POLARSTEM 75102240Recalls & reported problems

Summary

The FDA's MAUDE database contains 18 adverse event reports that list this exact device (DI 00885556535394), received between Sep 7, 2020 and Mar 31, 2025 — classified as 18 malfunctions.

The most frequently reported specific device problem is “Premature Separation” (10 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 18 most recent of 18 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 31, 2025Break; Break

  IT WAS REPORTED THAT, DURING A THR, TWO (2) DAA DOUBLE OFFSET ADAPTER RIGHT 80/45 BROKE. IT IS UNKNOWN HOW THE PROCEDURE WAS FINISHED OR IF THERE WAS A SURGICAL DELAY. NO INJURY WAS REPORTED AS A CONSEQUENCE OF THIS ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21733210 ↗
• MalfunctionJul 10, 2024Fracture; Fracture

  IT WAS REPORTED THAT DURING A THR SURGERY, IN THE DAA DOUBLE OFFSET ADAPTER RIGHT 80/45, THE CONNECTION TIP HAS BROKEN OFF. NO PIECES FELL INSIDE THE PATIENT. 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 19711042 ↗
• MalfunctionDec 1, 2023Mechanics Altered; Premature Separation; Mechanics Altered; Premature Separation

  IT WAS REPORTED THAT, WHEN ATTEMPTING TO EXPLANT AN UNDERSIZED TRIAL BROACH DURING A THR SURGERY, THE LOCKING MECHANISM OF A DAA DOUBLE OFFSET ADAPTER RIGHT 80/45 WAS NOT OPTIMAL. IT WAS PUSHING THE BROACH FURTHER DOWN THE FEMUR. THE PROCEDURE WAS RESUMED AFTER A SIGNIFICANT DELAY, USING A COMBINATION OF BONE HOOK, OSTEOTOME, RONGUER AND COBB. NO INJURY WAS REPORTED AS A CONSEQUENCE OF THIS ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18252186 ↗
• MalfunctionNov 13, 2023Fracture; Fracture

  IT WAS REPORTED THAT DURING A THR SURGERY, USING A DAA DOUBLE OFFSET ADAPTER RIGHT 80/45, WHEN BROACHING THE FEMORAL CANAL, THE MALE END OF THE BROACH HANDLE BROKE OFF INSIDE OF THE FEMALE END OF THE STRIKE PLATE. ALL PIECES WERE RETRIEVED. 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 18119926 ↗
• MalfunctionMay 23, 2022Break; Break

  IT WAS REPORTED THAT, DURING A FIELD INSPECTION, IT WAS NOTICED THAT THE TIP OF THE DAA DOUBLE OFFSET ADAPTER RIGHT 80/45 WAS FOUND BROKEN. NO CASE WAS INVOLVED; THEREFORE, THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14479607 ↗
• MalfunctionMay 26, 2021Connection Problem; Premature Separation; Connection Problem; Premature Separation

  IT WAS REPORTED THAT THE DAA DOUBLE OFFSET ADAPTER RIGHT 80/45 IS NOT LOCKING TIGHT ENOUGH ONTO THE BROACH AND THE SPRING FEELS LOOSE. IT IS UNKNOWN WHEN THE EVENT HAPPENED AND IF THERE WAS A PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11891043 ↗
• MalfunctionMay 7, 2021Premature Separation; Premature Separation

  IT WAS REPORTED THAT DURING THR, THE DAA DOUBLE OFFSET ADAPTER RIGHT 80/45 HANDLE MECHANISM WOULD REPEATEDLY RELEASE THE BROACH DURING THE REMOVAL, CAUSING THE SURGEON TO REATTACH MULTIPLE TIMES WHILE REMOVING THE BROACHES. THE PROCEDURE WAS FINISHED WITHOUT DELAY USING THE SAME DEVICE NO PATIENT INJURY OR OTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11793937 ↗
• MalfunctionApr 6, 2021Loose or Intermittent Connection; Loose or Intermittent Connection

  IT WAS REPORTED THAT THE DOUBLE OFFSET ADAPTER WILL NOT STAY LOCKED IN PLACE AND NEEDS TO BE REPLACED. FAILURE WAS DETECTED DURING SET UP OR INSPECTION. THEREFORE, NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11617772 ↗
• MalfunctionMar 4, 2021Premature Separation; Premature Separation

