CPT® 8114-02Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 00889024145771), received between Jul 2, 2021 and Mar 6, 2025 — classified as 8 injuries, 1 malfunction.

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

1 FDA recall record name this device's identifier, 1 still open.

13 other recalls cover devices cleared under the same FDA submission (K191735, K960658); 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.

Recalls naming this device

1. Jul 2, 2024Open, Classified

   Affected product has an increased risk of postoperative perisprosthetic femoral fracture (PFF). The IFU is being updated to reflect the risk of PFF.

   Z-2450-2024 · Root cause: Under Investigation by firm · FDA record ↗

Most reported problems

Recent adverse event reports

The 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• InjuryMar 6, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A REVISION PROCEDURE 1 YEAR AND 4 MONTHS POST IMPLANTATION DUE TO AN UNKNOWN FRACTURE. THERE IS NO ADDITIONAL INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

  Patient problems: Insufficient Information

  MAUDE report 21535882 ↗
• InjuryFeb 24, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED A PATIENT UNDERWENT A HIP REVISION APPROXIMATELY ELEVEN MONTHS POST IMPLANTATION TO LENGTHEN THE HIP. THE STEM AND HEAD WERE REMOVED AND REPLACED. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.

  Patient problems: Unequal Limb Length

  MAUDE report 21445065 ↗
• InjuryNov 5, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED A PATIENT UNDERWENT A HIP REVISION APPROXIMATELY THIRTEEN MONTHS POST IMPLANTATION FOR UNKNOWN REASONS. THE BEARING, STEM AND HEAD WERE REMOVED AND REPLACED. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Insufficient Information

  MAUDE report 20609930 ↗
• InjuryAug 27, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THERE IS NO UPDATE TO THE PRIOR EVENT DESCRIPTION PROVIDED.

  Patient problems: Bone Fracture(s)

  MAUDE report 20080213 ↗
• InjuryJun 25, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  NO ADDITIONAL EVENT INFORMATION TO REPORT AT THIS TIME.

  Patient problems: Bone Fracture(s)

  MAUDE report 19608874 ↗
• MalfunctionMar 13, 2024Packaging Problem; Packaging Problem

  IT WAS REPORTED THAT THE IMPLANT WAS DAMAGED IN THE PACKAGING AND THE PLASTIC SEAL WAS RIPPED. THE DEVICE IS NO LONGER STERILE. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE BEEN MADE; HOWEVER, NO MORE IS AVAILABLE AT THIS TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18897186 ↗
• InjuryAug 22, 2023Fracture; Adverse Event Without Identified Device or Use Problem; Fracture; Adverse Event Without Identified Device or Use Problem

  NO ADDITIONAL EVENT INFORMATION TO REPORT AT THIS TIME.

  Patient problems: Bone Fracture(s); Insufficient Information

  MAUDE report 17594507 ↗
• InjuryApr 19, 2022Material Erosion; Material Erosion

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED ELEVATED METAL ION LEVELS APPROXIMATELY 2 YEARS POST IMPLANTATION. HOWEVER, NO REVISION HAS BEEN REPORTED TO DATE. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.

  Patient problems: Metal Related Pathology

  MAUDE report 14148490 ↗
• InjuryJul 2, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A REVISION PROCEDURE APPROXIMATELY TWO YEARS POST IMPLANTATION DUE TO PERIPROSTHETIC FRACTURE. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.

  Patient problems: Bone Fracture(s); Pain

  MAUDE report 12108027 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K191735, K960658. One submission often covers many models, so check the product and lot details in each record.

• Z-1015-2018 · Nov 29, 2017 · Terminated
  CPT 12/14 COCR REVISION SIZE 2 180MM prosthesis, hip, semi-constrained, metal/polymer, porous uncemented
• Z-1018-2018 · Nov 29, 2017 · Terminated
  CPT 12/14 COCR SIZE 2 EXT prosthesis, hip, semi-constrained, metal/polymer, porous uncemented
• Z-1019-2018 · Nov 29, 2017 · Terminated
  CPT 12/14 COCR SIZE 2 STD prosthesis, hip, semi-constrained, metal/polymer, porous uncemented
• Z-1016-2018 · Nov 29, 2017 · Terminated
  CPT 12/14 COCR SIZE 0 STD prosthesis, hip, semi-constrained, metal/polymer, porous uncemented
• Z-1017-2018 · Nov 29, 2017 · Terminated
  CPT 12/14 COCR SIZE 1 EXT prosthesis, hip, semi-constrained, metal/polymer, porous uncemented
• Z-1119-2016 · Jan 11, 2016 · Terminated
  Product 21 consists of all product under product code: JDI and same usage: Item no: 811400218 CPT 12/14 COCR REVISION S 811400318 CPT 12/14 COCR REVISION S 811400420 CPT 12/14 CO
• Z-0844-2016 · Jan 11, 2016 · Terminated
  CPT 12/14 COCR prosthesis, hip, semi-constrained, metal/polymer, porous uncemented various sizes "The CPT Hip System is indicated for cemented use in: Patients suffering from sev
• Z-0610-2014 · Dec 10, 2013 · Terminated
  Versys Build-Up Block The VerSys CRC Hip System is indicated for total hip arthroplasty in patients whose bone stock is of poor quality or inadequate for other reconstruction tech
• Z-0608-2014 · Dec 10, 2013 · Terminated
  CPT Hip System, Parts 00-8114-002-10 and 00-8011-004-00 Hip joint metal/polymer semi-constrained cemented prosthesis. The CPT Hip System is indicated for cemented use in: Patients
• Z-1032-2014 · Oct 11, 2013 · Terminated
  CPT 12/14 COCR (various sizes)
• Z-1036-2014 · Oct 11, 2013 · Terminated
  CPT DEGREE TAPER (various sizes) and FEMORAL HD (various sizes)
• Z-0069-2014 · Aug 30, 2013 · Terminated
  CPT Femoral Stem (CPT 12/14 STEM SIZE 0 COCR; CPT 12/14 SIZE 0 COCR EXT; CPT 12/14 STEM SIZE 1 COCR; CPT 12/14 SIZE 1 COCR EXT CPT 12/14 STEM SIZE 2 COCR; CPT 12/14 SIZE 2 COCR EXT
• Z-0062-2013 · Sep 13, 2012 · Terminated
  CPT Femoral Stem 12/14 Neck Taper Extended Offset,(item 00-8114-001-10. CPT stems are primary cemented femoral hip stems used by surgeons in total hip arthroplasty.