POLARCUPRecalls & reported problems across all models
Smith & Nephew, Inc. · 61 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 245
- Deaths reported
- 0
- Injuries reported
- 108
- Recalls
- 0
We found 61 models of POLARCUP by Smith & Nephew, Inc. in the FDA's device registry (GUDID). Together they are named in 245 adverse event reports in the FDA's MAUDE database, received between Dec 27, 2017 and Jun 12, 2026 — classified as 108 injuries, 137 malfunctions.
The most frequently reported specific device problem is “Fracture” (84 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
Reports received per month, all models
Most reported POLARCUP problems
Device problems
- Fracture84
- Break55
- Adverse Event Without Identified Device or Use Problem45
- Insufficient Device Problem Information16
- Device Dislodged or Dislocated12
- Crack11
- Mechanical Jam9
- Deformation Due to Compressive Stress5
Patient problems
- No Clinical Signs, Symptoms or Conditions144
- Unspecified Infection28
- Injury17
- Joint Dislocation15
- No Known Impact Or Consequence To Patient12
- Failure of Implant10
- Pain5
- Inadequate Osseointegration4
POLARCUP models
61 models, most reported first. Each model has its own page with its reports, recalls and device details.
- POLARCUP 75017089ORTHOPEDIC MANUAL SURGICAL INSTRUMENT17 reports
- POLARCUP 75018956PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED16 reports
- POLARCUP 75023346Prosthesis, hip, hemi-, femoral, metal/polymer, cemented or uncemented14 reports
- POLARCUP 75023714PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED13 reports
- POLARCUP 75018942Prosthesis, hip, semi-constrained, metal/polymer, cemented11 reports
- POLARCUP 75023364ORTHOPEDIC MANUAL SURGICAL INSTRUMENT11 reports
- POLARCUP 75023362ORTHOPEDIC MANUAL SURGICAL INSTRUMENT9 reports
- POLARCUP 75018955PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED8 reports
- POLARCUP 75018957PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED8 reports
- POLARCUP 75000665ORTHOPEDIC MANUAL SURGICAL INSTRUMENT8 reports
- POLARCUP 75023360ORTHOPEDIC MANUAL SURGICAL INSTRUMENT7 reports
- POLARCUP 75023363ORTHOPEDIC MANUAL SURGICAL INSTRUMENT7 reports
- POLARCUP 75023365ORTHOPEDIC MANUAL SURGICAL INSTRUMENT7 reports
- POLARCUP 75000666ORTHOPEDIC MANUAL SURGICAL INSTRUMENT7 reports
- POLARCUP 75100442Prosthesis, hip, semi-constrained, metal/polymer, uncemented7 reports
- POLARCUP 75023344IMPACTOR6 reports
- POLARCUP 75000649ORTHOPEDIC MANUAL SURGICAL INSTRUMENT5 reports
- POLARCUP 75100453PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED5 reports
- POLARCUP 75018958PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED4 reports
- POLARCUP 75023366PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED4 reports
- POLARCUP 75023819Prosthesis, hip, semi-constrained, metal/polymer, cemented4 reports
- POLARCUP 75018959PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED3 reports
- POLARCUP 75023358ORTHOPEDIC MANUAL SURGICAL INSTRUMENT3 reports
- POLARCUP 75023359ORTHOPEDIC MANUAL SURGICAL INSTRUMENT3 reports
- POLARCUP 75023361ORTHOPEDIC MANUAL SURGICAL INSTRUMENT3 reports
- POLARCUP 75100410PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED3 reports
