NA 75100856Recalls & reported problems

Summary

The FDA's MAUDE database contains 44 adverse event reports that list this exact device (DI 07611996121896), received between May 4, 2020 and Apr 16, 2026 — classified as 4 injuries, 40 malfunctions.

The most frequently reported specific device problem is “Fracture” (22 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.

Most reported problems

Recent adverse event reports

The 25 most recent of 44 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 16, 2026Break

  IT WAS REPORTED THAT, DURING A THA, A TRIAL FEMORAL HEAD 36 S/+0 BROKE. 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 24896108 ↗
• MalfunctionDec 29, 2025Fracture; Fracture

  IT WAS REPORTED THAT, DURING A THA, AFTER TRIALING CUP AND HEAD, THE FLANGE INSIDE ONE (1) TRIAL FEMORAL HEAD 36 S/+0 BROKE OFF. ALL PIECES WERE RETRIEVED FROM THE PATIENT BY HAND. 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 23906192 ↗
• MalfunctionDec 8, 2025Break; Break

  IT WAS REPORTED THAT, DURING A THA SURGERY, THE TRIAL FEMORAL HEAD 36 S/+0 BROKE. THE PROCEDURE WAS RESUMED, AFTER A NON-SIGNIFICANT DELAY, USING AN EQUIVALENT S+N BACK-UP. NO ADDITIONAL ANESTHESIA WAS REQUIRED. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23741862 ↗
• MalfunctionJul 3, 2025Fracture; Fracture

  IT WAS REPORTED THAT, DURING A THR SURGERY, ONE OF THE TABS INSIDE ONE (1) TRIAL FEMORAL HEAD 36 S/+0 BROKE OFF. ALL PIECES WERE ACCOUNTED FOR. IT IS UNKNOWN HOW THE PROCEDURE WAS COMPLETED, HOWEVER, NO INJURY OR ANY DELAY WERE REPORTED AS A CONSEQUENCE OF THIS ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22392126 ↗
• MalfunctionApr 8, 2025Fracture; Separation Failure; Fracture; Separation Failure

  IT WAS REPORTED THAT DURING A THR SURGERY, THE TRIAL FEMORAL HEAD 36 S/+0 STUCK IN THE ACETABULAR PORTION. IT WAS USE A HOOK TO DISLOCATE WITHOUT SUCCESS. IT WAS USED OSTEOTOME THAT SLIDE AND BROKE THE TRIAL HEAD INSIDE OF THE WOUND. PIECES FELL INSIDE THE WOUND BUT ALL PARTS WERE REMOVED BY HAND WITH CLAMP. IN ADDITION, THE SURGEON WASHED THE WOUND CAREFULLY WITH BACTISURE WOUND LAVAGE. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING A S+N BACK-UP DEVICE. PATIENT WAS NOT INJURED AS CONSEQUENCE OF THIS PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21802759 ↗
• MalfunctionMar 31, 2025Break; Break

  IT WAS REPORTED THAT, DURING A THR SURGERY, ONE (1) TRIAL FEMORAL HEAD 36 S/+0 BROKE WHILE TRIALING. THERE WAS NO SURGICAL DELAY; HOWEVER, 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 21731374 ↗
• MalfunctionAug 22, 2024Fracture; Fracture

  IT WAS REPORTED THAT DURING A THR SURGERY, ONE (1) POLARSTEM STEM LAT.TI/HA 7 NON-CEM AND ONE (1) POLARSTEM DETACHABLE RASP 7 DID NOT ADEQUATELY MATCH THE UNCEMENTED IMPLANT, CAUSING THE STEM TO HANG UP DURING INSERTION. THERE SEEMS TO BE A DISTINCT DISCREPANCY BETWEEN THE BROACH AND THE ACTUAL STEM. ADDITIONALLY, ONE (1) TRIAL FEMORAL HEAD 36 S/+0 WAS NOTICED TO BE BROKEN DURING THE CASE, WITH SOME OF THE PLASTIC CLEARLY SNAPPED OFF. FURTHERMORE, ONE (1) POLARSTEM MODULAR HEAD FOR 21000662 WAS DAMAGED DURING USE, AS THE PLASTIC HAD BEGUN CRACKING AND REQUIRED REPLACEMENT. SURGERY WAS DELAYED WHILE THE SURGEON RE-BROACHED WITH THE SIZE 7 RASP AND INSERTED A CEMENTED STEM INSTEAD.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20030257 ↗
• MalfunctionJul 19, 2024Fracture; Fracture

  IT WAS REPORTED THAT, DURING A THR, AFTER TRAILING THE HEAD, THE INSIDE PIECES FROM THE TRIAL FEMORAL HEAD 36 S/+0 BROKE OFF. ALL PIECES WERE RETRIEVED BY HAND, NOTHING WAS LEFT IN THE PATIENT. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING A S+N BACK-UP DEVICE. PATIENT WAS NOT HARMED AS A CONSEQUENCE OF THIS PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19780230 ↗
• MalfunctionJul 18, 2024Fracture; Fracture

