SL-PLUS/INTEGRATION-PLUS 75000176Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 07611996092783), received between Apr 11, 2018 and Feb 25, 2026 — classified as 4 injuries.

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

1 other recall cover devices cleared under the same FDA submission (K122296, K143096, K211176); 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.

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.

• InjuryFeb 25, 2026Fracture

  IT WAS REPORTED THAT, AFTER A THR SURGERY WAS PERFORMED ON (B)(6) 2024, THE PATIENT EXPERIENCED A POTENTIAL BREAKAGE OF THE STEM NECK UNDER CT AND MRT IMAGES. NO PAIN AND NO DISCOMFORT. THIS ADVERSE EVENT WAS DIAGNOSED ON (B)(6) 2026. REVISION SURGERY IS BEING CONSIDERED. PATIENT'S CURRENT HEALTH STATUS IS UNKNOWN.

  Patient problems: Insufficient Information

  MAUDE report 24442436 ↗
• InjuryFeb 5, 2026Fracture

  IT WAS REPORTED THAT, AFTER A THR HAD BEEN PERFORMED ON AN UNKNOWN DATE, PATIENT EXPERIENCED A FRACTURE OF THE INSERTED HIP STEM WHEN LIFTING A WATER BOX. THE NECK OF THE STEM BROKE OFF LEAVING THE CONE STICK TOGETHER WITH THE CERAMIC HEAD. THIS ADVERSE EVENT WAS ADDRESSED BY PERFORMING A REVISION SURGERY ON (B)(6) 2026, DURING WHICH, SURGEON EXCHANGED THE STEM, HEAD AND LINER. PATIENT'S CURRENT HEALTH STATUS IS UNKNOWN.

  Patient problems: Extraskeletal ossification; Insufficient Information; Subluxation

  MAUDE report 24273299 ↗
• InjurySep 29, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD IMPLANTED SMITH AND NEPHEW DEVICES. THE PATIENT WAS EXPERIENCED INFECTION AND FEVER. REVISION SURGERY IS PLANNED TO RESOLVE THIS ISSUE ON (B)(6) 2020. THE DOCTOR SAYS THE DEVICES ARE NOT DEFECTIVE. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: Unspecified Infection

  MAUDE report 10604087 ↗
• InjuryApr 11, 2018Loss of Osseointegration; Loss of Osseointegration

  REVISION SURGERY DUE TO MISSING OSSEOINTEGRATION OF THE SL-PLUS MIA STEM AND THE EP-FIT SHELL. NO LUXATIONS HAPPENED, LEG LENGHT DISCREPANCIES OF 4 CM.

  Patient problems: No Information

  MAUDE report 7420932 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K122296, K143096, K211176. One submission often covers many models, so check the product and lot details in each record.

• Z-0326-2025 · Oct 15, 2024 · Open, Classified
  Tandem Intl Bipolar Cocr Shell/UHMWPE Liner, TI-6AL-4V Retaining Ring, 28MM I.D. 46 MM O.D., REF 71324046, sterile, femoral head bipolar component of the Tandem Bipolar Hip System.