- POLARCUP 75100440Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented3 reports
- POLARCUP 75100441Prosthesis, hip, hemi-, femoral, metal/polymer, cemented or uncemented3 reports
- POLARCUP 75100455PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED3 reports
- POLARCUP 75017221Prosthesis, hip, hemi-, femoral, metal/polymer, cemented or uncemented2 reports
- POLARCUP 75017222Prosthesis, hip, hemi-, femoral, metal/polymer, cemented or uncemented2 reports
- POLARCUP 75018943Prosthesis, hip, hemi-, femoral, metal/polymer, cemented or uncemented2 reports
- POLARCUP 75018962PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED2 reports
- POLARCUP 75023357ORTHOPEDIC MANUAL SURGICAL INSTRUMENT2 reports
- POLARCUP 75000664ORTHOPEDIC MANUAL SURGICAL INSTRUMENT2 reports
- POLARCUP 75100439PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED2 reports
- POLARCUP 75100454PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED2 reports
- POLARCUP 75100460PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED2 reports
- POLARCUP 75100514TRAY, SURGICAL, INSTRUMENT2 reports
- POLARCUP 75017231Prosthesis, hip, hemi-, femoral, metal/polymer, cemented or uncemented2 reports
- POLARCUP 75017223Prosthesis, hip, hemi-, femoral, metal/polymer, cemented or uncemented1 report
- POLARCUP 75017226Prosthesis, hip, hemi-, femoral, metal/polymer, cemented or uncemented1 report
- POLARCUP 75017083EXTRACTOR1 report
- POLARCUP 75017087ORTHOPEDIC MANUAL SURGICAL INSTRUMENT1 report
- POLARCUP 75017138PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED1 report
- POLARCUP 75018960PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED1 report
- POLARCUP 75018961Prosthesis, hip, hemi-, femoral, metal/polymer, cemented or uncemented1 report
- POLARCUP 75023343Prosthesis, hip, hemi-, femoral, metal/polymer, cemented or uncemented1 report
- POLARCUP 75023345ORTHOPEDIC MANUAL SURGICAL INSTRUMENT1 report
- POLARCUP 75023347Prosthesis, hip, semi-constrained, metal/polymer, uncemented1 report
- POLARCUP 75023367PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED1 report
- POLARCUP 75000650ORTHOPEDIC MANUAL SURGICAL INSTRUMENT1 report
- POLARCUP 75000651ORTHOPEDIC MANUAL SURGICAL INSTRUMENT1 report
- POLARCUP 75000652ORTHOPEDIC MANUAL SURGICAL INSTRUMENT1 report
- POLARCUP 75000669ORTHOPEDIC MANUAL SURGICAL INSTRUMENT1 report
- POLARCUP 75000670ORTHOPEDIC MANUAL SURGICAL INSTRUMENT1 report
- POLARCUP 75100409PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED1 report
- POLARCUP 75100437Prosthesis, hip, semi-constrained, metal/polymer, cemented1 report
- POLARCUP 75100443Prosthesis, hip, semi-constrained, metal/polymer, uncemented1 report
- POLARCUP 75100444Prosthesis, hip, semi-constrained, metal/polymer, uncemented1 report
- POLARCUP 75100456PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED1 report
Recent POLARCUP adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
InjuryJun 12, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT, AFTER A THR SURGERY WAS PERFORMED IN 2009, THE PATIENT EXPERIENCED AN UNKNOWN ISSUE. THIS ADVERSE EVENT WAS TREATED BY A REVISION SURGERY IN 2021, IN WHICH A POLARCUP ACETABULAR CUP WAS EXCHANGED. THERE WERE NO ISSUES WITH THE STEM, NOR WERE THERE ANY TECHNICAL DIFFICULTIES. PATIENT'S CURRENT HEALTH STATUS IS UNKNOWN.
