CPCS 71312363Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 03596010462022), received between Jun 29, 2020 and Feb 26, 2025 — classified as 8 injuries.

The most frequently reported specific device problem is “Fracture” (1 report).

1 other recall cover devices cleared under the same FDA submission (K211176, K823727); 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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 26, 2025Adverse 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) 2025, THE PATIENT EXPERIENCED A PERI-PROSTHETIC FRACTURE. THIS ADVERSE EVENT WAS TREATED BY A REVISION SURGERY ON (B)(6) 2025, IN WHICH A CPCS COCR PRIM SO 12/14 SZ 3, TANDEM INTL BIPOLAR 51OD 28ID AND COCR 12/14 FEM HEAD 28 +0 WERE EXCHANGED. PATIENT'S CURRENT HEALTH STATUS IS UNKNOWN.

  Patient problems: Periprosthetic fracture

  MAUDE report 21469042 ↗
• InjuryAug 21, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AFTER HAVING A PRIMARY SURGERY IN WHICH A CPCS STEM WAS IMPLANTED, ONE (1) PATIENT UNDERWENT A REVISION SURGERY DUE TO A PERI-PROSTHETIC FRACTURE. NO FURTHER INFORMATION IS AVAILABLE. THE CURRENT STATE OF HEALTH OF THE PATIENTS IS UNKNOWN.

  Patient problems: Bone Fracture(s)

  MAUDE report 20015016 ↗
• InjuryAug 21, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AFTER HAVING A PRIMARY SURGERY IN WHICH A CPCS STEM WAS IMPLANTED, ONE (1) PATIENT UNDERWENT A REVISION SURGERY DUE TO A PERI-PROSTHETIC FRACTURE. NO FURTHER INFORMATION IS AVAILABLE. THE CURRENT STATE OF HEALTH OF THE PATIENTS IS UNKNOWN.

  Patient problems: Bone Fracture(s)

  MAUDE report 20011727 ↗
• 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 SURGERY PERFORMED ON (B)(6) 2009, THE PATIENT PRESENTED PERIPROSTHETIC FRACTURE. THE ADVERSE EVENT WAS ADDRESSED VIA REVISION SURGERY ON (B)(6) 2011, WHERE THE CPCS COCR PRIM SO 12/14 SZ 3, METAL BALL HEAD 28L CONE 12/14 AND THE POLARCUP LINER 55/28 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.

  Patient problems: Hip Fracture

  MAUDE report 15085933 ↗
• InjuryJul 21, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AFTER A LEFT THR PERFORMED ON (B)(6) 2008, THE PATIENT EXPERIENCED A FEMORAL PERIPROSTHETIC FRACTURE ON THE CPCS COCR PRIM SO 12/14 SZ 3 IMPLANT AREA. THE ADVERSE EVENT WAS TREATED VIA REVISION SURGERY ON (B)(6) 2011 AND THE CPCS COCR PRIM SO 12/14 SZ 3, THE COCR 12/14 FEM HEAD 28 +0 AND THE CPCS DIST CENT SZ 14MM 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.

  Patient problems: Bone Fracture(s); Hip Fracture

  MAUDE report 15076727 ↗
• 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: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11685262 ↗
• InjuryFeb 15, 2021Fracture; Fracture

  IT WAS REPORTED THAT DURING PROCEDURE, WHILE THE SURGEON WAS REDUCING THE HEMI HIP WITH ALL IMPLANTS IN PLACE, THE 22 HEAD DISASSOCIATED FROM THE TANDEM IMPLANT AND STAYED ON THE CPCS COCR PRIM SO 12/14 SZ 3. THE SURGEON WAS ABLE TO REMOVE THE HEAD FROM STEM. A SECOND TRY WAS ATTEMPTED BUT IMPLANT KEPT DISASSOCIATING EVEN THOUGH THE RING IN TANDEM WAS SECURE. ON THE SECOND TIME OF TRYING TO REMOVE THE HEAD FROM THE STEM THE WHOLE CEMENTED STEM CAME OUT. SURGEON HAD TO PLACE NEW STEM AND WHOLE NEW TANDEM IMPLANTS. THERE WAS A DELAY GREATER THAN 30 MIN DUE TO THIS MALFUNCTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11327133 ↗
• InjuryJun 29, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A TOTAL HIP REPLACEMENT WAS PERFORMED ON 2016 USING R3/CPCS TO TREAT NECK OF FEMUR FRACTURE IN OF A FEMALE PATIENT BORN IN (B)(6). IT WAS REPORTED THAT THE PATIENT HAD DISLOCATED SEVERAL TIMES OVER THE PAST 4 YEARS. DURING THE REVISION OPERATION, SURGEON NOTED THAT THE FEMORAL HEAD WAS SCRATCHED, AND APPEARED TO BE DISLOCATING POSTERIOR, AND THAT THE FEMORAL STEM WAS SLIGHTLY RE-TROVERTED. SURGEON NOTED THAT THIS WAS MOST LIKELY THE REASON FOR THE DISLOCATION. DURING REVISION SURGERY, THE FEMORAL HEAD, FEMORAL STEM, AND CUP LINER WERE REMOVED. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: Joint Dislocation

  MAUDE report 10209422 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K211176, K823727. 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.