POLARSTEMRecalls & reported problems across all models

We found 63 models of POLARSTEM by Smith & Nephew, Inc. in the FDA's device registry (GUDID). Together they are named in 518 adverse event reports in the FDA's MAUDE database, received between Aug 25, 2017 and Jul 27, 2026 — classified as 277 injuries, 241 malfunctions.

The most frequently reported specific device problem is “Fracture” (170 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

Most reported POLARSTEM problems

POLARSTEM models

63 models, most reported first. Each model has its own page with its reports, recalls and device details.

• POLARSTEM 75023711

  ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
  174 reports
• POLARSTEM 75100464

  Prosthesis, hip, semi-constrained, metal/polymer, uncemented
  38 reports
• POLARSTEM 75100466

  Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented
  29 reports
• POLARSTEM 75100465

  Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented
  27 reports
• POLARSTEM 75100467

  Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented
  22 reports
• POLARSTEM 75102240

  Prosthesis, hip, semi-constrained, metal/polymer, cemented
  18 reports
• POLARSTEM 75004650

  ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
  18 reports
• POLARSTEM 75102205

  ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
  16 reports
• POLARSTEM 75100474

  Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented
  15 reports
• POLARSTEM 75102237

  Prosthesis, hip, semi-constrained, metal/polymer, cemented
  13 reports
• POLARSTEM 75023710

  IMPACTOR
  12 reports
• POLARSTEM 75100475

  Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented
  11 reports
• POLARSTEM 75100463

  Prosthesis, hip, semi-constrained, metal/polymer, uncemented
  9 reports
• POLARSTEM 75100479

  Prosthesis, hip, hemi-, femoral, metal/polymer, cemented or uncemented
  9 reports
• POLARSTEM 75100469

  Prosthesis, hip, semi-constrained, metal/polymer, uncemented
  8 reports
• POLARSTEM 75100476

  Prosthesis, hip, semi-constrained, metal/polymer, uncemented
  8 reports
• POLARSTEM 75018403

  Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented
  6 reports
• POLARSTEM 75018402

  Prosthesis, hip, semi-constrained, metal/polymer, uncemented
  5 reports
• POLARSTEM 75100468

  Prosthesis, hip, semi-constrained, metal/polymer, uncemented
  5 reports
• POLARSTEM 75102207

  ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
  4 reports
• POLARSTEM 75100471

  Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented
  4 reports
• POLARSTEM 75100480

  Prosthesis, hip, hemi-, femoral, metal/polymer, cemented or uncemented
  4 reports
• POLARSTEM 75102238

  Prosthesis, hip, semi-constrained, metal/polymer, cemented
  3 reports
• POLARSTEM 75002112

  Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented
  3 reports
• POLARSTEM 75004678

  Prosthesis, hip, semi-constrained, metal/polymer, cemented
  3 reports
• POLARSTEM 75100477

  Prosthesis, hip, hemi-, femoral, metal/polymer, cemented or uncemented
  3 reports
• POLARSTEM 75100478

  Prosthesis, hip, semi-constrained, metal/polymer, uncemented
  3 reports
• POLARSTEM 75100481

  Prosthesis, hip, semi-constrained, metal/polymer, uncemented
  3 reports
• POLARSTEM 75002122

  Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented
  2 reports
• POLARSTEM 75004644

  Prosthesis, hip, semi-constrained, metal/polymer, cemented
  2 reports
• POLARSTEM 75004646

  Prosthesis, hip, semi-constrained, metal/polymer, cemented
  2 reports
• POLARSTEM 75018400

  Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented
  2 reports
• POLARSTEM 75018414

  Prosthesis, hip, hemi-, femoral, metal/polymer, cemented or uncemented
  2 reports
• POLARSTEM 75018415

  Prosthesis, hip, semi-constrained, uncemented, metal/polymer, non-porous, calicum-phosphate
  2 reports
• POLARSTEM 75100470

  Prosthesis, hip, semi-constrained, metal/polymer, uncemented
  2 reports
• POLARSTEM 75100472

  Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented
  2 reports
• POLARSTEM 75102074

  Prosthesis, hip, semi-constrained, uncemented, metal/polymer, non-porous, calicum-phosphate
  2 reports
• POLARSTEM 75102076

  Prosthesis, hip, semi-constrained, metal/polymer, uncemented
  2 reports
• 'POLARSTEM¿' 75102253

  Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented
  1 report
• POLARSTEM 75102208

  ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
  1 report
• POLARSTEM 75000675

  Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented
  1 report
• POLARSTEM 75102261

  Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented
  1 report
• POLARSTEM 75103197

  Orthopedic manual surgical instrument
  1 report
• POLARSTEM 75002114

  Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented
  1 report
• POLARSTEM 75002115

  Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented
  1 report
• POLARSTEM 75002120

  Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented
  1 report
• POLARSTEM 75004637

  Prosthesis, hip, femoral component, cemented, metal
  1 report
• POLARSTEM 75004647

  Prosthesis, hip, semi-constrained, metal/polymer, cemented
  1 report
• POLARSTEM 75018401

  Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented
  1 report
• POLARSTEM 75018405

  Prosthesis, hip, semi-constrained, uncemented, metal/polymer, non-porous, calicum-phosphate
  1 report
• POLARSTEM 75018406

  Prosthesis, hip, hemi-, femoral, metal/polymer, cemented or uncemented
  1 report
• POLARSTEM 75018412

  Prosthesis, hip, semi-constrained, metal/polymer, uncemented
  1 report
• POLARSTEM 75018419

  Prosthesis, hip, semi-constrained, uncemented, metal/polymer, non-porous, calicum-phosphate
  1 report
• POLARSTEM 75023019

  Prosthesis, hip, semi-constrained, metal/polymer, cemented
  1 report
• POLARSTEM 75023745

  Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented
  1 report
• POLARSTEM 75100482

  Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented
  1 report
• POLARSTEM 75100483

  Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented
  1 report
• POLARSTEM 75102072

  Prosthesis, hip, semi-constrained, uncemented, metal/polymer, non-porous, calicum-phosphate
  1 report
• POLARSTEM 75102073

  Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented
  1 report
• POLARSTEM 75102075

  Prosthesis, hip, semi-constrained, uncemented, metal/polymer, non-porous, calicum-phosphate
  1 report
• POLARSTEM 75102077

  Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented
  1 report
• POLARSTEM 75102209

  Prosthesis, hip, hemi-, femoral, metal/polymer, cemented or uncemented
  1 report
• POLARSTEM 75102210

  Prosthesis, hip, semi-constrained, uncemented, metal/polymer, non-porous, calicum-phosphate
  1 report

Recent POLARSTEM adverse event reports

The 15 most recent reports across all models, in the reporter's own words as published by the FDA.

• InjuryJul 27, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that, during the first week of recovery following a BHR to THR conversion performed on (b)(6) 2018, the patient experienced persistent pain in the anterior groin. It is particularly painful when lifting the right leg, when he goes from sitting to standing, and getting into or out of cars. The pain is described as burning sharp sensation, and the patient reported weakness and limited movement. The patient received a fluoroscopy guided injection in the iliopsoas bursa on (b)(6) 2025, but he states that it really did not help at all. A recent MRI on (b)(6) 2026 revealed mild capsulitis, capsular fluid prolapsing into the iliopsoas bursa, and mild thickened synovium. The adverse event had not been resolved. A revision surgery has been scheduled for ON (b)(6) 2026.

  Patient problems: Bursitis; Implant site sclerosis; Pain; Prolapse

  MAUDE report 50029306 ↗
• MalfunctionJul 10, 2026Break

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25785459 ↗
• MalfunctionJun 22, 2026Fracture

  IT WAS REPORTED THAT, DURING A TOTAL HIP REPLACEMENT SURGERY, THE RELEASE LEVER OF ONE (1) POLARSTEM COLLAR REAMER GUIDE SNAPPED OFF AFTER BECOMING UNABLE TO MOVE. NO PIECES REQUIRED REMOVAL. THE PROCEDURE WAS RESUMED, AFTER A NON-SIGNIFICANT DELAY, USING AN EQUIVALENT S+N BACK-UP. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25573018 ↗
• InjuryMay 31, 2026Degraded

  IT WAS REPORTED THAT, AFTER A THR HAD BEEN PERFORMED ON AN UNKNOWN DATE, PATIENT EXPERIENCED PREMATURE POLYETHYLENE WEAR. THIS ADVERSE EVENT WAS ADDRESSED BY PERFORMING A REVISION SURGERY ON UNKNOWN DATE, DURING WHICH THE POLARSTEM STEM STD TI/HA 2 NON-CEM WAS EXCHANGED. PATIENT'S CURRENT HEALTH CONDITION IS UNKNOWN.

  Patient problems: Insufficient Information

  MAUDE report 25341976 ↗
• InjuryMay 14, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THAT, AFTER A HIP REPLACEMENT SURGERY/TREATMENT HAD BEEN PERFORMED ON (B)(6) 2026, THE PATIENT EXPERIENCED ISSUES INVOLVING DISLOCATION OF A POLARSTEM STEM STD TI/HA 2 NON-CEM. THIS ADVERSE EVENT WAS SOLVED BY A REVISION SURGERY ON (B)(6) 2026 IN WHICH ALL COMPONENTS WERE REMOVED AND THE CUP ALONG WITH ITS METAL LINE WERE REPOSITIONED. IN ADDITION, IT WAS DECIDED TO CEMENT THE FEMORAL CANAL USING THE SAME STEM THAT HAD BEEN IMPLANTED PREVIOUSLY (AN UNCEMENTED STEM), CITING PRIOR EXPERIENCE WITH THIS PRACTICE AS JUSTIFICATION. CURRENT HEALTH STATUS OF PATIENT IS STABLE.

