse Event

  IT WAS REPORTED THAT AFTER A LEFT THR PERFORMED ON (B)(6) 2009, THE PATIENT PRESENTED LOOSENING OF THE STEM, UNEXPLAINED PAIN AND INFECTION. A REVISION SURGERY WAS PERFORMED ON (B)(6) 2013 TO TREAT THE ADVERSE EVENT AND ALL DEVICES WERE EXPLANTED. THIS INFORMATION WAS PROVIDED BY THE NATIONAL JOINT REGISTRY OF THE (B)(6), 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: Failure of Implant; Pain; Unspecified Infection

  MAUDE report 15080103 ↗
• InjuryJun 17, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AFTER A THR PERFORMED ON (B)(6) 2002, THE PATIENT REPORTED HIP PAIN. THERE WAS A REVISION SURGERY ON (B)(6) 2021, IN WHICH IT WAS DECIDED TO EXPLANT THE REF CEMENT ACET COM 28/55 AND THE COCR 12/14 FEM HEAD 28 + 4 AND REPLACE THEM. IT WAS REPORTED THAT AFTER THE REPLACEMENT, THE PATIENT WAS STABLE.

  Patient problems: Pain

  MAUDE report 12020281 ↗
• InjuryMay 31, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  *US LEGAL* THE PATIENT KEPT BEING TREATED WITH SUBOXONE AND RECEIVING LEFT HIP INJECTIONS DUE TO CHRONIC PAIN. AFTER THE DISLOCATION IN 2018 (COVERED UNDER C-0283471 AND C-0283572), THE DOCTOR INDICATED THAT THE PATIENT NEEDED ANOTHER REVISION SURGERY. THE PATIENT CANCELED THE APPOINTMENT DUE TO A PERSONAL SITUATION AND WILL HAVE TO RESCHEDULE IT.

  Patient problems: Joint Dislocation; Pain

  MAUDE report 11907601 ↗
• InjuryJun 24, 2020Defective Device; Defective Device

  IT WAS REPORTED THAT, AFTER A THA SURGERY HAD BEEN PERFORMED, THE PATIENT EXPERIENCED AN UNSPECIFIED ADVERSE EVENT. A REVISION SURGERY WAS PERFORMED IN WHICH THE FEMORAL HEAD WAS EXCHANGED. THE PATIENT OUTCOME IS UNKNOWN.

  Patient problems: No Information

  MAUDE report 10188220 ↗
• InjuryMar 3, 2020Patient-Device Incompatibility; Patient-Device Incompatibility

  IT WAS REPORTED THAT THE PATIENT HAD S&N COMPONENTS SINCE THE UNKNOWN DATE AND REVISION SURGERY WAS PERFORMED DUE TO INFECTION. COCR 12/14 FEM HEAD 28 + 4 WAS EXPLANTED.

  Patient problems: Injury

  MAUDE report 9779252 ↗
• InjuryDec 26, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A CLOSED REDUCTION DUE TO DISLOCATION.

  Patient problems: Joint Dislocation

  MAUDE report 9520419 ↗
• InjuryAug 29, 2019Device Dislodged or Dislocated; Device Dislodged or Dislocated

  A REVISION SURGERY WAS REPORTED AS THE THR PRESENTED A CEMENT MANTLE AND THE FEMORAL HEAD WAS DISLOCATING FROM THE ACETABULAR. POLARCUP WAS NOT DISLOCATING BUT THE FEMORAL HEAD AND POLAR INSERT WERE PUNCHING OFF THE FEMORAL STEM.

  Patient problems: Injury

  MAUDE report 8947674 ↗
• InjuryApr 29, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT A REVISION SURGERY WAS PERFORMED DUE TO ECCENTRIC FEMORAL HEAD/POLYETHYLENE POSITIONING ON X-RAY AND RADIOGRAPHIC APPEARANCE OF OSTEOLYSIS IN PROXIMAL FEMORAL REGION. HEAD AND LINER REMOVED AND REPLACED WITH NEW PROSTHESIS.

