CPT® 8114-01-10Recalls & reported problems

Summary

The FDA's MAUDE database contains 24 adverse event reports that list this exact device (DI 00889024145764), received between Jan 28, 2020 and Apr 15, 2026 — classified as 24 injuries.

The most frequently reported specific device problem is “Migration” (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 16, 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 · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 24 most recent of 24 reports, in the reporter's own words as published by the FDA.

• InjuryApr 15, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A HIP REVISION APPROXIMATELY 1-MONTH POST IMPLANTATION DUE TO A SUSPECTED POST-OPERATIVE INFECTION. DURING THE PROCEDURE, THE SURGEON NOTED THAT THERE WAS A FRACTURE OF THE GREATER TROCHANTER WHICH WAS NOT EVIDENT ON X-RAY. MAY HAVE INDICATED A FALL OR MIGHT BE RELATED TO INFECTION. THE STEM REMAINS IMPLANTED, FEMORAL HEAD AND BIPOLAR COMPONENTS REVISED. IT WAS CONFIRMED THAT NO FURTHER INFORMATION COULD BE PROVIDED.

  Patient problems: Bone Fracture(s); Unspecified Infection

  MAUDE report 24887115 ↗
• InjuryJan 6, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A HIP REVISION APPROXIMATELY 1-MONTH POST IMPLANTATION DUE TO A SUSPECTED POST OPERATIVE INFECTION. DURING THE PROCEDURE, THE SURGEON NOTED THAT THERE WAS A FRACTURE OF THE GREATER TROCHANTER WHICH WAS NOT EVIDENT ON X-RAY. MAY HAVE INDICATED A FALL OR MIGHT BE RELATED TO INFECTION. IT WAS CONFIRMED THAT NO FURTHER INFORMATION COULD BE PROVIDED.

  Patient problems: Bone Fracture(s); Unspecified Infection

  MAUDE report 23977140 ↗
• InjuryJun 11, 2025Adverse 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: Periprosthetic fracture

  MAUDE report 22182733 ↗
• InjuryJun 3, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THE PATIENT UNDERWENT A HIP PROCEDURE ON AN UNKNOWN DATE. SUBSEQUENTLY, THE PATIENT WAS REVISED DUE TO A PERIPROSTHETIC FRACTURE. IT WAS REPORTED THAT NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Periprosthetic fracture

  MAUDE report 22132892 ↗
• InjuryMar 5, 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 7 YEARS AND 8 MONTHS POST IMPLANTATION DUE TO A PERIPROSTHETIC FRACTURE AFTER A FALL AT HOME. THERE IS NO FURTHER INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

  Patient problems: Bone Fracture(s)

  MAUDE report 21524944 ↗
• InjuryFeb 20, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

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

  Patient problems: Bone Fracture(s)

  MAUDE report 21420688 ↗
• InjuryDec 26, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  NO FURTHER INFORMATION AT THE TIME OF THIS REPORT.

  Patient problems: Bone Fracture(s)

  MAUDE report 21021059 ↗
• InjuryDec 4, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING A LEFT INITIAL TOTAL HIP ARTHROPLASTY, THE FEMUR FRACTURED DURING FINAL REDUCTION REQUIRING A DIFFERENT STEM AND A PERIPROSTHETIC FEMUR PLATE SYSTEM. THE SURGEON SUSPECTS THE ISSUE WAS THE PATIENT'S AGE AND BONE QUALITY. SURGICAL TECHNIQUE FOR THE PRODUCT WAS UTILIZED. ATTEMPTS HAVE BEEN MADE, AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: Bone Fracture(s)

  MAUDE report 20843758 ↗
• InjuryNov 19, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

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

  Patient problems: Bone Fracture(s)

  MAUDE report 20727213 ↗
• InjuryOct 1, 2024Migration; Migration

  IT WAS REPORTED THAT APPROXIMATELY TWO DAYS POST-IMPLANTATION, THE PATIENT UNDERWENT A HIP REVISION FOLLOWING A FALL DUE TO DISLOCATION. THE SHELL DISLOCATED FROM THE ACETABULUM. THE SHELL, LINER, AND HEAD WERE REVISED TO INCREASE STABILITY WITH A CONSTRAINED CUP. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: Failure of Implant

  MAUDE report 20344334 ↗
• InjurySep 9, 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 20169964 ↗
• InjuryAug 27, 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 SIX YEARS POST IMPLANTATION DUE TO A FEMUR FRACTURE FOLLOWING A FALL. IT WAS REPORTED THAT NO FURTHER INFORMATION IS AVAILABLE