  Patient problems: Joint Dislocation

  MAUDE report 25175033 ↗
• InjuryMay 3, 2026Break

  IT WAS REPORTED THAT, AFTER A THR HAD BEEN PERFORMED ON AN UNKNOWN DATE, ONE (1) POLARSTEM STEM LAT.TI/HA 6 NON-CEM BROKE ON THE NECK. THIS ADVERSE EVENT WAS SOLVED BY A REVISION SURGERY ON (B)(6) 2026. CURRENT HEALTH STATUS OF PATIENT IS UNKNOWN.

  Patient problems: Insufficient Information

  MAUDE report 25062854 ↗
• MalfunctionApr 23, 2026Fracture

  IT WAS REPORTED THAT, DURING A HEMI HIP SURGERY, AFTER IMPACTING THE FEMORAL HEAD, BLACK PLASTIC CHIPS WERE COMING OFF THE POLARSTEM MODULAR HEAD FOR 21000662. THIS WAS NOTICED UNTIL THE CASE WAS OVER, SO THE SURGERY WAS COMPLETED WITH THE SAME REPORTED DEVICE, WITHOUT ANY DELAY. IT IS UNKNOWN IF ANY PIECE FELL INSIDE THE PATIENT. NO INJURIES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24973676 ↗
• MalfunctionApr 22, 2026Material Deformation; Material Split, Cut or Torn

  IT WAS REPORTED THAT, DURING A THR SURGERY, ONE (1) POLARSTEM COLLAR REAMER GUIDE WAS CUT UP AND DAMAGED. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING AN EQUIVALENT S+N BACK-UP. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24952910 ↗
• InjuryApr 16, 2026Inadequacy of Device Shape and/or Size; Migration

  IT WAS REPORTED THAT, AFTER A THR SURGERY WAS PERFORMED ON (B)(6) 2025, IT WAS NOTICED THAT THE POLARSTEM STEM LAT.TI/HA 1 NON-CEM WAS UNDERSIZED, CAUSING IT TO SUBSIDE AND MOVE IN THE FEMUR. A REVISION SURGERY WAS PERFORMED ON (B)(6) 2026 TO ADDRESS THIS PROBLEM AND EXCHANGE THE STEM TO A 3 LATERALIZED POLARSTEM, FOR A BETTER PROXIMAL FIT. CURRENT HEALTH STATUS OF PATIENT IS UNKNOWN.

  Patient problems: Joint Laxity

  MAUDE report 24897349 ↗
• MalfunctionMar 23, 2026Break

  IT WAS REPORTED THAT, DURING A THR, ONE (1) POLARSTEM MODULAR HEAD FOR (B)(6) CHIPPED DURING STANDARD USAGE. NO PIECES FELL INSIDE PATIENT. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING AN EQUIVALENT S+N BACK-UP. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24663243 ↗
• MalfunctionMar 8, 2026Fracture

  IT WAS REPORTED THAT, DURING A THR SURGERY, WHILE IMPACTING THE HEAD ON TO THE STEM, ONE (1) POLARSTEM MODULAR HEAD FOR 21000662 BROKE. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, A BACK-UP DEVICE WAS NOT NEEDED. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24542265 ↗
• InjuryFeb 23, 2026Positioning Failure

  IT WAS REPORTED THAT, DURING A HIP ARTHROSCOPY SURGERY, DURING THE IMPROPER INSERTION OF ONE (1) POLARSTEM STEM STD TI/HA 1 NON-CEM, THE STEM SANK. THIS REQUIRED DISCARDING THE STEM AND INSERTING ANOTHER SIZE 3 STEM LATERALLY. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING A SIMILAR S+N BACK-UP PRODUCT. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24413626 ↗
• MalfunctionFeb 17, 2026Fracture

  IT WAS REPORTED THAT DURING A THR SURGERY, THE POLARSTEM MODULAR HEAD FOR 21000662 CHIPPED OFF WHILE IN USE. ALL PIECES RECOVERED. IT IS UNKNOWN HOW WAS COMPLETED THE SURGERY, OR IF A DELAY WAS PRESENTED. NO INJURY TO PATIENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24364566 ↗
• MalfunctionFeb 3, 2026Delivered as Unsterile Product

  IT WAS REPORTED THAT, DURING A THA SURGERY, THE INNER PACKAGE OF ONE (1) POLARSTEM STEM STD TI/HA 0 NON-CEM WAS DAMAGED AND NO LONGER STERILE. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING AN EQUIVALENT S+N BACK-UP. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24245020 ↗
• InjuryJan 26, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER TOTAL LEFT HIP REPLACEMENT SURGERY HAD BEEN PERFORMED ON (B)(6) 2025, THE PATIENT EXPERIENCED AN EARLY INFECTION OF THE PRIMARY IMPLANT. THIS ADVERSE EVENT WAS TREATED WITH A REVISION SURGERY ON (B)(6) 2025, IN WHICH THE POLARSTEM STEM STD TI/HA 1 NON-CEM (PRIMARY STEM) WAS COMPLETELY REMOVED THROUGH A CONTROLLED FEMORAL OSTEOTOMY, AND A REDAPT STEM WAS IMPLANTED. CURRENT HEALTH STATUS OF PATIENT IS UNKNOWN.

  Patient problems: Medical device site infection

  MAUDE report 24184633 ↗

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