NA 71364011Recalls & reported problems

Summary

The FDA's MAUDE database contains 176 adverse event reports that list this exact device (DI 03596010199270), received between May 9, 2017 and May 31, 2026 — classified as 27 injuries, 149 malfunctions.

The most frequently reported specific device problem is “Break” (97 reports).

2 other recalls cover devices cleared under the same FDA submission (K123598); 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 176 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 31, 2026Fracture

  IT WAS REPORTED THAT, DURING A THA SURGERY, THE THREADED TIP AT THE END OF ONE (1) STEM IMPACTOR ROD BROKE. THE PROCEDURE WAS RESUMED, AFTER A NON-SIGNIFICANT DELAY, USING A SIMILAR S+N BACK-UP PRODUCT NO FURTHER COMPLICATIONS WERE REPORTED. ADDITIONAL ANESTHESIA WAS REQUIRED AS CONSEQUENCE OF THE SURGICAL PROLONGATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25342927 ↗
• MalfunctionMay 28, 2026Break

  IT WAS REPORTED THAT, DURING A THA SURGERY, THE THREADED TIP OF ONE (1) STEM IMPACTOR ROD BROKE. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, WITH A CHANGE IN SURGICAL TECHNIQUE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25325281 ↗
• MalfunctionMay 5, 2026Fracture

  IT WAS REPORTED THAT, DURING A HIP REVISION SURGERY, ONE (1) CS/CSL/GERADSCHAFT-PLUS EXTRACT.SCREW M6 AND ONE (1) STEM IMPACTOR ROD FRACTURED DURING REMOVAL OF A PRIMARY STEM. THE FRACTURED COMPONENT DID NOT FALL INSIDE THE PATIENT. THE PROCEDURE WAS PERFORMED, 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 25078696 ↗
• MalfunctionMar 25, 2026Fracture

  IT WAS REPORTED THAT, DURING A THR, THE THREADS OF ONE (1) STEM IMPACTOR ROD BROKE OFF IN THE STEM. ALL PIECES WERE RETRIEVED FROM THE PATIENT WITH A REMOVAL TOOL. 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 24687134 ↗
• MalfunctionDec 18, 2025Fracture; Fracture

  IT WAS REPORTED THAT DURING A THR REVISION SURGERY, ONE (1) STEM IMPACTOR ROD WAS THREADED INTO THE REDAPT STEM BEING REVISED AND USED AS AN EXTRACTION TOOL. DURING THE EXTRACTION ATTEMPT, THE STEM IMPACTOR ROD BROKE. THE BROKEN TIP OF THE STEM IMPACTOR ROD REMAINED THREADED INTO THE STEM. THE PROCEDURE WAS COMPLETED, AFTER NO DELAY, USING AN SHUKLA DEVICE TO REMOVE THE STEM. NO INJURY WAS REPORTED AS A CONSEQUENCE OF THIS ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23839825 ↗
• MalfunctionDec 11, 2025Fracture; Fracture

  IT WAS REPORTED THAT, DURING A THR SURGERY, THE TIP OF ONE (1) STEM IMPACTOR ROD WAS THREADED INTO A STEM AND IT BROKE OFF. 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 23784402 ↗
• MalfunctionAug 4, 2025Break; Break

  IT WAS REPORTED THAT, DURING A THR SURGERY, WHEN TIGHTENING FINAL IMPLANT ONTO THE IMPACTOR, THE THREADED PIECE OF A STEM IMPACTOR ROD BROKE. 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 22710792 ↗
• MalfunctionMay 9, 2025Fracture; Fracture

  IT WAS REPORTED THAT THE THREADED SCREW OF ONE (1) STEM IMPACTOR ROD BROKE OFF DURING EXTRACTION. 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 21992226 ↗
• InjuryApr 29, 2025Fracture; Material Fragmentation; Fracture; Material Fragmentation

