CPT® 8114-00-10Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 00889024145740), received between Jun 30, 2021 and Jan 6, 2026 — classified as 10 injuries.

The most frequently reported specific device problem is “Loosening of Implant Not Related to Bone-Ingrowth” (3 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 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• InjuryJan 6, 2026Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT THE PATIENT INITIALLY UNDERWENT HIP ARTHROPLASTY WITH IMPLANTATION OF ZIMMER BIOMET PRODUCTS. MORE THAN TWO (2) YEARS AFTER IMPLANTATION, THE PATIENT UNDERWENT REVISION SURGERY DUE TO LOOSENING. THE ENTIRE CONSTRUCT WAS REMOVED.

  Patient problems: Aseptic loosening

  MAUDE report 23977247 ↗
• InjuryAug 21, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A HIP REVISION APPROXIMATELY TWO YEARS POST-IMPLANTATION AFTER THE PATIENT FELL, RESULTING IN A PERIPROSTHETIC FRACTURE. NO ADDITIONAL INFORMATION AVAILABLE FOR THE REPORTED EVENT.

  Patient problems: Fall; Periprosthetic fracture

  MAUDE report 22859790 ↗
• InjuryJul 14, 2025Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN INITIAL HIP PROCEDURE. SUBSEQUENTLY, THE PATIENT WAS REVISED APPROXIMATELY 1 MONTH LATER DUE TO DISLOCATION AND INSTABILITY. DURING THE REMOVAL OF THE HEAD, THE STEM CAME LOOSE. ALL DEVICES WERE REVISED AND REPLACED. IT WAS REPORTED THAT NO FURTHER INFORMATION COULD BE PROVIDED.

  Patient problems: Aseptic loosening; Joint Dislocation; Joint Laxity

  MAUDE report 22492704 ↗
• InjuryApr 18, 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: Ambulation or Postural Difficulties; Pain

  MAUDE report 21865474 ↗
• InjuryDec 12, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN OPEN REDUCTION APPROXIMATELY THREE YEARS POST IMPLANTATION DUE FOR UNKNOWN REASONS. NO HIP IMPLANTS WERE EXCHANGED AT THIS TIME. APPROXIMATELY, EIGHT MONTHS AFTER THE OPEN REDUCTION, THE PATIENT UNDERWENT A HIP REVISION DUE TO A TRAUMATIC PERIPROSTHETIC FRACTURE. THE FEMORAL HEAD AND STEM WERE REMOVED AND REPLACED. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Bone Fracture(s)

  MAUDE report 20912167 ↗
• InjuryNov 22, 2023Adverse 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: Insufficient Information

  MAUDE report 18192896 ↗
• InjuryNov 9, 2023Adverse 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); Fall

  MAUDE report 18104087 ↗
• InjuryJun 27, 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

  NO ADDITIONAL INFORMATION ON THE REPORTED EVENT.

  Patient problems: Bone Fracture(s)

  MAUDE report 17209221 ↗
• InjurySep 2, 2021Adverse 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: Bone Fracture(s)

  MAUDE report 12416729 ↗
• InjuryJun 30, 2021Fracture; Fracture

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

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

  MAUDE report 12093151 ↗

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-1017-2018 · Nov 29, 2017 · Terminated
  CPT 12/14 COCR SIZE 1 EXT 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-1015-2018 · Nov 29, 2017 · Terminated
  CPT 12/14 COCR REVISION SIZE 2 180MM 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.