Tandem 126649Recalls & reported problems
Smith & Nephew, Inc. · TANDEM UNIPOLAR HEAD 49MM · Class 2 · Implant
- 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 03596010079787), received between May 10, 2019 and May 10, 2019 — classified as 1 injury.
The most frequently reported specific device problem is “Insufficient Device Problem Information” (1 report).
1 other recall cover devices cleared under the same FDA submission (K211176, K231448, K896580); 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. How this data works · Data updated Oct 13, 2026.
Most reported problems
Device problems
- Insufficient Device Problem Information1
Patient problems
- Unspecified Infection1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryMay 10, 2019Insufficient Device Problem Information; Insufficient Device Problem Information
IT WAS REPORTED THAT A REVISION SURGERY WAS PERFORMED TO THE PATIENT DUE TO AN INFECTION. THREE DEVICES EXPLANTED. NO ADDITIONAL INFORMATION AVAILABLE.
Patient problems: Unspecified Infection
MAUDE report 8601008 ↗
Recalls under the same FDA submission
These recalls involve devices cleared under K211176, K231448, K896580. 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, hemi-, femoral, metal ball devices
- NA 1363-10-000Depuy Orthopaedics, Inc. · Prosthesis, hip, hemi-, femoral, metal ball117 reports
- NA 1363-08-000Depuy Orthopaedics, Inc. · Prosthesis, hip, hemi-, femoral, metal ball66 reports
- NA 1363-12-000Depuy Orthopaedics, Inc. · Prosthesis, hip, hemi-, femoral, metal ball44 reports
- NA 1363-46-000Depuy Orthopaedics, Inc. · Prosthesis, hip, hemi-, femoral, metal ball39 reports
- NA 1363-47-000Depuy Orthopaedics, Inc. · Prosthesis, hip, hemi-, femoral, metal ball34 reports
- NA 1363-45-000Depuy Orthopaedics, Inc. · Prosthesis, hip, hemi-, femoral, metal ball31 reports
- NA 1363-44-000Depuy Orthopaedics, Inc. · Prosthesis, hip, hemi-, femoral, metal ball25 reports
- NA 1363-48-000Depuy Orthopaedics, Inc. · Prosthesis, hip, hemi-, femoral, metal ball23 reports
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.