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SL-PLUS 75002695Recalls & reported problems

Smith & Nephew, Inc. · SL-PLUS STEM STANDARD NON-CEMENTED 1 · Class 2 · Implant

All models of SL-PLUS (18)

Data updated Oct 16, 2026 from official FDA records · Editorial policy

Adverse event reports
2
Deaths reported
0
Injuries reported
2
Recalls naming it
0

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 07611996078633), received between Oct 14, 2020 and Apr 16, 2022 — classified as 2 injuries.

The most frequently reported specific device problem is “Loosening of Implant Not Related to Bone-Ingrowth” (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

Device problems

  • Loosening of Implant Not Related to Bone-Ingrowth1
  • Loss of Osseointegration1

Patient problems

  • Failure of Implant1
  • Inadequate Osseointegration1

Recent adverse event reports

The 2 most recent of 2 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 RIGHT THA HAD BEEN PERFORMED ON (B)(6) 2004, THE PATIENT EXPERIENCED LOOSENING OF THE FEMORAL STEM AND PAIN. A REVISION SURGERY WAS PERFORMED ON (B)(6) 2010 TO TREAT THIS ADVERSE EVENT. DURING THIS PROCEDURE, THE FEMORAL STEM WAS EXPLANTED AND REPLACED WITH AN UNSPECIFIED PROSTHESIS. 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

    MAUDE report 14131599 ↗
  • InjuryOct 14, 2020Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

    IT WAS REPORTED THAT, AFTER A HEMIARTHROPLASTY HAD BEEN PERFORMED, THE PATIENT EXPERIENCED PAIN DUE TO STEM LOOSENING. A REVISION SURGERY WAS PERFORMED TO EXPLANT STEM, OXINIUM HEAD AND BIPOLAR HEAD. THE PATIENT OUTCOME IS UNKNOWN.

    Patient problems: Failure of Implant

    MAUDE report 10679854 ↗

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.

Other Prosthesis, hip, hemi-, femoral, metal/polymer, cemented or uncemented devices

All Prosthesis, hip, hemi-, femoral, metal/polymer, cemented or uncemented devices →

Sources and updates

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