  IT WAS REPORTED THAT, DURING THR SURGERY, A TAB FROM ONE (1) TRIAL FEMORAL HEAD 36 S/+0 SNAPPED WHEN BEING REMOVED FROM THE PATIENT. THE BROKEN PIECE WAS FOUND ON THE FLOOR. ALL THE BITS WERE ACCOUNTED FOR AND NONE FELL NEAR THE PATIENT. NO X-RAYS WERE NEEDED AS ALL BROKEN PARTS WERE FOUND. THE PROCEDURE WAS RESUMED, AFTER A NON-SIGNIFICANT DELAY, USING A S+N BACKUP DEVICE. NO INJURY WAS REPORTED AS A CONSEQUENCE OF THIS ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19772266 ↗
• MalfunctionMay 22, 2024Fracture; Fracture

  IT WAS REPORTED THAT, DURING A THR, ONE (1) TRIAL FEMORAL HEAD 36 S/+0 WAS FRACTURED ON THE HEAD. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING A S+N BACK-UP DEVICE. NO PIECES OF THE DEVICE FELL INTO THE PATIENT. NO INJURY WAS REPORTED AS A CONSEQUENCE OF THIS ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19377119 ↗
• MalfunctionApr 11, 2024Fracture; Fracture

  IT WAS REPORTED THAT, DURING A THR PROCEDURE, THE INNER TABS OF A TRIAL FEMORAL HEAD 36 S/+0 WERE BROKEN AND DID NOT HOLD ONTO STEM AS DESIGNED. NO PIECES FELL INTO PATIENT. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING A S+N BACK-UP DEVICE. PATIENT WAS NOT INJURED AS CONSEQUENCE OF THIS PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19093001 ↗
• MalfunctionApr 8, 2024Fracture; Fracture

  IT WAS REPORTED THAT DURING A THR SURGERY, THE INNER TAB OF THE TRIAL FEMORAL HEAD 36 S/+0 GOT FRACTURED. NO PIECES FELL INTO PATIENT. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING A S+N BACK-UP DEVICE. PATIENT WAS NOT INJURED AS CONSEQUENCE OF THIS PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19061108 ↗
• MalfunctionOct 16, 2023Fracture; Fracture

  IT WAS REPORTED THAT, DURING THE TRIALING STAGE OF A TKA SURGERY, WHEN AN TRIAL FEMORAL HEAD 36 S/+0 WAS REMOVED, TWO OF THE LOCKING TABS WERE FOUND TO BE MISSING. ONE OF THE PIECES WAS STILL IN THE HEAD BUT NOT CONNECTED. THE SURGEON USED X-RAY TO TRY TO LOCATE THE SECOND PIECE BUT COULD NOT. AFTER MUCH DISCUSSION THE SCRUB NURSE ADMITTED SHE COULD NOT SAY IF THE MISSING PIECE WAS EVER ACTUALLY THERE. THE PROCEDURE WAS RESUMED, AFTER A SIGNIFICANT DELAY, WITH 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 17940731 ↗
• MalfunctionApr 10, 2023Fracture; Fracture

  IT WAS REPORTED THAT, DURING A THR, THE INNER LOCKING MECHANISM THAT ATTACHES TO A TRIAL FEMORAL HEAD 36 S/+0 HAD FRACTURED. FURTHERMORE, NO PIECES FELL INTO THE PATIENT. SURGERY WAS RESUMED, WITHOUT ANY DELAY, WITH A SMITH AND NEPHEW BACK-UP DEVICE. PATIENT WAS NOT HARMED AS CONSEQUENCE OF THIS PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16709671 ↗
• MalfunctionJan 18, 2023Break; Break

  IT WAS REPORTED THAT DURING A THR SURGERY, A TRIAL FEMORAL HEAD 36 S/+0 BROKE IN A CASE AND PIECE WAS REMOVED. SURGERY WAS RESUMED, WITHOUT ANY DELAY BUT IS UNKNOWN HOW THE PROCEDURE WAS FINISHED. PATIENT WAS NOT HARMED AS CONSEQUENCE OF THIS PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16195923 ↗
• MalfunctionNov 12, 2022Fracture; Fracture

  IT WAS REPORTED THAT DURING A THR, THE INTERNAL PLASTIC LOCKING MECHANISM OF ONE TRIAL FEMORAL HEAD 36 S/+0 BROKE. NO PIECES FELL INTO PATIENT. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING A S+N BACK-UP DEVICE. PATIENT WAS NOT INJURED AS CONSEQUENCE OF THIS PROBLEM. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15785881 ↗
• MalfunctionOct 13, 2022Fracture; Fracture

