SL-PLUS 75004613Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 07611996085471), received between Jan 9, 2020 and Apr 17, 2025 — classified as 3 injuries, 5 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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 17, 2025Fracture; Fracture

  IT WAS REPORTED THAT, DURING A THR SURGERY, ONE (1) PLUS SL MIA DBL OFFSET ADAPT. RT 60/25MM BROKE DURING THE FEMORAL BROACHING. IT IS UNKNOWN IF ANY PIECE FELL INSIDE THE INCISION. 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 21862220 ↗
• InjuryJan 18, 2022Break; Break

  IT WAS REPORTED THAT, DURING A THR SURGERY, THE END OF A PLUS SL MIA DBL OFFSET ADAPT. RT 60/25MM, THAT CONNECTS TO THE STRIKE PAD, BROKE OFF. IT IS UNKNOWN IF ANY PIECES FELL INSIDE OF 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 13280623 ↗
• InjuryDec 21, 2021Break; Break

  IT WAS REPORTED THAT, DURING TOTAL HIP REPLACEMENT, A PLUS SL-PLUS MIA DBL OFFSET ADAPT. RIGHT 60/25MM BROKE ON IMPACTION, INSIDE THE PATIENT. ALL PARTS WERE RETRIEVED BY HAND. SURGERY WAS RESUMED, 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 13054835 ↗
• InjuryDec 10, 2021Break; Break

  IT WAS REPORTED THAT, DURING TOTAL HIP REPLACEMENT, THE END OF THE HANDLE OF A SL- PLUS MIA DBL OFFSET ADAPT. RT 60/25MM BROKE OFF AT THE STRIKE PLATE CONNECTION, INSIDE THE PATIENT. SURGERY WAS RESUMED, 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 12976215 ↗
• MalfunctionDec 10, 2021Break; Break

  IT WAS REPORTED THAT, DURING A THR SURGERY, THE PLUS SL MIA DBL OFFSET ADAPT. RT 60/25 MM BROKE WHILE IMPACTING. SURGERY WAS RESUMED, WITH A BACK-UP DEVICE. IT IS UNKNOWN IF THERE WAS A DELAY AS CONSEQUENCE OF THIS ALLEGATION. PATIENT WAS NOT INJURED AS CONSEQUENCE OF THIS PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12976135 ↗
• MalfunctionMay 13, 2021Break; Break

  IT WAS REPORTED THAT, DURING THR SURGERY, THE CONNECTION POST FOR STRIKE PLATE OF A POLARSTEM BROACH HANDLE SNAPPED OFF OUTSIDE THE PATIENT. NO SIGNIFICANT SURGICAL DELAY WAS REPORTED AS A SMITH AND NEPHEW BACK UP DEVICE WAS AVAILABLE. NEITHER PATIENT INJURY NOR OTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11821071 ↗
• MalfunctionFeb 21, 2020Break; Break

  IT WAS REPORTED THAT THE BROACH HANDLE BROKE UPON IMPACTION. A PIECE FELL INTO THE PATIENT'S WOUND AND IT WAS SUCCESSFULLY RECOVERED. S+N BACKUP DEVICE WAS AVAILABLE AND NO DELAY WAS RECORDED.

  Patient problems: No Information

  MAUDE report 9738322 ↗
• MalfunctionJan 9, 2020Break; Break

  IT WAS REPORTED THAT THE CONNECTOR OF OFFSET BROACH HANDLE BROKE UPON IMPACTION. ALL PARTS RECOVERED WITHOUT ISSUE. DELAY NO GREATER THAN THIRTY MINUTES WAS REPORTED. BACKUP DEVICE WAS AVAILABLE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9568469 ↗

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