  Patient problems: Injury

  MAUDE report 8561010 ↗
• InjuryApr 11, 2019Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE BIPOLAR HIP PROSTHESIS DISENGAGED AFTER PATIENT HAD A FALL. A REVISION SURGERY WAS PERFORMED. THE TANDEM BIPOLAR AND THE FEMORAL HEAD WERE REMOVED.

  Patient problems: Injury

  MAUDE report 8504747 ↗
• InjuryDec 2, 2018Degraded; Degraded

  IT WAS REPORTED THAT A REVISION OF R3 HOLE CUP SIZE 46 WITH 20 DEGREE 28/46 LINER AND COCR FEMORAL HEAD SZ 28 DUE TO OSTEOLYSIS CAUSING WEAR ON THE LINER. ORIGINAL TOTAL HIP WAS COMPLETED IN THE 1990'S UNABLE TO LOCATE EXACT DATES.

  Patient problems: Injury; Osteolysis

  MAUDE report 8123192 ↗
• InjuryMar 11, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  UNEXPLAINED PAIN IN LATERAL TROCHANTERIC REGION. POSSIBLY ASSOCIATED WITH A SIGNIFICANT LOSS OF OFFSET IN THE JOINT POST PRIMARY SURGERY. SURGEON BEGAN DISSECTING DOWN TO HIP JOINT. ON APPROACH TO THE HIP JOINT A TROCHANTERIC SOFT TISSUE MASS WAS IDENTIFIED. ACCORDING TO SURGEON IS WAS PROBABLY CALCIFIC TENDINOPATHY ASSOCIATED WITH LOSS OF FUNCTION AS RESULT OF THE REDUCED OFFSET IN THE HIP AFTER THE PRIMARY SURGERY. THE AREA WAS EXTREMELY INFLAMED WITH SOME MINOR BLEEDING OVER AND AROUND THE SITE. THE CALCIFICATION DEPOSIT WAS DEBRIDED. HIP JOINT OPENED. DISLOCATED HIP. TAPPED OFF BIPOLAR HEAD WITH BONE PUNCH. REMOVED CEMENT FROM AROUND SHOULDER OF THE STEM. STEM REMOVED WITH RENOVATION SLAP HAMMER. MANTLE WITHIN CANAL ASSESSED AND DEEMED APPROPRIATE FOR CEMENT IN CEMENT REVISION OF STEM. ACETABULUM PREPARED FOR CORIN TRINITY SHELL. SHELL IMPACTED AND LINER INSERTED. SIZE 1 HIGH OFFSET STEM CEMENTED INTO EXISTING MANTLE WITHIN PROXIMAL FEMUR. CONSTRUCT TRIALLED AND DEEMED STABLE. DEFINITIVE HEAD IMPLANTED INTO THE STEM. HIP REDUCED. WOUND CLOSED

  Patient problems: Pain

  MAUDE report 7329702 ↗
• InjuryMar 10, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  STEM SUBSIDENCE OWING TO FRACTURE AT CALCAR AND GREATER TROCHANTER SURGEON DISSECTED DOWN TO HIP JOINT. DISLOCATED HIP. REMOVED STEM AND BIPOLAR HEAD AS ONE CONSTRUCT USING THE POLARSTEM REMOVAL TOOL PREPARED CANAL FOR ECHELON CEMENTED STEM CEMENTED SIZE 14 175MM ECHELON STEM STD COLLAR. TRIALED BIPOLAR HEAD AND HIP DEEMED STABLE. INSERTED DEFINITIVE BIPOLAR CONSTRUCT ONTO STEM. REDUCED HIP. REDUCED GT FRACTURE AND FIXATED WITH PERIPROSTHETIC PLATE.

  Patient problems: Bone Fracture(s)

  MAUDE report 7329678 ↗
• InjuryOct 31, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A FEW ITEMS WERE EXPLANTED DUE TO INFECTION.

  Patient problems: Injury; Unspecified Infection

  MAUDE report 6992303 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K211176, K963509. 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.