SL-PLUS 75002699Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 07611996078657), received between Sep 25, 2018 and Apr 15, 2022 — classified as 3 injuries.

The most frequently reported specific device problem is “Break” (1 report).

1 other recall cover devices cleared under the same FDA submission (K072852, 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryApr 15, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER A LEFT THA HAD BEEN PERFORMED ON (B)(6) 2009, THE PATIENT EXPERIENCES A PERIPROSTHETIC FRACTURE ON THE SL-PLUS STANDARD STEM 3 NON-CEMENTED. THIS EVENT WAS ADDRESSED VIA REVISION SURGERY ON (B)(6) 2017 TO EXPLANT CUP, LINER, HEAD AND STEM. PATIENT HEALTH STATUS IS NOT KNOWN. THIS INFORMATION WAS PROVIDED BY THE NATIONAL JOINT REGISTRY OF THE (B)(6), FOLLOWING A REVIEW OF THE DATA CONDUCTED IN SEPTEMBER 2021.

  Patient problems: Bone Fracture(s)

  MAUDE report 14120863 ↗
• InjuryJul 11, 2020Break; Break

  IT WAS REPORTED THAT PATIENT SUFFERED THE BREAKAGE OF THE SL-PLUS STANDARD STEM 3 NON-CEMENTED. ITS IS NOT KNOWN HOW LONG AFTER PRIMARY PROCEDURE IT HAPPENED.

  Patient problems: Injury

  MAUDE report 10261770 ↗
• InjurySep 25, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT A REVISION SURGERY WAS PERFORMED DUE TO INFECTION. BIPOLAR HEAD AND INNER HEAD WERE REMOVED AND ANTIBIOTIC-LOADED CEMENT WAS PLACED. STEM WAS REMAINED.

  Patient problems: Unspecified Infection

  MAUDE report 7908662 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K072852, 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.