POLARSTEM 75100477Recalls & reported problems
Smith & Nephew, Inc. · POLARSTEM LATERAL NON-CEMENTED WITH Ti/HA 4 · Class 2 · Implant
All models of POLARSTEM (63)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 3
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 07611996118681), received between Jul 24, 2022 and Jan 31, 2025 — classified as 3 injuries.
The most frequently reported specific device problem is “Fracture” (2 reports).
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.
Reports received per month
Most reported problems
Device problems
- Fracture2
- Adverse Event Without Identified Device or Use Problem1
Patient problems
- Failure of Implant2
- Bone Fracture(s)1
- Insufficient Information1
- Unspecified Infection1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
InjuryJan 31, 2025Fracture; Fracture
IT WAS REPORTED THAT, AFTER A THR WAS PERFORMED ON (B)(6) 2015, ON (B)(6) 2025 THE NECK OF THE POLARSTEM STEM LAT.TI/HA 4 NON-CEM FRACTURED. PATIENT DID NOT EXPERIENCE ANY TRAUMATIC EVENT PRIOR TO THE MALFUNCTION. ON (B)(6) 2025 PATIENT UNDERWENT A REVISION SURGERY, TO REPLACE THE STEM FOR A REDAPT STEM 240MM. ADDITIONALLY, THE PATIENT UNDERWENT AN OXINIUM FEMORAL HEAD EXCHANGE ON (B)(6) 2017. NO OTHER COMPLICATIONS WERE REPORTED.
Patient problems: Failure of Implant; Insufficient Information
MAUDE report 21282797 ↗InjuryJan 20, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT, AFTER A LEFT THR INDEX SURGERY PERFORMED ON (B)(6) 2018 TO ADDRESS AN UNSPECIFIED INFLAMMATORY ARTHROPATHY SYMPTOMS AS PRIMARY DIAGNOSIS, THE PATIENT EXPERIENCED A PERI-PROSTHETIC FRACTURE OF THE STEM COMPONENT AND UNSPECIFIED INFECTION THAT MADE NECESSARY A REVISION SURGERY ON (B)(6) 2018. DURING THIS PROCEDURE, THE FEMORAL STEM AND THE ACETABULAR CUP WERE EXPLANTED AND REPLACED. THIS INFORMATION WAS PROVIDED BY THE NATIONAL JOINT REGISTRY OF THE UNITED KINGDOM, AS PART OF A RETROSPECTIVE DATA COLLECTION OF PATIENTS WHO UNDERWENT A PRIMARY THR SURGERY WITH A HIP PROSTHESIS CONSTRUCT THAT INCLUDED A POLARSTEM STEM WITH AN R3 ACETABULAR CUP AND THAT REQUIRED A REVISION SURGERY DUE TO SPECIFIC REASONS. AS SUCH, NO FURTHER INFORMATION WILL BE AVAILABLE.
Patient problems: Bone Fracture(s); Unspecified Infection
MAUDE report 16214738 ↗InjuryJul 24, 2022Fracture; Fracture
IT WAS REPORTED THAT, AFTER A RIGHT THA SURGERY WAS PERFORMED ON (B)(6) 2011, THE PATIENT EXPERIENCED A POLARSTEM STEM LAT.TI/HA 4 NON-CEM FRACTURE AFTER A FALL. THIS ADVERSE EVENT WAS ADDRESSED VIA REVISION SURGERY ON (B)(6) 2022, WHERE THE FEMORAL STEM AND HEAD WERE EXPLANTED. CURRENT HEALTH STATUS OF PATIENT IS UNKNOWN.
Patient problems: Failure of Implant
MAUDE report 15090637 ↗
Other Prosthesis, hip, hemi-, femoral, metal/polymer, cemented or uncemented devices
- STAGEONE 431209Biomet Orthopedics, LLC · Prosthesis, hip, hemi-, femoral, metal/polymer, cemented or uncemented2 recalls0 reports
- SELF CENTERING 1035-45-000Depuy Orthopaedics, Inc. · Prosthesis, hip, hemi-, femoral, metal/polymer, cemented or uncemented84 reports
- LFIT 6260-9-036Howmedica Osteonics Corp. · Prosthesis, hip, hemi-, femoral, metal/polymer, cemented or uncemented80 reports
- ACTIS 101011060Depuy (Ireland) · Prosthesis, hip, hemi-, femoral, metal/polymer, cemented or uncemented66 reports
- RINGLOC BI-POLAR HIP SYSTEM 11-165228Biomet Orthopedics, LLC · Prosthesis, hip, hemi-, femoral, metal/polymer, cemented or uncemented1 recall1 death12 reports
- SELF CENTERING 1035-44-000Depuy Orthopaedics, Inc. · Prosthesis, hip, hemi-, femoral, metal/polymer, cemented or uncemented60 reports
- TANDEM 71324046Smith & Nephew, Inc. · Prosthesis, hip, hemi-, femoral, metal/polymer, cemented or uncemented1 recall9 reports
- TAPERLOC COMPLETE XR 123 MICRO FEMORAL 51-145170Biomet Orthopedics, LLC · Prosthesis, hip, hemi-, femoral, metal/polymer, cemented or uncemented59 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.
How reports and recalls are matched · Editorial policy · Report an error on this page