SL-PLUS 75002707Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 07611996078695), received between Apr 9, 2022 and Apr 16, 2022 — classified as 3 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 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 16, 2022Loss of Osseointegration; Loss of Osseointegration

  IT WAS REPORTED THAT, AFTER A LEFT THA PERFORMED ON (B)(6) 2008, THE PATIENT EXPERIENCED LOOSENING OF THE ACETABULAR CUP AND LOOSENING OF THE FEMORAL STEM ALONG WITH AN UNSPECIFIED LYSIS IN THE PROSTHESIS REGION. A REVISION SURGERY WAS PERFORMED ON (B)(6) 2015 TO TREAT THIS ADVERSE EVENT. DURING THIS PROCEDURE, ALL THE COMPONENTS FROM THE THA PROSTHESIS CONSTRUCT WERE EXPLANTED AND REPLACED WITH AN UNSPECIFIED SYSTEM. THE PATIENT'S 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: Inadequate Osseointegration; Osteolysis

  MAUDE report 14131587 ↗
• InjuryApr 16, 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) 2011, THE PATIENT EXPERIENCED A JOINT DISLOCATION. A REVISION SURGERY WAS PERFORMED ON (B)(6) 2011 TO TREAT THIS ADVERSE EVENT. DURING THIS PROCEDURE, ALL THE COMPONENTS FROM THE THA PROSTHESIS CONSTRUCT WERE EXPLANTED AND REPLACED WITH AN UNSPECIFIED SYSTEM. THE PATIENT'S 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: Joint Dislocation

  MAUDE report 14131582 ↗
• InjuryApr 9, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER A RIGHT THA HAD BEEN PERFORMED ON (B)(6) 2008, THE PATIENT EXPERIENCES A PERI-PROSTHETIC FRACTURE. THIS EVENT WAS ADDRESSED VIA REVISION SURGERY ON (B)(6) 2020 TO EXPLANT THE HEAD AND STEM. PATIENT HEALTH STATUS IS NOT KNOWN. THIS INFORMATION WAS PROVIDED BY THE (B)(6), FOLLOWING A REVIEW OF THE DATA CONDUCTED IN SEPTEMBER 2021.

  Patient problems: Bone Fracture(s)

  MAUDE report 14067865 ↗

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.