Tandem 126651Recalls & reported problems
Smith & Nephew, Inc. · TANDEM UNIPOLAR HEAD 51MM · Class 2 · Implant
Data updated Oct 13, 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 03596010079800), received between Apr 19, 2021 and Mar 4, 2024 — classified as 2 injuries.
The most frequently reported specific device problem is “Device Dislodged or Dislocated” (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.
Reports received per month
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem1
- Device Dislodged or Dislocated1
Patient problems
- Fall1
- Joint Dislocation1
- Unspecified Infection1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryMar 4, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated
IT WAS REPORTED THAT, AFTER A THR HAD BEEN PERFORMED ON AN UNKNOWN DATE, THE PATIENT FELL AND THE UNIPOLAR HEAD DISASSOCIATED FROM THE SLEEVE. A REVISION SURGERY WAS PERFORMED ON (B)(6) 2024 TO ADDRESS THIS ADVERSE EVENT. THE TANDEM UNIPOLAR 51MM AND THE TANDEM UNI 12/14 TPR SLV + 4 WERE REMOVED AND REPLACED. PATIENTS' CURRENT HEALTH STATUS IN UNKNOWN.
Patient problems: Fall; Joint Dislocation
MAUDE report 18831004 ↗InjuryApr 19, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT A REVISION HEMIARTHROSPLASTY WAS PERFORMED DUE TO AN UNSPECIFIC INFECTION. A PRE-OPERATIVE PLAN WAS MADE TO DEBRIDE AS MUCH OF THE INFECTED TISSUE AS POSSIBLE AND ONLY REMOVE AND REPLACE THE TANDEM UNIPOLAR SLEEVE AND HEAD FROM THE EXISTING CONSTRUCT.
Patient problems: Unspecified Infection
MAUDE report 11689164 ↗
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 and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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