TANDEM 71322055Recalls & reported problems

Smith & Nephew, Inc. · TANDEM BIPOLAR COBALT CHROME 55MM OUTER DIAMETER 28MM INNER DIAMETER · Class 2 · Implant

All models of TANDEM (58)

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 03596010492548), received between May 6, 2021 and May 6, 2021 — classified as 1 injury.

3 other recalls cover devices cleared under the same FDA submission (K023743); 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

Adverse Event Without Identified Device or Use Problem1

Patient problems

Bacterial Infection1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

InjuryMay 6, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT AFTER THR SURGERY PERFORMED FIVE WEEKS BEFORE REVISION SURGERY, THE PATIENT EXPERIENCED AN INFECTION ((B)(6) BACTERAEMIA). THE REVISION SURGERY WAS PERFORMED ON (B)(6) 2021. THE FOLLOWING DEVICES WERE EXPLANTED FROM THE PATIENT: CPCS SS PRIM SO 12/14 SZ 3 ((B)(4)), TANDEM BIPOLAR COCR 55OD 28ID ((B)(4)) AND COCR 12/14 FEM HEAD 28 +0 ((B)(4)). NEW DEVICES WERE IMPLANTED. THE PATIENT OUTCOME IS UNKNOWN.
Patient problems: Bacterial Infection
MAUDE report 11781925 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K023743. One submission often covers many models, so check the product and lot details in each record.

Z-0326-2025 · Oct 15, 2024 · Open, Classified
Tandem 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.
Z-0350-2017 · Aug 29, 2016 · Terminated
TANDEM (TM) COCR SHELL UHMWPE LINER BIPOLAR, REF NUMBERS: 71322040, 71322041, 71322042, 71322043, 71322044, 71322045, 71322046, 71322047, 71322048, 71322049, 71322050, 71322051,
Z-0351-2017 · Aug 29, 2016 · Terminated
TANDEM (TM) INTL COCR SHELL UHMWPE LINER BIPOLAR, REF NUMBERS: 71324038, 71324039, 71324040, 71324041, 71324042, 71324043, 71324044, 71324045, 71324046, 71324047, 71324048, 7132

Device details

UDI-DI	`03596010492548`
Brand	TANDEM
Model	71322055
Company	Smith & Nephew, Inc.
Product code	KWY · Prosthesis, hip, hemi-, femoral, metal/polymer, cemented or uncemented
Class	Class 2
FDA submission	K023743
Implant	Yes
Rx / OTC	Prescription
Single use	Yes
Sterile	Yes
MRI safety	Labeling does not contain MRI Safety Information
Status	In Commercial Distribution
Record updated	Sep 7, 2023

Device type (GMDN): Bipolar femoral head outer component, hemiarthroplasty

An implantable hemisphere-shaped device used as part of a partial hip replacement (femoral) and designed to interface with the acetabulum on its outer surface where it freely rotates, and interface with a femoral head prosthesis on its inner surface where it allows free rotation of the head. It is a one-piece device typically composed of an outer metal shell [e.g., cobalt-chrome (Co-Cr), titanium (Ti), stainless steel] and an inner polyethylene (PE) liner.

Other Prosthesis, hip, hemi-, femoral, metal/polymer, cemented or uncemented devices

STAGEONE 431209
Biomet Orthopedics, LLC · Prosthesis, hip, hemi-, femoral, metal/polymer, cemented or uncemented
2 recalls0 reports
SELF CENTERING 1035-45-000
Depuy Orthopaedics, Inc. · Prosthesis, hip, hemi-, femoral, metal/polymer, cemented or uncemented
84 reports
LFIT 6260-9-036
Howmedica Osteonics Corp. · Prosthesis, hip, hemi-, femoral, metal/polymer, cemented or uncemented
80 reports
ACTIS 101011060
Depuy (Ireland) · Prosthesis, hip, hemi-, femoral, metal/polymer, cemented or uncemented
66 reports
RINGLOC BI-POLAR HIP SYSTEM 11-165228
Biomet Orthopedics, LLC · Prosthesis, hip, hemi-, femoral, metal/polymer, cemented or uncemented
1 recall1 death12 reports
SELF CENTERING 1035-44-000
Depuy Orthopaedics, Inc. · Prosthesis, hip, hemi-, femoral, metal/polymer, cemented or uncemented
60 reports
TANDEM 71324046
Smith & Nephew, Inc. · Prosthesis, hip, hemi-, femoral, metal/polymer, cemented or uncemented
1 recall9 reports
TAPERLOC COMPLETE XR 123 MICRO FEMORAL 51-145170
Biomet Orthopedics, LLC · Prosthesis, hip, hemi-, femoral, metal/polymer, cemented or uncemented
59 reports

All Prosthesis, hip, hemi-, femoral, metal/polymer, cemented or uncemented devices →

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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