SL-PLUS/INTEGRATION-PLUS 75000174Recalls & reported problems
Smith & Nephew, Inc. · SL-PLUS MIA STEM STANDARD NON-CEMENTED WITH TI/HA 1 · Class 2 · Implant
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 07611996092769), received between Aug 24, 2023 and Aug 24, 2023 — classified as 1 injury.
The most frequently reported specific device problem is “Fracture” (1 report).
1 other recall cover devices cleared under the same FDA submission (K122296, K143096, 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
- Fracture1
Patient problems
- Failure of Implant1
- Inadequate Osseointegration1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryAug 24, 2023Fracture; Fracture
IT WAS REPORTED THAT, AFTER A THA SURGERY WAS PERFORMED ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED A BREAKAGE OF THE NECK OF THE FEMORAL STEM ON (B)(6) 2022. THIS ADVERSE EVENT WAS TREATED BY A REVISION SURGERY ON (B)(6) 2022, IN WHICH A SMITH AND NEPHEW HIP STEM WAS EXCHANGED TO A PETER-BREHM HIP STEM. PATIENT'S CURRENT HEALTH STATUS IS UNKNOWN.
Patient problems: Failure of Implant; Inadequate Osseointegration
MAUDE report 17619616 ↗
Recalls under the same FDA submission
These recalls involve devices cleared under K122296, K143096, K211176. One submission often covers many models, so check the product and lot details in each record.
- Z-0326-2025 · Oct 15, 2024 · Open, ClassifiedTandem 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, semi-constrained, metal/polymer, uncemented devices
- LFIT 6260-9-136Howmedica Osteonics Corp. · Prosthesis, hip, semi-constrained, metal/polymer, uncemented166 reports
- Trident 623-00-36EHowmedica Osteonics Corp. · Prosthesis, hip, semi-constrained, metal/polymer, uncemented112 reports
- Accolade 6021-0435Howmedica Osteonics Corp. · Prosthesis, hip, semi-constrained, metal/polymer, uncemented88 reports
- EXETER 0580-1-044Howmedica Osteonics Corp. · Prosthesis, hip, semi-constrained, metal/polymer, uncemented1 recall22 reports
- Endo-Model SL Knee Prosthesis System 16-2840/02WALDEMAR LINK GmbH & Co. KG · Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Uncemented1 recall17 reports
- Endo-Model SL Knee Prosthesis System 16-2840/05WALDEMAR LINK GmbH & Co. KG · Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Uncemented1 recall12 reports
- Trident 623-10-36EHowmedica Osteonics Corp. · Prosthesis, hip, semi-constrained, metal/polymer, uncemented57 reports
- LFIT 6260-9-336Howmedica Osteonics Corp. · Prosthesis, hip, semi-constrained, metal/polymer, uncemented56 reports
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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