SL-PLUS 75004612Recalls & reported problems

Summary

The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 07611996085464), received between Sep 7, 2020 and May 22, 2025 — classified as 2 injuries, 12 malfunctions.

The most frequently reported specific device problem is “Fracture” (8 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 14 most recent of 14 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 22, 2025Fracture; Fracture

  IT WAS REPORTED THAT DURING THR SURGERY, A PIECE OF ONE (1) PLUS SL MIA DBL OFFSET ADAPT. LT 60/25MM BROKE WHILE IMPACTING BROACH INTO FEMUR. THE PROCEDURE WAS COMPLETED WITHOUT DELAY USING A S+N BACK-UP DEVICE. NO INJURY WAS REPORTED AS A CONSEQUENCE OF THIS ISSUE. IT WAS REPORTED THAT DURING A THR SURGERY, A PIECE OF ONE (1) PLUS SL MIA DBL OFFSET ADAPT. LT 60/25MM BROKE WHILE IMPACTING THE BROACH INTO THE FEMUR. THE PROCEDURE WAS COMPLETED WITHOUT SURGICAL 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 22067999 ↗
• MalfunctionMar 5, 2025Fracture; Fracture

  IT WAS REPORTED THAT DURING A THR, THE LOCKING MECHANISM SHEARED OFF INSIDE THE PLUS SL MIA DBL OFFSET ADAPT. LT 60/25MM WHILE DOING INSERTION. IT IS UNKNOWN HOW SURGERY WAS PERFORMED AND IF THERE WAS ANY DELAY. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21531814 ↗
• MalfunctionOct 25, 2024Fracture; Fracture

  IT WAS REPORTED THAT, DURING A THR SURGERY, THE BUTTON USED TO ENGAGE THE BROACHES TO ONE (1) PLUS SL MIA DBL OFFSET ADAPT. LT 60/25MM SNAPPED OFF THE BROACH HANDLE UPON IMPACTION. IT IS UNKNOWN HOW THE PROCEDURE WAS COMPLETED, AND IF THERE WAS SURGICAL DELAY. NO INJURY WAS REPORTED AS A RESULT OF THIS ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20537046 ↗
• MalfunctionSep 26, 2024Fracture; Fracture

  IT WAS REPORTED THAT DURING THR SURGERY, THE CONNECTION OF THE PLUS SL MIA DBL OFFSET ADAPT. LT 60/25MM BROKE WHILE IMPACTING. CARE WAS TAKEN TO ENSURE THAT NO ADDITIONAL FRAGMENTS WERE PRESENT. X-RAYS WERE ALWAYS USED DURING SURGERY TO ENSURE THAT NO ADDITIONAL FRAGMENTS WERE PRESENT. 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 20311452 ↗
• MalfunctionJun 17, 2024Break; Break

  IT WAS REPORTED THAT, DURING THR SURGERY, A BROACH HANDLE BROKE. THE PROCEDURE WAS RESUMED, AFTER A NON-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 19547264 ↗
• MalfunctionMay 26, 2023Break; Fracture; Break; Fracture

  IT WAS REPORTED THAT, DURING A THR, THE CONNECTION SECTION ON A PLUS SL MIA DBL OFFSET ADAPT. LT 60/25MM WAS FOUND TO BE BROKEN. SURGERY WAS RESUMED, AFTER A NON-SIGNIFICANT DELAY, WITH THE SAME DEVICE. NO PATIENT HARM HAS BEEN REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17008449 ↗
• MalfunctionFeb 15, 2023Fracture; Fracture

  IT WAS REPORTED THAT, DURING A THR SURGERY, THE TIP OF BROACH HANDLE OF ONE (1) PLUS SL MIA DBL OFFSET ADAPT. LT 60/25MM BROKE OFF WHILE BROACHING. 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 16383549 ↗
• MalfunctionJan 25, 2022Break; Fracture; Break; Fracture

  IT WAS REPORTED THAT, DURING A THR SURGERY, A PLUS SL-PLUS MIA DBL OFFSET ADAPT. LT 60/25MM BROKE ON IMPACTION AT CONNECTOR, NO PIECES FELL INSIDE OF THE PATIENT, ALL PIECES WERE RETRIEVED. 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 13339680 ↗
• InjuryDec 21, 2021Break; Break

  IT WAS REPORTED THAT, DURING A THR SURGERY, WHILE IMPACTING THE HANDLE OF A PLUS SL-PLUS MIA DBL OFFSET ADAPT. LT 60/25MM BROKE, ALL PARTS WERE RETRIEVED BY HAND. 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 13052289 ↗
• MalfunctionJun 22, 2021Break; Break

  IT WAS REPORTED THAT DURING A THA, AN OFFSET-ADAPTER 60 MM LEFT 60/25 MM BROKE OFF IN THE BROACH HANDLE SO THE QUICK CONNECT HANDLE IS NOT CONNECTING TO IT. THE PROCEDURE WAS FINISHED WITHOUT DELAY USING 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 12043030 ↗
• MalfunctionJun 7, 2021Unstable; Detachment of Device or Device Component; Unstable; Detachment of Device or Device Component

  IT WAS REPORTED THAT, DURING AN UNKNOWN SURGERY, THE LOCKING SPRING OF A SL/SBG/IPA MIA DOUBLE OFFSET ADAP.R17/13 WAS TAKEN OFF. THERE WAS A SURGICAL DELAY OF 5 MIN WAS REPORTED, AND A SMITH AND NEPHEW BACKUP DEVICE WAS AVAILABLE TO CONCLUDE THE PROCEDURE. NEITHER PATIENT INJURY NOR OTHER COMPLICATIONS WERE REPORTED DUE TO THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11952784 ↗
• MalfunctionApr 25, 2021Break; Break

  IT WAS REPORTED THAT DURING TOTAL HIP REPLACEMENT IT WAS NOTICED THAT THE PLUS SL PLUS MIA DBL OFFSET ADAPT LEFT 60/25MM THE HANDLE BROKE. THE DEVICE BROKE OUTSIDE THE PATIENT. NO DELAY OR INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11722150 ↗
• InjuryJan 19, 2021Fracture; Fracture

  IT WAS REPORTED THAT AN ATTACHMENT OF THE PLUS SL-PLUS MIA DBL OFFSET ADAPT. HAS BROKEN OFF IN THE STRIKE PLATE. DEVICE BROKE DURING USE, WHILE INSIDE THE PATIENT. PROCEDURE WAS COMPLETED USING A S+N BACKUP DEVICE. NO SURGICAL DELAY OR INJURY TO THE PATIENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11194293 ↗
• MalfunctionSep 7, 2020Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT DURING PROCEDURE THE PLUS SL MIA DBL OFFSET ADAPT. LT 60/25MM BROKE NO INFORMATION ABOUT SURGICAL DELAYS OR S+N BACKUP DEVICES WAS INITIALLY PROVIDED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10500256 ↗

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