NA 71364008Recalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 03596010199249), received between Aug 12, 2019 and Jul 15, 2026 — classified as 2 injuries, 10 malfunctions.

The most frequently reported specific device problem is “Break” (7 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 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 15, 2026Fracture

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25821937 ↗
• InjuryFeb 28, 2022Break; Break

  IT WAS REPORTED THAT, AFTER THR SURGERY, POST-OPERATIVE X RAY REVEALED A FOREIGN 7MM METAL OBJECT AROUND THE LESSER TROCHANTER OF THE PATIENT. AFTER REVIEWING THE SALES REP INSPECTED THE INSTRUMENT AND FOUND THAT THE TOOTH WAS MISSING FROM THE STEM INSERTER FRAME THAT IS PRESUMED THE FOREIGN OBJECT. A REVISION IS NOT SCHEDULED AT THIS TIME.

  Patient problems: Foreign Body In Patient

  MAUDE report 13620438 ↗
• InjuryJan 25, 2022Break; Break

  IT WAS REPORTED THAT, DURING TOTAL HIP REPLACEMENT, A STEM INSERTER FRAME BROKE WHILE SEATING THE FINAL IMPLANT. THE BROKEN PIECE WAS RETRIEVED BY HAND FROM THE PATIENT. SURGERY WAS COMPLETED, WITHOUT ANY DELAY, WITH A SMITH & NEPHEW BACK-UP DEVICE. PATIENT WAS NOT INJURED AS CONSEQUENCE OF THIS PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13353197 ↗
• MalfunctionSep 9, 2021Break; Break

  IT WAS REPORTED THAT, DURING SET UP, BEFORE A THR SURGERY, ONE STEM INSERTER FRAME BROKE OFF. THIS HAPPENED BEFORE USE IN PATIENT. SURGERY WAS PERFORMED, WITHOUT ANY DELAY, WITH A SMITH AND NEPHEW BACK-UP DEVICE INSTEAD. NO HEALTH CONSEQUENCES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12450547 ↗
• MalfunctionJun 1, 2021Unstable; Unstable

  IT WAS REPORTED THAT, DURING THR SURGERY, A STEM IMPACTOR ROD (CASE-(B)(4)) AND A STEM INSERTER FRAME (CASE-(B)(4) WERE NOTICED TO BE LOOSE UPON IMPACTION, AND COULD NOT BE TIGHTENED ENOUGH TO GET FIRM FIXATION BETWEEN THEM. THERE WAS A SURGICAL DELAY LESS THAN 30 MINUTES REPORTED DUE TO THIS EVENT, AND THE PROCEDURE WAS CONCLUDED USING SMITH AND NEPHEW BACKUP DEVICES. NEITHER PATIENT INJURY NOR OTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11914395 ↗
• MalfunctionApr 21, 2021Material Deformation; Material Deformation

  IT WAS REPORTED THAT THE THREADS OF ONE STEM INSERTER FRAME AND ONE STEM IMPACTOR ROD ARE STRIPPED. IT IS UNKNOWN IF THIS WAS NOTICED DURING SURGERY OR NOT; THEREFORE, PATIENT INVOLVEMENT IS NOT CONFIRMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11704317 ↗
• MalfunctionApr 21, 2021Break; Break

  IT WAS REPORTED THAT THE STEM INSERTER FRAME IS BROKEN. NO CASE INVOLVED THEREFORE NO OTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11704298 ↗
• MalfunctionJul 15, 2020Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT DURING A ROUTINE EFIP INSPECTION, THE STEM INSERTER FRAME WAS FOUND TO HAVE ONE OF THE TIPS BROKEN OFF. THERE WAS NO CASE INVOLVED.

  Patient problems: No Patient Involvement

  MAUDE report 10280219 ↗
• MalfunctionMay 15, 2020Fracture; Fracture

  IT WAS REPORTED THAT, DURING AN INSTRUMENT INSPECTION, IT WAS NOTICED THAT THE END OF THE STEM INSERTER FRAME WAS BROKEN. NO CASE INVOLVED.

  Patient problems: No Patient Involvement

  MAUDE report 10063420 ↗
• MalfunctionOct 14, 2019Break; Break

  IT WAS REPORTED THAT ONE OF THE 2 PIECES THAT ALLOWS THE SYNERGY FEMORAL STEM IMPLANT TO SEAT ON THE INSERTER FRAME HAS BROKEN OFF. NO DELAY REPORTED. NO PATIENT INJURIES REPORTED. AN S&N BACKUP WAS AVAILABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9187051 ↗
• MalfunctionSep 19, 2019Break; Break

  IT WAS REPORTED THAT DURING SURGERY, WHILE IMPACTING, THE TIP OF THE DEVICE BROKE. PIECES REMAIN ON THE PATIENT. DELAY FROM FIFTEEN MINUTES REPORTED. NO BACKUP DEVICE WAS REQUIRED. NO IMPACT OR INJURY TO PATIENT REPORTED.

  Patient problems: Foreign Body In Patient

  MAUDE report 9088147 ↗
• MalfunctionAug 12, 2019Break; Break

  IT WAS REPORTED THAT DURING SURGERY, INSTRUMENT BROKE WHILE BEING USED. NO INJURY REPORTED. NO DELAY AND PROCEDURE WAS CONCLUDED WITH A BACKUP FROM SMITH AND NEPHEW.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8884022 ↗

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