Kinectiv® 00-7848-002-00Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00889024137745), received between Oct 7, 2021 and Jun 20, 2023 — classified as 4 injuries.

The most frequently reported specific device problem is “Material Erosion” (2 reports).

4 other recalls cover devices cleared under the same FDA submission (K063251, K182678); 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.

Most reported problems

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryJun 20, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT IS SCHEDULED FOR A REVISION APPROXIMATELY FOUR YEARS POST IMPLANTATION FOR UNKNOWN REASONS. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Insufficient Information

  MAUDE report 17164192 ↗
• InjuryFeb 23, 2023Material Erosion; Adverse Event Without Identified Device or Use Problem; Material Erosion; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT APPROXIMATELY 4 YEARS POST IMPLANTATION OF A RIGHT TOTAL HIP ARTHROPLASTY, THE PATIENT WAS REVISED DUE TO PAIN, TENDINITIS, AND ELEVATED COBALT AND CHROMIUM LEVELS. DURING THE REVISION, TRUNNION WEAR WAS NOTED. THE GREATER TROCHANTER ALSO HAD A PARTIAL UNDER-SURFACE DETACHMENT OF THE ABDUCTOR TENDON WITH MODERATE DEGENERATION WHICH INCLUDED THE GLUTEUS MEDIUS AND MINIMUS. THE WELL-FIXED SHELL AND STEM WERE LEFT INTACT, AND ALL OTHER COMPONENTS WERE REVISED WITHOUT COMPLICATION. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Failure of Implant; Inflammation; Metal Related Pathology; Muscle/Tendon Damage; No Clinical Signs, Symptoms or Conditions; Pain

  MAUDE report 16425977 ↗
• InjuryOct 13, 2021Unstable; Separation Failure; Unstable; Separation Failure

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A RIGHT HIP ARTHROPLASTY AND SUBSEQUENTLY WAS REVISED 9 YEARS LATER DUE INSTABILITY, SUBLUXATION AND DISLOCATION AND PAIN. ELEVATED METAL IONS WERE NOTED. DURING THE REVISION THE SURGEON WAS UNABLE TO REMOVE NECK FROM TAPER, AND ELECTED TO RETAIN STEM AS IT WAS COLD-WELDED. ALL OTHER COMPONENTS REVISED. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: Failure of Implant; Joint Dislocation; Metal Related Pathology; Muscle/Tendon Damage; Necrosis; Osteopenia/ Osteoporosis; Pain; Scar Tissue; Subluxation

  MAUDE report 12627957 ↗
• InjuryOct 7, 2021Corroded; Material Erosion; Corroded; Material Erosion

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

  Patient problems: Inflammation; Metal Related Pathology; Necrosis; Pain; Scar Tissue

  MAUDE report 12592626 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K063251, K182678. One submission often covers many models, so check the product and lot details in each record.

• Z-2364-2018 · May 30, 2018 · Terminated
  Zimmer M/L Taper Hip Prosthesis With Kinectiv Technology Cementless, Size 6; 00-7713-006-00
• Z-2375-2018 · May 30, 2018 · Terminated
  Zimmer M/L Taper Hip Prosthesis With Kinective Technology Cementless, Size 9; 00-7713-009-00
• Z-2365-2018 · May 30, 2018 · Terminated
  Zimmer M/L Taper Hip Prosthesis With Kinective Technology Cementless, Size 10; 00-7713-010-00
• Z-1617-2009 · May 29, 2009 · Terminated
  Zimmer Kinectivo Technology Modular Neck, BB, 12/14 neck taper, sterile, Zimmer, Warsaw, IN; Catalog Number: 00-7848-022-01. Orthopedic implant used in total hip arthroplasty.