CPCS 71312362Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 03596010462015), received between Mar 11, 2018 and Jul 22, 2022 — classified as 5 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjuryJul 22, 2022Loss of Osseointegration; Adverse Event Without Identified Device or Use Problem; Loss of Osseointegration; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AFTER A RIGHT THR HAD BEEN PERFORMED ON (B)(6) 2009, THE PATIENT EXPERIENCED LOOSENING OF THE CPCS COCR PRIM SO 12/14 SZ 2 AND A PERIPROSTHETIC FRACTURE ON THE FEMUR. THIS WAS ADDRESSED VIA REVISION SURGERY ON (B)(6) 2015, WHERE THE FEMORAL STEM, THE FEMORAL HEAD AND THE ACETABULAR LINER 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; Inadequate Osseointegration

  MAUDE report 15089940 ↗
• 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) 2017, THE PATIENT EXPERIENCED AN INFECTION. THIS ADVERSE EVENT WAS TREATED BY A REVISION SURGERY ON (B)(6) 2020, IN WHICH THE STEM, CUP, HEAD AND LINER WERE EXPLANTED AND REPLACED WITH A NEW THR SYSTEM. THE 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 15089922 ↗
• InjuryJan 24, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT A REVISION SURGERY WAS PERFORMED DUE TO DISLOCATION. STEM, HEAD AND ACETABULAR LINER REMOVED.

  Patient problems: Injury; Joint Dislocation

  MAUDE report 8276182 ↗
• InjuryMay 8, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED A REVISION SURGERY WAS PERFORMED DUE TO DISLOCATION.

  Patient problems: Joint Dislocation

  MAUDE report 7496985 ↗
• 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 TENDONOPATHY 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 7329704 ↗

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.