SL-PLUS MIA 75001941Recalls & reported problems
Smith & Nephew, Inc. · SL-PLUS MIA STEM 3 NON-CEM · Class 2 · Implant
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 07611996078879), received between Nov 30, 2023 and Dec 16, 2024 — classified as 2 injuries.
The most frequently reported specific device problem is “Failure to Osseointegrate” (1 report).
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.
Reports received per month
Most reported problems
Device problems
- Failure to Osseointegrate1
- Loss of Osseointegration1
Patient problems
- Inadequate Osseointegration2
- Arthralgia1
- Discomfort1
- Insufficient Information1
- Muscle Weakness/Atrophy1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryDec 16, 2024Loss of Osseointegration; Loss of Osseointegration
IT WAS REPORTED THAT, AFTER A THR ON (B)(6) 2013, A REVISION SURGERY WAS PERFORMED ON (B)(6) 2024 DUE TO STEM LOOSENING. THE STEM WAS EXCHANGED TO COMPETITOR'S PRODUCT. PATIENT'S CURRENT HEALTH STATUS IS UNKNOWN.
Patient problems: Inadequate Osseointegration
MAUDE report 20938790 ↗InjuryNov 30, 2023Failure to Osseointegrate; Failure to Osseointegrate
IT WAS REPORTED THAT AFTER A RIGHT THR SURGERY HAD BEEN PERFORMED ON (B)(6) 2012, THE PATIENT EXPERIENCED SHAFT LOOSENING, PAIN AND FEELING OF WEAKENING MUSCLE. THIS ADVERSE EVENT WAS TREATED BY A REVISION SURGERY ON (B)(6) 2023. PATIENT LEFT THE HOSPITAL IF STABLE CONDITIONS WITHOUT FURTHER NEED OF STRONG PAIN KILLERS OR ANTIBIOTICS.
Patient problems: Arthralgia; Discomfort; Inadequate Osseointegration; Insufficient Information; Muscle Weakness/Atrophy
MAUDE report 18237332 ↗
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Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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