SL-PLUS 75002758Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 07611996078053), received between Jun 7, 2022 and Jul 21, 2022 — classified as 2 injuries.

The most frequently reported specific device problem is “Loss of Osseointegration” (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 18, 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.

• InjuryJul 21, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER A THA SURGERY WAS PERFORMED ON (B)(6) 2008, THE PATIENT EXPERIENCED AN INFECTION. THIS ADVERSE EVENT WAS TREATED BY A REVISION SURGERY ON (B)(6) 2009 DURING WHICH THE STEM WAS EXPLANTED AND EXCHANGED WITH NEW THA COMPONENTS. THE CURRENT HEALTH STATUS OF PATIENT IS UNKNOWN. THIS INFORMATION WAS PROVIDED BY THE NATIONAL JOINT REGISTRY OF THE UNITED KINGDOM, AS PART OF A RETROSPECTIVE DATA COLLECTION OF PATIENTS WHO UNDERWENT EITHER A REVISION OR RE-REVISION SURGERY WHERE A POLARCUP SHELL WAS PART OF THE HIP CONSTRUCT. AS SUCH, NO FURTHER INFORMATION WILL BE AVAILABLE.

  Patient problems: Unspecified Infection

  MAUDE report 15077688 ↗
• InjuryJun 7, 2022Loss of Osseointegration; Loss of Osseointegration

  IT WAS REPORTED THAT, AFTER A THR SURGERY PERFORMED ON (B)(6) 2006, A REVISION SURGERY ON A TOTAL HIP PROSTHESIS WAS PERFORMED ON (B)(6) 2021 TO EXPLANT THE CERAMIC CERAMIC INSERT STANDARD 48/36 THAT HAD BEEN FRACTURED FOR SEVERAL WEEKS. THE PATIENT COMPLAINED OF PAIN AROUND THE RIGHT HIP. A LOOSENING OF THE SL-PLUS STEM LATERAL 5 NON-CEMENTED WAS NOTED. CURRENT HEALTH STATUS OF THE PATIENT IS UNKNOWN.

  Patient problems: Failure of Implant; Inadequate Osseointegration

  MAUDE report 14626900 ↗

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.