  IT WAS REPORTED THAT AFTER A TOTAL RIGHT HIP REPLACEMENT (THR) SURGERY PERFORMED ON (B)(6) 2025; A BROKEN PIECE OF FOREIGN METAL WAS DISCOVERED BY THE SURGEONS DURING A ROUTINE POSTOPERATIVE X-RAY ON (B)(6) 2025. THE FRAGMENT, DESCRIBED AS A METALLIC WIRE LOCATED IN THE SOFT TISSUE LATERAL TO THE NECK OF THE PROSTHESIS, WAS SUSPECTED TO BE A LOOSE PART FROM ONE (1) STEM IMPACTOR ROD. THE FINDING WAS CONFIRMED BY A SECOND X-RAY ON (B)(6) 2025. THIS ADVERSE EVENT WAS RESOLVED BY A SUBSEQUENT SURGICAL EXPLORATION PERFORMED LATER THAT SAME DAY, DURING WHICH THE METALLIC FRAGMENT WAS SUCCESSFULLY REMOVED FROM THE PATIENT. THE CURRENT HEALTH STATUS OF THE PATIENT REMAINS UNKNOWN.

  Patient problems: Foreign Body In Patient

  MAUDE report 21931856 ↗
• MalfunctionFeb 5, 2025Fracture; Fracture

  IT WAS REPORTED THAT, DURING THR SURGERY, A STEM IMPACTOR ROD SNAPPED OFF WHILE EXPLANTING STEM. 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 21313572 ↗
• MalfunctionDec 19, 2024Fracture; Fracture

  IT WAS REPORTED THAT DURING A THR, THE STEM WAS INSERTED IN THE HIP AND THE SURGEON WANTED TO USE THE STEM IMPACTOR ROD TO READ THE STEM, AND ACCIDENTALLY SNAPPED THE THREADED PIECE OF THE STEM IMPACTOR ROD INTO THE STEM. THE STEM HAD TO BE REMOVED AND EXCHANGED, BECAUSE THE THREADED PIECE OF THE EXTRACTOR WAS STILL IN THE STEM. THE STEM IMPACTOR ROD BROKE CLEAN INTO 2 PIECE THERE WAS NO DELAY AND THE PROCEDURE WAS FINISHED USING A SMITH & NEPHEW BACK UP. NO INJURY WAS REPORTED AS A CONSEQUENCE OF THIS ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20984822 ↗
• MalfunctionNov 11, 2024Fracture; Fracture

  IT WAS REPORTED THAT, DURING A THA SURGERY UPON INSERTING THE STEM, THE TIP OF A STEM IMPACTOR ROD CAPTURE BROKE OFF. THE BROKEN TIP WAS RECOVERED BY DR. (B)(6) WITH A HEMOSTAT AND DISCARDED WITH THE "SHARPS" BY THE SCRUB NURSE. THE PROCEDURE WAS RESUMED, AFTER NO SUBSTANTIAL 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 20652685 ↗
• MalfunctionOct 24, 2024Fracture; Fracture

  IT WAS REPORTED THAT, DURING THR SURGERY, A BROKEN STEM WAS TRIED TO BE REMOVED, AND WHEN BACK SLAPPING ONE (1) STEM IMPACTOR ROD, THE POMMEL BROKE, AND THE THREADS STAYED IN THE STEM. THE PROCEDURE WAS RESUMED, AFTER A SIGNIFICANT DELAY, WITH A CHANGE IN THE SURGICAL TECHNIQUE. PATIENT'S CURRENT HEALTH STATUS IS UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20529629 ↗
• MalfunctionSep 4, 2024Fracture; Fracture

  IT WAS REPORTED THAT DURING THR SURGERY, A STEM IMPACTOR ROD TIP BROKE OFF WHILE IMPACTING FOR IMPLANT INSERTION. THE BROKEN PIECE WAS EXTRACTED BY HAND AND X-RAY CONFIRMED THAT NO PIECES WERE LEFT INSIDE THE PATIENT. THE PROCEDURE WAS COMPLETED WITHOUT 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 20136045 ↗
• MalfunctionAug 27, 2024Fracture; Fracture

  IT WAS REPORTED THAT, DURING A THR, THREADED PIECE OF ONE (1) STEM IMPACTOR ROD BROKE OFF IN IMPLANT. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING A COMPETITOR DEVICE. PATIENT WAS NOT HARMED AS A CONSEQUENCE OF THIS PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20076230 ↗
• MalfunctionJul 15, 2024Fracture; Fracture

  IT WAS REPORTED THAT, DURING A THR SURGERY, THE TIP OF A STEM IMPACTOR ROD FRACTURED OFF EXTERNAL TO THE PATIENT. NO PIECES FELL INTO THE PATIENT. 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 19741044 ↗
• MalfunctionJun 12, 2024Fracture; Fracture

