Kinectiv® 00-7848-022-00Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00889024137882), received between Aug 25, 2021 and Jul 18, 2023 — classified as 2 injuries, 1 malfunction.

The most frequently reported specific device problem is “Device Contaminated During Manufacture or Shipping” (1 report).

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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryJul 18, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN INITIAL RIGHT TOTAL HIP ARTHROPLASTY REVISION. AFTER THE REVISION, THE PATIENT DID VERY WELL THEN PRESENTED WITH SUDDEN ONSET SWELLING ALONG THE DISTAL INCISION. AS THERE WERE NO CLINICAL INDICATIONS OF INFECTION, THIS WAS THOUGHT TO BE A SEROMA, AND THE PATIENT WAS SCHEDULED FOR AN INCISION AND DRAINAGE PROCEDURE. DURING THE PROCEDURE APPROXIMATELY 1-MONTH POST-REVISION, THE AREA OF THE SEROMA HAD A SLIGHT BROWN TINGE IN THE FLUID, BUT NO GROSS PURULENCE NOTED. THE SOFT TISSUES WERE THEN DEBRIDED WHICH REVEALED DEFECTS IN THE ILIOTIBIAL BAND WITH HETEROTOPIC OSSIFICATION AND GRANULATION TISSUE. AN EXTENSIVE IRRIGATION AND DEBRIDEMENT WAS PERFORMED WITH PLACEMENT OF ANTIBIOTIC BEADS. THE STEM AND SHELL WERE LEFT IN PLACE. ALL OTHER COMPONENTS WERE REVISED WITHOUT COMPLICATION. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: Extraskeletal ossification; Muscle/Tendon Damage; Seroma; Subclinical Infection

  MAUDE report 17344467 ↗
• InjuryApr 15, 2022Adverse 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 PAIN AND POOR CUP POSITION APPROXIMATELY 2 YEARS POST IMPLANTATION. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE.

  Patient problems: Pain

  MAUDE report 14117316 ↗
• MalfunctionAug 25, 2021Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12365608 ↗

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-2365-2018 · May 30, 2018 · Terminated
  Zimmer M/L Taper Hip Prosthesis With Kinective Technology Cementless, Size 10; 00-7713-010-00
• Z-2375-2018 · May 30, 2018 · Terminated
  Zimmer M/L Taper Hip Prosthesis With Kinective Technology Cementless, Size 9; 00-7713-009-00
• Z-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.