CPT® 8114-03-10Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 00889024145825), received between Jan 26, 2021 and Dec 18, 2025 — classified as 11 injuries.

The most frequently reported specific device problem is “Loosening of Implant Not Related to Bone-Ingrowth” (2 reports).

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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Recalls naming this device

1. Jul 2, 2024Class IIOpen, 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 · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• InjuryDec 18, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  NO ADDITIONAL INFORMATION AVAILABLE FOR THE REPORTED EVENT.

  Patient problems: Pain; Periprosthetic fracture

  MAUDE report 23843122 ↗
• InjuryNov 19, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THE PATIENT UNDERWENT A HIP REVISION APPROXIMATELY 18 MONTHS POST-IMPLANTATION DUE TO A PERIPROSTHETIC FRACTURE. PRIOR TO THE REVISION, THE PATIENT SUSTAINED A FALL. DURING THE REVISION PROCEDURE, THE FEMORAL STEM WAS EXPLANTED. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: Fall; Periprosthetic fracture

  MAUDE report 23594717 ↗
• InjurySep 8, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN INITIAL HIP PROCEDURE ON AN UNKNOWN DATE. SUBSEQUENTLY, THE PATIENT WAS REVISED DUE TO A FRACTURE. THE STEM WAS REVISED AND CABLES WERE IMPLANTED. ATTEMPTS HAVE BEEN MADE, AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: Periprosthetic fracture

  MAUDE report 22991166 ↗
• InjuryApr 2, 2025Adverse 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 NEARLY 3 YEARS POST IMPLANTATION DUE TO A PERI-PROSTHETIC FRACTURE FROM FALLING. THERE IS NO FURTHER INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

  Patient problems: Bone Fracture(s)

  MAUDE report 21753965 ↗
• InjuryJun 14, 2024Adverse 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 3 YEARS AND 3 MONTHS POST IMPLANTATION DUE A BONE FRACTURE FROM A FALL. THERE IS NO ADDITIONAL INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

  Patient problems: Bone Fracture(s); Fall

  MAUDE report 19536027 ↗
• InjuryMar 13, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A HIP REVISION APPROXIMATELY SEVEN MONTHS POST-IMPLANTATION DUE TO LIMB LENGTH DISCREPANCY. THE STEM WAS REMOVED AND REPLACED. IT WAS REPORTED THAT NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Unequal Limb Length

  MAUDE report 18895685 ↗
• InjuryOct 23, 2023Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  NO FURTHER INFORMATION AT THE TIME OF THIS REPORT.

  Patient problems: Bone Fracture(s); Failure of Implant; Osteopenia/ Osteoporosis

  MAUDE report 17984364 ↗
• InjuryJul 12, 2023Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information

  IT WAS REPORTED PATIENT UNDERWENT A REVISION PROCEDURE POST IMPLANTATION DUE TO INFECTION. DURING THIS PROCEDURE, THE ORIGINAL IMPLANTS WERE REMOVED AND A SPACER WAS IMPLANTED. IT WAS REPORTED THAT NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Insufficient Information; Unspecified Infection

  MAUDE report 17306704 ↗
• InjuryJun 1, 2023Adverse 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: Insufficient Information; Unspecified Infection

  MAUDE report 17038897 ↗
• InjuryMar 6, 2023Adverse Event Without Identified Device or Use Problem; Loosening of Implant Not Related to Bone-Ingrowth; Adverse Event Without Identified Device or Use Problem; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS FURTHER REPORTED THAT WHEN THE PATIENT FELL AND FRACTURED THE FEMUR, IT CAUSED LOOSENING. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Bone Fracture(s); Fall

  MAUDE report 16488115 ↗
• InjuryJan 26, 2021Loss of or Failure to Bond; Loss of or Failure to Bond

  NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

  Patient problems: Bone Fracture(s)

  MAUDE report 11230601 ↗

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-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-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-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-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-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-1036-2014 · Oct 11, 2013 · Terminated
  CPT DEGREE TAPER (various sizes) and FEMORAL HD (various sizes)
• Z-1032-2014 · Oct 11, 2013 · Terminated
  CPT 12/14 COCR (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.