Patient problems: Insufficient Information
MAUDE report 25485044 ↗MalfunctionMay 7, 2026Mechanical Jam
IT WAS REPORTED THAT, DURING AN ACETABULAR REVISION SURGERY (UNKNOWN IF FROM S+N IMPLANTS), ON ATTEMPTING TO UNSCREW ONE (1) POLARCUP ANCHORING PEG 2 EACH OF THE PEG HOLE COVERS FROM ONE (1) POLARCUP SHELL TI-PLASMA/HA 51 NON-CEM, THE THREADS CROSS THREADED AND COULD NOT BE REMOVED. THE SURGEON ATTEMPTED TO SEAT A PEG IN THE SECOND, AVAILABLE PEG HOLE AFTER DRILLING THE HOLE AS PER THE TECHNIQUE, BUT THE PEG FAILED TO SEAT FLUSH WITH THE CUP AND HAD TO BE REMOVED. THE PEG HOLE WAS LEFT OPEN. THE PROCEDURE WAS RESUMED, AFTER A NON-SIGNIFICANT DELAY. NO FURTHER COMPLICATIONS WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25112276 ↗MalfunctionMay 7, 2026Positioning Failure; Difficult to Remove
IT WAS REPORTED THAT, DURING AN ACETABULAR REVISION SURGERY (UNKNOWN IF FROM S+N IMPLANTS), ON ATTEMPTING TO UNSCREW ONE (1) POLARCUP ANCHORING PEG 2 EACH OF THE PEG HOLE COVERS FROM ONE (1) POLARCUP SHELL TI-PLASMA/HA 51 NON-CEM, THE THREADS CROSS THREADED AND COULD NOT BE REMOVED. THE SURGEON ATTEMPTED TO SEAT A PEG IN THE SECOND, AVAILABLE PEG HOLE AFTER DRILLING THE HOLE AS PER THE TECHNIQUE, BUT THE PEG FAILED TO SEAT FLUSH WITH THE CUP AND HAD TO BE REMOVED. THE PEG HOLE WAS LEFT OPEN. THE PROCEDURE WAS RESUMED, AFTER A NON-SIGNIFICANT DELAY. NO FURTHER COMPLICATIONS WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25112264 ↗MalfunctionApr 16, 2026Fracture
IT WAS REPORTED THAT, DURING A THR, A POLARCUP TRIAL INSERT SLOTTED 28/47 SNAPPED INTO TWO BITS WHILE REDUCING THE HIP JOINT. ALL PARTS WERE REMOVED FROM THE PATIENT. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING A SIMILAR S+N BACK UP PRODUCT. NO FURTHER COMPLICATIONS WERE REPORTED. PATIENT'S STATUS IS WELL.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24901671 ↗MalfunctionJan 9, 2026Fracture
IT WAS REPORTED THAT, DURING A THR SURGERY, TWO TABS OF ONE (1) POLARCUP TRIAL INSERT NAV 22/59 BROKE OFF DURING IMPACTION OF THE POLAR CUP. THE TWO PIECES FELL INSIDE PATIENT'S WOUND AND WERE RECOVERED. THE PROCEDURE WAS RESUMED, AFTER A NON-SIGNIFICANT DELAY, WITHOUT THE USAGE OF THE REPORTED DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24030466 ↗MalfunctionDec 2, 2025Fracture; Fracture
IT WAS REPORTED THAT, DURING A THA SURGERY, ONE (1) POLARCUP TRIAL INSERT SLOTTED 22/63 BROKE UPON IMPLANTING THE HIP POLARCUP. THE BROKEN PIECE WAS RECOVERED FROM THE WOUND. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING THE SAME DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23700220 ↗MalfunctionOct 23, 2025Detachment of Device or Device Component; Misassembly During Maintenance/Repair; Detachment of Device or Device Component; Misassembly During Maintenance/Repair
IT WAS REPORTED THAT, DURING A THR SURGERY ONE OF THE TABS ON THE DISTAL PART OF ONE (1) POLARCUP TRIAL SHELL HANDLE NAV LOOSENED AND DETACHED. IT IS UNKNOWN HOW THE PROCEDURE WAS COMPLETED; HOWEVER, NO DELAY OR FURTHER COMPLICATIONS WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23366968 ↗MalfunctionAug 21, 2025Fracture; Fracture
IT WAS REPORTED THAT, DURING A THR SURGERY, ONE (1) POLARCUP TRIAL INSERT SLOTTED 28/49 BROKE IN HALF WHILE TRIAL REDUCING. IT IS UNKNOWN IF THERE WAS ANY SURGICAL DELAY. ALSO, IT IS UNKNOWN HOW THE PROCEDURE WAS FINISHED. NO INJURY WAS REPORTED AS A CONSEQUENCE OF THIS ISSUE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22861601 ↗MalfunctionJun 25, 2025Break; Break