  Patient problems: Bone Fracture(s)

  MAUDE report 20074918 ↗
• InjuryAug 26, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT APPROXIMATELY SIX YEARS POST-IMPLANTATION, THE PATIENT UNDERWENT A HIP REVISION DUE TO UNKNOWN REASONS. THE LINER WAS REVISED. IT IS UNKNOWN IF OTHER COMPONENTS WERE REVISED. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: Insufficient Information

  MAUDE report 20071297 ↗
• InjuryJul 18, 2024Migration; Migration

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A REVISION PROCEDURE 2 MONTHS AND 13 DAYS POST IMPLANTATION DUE TO DISLOCATION. THE STAFF IN EMERGENCY DEPARTMENT ATTEMPTED CLOSED REDUCTION UNSUCCESSFULLY. THIS RESULTED IN BOTH THE HEAD DISSOCIATING FROM THE DM BEARING AND THE CPT STEM MIGRATING CRANIALLY OUT OF THE CEMENT MANTLE. THERE IS NO ADDITIONAL INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

  Patient problems: Insufficient Information

  MAUDE report 19772067 ↗
• InjuryJul 15, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT APPROXIMATELY 4 YEARS POST IMPLANTATION OF A LEFT TOTAL HIP ARTHROPLASTY, THE PATIENT WAS REVISED DUE TO PERIPROSTHETIC FRACTURE. NO ADDITIONAL INFORMATION WAS AVAILABLE.

  Patient problems: Bone Fracture(s)

  MAUDE report 19739129 ↗
• InjuryMay 22, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

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

  Patient problems: Bone Fracture(s)

  MAUDE report 19370481 ↗
• InjuryMay 22, 2024Fracture; Adverse Event Without Identified Device or Use Problem; Fracture; Adverse Event Without Identified Device or Use Problem

  THERE IS NO UPDATE TO THE PRIOR EVENT DESCRIPTION PROVIDED.

  Patient problems: Bone Fracture(s); Fall

  MAUDE report 19370345 ↗
• InjuryMar 22, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT 7 YEARS AND 5 MONTHS POST IMPLANTATION THE PATIENT UNDERWENT A REVISION PROCEDURE DUE TO UNKNOWN REASONS. THE FEMORAL HEAD AND STEM WERE BOTH REVISED. THERE IS NO ADDITIONAL INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

  Patient problems: Bone Fracture(s); Insufficient Information

  MAUDE report 18958219 ↗
• InjuryMar 8, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT APPROXIMATELY 2 YEARS POST IMPLANTATION OF A TOTAL HIP ARTHROPLASTY, THE PATIENT HAD A FALL AND WAS REVISED DUE TO PERIPROSTHETIC FRACTURE. NO ADDITIONAL INFORMATION AVAILABLE.

  Patient problems: Bone Fracture(s); Fall

  MAUDE report 18865200 ↗
• InjuryNov 29, 2023Adverse 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 PERI-PROSTHETIC FRACTURE. THERE IS NO ADDITIONAL INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

  Patient problems: Bone Fracture(s)

  MAUDE report 18226512 ↗
• InjuryDec 1, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED A PATIENT UNDERWENT RIGHT TOTAL HIP ARTHROPLASTY (THA). SUBSEQUENTLY PATIENT WAS REVISED DUE TO PERI PROSTHETIC FRACTURE OF THE RIGHT HIP. NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

  Patient problems: Bone Fracture(s)

  MAUDE report 12907807 ↗
• InjuryMar 8, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THE PATIENT UNDERWENT A TOTAL HIP ARTHROPLASTY. SUBSEQUENTLY, THE PATIENT WAS REVISED 7 YEARS POST IMPLANTATION DUE TO PERIPROSTHETIC HIP FRACTURE. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.

  Patient problems: Bone Fracture(s)

  MAUDE report 11439556 ↗
• InjuryFeb 25, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS REVISED DUE TO FEMORAL AND ACETABULAR PERIPROSTHETIC FRACTURE APPROXIMATELY 11 MONTHS POST IMPLANTATION. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.

  Patient problems: Bone Fracture(s)

  MAUDE report 9750256 ↗
• InjuryJan 28, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

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

  Patient problems: Hip Fracture

  MAUDE report 9638709 ↗

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-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-1019-2018 · Nov 29, 2017 · Terminated
  CPT 12/14 COCR SIZE 2 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-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-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-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-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.