PROSTALAC 2541-43-000Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 10603295129554), received between Jan 15, 2020 and Jan 18, 2022 — classified as 11 malfunctions.

The most frequently reported specific device problem is “Device-Device Incompatibility” (7 reports).

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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 18, 2022Device-Device Incompatibility; Naturally Worn; Device-Device Incompatibility; Naturally Worn

  IT WAS REPORTED THAT THE TWO OF THE PROSTALAC MOLD QUICK RELEASE NUTS ARE STRIPPED AND NO LONGER THREAD ONTO THE MOLD BOLTS. NO SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13283944 ↗
• MalfunctionJan 18, 2022Device-Device Incompatibility; Naturally Worn; Device-Device Incompatibility; Naturally Worn

  IT WAS REPORTED THAT THE TWO OF THE PROSTALAC MOLD QUICK RELEASE NUTS ARE STRIPPED AND NO LONGER THREAD ONTO THE MOLD BOLTS. NO SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13283800 ↗
• MalfunctionOct 15, 2020Break; Break

  ADDITIONAL INFORMATION RECEIVED INDICATED THAT THE PART THAT WAS BROKEN WAS THE THREADED PART OF THE ASSEMBLY. THE BROKEN PART STAYED INSIDE OF THE STEM. NO BROKEN PIECES WERE LEFT INSIDE THE PATIENT.

  Patient problems: No Code Available; No Consequences Or Impact To Patient

  MAUDE report 10684287 ↗
• MalfunctionOct 15, 2020Break; Break

  ADDITIONAL INFORMATION RECEIVED INDICATED THAT THE PART THAT WAS BROKEN WAS THE THREADED PART OF THE ASSEMBLY. THE BROKEN PART STAYED INSIDE OF THE STEM. NO BROKEN PIECES WERE LEFT INSIDE THE PATIENT.

  Patient problems: No Code Available; No Consequences Or Impact To Patient

  MAUDE report 10684276 ↗
• MalfunctionOct 15, 2020Break; Break

  ADDITIONAL INFORMATION RECEIVED INDICATED THAT THE PART THAT WAS BROKEN WAS THE THREADED PART OF THE ASSEMBLY. THE BROKEN PART STAYED INSIDE OF THE STEM. NO BROKEN PIECES WERE LEFT INSIDE THE PATIENT.

  Patient problems: No Code Available; No Consequences Or Impact To Patient

  MAUDE report 10684264 ↗
• MalfunctionOct 15, 2020Break; Break

  ADDITIONAL INFORMATION RECEIVED INDICATED THAT THE PART THAT WAS BROKEN WAS THE THREADED PART OF THE ASSEMBLY. THE BROKEN PART STAYED INSIDE OF THE STEM. NO BROKEN PIECES WERE LEFT INSIDE THE PATIENT.

  Patient problems: No Code Available; No Consequences Or Impact To Patient

  MAUDE report 10684253 ↗
• MalfunctionApr 8, 2020Device-Device Incompatibility; Material Twisted/Bent; Device-Device Incompatibility; Material Twisted/Bent

  IT WAS REPORTED THAT THE PROSTALAC QK REL NUT WAS STRIPPED ON THE INSIDE AND WOULD NOT SCREW TIGHTLY ONTO THE MOLDS. THERE WAS NO SURGICAL DELAY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9934242 ↗
• MalfunctionApr 8, 2020Device-Device Incompatibility; Material Twisted/Bent; Device-Device Incompatibility; Material Twisted/Bent

  IT WAS REPORTED THAT THE PROSTALAC QK REL NUT WAS STRIPPED ON THE INSIDE AND WOULD NOT SCREW TIGHTLY ONTO THE MOLDS. THERE WAS NO SURGICAL DELAY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9934216 ↗
• MalfunctionJan 15, 2020Mechanical Problem; Device-Device Incompatibility; Mechanical Problem; Device-Device Incompatibility

  ADDITIONAL INFORMATION RECEIVED THAT THE PROSTALAC NUTS DON¿T LOCK AND COULD NEVER GET THEM TO TIGHTEN DOWN CORRECTLY. THEY WOULD JUST SPIN ON THE THREADS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9592202 ↗
• MalfunctionJan 15, 2020Mechanical Problem; Device-Device Incompatibility; Mechanical Problem; Device-Device Incompatibility

  THEY WERE THROWN AWAY BY THE ACCOUNT. THEY DON¿T LOCK BUT WE COULD NEVER GET THEM TO TIGHTEN DOWN CORRECTLY. THEY WOULD JUST SPIN ON THE THREADS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9592196 ↗
• MalfunctionJan 15, 2020Mechanical Problem; Device-Device Incompatibility; Mechanical Problem; Device-Device Incompatibility

  THEY WERE THROWN AWAY BY THE ACCOUNT. THEY DON¿T LOCK BUT WE COULD NEVER GET THEM TO TIGHTEN DOWN CORRECTLY. THEY WOULD JUST SPIN ON THE THREADS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9592195 ↗