IT WAS REPORTED THAT, DURING A THR SURGERY, ONE (1) POLARCUP TRIAL INSERT SLOTTED 28/57 BROKE DURING IMPACTION. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING A S+N BACK-UP DEVICE. NO INJURY WAS REPORTED AS A CONSEQUENCE OF THIS ISSUE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22328744 ↗MalfunctionApr 1, 2025Degraded; Fracture; Degraded; Fracture
IT WAS REPORTED THAT, DURING A THR SURGERY, ONE (1) POLARCUP TRIAL INSERT SLOTTED 28/49 BROKE IN HALF DURING TRIALING; ALSO, THE LOT NUMBER IS WORN AND CANNOT BE READ. ALL PIECES WERE ACCOUNTED FOR. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING A S+N BACK-UP DEVICE. NO INJURY WAS REPORTED AS A CONSEQUENCE OF THIS ISSUE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21749280 ↗MalfunctionMar 21, 2025Fracture; Fracture
IT WAS REPORTED THAT, DURING THR SURGERY, ONE (1) POLARCUP TRIAL INSERT NAV 22/61 BROKE WHEN THE IMPLANT WAS BEING INSERTED. IT IS UNKNOWN IF ANY PIECE FELL INSIDE THE INCISION. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING THE SAME DEVICE. NO INJURY WAS REPORTED AS A CONSEQUENCE OF THIS ISSUE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21662040 ↗MalfunctionMar 14, 2025Fracture; Fracture
IT WAS REPORTED THAT DURING A THR SURGERY, THE POLARCUP TRIAL INSERT NAV 22/61 BROKE UPON WHEN IMPLANTING THE POLAR CUP. ALL OF THE PLASTIC BROKEN PIECES WERE REMOVED FROM THE PATIENT. IT IS UNKNOWN HOW WAS COMPLETED THE SURGERY. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY. PATIENT WAS NOT INJURED AS CONSEQUENCE OF THIS PROBLEM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21608428 ↗MalfunctionMar 5, 2025Break; Break
IT WAS REPORTED THAT, DURING A THR SURGERY, ONE (1) POLARCUP TRIAL INSERT NAV 22/45 BROKE WHILE REDUCING HIP. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, WITH A CHANGE IN SURGICAL TECHNIQUE. NO INJURY WAS REPORTED AS A CONSEQUENCE OF THIS ISSUE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21532498 ↗MalfunctionJan 24, 2025Fracture; Fracture
IT WAS REPORTED THAT DURING A THR, THE POLARCUP TRIAL INSERT NAV 22/51 BROKE AFTER IT WAS DONE BEING USED IN THE OPERATIVE SITE. ALL PIECES WERE ACCOUNTED FOR. THERE WAS NO DELAY AND THE PROCEDURE WAS FINISHED USING THE SAME DEVICE. PATIENT WAS NOT HARMED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21231533 ↗MalfunctionDec 19, 2024Fracture; Fracture
IT WAS REPORTED THAT DURING A THR, THE POLARCUP TRIAL INSERT NAV 22/55 BROKE DURING IMPACTION. THERE WAS NO DELAY AND THE PROCEDURE WAS FINISHED USING THE SAME DEVICE. PATIENT WAS NOT HARMED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20977490 ↗
Other Smith & Nephew, Inc. products
- FAST-FIX18 models · 9,554 reports
- JOURNEY566 models · 6,250 reports · 4 recalls
- GENESIS II462 models · 4,599 reports · 2 recalls
- DYONICS, POWERMAX, ELITE2 models · 4,308 reports
- TRIGEN381 models · 3,599 reports · 5 recalls
- LEGION446 models · 2,039 reports · 4 recalls
- REAL INTELLIGENCE32 models · 2,017 reports · 3 recalls
- Coblation62 models · 2,126 reports
Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- 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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