CPCS 71312374Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 03596010462176), received between Oct 15, 2019 and Dec 31, 2025 — classified as 4 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Device Markings/Labelling Problem” (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. 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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 31, 2025Illegible Information; Inaccurate Information; Illegible Information; Inaccurate Information

  IT WAS REPORTED THAT, DURING IMPLANT CEMENTING IN A THR, THE DEPTH MARKINGS ON ONE (1) CPCS COCR PRIM HO 12/14 SZ 4 WERE BARELY VISIBLE, THE SURGEON WAS UNABLE TO LOCATE THE DEPTH MARKS AND SUSPECTS THAT MARKINGS ON THE FADED ETCHINGS ARE ALSO NOT CORRECTLY SPACED. THE SURGEON DID NOT NOTICE THE FADED NATURE OF THE DEPTH MARKINGS UNTIL AFTER THE CEMENT WAS ON FOR 6 MIN AND STEM WAS MOSTLY IN. THE SURGEON SUSPECTS THE STEM MIGHT BE SITTING HIGHER THAN THE TRIAL DUE TO NOT HAVING THE MARKINGS VISIBLE TO REFERENCE CORRECTLY. THE PROCEDURE WAS RESUMED, AFTER A NON-SIGNIFICANT DELAY, USING THE SAME DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23935121 ↗
• InjuryFeb 24, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER THR SURGERY HAD BEEN PERFORMED ON UNKNOWN DATE, THE PATIENT EXPERIENCED A PERIPROSTHETIC FRACTURE FOLLOWING A FALL. THIS ADVERSE EVENT WAS TREATED BY A REVISION SURGERY ON (B)(6) 2025, IN WHICH THE CPCS COCR PRIM HO 12/14 SZ 4, THE TANDEM INTL BIPOLAR 51OD 28ID AND THE COCR 12/14 FEM HEAD 28 +0 WERE EXPLANTED. IN ADDITION, AN EVOS PERIPROSTHETIC PROXIMAL FEMUR PLATE WITH SCREWS AND CABLES WERE USED TO FIX THE FRACTURE. THE PATIENT PASSED AWAY DURING THE RECOVERY PHASE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: Failure of Implant; Periprosthetic fracture

  MAUDE report 21453046 ↗
• InjuryMar 21, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON THE PMCF TITLED DCA-1000 ACCORD SS CLINICAL DATASET, IT WAS REPORTED THAT, AFTER UNDERGOING LEFT HIP HEMIARTHROPLASTY, ONE (1) PATIENT EXPERIENCED DISPLACED FEMORAL NECK FRACTURE. THIS ADVERSE EVENT WAS TREATED BY PERFORMING AN INTERNAL FIXATION SURGERY ON (B)(6) 2021, IN WHICH AN ACCORD CABLE SYSTEM WAS IMPLANTED. A POST-OPERATIVE FOLLOW-UP DETERMINED A GOOD ALIGNMENT WITH NO EVIDENCE OF FRACTURE OR LOOSENING.

  Patient problems: Hip Fracture

  MAUDE report 16583217 ↗
• 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 WAS PERFORMED ON (B)(6) 2009, THE PATIENT EXPERIENCED LOOSENING AND LYSIS AROUND THE POLARCUP SHELL HA COATED 45 NON CEMENTED IMPLANT AREA, ALONG WITH AN UNSPECIFIED INFECTION. THIS ADVERSE EVENT WAS TREATED BY A REVISION SURGERY ON (B)(6) 2011, IN WHICH ALL THE THR COMPONENTS WERE EXPLANTED AND REPLACED WITH AN UNSPECIFIED PROSTHESIS. THE PATIENT'S OUTCOME 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: Inadequate Osseointegration; Osteolysis; Unspecified Infection

  MAUDE report 15089920 ↗
• InjuryOct 1, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER THR SURGERY PERFORMED ON (B)(6) 2021, PATIENT SUFFERED A FALL RESULTING IN A PERIPROSTHETIC FRACTURE. THIS ADVERSE EVENT WAS SOLVED BY A REVISION SURGERY ON (B)(6) 2021, IN WHICH THE OXINIUM FEM HD 12/14 36 MM +0, CPCS COCR PRIM HO 12/14 SZ 4 AND CPCS DIST CENT SZ 14MM WERE REVISED. CURRENT HEALTH STATUS OF PATIENT IS UNKNOWN.

  Patient problems: Bone Fracture(s); Fall

  MAUDE report 12560989 ↗
• MalfunctionOct 15, 2019Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT A THR WAS PERFORMED. SURGEON PREPARED ACETABULUM AS PER TECHNIQUE AND INSERTED DEFINITIVE COMPONENTS. SURGEON PREPPED FEMUR FOR SIZE 4HO CPCS CEMENTED FEMORAL STEM. FEMUR PREPPED FOR CEMENTING AND 12MM CENTRALIZER APPLIED TO FEMORAL STEM AND CEMENT APPLIED TO FEMORAL CANAL. AS THE SURGEON WAS ABOUT TO CEMENT THE FEMORAL COMPONENT INTO FEMUR HE NOTICED THERE WASN'T ANY LASER ETCHING ON THE LATERAL SIDE (SURGEON FACING) SIDE OF THE STEM. THE SURGEON COULD NOT VISUALIZE WHERE THE STEM WAS TO STOP ON CALCAR. THE SURGEON QUICKLY USED THE MARKING PEN TO TRACE AROUND THE MARKED SIDE OF THE PROSTHESIS AND INSERTED STEM TO THE APPROXIMATE POSITION. HEAD RETRIALED AND ROM PERFORMED. THE DEFINITIVE HEAD IMPLANTED AND THE WOUND WASHED AND CLOSED IN LAYERS. NO IMPACT TO THE PATIENT WAS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9194867 ↗
• MalfunctionOct 15, 2019Device Markings/Labelling Problem; Device Markings/Labelling Problem

  IT WAS REPORTED THAT DURING SURGERY, WHILE INSERTING THE STEM DOCTOR NOTICED THAT DEVICE DIDN;T HAVE ANY LASER ETCHING ON LATERAL SIDE OF THE STEM. SURGEON USED A MARKING PEN TO TRACE ROUND MARKED SIDE OF THE PROSTHESIS AND INSERTED STEM TO APPROXIMATE POSITION. NO INJURY REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9191893 ↗

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.