  IT WAS REPORTED THAT THE BROACH HANDLE IS LOOSE AND WILL NOT HOLD THE TRIAL FIRMLY. THE FAILURE IN THE DEVICE WAS NOTICED DURING SET UP OR INSPECTION. THE PROCEDURE WAS COMPLETED USING THE SAME DEVICE . NO SURGICAL DELAY OR INJURY TO THE PATIENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11409071 ↗
• MalfunctionMar 4, 2021Physical Resistance/Sticking; Premature Separation; Physical Resistance/Sticking; Premature Separation

  IT WAS REPORTED THAT THE BROACH HANDLE IS LOOSE AND WILL NOT HOLD THE TRIAL FIRMLY. THE FAILURE IN THE DEVICE WAS NOTICED DURING SET UP OR INSPECTION. THE PROCEDURE WAS COMPLETED USING THE SAME DEVICE . NO SURGICAL DELAY OR INJURY TO THE PATIENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11409070 ↗
• MalfunctionJan 19, 2021Premature Separation; Premature Separation

  IT WAS REPORTED THAT THE LOCKING MECHANISM BETWEEN HANDLE AND BROACH IS LOOSENING. FAULT IN DEVICE WAS NOTICED DURING USE. THE PROCEDURE WAS COMPLETED WITH THE SAME DEVICE. A DELAY OF 30 MIN OR LESS WAS REPORTED. NO PATIENT HARM WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11196387 ↗
• MalfunctionJan 19, 2021Premature Separation; Premature Separation

  IT WAS REPORTED THAT THE LOCKING MECHANISM BETWEEN HANDLE AND BROACH IS LOOSENING. FAULT IN DEVICE WAS NOTICED DURING USE. THE PROCEDURE WAS COMPLETED WITH THE SAME DEVICE. A DELAY OF 30 MIN OR LESS WAS REPORTED. NO PATIENT HARM WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11196301 ↗
• MalfunctionJan 19, 2021Premature Separation; Premature Separation

  IT WAS REPORTED THAT THE LOCKING MECHANISM BETWEEN HANDLE AND BROACH IS LOOSENING. FAULT IN DEVICE WAS NOTICED DURING USE. THE PROCEDURE WAS COMPLETED WITH THE SAME DEVICE. A DELAY OF 30 MIN OR LESS WAS REPORTED. NO PATIENT HARM WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11195424 ↗
• MalfunctionJan 19, 2021Premature Separation; Premature Separation

  IT WAS REPORTED THAT THE LOCKING MECHANISM BETWEEN HANDLE AND BROACH IS LOOSENING. FAULT IN DEVICE WAS NOTICED DURING USE. THE PROCEDURE WAS COMPLETED WITH THE SAME DEVICE. A DELAY OF 30 MIN OR LESS WAS REPORTED. NO PATIENT HARM WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11195417 ↗
• MalfunctionNov 17, 2020Corroded; Corroded

  IT WAS REPORTED THAT THE DAA DOUBLE OFFSET ADAPTER RIGHT 80/45. NO PROCEDURE-RELATED.

  Patient problems: No Patient Involvement

  MAUDE report 10857382 ↗
• MalfunctionSep 25, 2020Misconnection; Detachment of Device or Device Component; Misconnection; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE DAA DOUBLE OFFSET ADAPTER RIGHT 80/45 DID NOT CONNECT TO THE BROACHES, NO PROCEDURE-RELATED.

  Patient problems: No Patient Involvement

  MAUDE report 10590808 ↗
• MalfunctionSep 25, 2020Break; Connection Problem; Break; Connection Problem

  IT WAS REPORTED THAT DURING A THR PROCEDURE AND OUTSIDE THE PATIENT, THE DAA DOUBLE OFFSET ADAPTER RIGHT 80/45 DID NOT HOLD BROACH PROPERLY. SURGERY WAS FINISHED WITH AN S+N BACKUP DEVICE. NO INJURIES OR SURGICAL DELAYS REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10590765 ↗
• MalfunctionSep 7, 2020Premature Separation; Premature Separation

  IT WAS REPORTED THAT DAA DOUBLE OFFSET ADAPTER RIGHT 80/45 DEFECT IS LOCATED AT THE RELEASE BUTTON LOCATED AT THE DISTAL PORTION OF THE IMPACTOR. THE BROACH HANDLE DIDN¿T ¿LOCK¿ ONTO THE BROACH VERY EFFICIENTLY CAUSING THE IMPACTOR TO RELEASE FROM THE EMBEDDED BROACH DURING BROACH REMOVAL. AN S+N BACKUP BROACH HANDLE WAS AVAILABLE. NO INJURIES OR SURGICAL DELAYS REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10500264 ↗

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