NA 71344245Recalls & reported problems
Smith & Nephew, Inc. · TITANIUM MODULAR HEAD SLEEVE 12/14 TAPER -4 · Class 2 · Implant
Data updated Oct 18, 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 00885556022276), received between Nov 21, 2019 and Nov 21, 2019 — classified as 1 injury.
The most frequently reported specific device problem is “Loose or Intermittent Connection” (1 report).
1 other recall cover devices cleared under the same FDA submission (K093363, 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
Device problems
- Loose or Intermittent Connection1
Patient problems
- Injury1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryNov 21, 2019Loose or Intermittent Connection; Loose or Intermittent Connection
IT WAS REPORTED THAT REVISION SURGERY WAS PERFORMED FOR THE THIRD TIME. ASEPTIC LOOSENING. HIP PREPPED AND DRAPED, JOINTLY OPENED, SPECIMENS TAKEN. JOINT LAVAGED AND DEBRIDED INTENSELY. THE FEMORAL HEAD REMOVED, POLY LINER AND CUP AND SCREWS REMOVED. EXISTING SOCKET REAMED TO A BLEEDING BONE BED. IMPLANT TRIALED, JOINT LAVAGED AGAIN WITH HYDROGEN PEROXIDE AND MORE SALINE. DEFINITIVE ACETABULAR IMPLANT INSERTED WITH BONE CEMENT. TRIPOLAR LINER/HEAD TRIALED VIA REDUCTION, HIP STABLE, DEFINITIVE TRIPOLAR IMPLANTS INSERTED AND HIP REDUCED, HIP CLOSED. NO MORE INFORMATION IS AVAILABLE.
Patient problems: Injury
MAUDE report 9360112 ↗
Recalls under the same FDA submission
These recalls involve devices cleared under K093363, 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, uncemented, metal/polymer, porous devices
- Accolade 6021-0537Howmedica Osteonics Corp. · Prosthesis, hip, semi-constrained, uncemented, metal/polymer, porous46 reports
- PROFEMUR® PHAC1252Microport Orthopedics Inc. · Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Porous37 reports
- Accolade 6020-0335Howmedica Osteonics Corp. · Prosthesis, hip, semi-constrained, uncemented, metal/polymer, porous35 reports
- OXINIUM 71342340Smith & Nephew, Inc. · Prosthesis, hip, semi-constrained, uncemented, metal/polymer, porous32 reports
- EXETER 0580-1-351Howmedica Osteonics Corp. · Prosthesis, hip, semi-constrained, uncemented, metal/polymer, porous29 reports
- INSTRUMENT 2101-0200Howmedica Osteonics Corp. · Prosthesis, hip, semi-constrained, uncemented, metal/polymer, porous27 reports
- REFLECTION 71330001Smith & Nephew, Inc. · Prosthesis, hip, semi-constrained, uncemented, metal/polymer, porous20 reports
- Accolade 6720-0330Howmedica Osteonics Corp. · Prosthesis, hip, semi-constrained, uncemented, metal/polymer, porous18 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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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