SL-PLUS 75002756Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 07611996078046), received between Oct 29, 2019 and Jul 22, 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 18, 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.

• InjuryJul 22, 2022Loss of Osseointegration; Loss of Osseointegration

  IT WAS REPORTED THAT AFTER A RIGHT THR PERFORMED ON (B)(6) 2008 THE PATIENT PRESENTED LOOSENING OF THE SL-PLUS STEM LATERAL 4 NON-CEMENTED ELEVEN (11) YEARS POSTOPERATIVELY. THIS COMPLICATION WAS ADDRESSED VIA REVISION SURGERY ON (B)(6) 2019 AND ALL DEVICES WERE EXPLANTED AND REPLACED WITH A COMPETITORS' PROSTHESIS CONSTRUCT. 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: Inadequate Osseointegration

  MAUDE report 15089666 ↗
• InjuryApr 18, 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) 2004, THE PATIENT EXPERIENCED A PERI-PROSTHETIC FRACTURE AROUND THE SL-PLUS STEM LATERAL 4 NON-CEMENTED. THIS EVENT WAS ADDRESSED VIA REVISION SURGERY ON (B)(6) 2021 TO EXPLANT THE HEAD AND STEM. PATIENT HEALTH STATUS IS NOT KNOWN. THIS INFORMATION WAS PROVIDED BY THE NATIONAL JOINT REGISTRY OF (B)(6), FOLLOWING A REVIEW OF THE DATA CONDUCTED IN SEPTEMBER 2021.

  Patient problems: Bone Fracture(s)

  MAUDE report 14134437 ↗
• InjuryOct 29, 2019Migration or Expulsion of Device; Migration or Expulsion of Device

  IT WAS REPORTED THAT A REVISION SURGERY WAS PERFORMED DUE TO MOBILIZATION OF THE STEM AND WEAR OF THE POLYETHYLENE.

  Patient problems: Injury

  MAUDE report 9252705 ↗

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.