SL-PLUS/INTEGRATION-PLUS 75000191Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 07611996092936), received between Sep 5, 2018 and Jan 10, 2022 — classified as 2 injuries.

The most frequently reported specific device problem is “Improper or Incorrect Procedure or Method” (1 report).

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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryJan 10, 2022Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

  IT WAS REPORTED THAT, DURING THE COURSE OF A HIP HEMI ARTHROPLASTY FOR HIP FRACTURE, A SL-PLUS INTEGR MIA STEM LAT. W. TI/HA 6 WAS DETERMINED NECESSARY TO PROVIDE A STABLE HIP CONSTRUCT. AFTER THE STEM WAS INSERTED, IT WAS DETERMINED THAT THE IMPLANT WAS EXPIRED (EXPIRATION DATE 6/2021). THE CHARGE NURSE WAS NOTIFIED AND A DECISION WAS MADE TO CONTINUE WITH THE PROCEDURE FOR THE FOLLOWING REASONS: A SPARE IMPLANT COULD NOT BE DELIVERED TO THE OR IN LESS THAN 1.5 HOURS, THE CHARGE NURSE DETERMINED THE RISK OF WAITING WAS NOT ACCEPTABLE. THE USE OF A STANDARD OFFSET WAS DEEMED ALSO NOT AN OPTION DUE TO A LESS STABLE HIP CONSTRUCT. A RISK FOR A UNSTABLE REPAIR WAS ALSO DEEMED UNACCEPTABLE. THE PROCEDURE WAS COMPLETED WITH THE SAME DEVICE WITHOUT DELAYS. THE PATIENT OUTCOME IS UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13205749 ↗
• InjurySep 5, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A SPIRAL FRACTURE OCCURRED WHEN THE PATIENT STOOD UP AND TWIST LEG. THE STEM WAS REPLACED AS CONSEQUENCE.

  Patient problems: Bone Fracture(s)

  MAUDE report 7845083 ↗

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.