CPCS 71312361Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 03596010462008), received between Nov 9, 2020 and Jul 18, 2023 — classified as 3 injuries.

The most frequently reported specific device problem is “Loosening of Implant Not Related to Bone-Ingrowth” (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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryJul 18, 2023Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT, AFTER A THR SURGERY, THE PATIENT EXPERIENCED LOOSENING OF THE CPCS COCR PRIM SO 12/14 SZ 1 STEM. THIS ADVERSE EVENT WAS SOLVED VIA REVISION SURGERY ON (B)(6) 2023, IN WHICH THE STEM, THE LINER AND AN UNKNOWN 28 MM FEMORAL HEAD WERE EXPLANTED. PATIENT'S CURRENT HEALTH STATUS IS UNKNOWN.

  Patient problems: Inadequate Osseointegration

  MAUDE report 17347703 ↗
• 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 CPCS COCR PRIM SO 12/14 SZ 1 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 13939315 ↗
• InjuryNov 9, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT SUFFERED A PERIPROSTHETIC FRACTURE OF THE FEMUR BELOW A HIP REPLACEMENT .THIS WAS FIXED WITH A STRYKER PLATE ,SUBSEQUENTLY THE STEM HAS SUBSIDED DUE TO NON UNION OF THE FRACTURE. IT IS UNKNOWN WHEN THIS HAPPENED OR THE PATIENT HEALTH.

  Patient problems: Injury

  MAUDE report 10814176 ↗

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.