  IT WAS REPORTED THAT THE PLASTIC SNAP IN THE CENTER OF THE TRIAL FEMORAL HEAD 36 S/+0 IS BROKE OFF. NO CASE INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15601781 ↗
• MalfunctionOct 13, 2022Fracture; Fracture

  IT WAS REPORTED THAT THE PLASTIC SNAP IN THE CENTER OF THE TRIAL FEMORAL HEAD 36 S/+0 IS BROKE OFF. NO CASE INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15601605 ↗
• MalfunctionOct 6, 2022Fracture; Fracture

  IT WAS REPORTED THAT, A TRIAL FEMORAL HEAD 36 S/+0 WAS NOTICED TO BE FRACTURED. AS THIS WAS NOTICED UPON CLEANING AND STERILIZATION ACTIVITIES, THERE WAS NOT PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15553650 ↗
• MalfunctionApr 22, 2022Break; Fracture; Break; Fracture

  IT WAS REPORTED THAT, DURING THR, THE TRIAL FEMORAL HEAD BROKE, OUTSIDE OF THE PATIENT. PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, WITH A BACK-UP DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14182336 ↗
• InjuryApr 4, 2022Component Missing; Adverse Event Without Identified Device or Use Problem; Component Missing; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, DURING THR SURGERY, A TRIAL HEAD LAT. 32 M /+4 WAS MISSING FROM A S&N LOAN INSTRUMENT SET, IT WAS TOLD THAT THE CURRENT SMITH AND NEPHEW TRIAL HEADS COULD BE USED AS A REPLACEMENT HOWEVER THEY GAVE A FALSE LEG LENGTH WHILST TRIALING THIS MEANT IT WAS IMPLANTED THE 36 +0 DEFINITIVE CERAMIC HEAD THAT THE PHYSICIAN WAS HAPPY WITH AFTER THE TRIAL. THE DEFINITIVE FEMORAL HEAD HOWEVER WASN'T THE SAME IN OFFSET AND LEG LENGTH AS WAS TRIALED, THIS MEANT THEN HAD TO REMOVE THE HEAD (POSSIBLY LOOSENING THE STEM IN THE PROCESS + POTENTIALLY FRACTURING THE CERAMIC HEAD CAUSING MORE DAMAGE) AND RE TRIAL WITH THE AVAILABLE NANOS TRIAL HEADS. THIS ENDED UP BEING A 36 L (+8) FEMORAL HEAD WHICH WAS IMPLANTED. THE PHYSICIAN WASN¿T HAPPY WITH THIS AS IT MAY HAVE IMPLICATIONS FOR THE YOUNG PATIENT. THIS ONCE AGAIN HIGHLIGHTS THE ISSUES IS FACE WORKING WITH LOAN KITS THAT SHIP SHORT OF REQUIRED INSTRUMENTS. THE PROCEDURE WAS COMPLETED USING A S+N BACK-UP DEVICE. SURGERY WAS GREATER THAN 30MINS DELAYED. PATIENT WAS NOT HARMED. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions; Unequal Limb Length

  MAUDE report 13996277 ↗
• MalfunctionMar 10, 2022Break; Break

  IT WAS REPORTED THAT, DURING THR, THE TRIAL FEMORAL HEAD BROKE, OUTSIDE OF THE PATIENT. PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, WITH A BACK-UP DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13722524 ↗
• InjuryFeb 11, 2022Fracture; Fracture

  IT WAS REPORTED THAT, DURING A THR SURGERY, A PIECE OF A TRIAL FEMORAL HEAD 36 S/+0 BROKE OFF, IT WAS RETRIEVED FROM THE PATIENT'S WOUND BY THE OPERATING SURGEON. SURGERY WAS PERFORMED, WITHOUT ANY DELAY, WITH THE SAME DEVICE. PATIENT WAS NOT HARMED AS CONSEQUENCE OF THIS PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13515313 ↗
• MalfunctionDec 23, 2021Break; Break

  IT WAS REPORTED THAT, DURING A THR SURGERY, A TRIAL FEMORAL HEAD 36 S/+0 BROKE OUTSIDE THE PATIENT. SURGERY WAS RESUMED, WITHOUT ANY DELAY, WITH A BACK-UP DEVICE. PATIENT WAS NOT INJURED AS CONSEQUENCE OF THIS PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13078552 ↗
• MalfunctionNov 11, 2021Break; Break

  IT WAS REPORTED THAT, A TRIAL FEMORAL HEAD 36 S/+0 WAS BROKEN. SURGERY WAS FINISHED WITH THE SAME DEVICE, WITHOUT ANY SURGICAL DELAY. PATIENT WAS NOT INJURED AS CONSEQUENCE OF THIS PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12795599 ↗