  IT WAS REPORTED THAT DURING A THR SURGERY, WHEN ATTEMPTING TO EXTRACT A SYNERGY STEM, THE TIP OF ONE (1) STEM IMPACTOR ROD FRACTURED AT THE THREADS. THE PROCEDURE RESUMED, WITHOUT ANY DELAY, USING A S+N BACK-UP DEVICE. NO PIECES FELL INTO THE PATIENT AND NO INJURY WAS REPORTED AS A CONSEQUENCE OF THIS ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19520792 ↗
• MalfunctionMay 28, 2024Fracture; Fracture

  IT WAS REPORTED THAT, DURING THR SURGERY, THE THREADS OF THE STEM IMPACTOR ROD BROKE WHILE IMPACTING. ALL PIECES WERE RECOVERED. 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 19410576 ↗
• MalfunctionApr 5, 2024Fracture; Fracture

  IT WAS REPORTED THAT, DURING THR SURGERY, WHEN DOCTOR WAS IMPACTING REAL DEAL STEM WITH THE STEM IMPACTOR ROD UPON USING THE MALLET TO IMPACT, THE THREAD PART SNAPPED IN HALF AND THE END OF THE THREAD WAS LODGE IN THE STEM. THE PROCEDURE WAS RESUMED, AFTER A NON-SIGNIFICANT DELAY, WITH 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 19053674 ↗
• MalfunctionMar 6, 2024Fracture; Fracture

  IT WAS REPORTED THAT DURING A THR, THE TIP OF STEM IMPACTOR ROD FRACTURED DURING IMPLANTATION OF STEM. 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 18849537 ↗
• MalfunctionMar 5, 2024Fracture; Fracture

  IT WAS REPORTED THAT, DURING THR SURGERY, THE TIP OF A STEM IMPACTOR ROD FRACTURED OFF DURING STEM IMPLANTATION. NO PIECES FELL INTO PATIENT. SURGERY WAS RESUMED, WITHOUT ANY DELAY, WITH A S+N BACK-UP DEVICE. NO INJURIES TO THE PATIENT WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18842010 ↗
• MalfunctionMar 5, 2024Fracture; Fracture

  IT WAS REPORTED THAT, DURING A THR SURGERY, DR WAS TRYING TO REMOVE THE STEM USING A SLAP HAMMER AND A STEM IMPACTOR ROD, THE THREADS OF THE STEM IMPACTOR ROD BROKE OFF. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, BY CHANGING THE SURGICAL TECHNIQUE. PATIENT WAS NOT INJURED AS CONSEQUENCE OF THIS PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18836701 ↗
• MalfunctionFeb 6, 2024Fracture; Fracture

  IT WAS REPORTED THAT DURING A THR SURGERY THE TIP OF THE STEM IMPACTOR ROD FRACTURED. NO PIECES FELL INTO THE PATIENT. 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 18654878 ↗
• MalfunctionJan 30, 2024Fracture; Fracture

  IT WAS REPORTED THAT DURING A THR SURGERY, THE THREADS OF A STEM IMPACTOR ROD BROKE OFF THE END OF THE PUMMEL. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING THE SAME DEVICE. PATIENT WAS NOT HARMED AS CONSEQUENCE OF THIS PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18608976 ↗
• MalfunctionOct 23, 2023Fracture; Fracture

  IT WAS REPORTED THAT, DURING A THR, A STEM IMPACTOR ROD BROKE WHEN BACKSLAPPING OUT THE STEM. SURGERY WAS RESUMED, AFTER A SIGNIFICANT DELAY, WITH A SMITH AND NEPHEW BACK-UP DEVICE. NO PATIENT HARM WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17984472 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K123598. One submission often covers many models, so check the product and lot details in each record.

• Z-0730-2019 · Jan 7, 2019 · Terminated
  SL PLUS MIA DOUBLE OFFSET ADAPTER RIGHT 60/25MM, S&N 75004613
• Z-1008-2017 · Nov 16, 2016 · Terminated
  REFLECTION(R) DEAD BLOW MALLET, REF 71362106, QTY: (1), NON-STERILE, Smith & Nephew, Inc,. Memphis, TN 38116