POLARSTEM 75102237Recalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 00885556535424), received between Nov 15, 2020 and May 24, 2022 — classified as 2 injuries, 11 malfunctions.

The most frequently reported specific device problem is “Premature Separation” (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 13 most recent of 13 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 24, 2022Break; Break

  IT WAS REPORTED THAT, DURING A FIELD INSPECTION, IT WAS NOTICED THAT THE TIP OF THE DAA DOUBLE OFFSET ADAPTER LEFT 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 14485925 ↗
• InjuryApr 19, 2021Fracture; Fracture

  IT WAS REPORTED THAT DURING A THR PROCEDURE AND INSIDE THE PATIENT THE ATTACHMENT FOR THE DAA DOUBLE OFFSET ADAPTER LEFT 80/45 BROKE. PROCEDURE WAS COMPLETED USING THE SAME DEVICE. NO SURGICAL DELAYS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11684518 ↗
• MalfunctionApr 13, 2021Difficult to Insert; Incomplete or Inadequate Connection; Difficult to Insert; Incomplete or Inadequate Connection

  IT WAS REPORTED THAT THE HANDLE IS NOT LOCKING ONTO THE BROACHES. THE ISSUE WAS NOTICED DURING SURGERY. THE PROCEDURE WAS COMPLETED USING THE SAME DEVICE. A DELAY OF 30 MIN OR LESS WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11654380 ↗
• MalfunctionMar 25, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING SURGERY, WHILE USING IT INSIDE THE PATIENT, THE BROACH DETACHES WHEN TRYING TO BACK BROACH OUT OF THE CANAL. THE PROCEDURE CONTINUED USING A BACKUP DEVICE FROM SMITH AND NEPHEW, WITH A SURGICAL DELAY OF LESS THAN 30 MINUTES AND NO INJURY TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11568220 ↗
• MalfunctionMar 9, 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 11444023 ↗
• 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 11409069 ↗
• MalfunctionMar 1, 2021Premature Separation; Premature Separation

  IT WAS REPORTED THAT THE HANDLE DISENGAGES WHEN IMPACTED. FAILURE IN 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 11396827 ↗
• 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 11196444 ↗
• 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 11196312 ↗
• 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 11195432 ↗
• 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 11195419 ↗
• MalfunctionNov 17, 2020Corroded; Corroded

  IT WAS REPORTED THAT DAA DOUBLE OFFSET ADAPTER LEFT 80/45 WERE FOUND WITH SOME RUST STARTING TO FORM. NO PROCEDURE-RELATED.

  Patient problems: No Patient Involvement

  MAUDE report 10857383 ↗
• InjuryNov 15, 2020Fracture; Fracture

  IT WAS REPORTED THAT DURING A THR PROCEDURE AND INSIDE THE PATIENT, THE ATTACHMENT FOR THE DAA DOUBLE OFFSET ADAPTER LEFT 80/45 BROKE. PROCEDURE WAS COMPLETED USING THE SAME DEVICE. NO SURGICAL DELAYS REPORTED.

  Patient problems: Injury

  MAUDE report 10841650 ↗

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