LPS 2987-70-003Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 10603295158813), received between Jan 31, 2018 and Aug 3, 2023 — classified as 6 malfunctions.

The most frequently reported specific device problem is “Device-Device Incompatibility” (3 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 3, 2023Break; Crack; Break; Crack

  IT WAS REPORTED THAT THE LPS FEMORAL IMPACTOR WAS CRACKED DURING USE. BROKEN PIECE WAS REMOVED. NO PATIENT HARM WAS OCCURRED. NO SURGICAL DELAY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17452320 ↗
• MalfunctionSep 15, 2022Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT THE IMPACTOR WILL NOT CONNECT WITH HANDLE COUPLING. IMPACTOR COUPLING APPEARS TO BE OUT OF TOLERANCE FOR THE HANDLE. THE HANDLE COUPLING DOES CONNECT WITH A DIFFERENT IMPACTOR. THERE WAS NO SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15428897 ↗
• MalfunctionDec 3, 2021Device-Device Incompatibility; Device-Device Incompatibility

  THIS PC CAPTURES THE S-ROM FEMORAL DRIVER THAT WOULD NOT CONNECT TO THE SROM UNIVERSAL HANDLE QUICK RELEASE. IT WAS REPORTED THAT THERE WAS A LEFT-SIDED PERIPROSTHETIC NONUNION FRACTURE PROXIMAL TO THE CONSTRAINED TKA. ALSO, THE S-ROM FEMORAL DRIVER WOULD NOT CONNECT TO THE SROM UNIVERSAL HANDLE QUICK RELEASE. NO SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12924924 ↗
• MalfunctionJul 15, 2021Use of Device Problem; Use of Device Problem

  IT WAS REPORTED THAT PRIOR TO SURGERY THE SPRING PORTION OF THE HANDLE WAS MISSING FROM THE HANDLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12173229 ↗
• MalfunctionOct 16, 2020Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT THE DEPUY OFFICE PERSONNEL CALLED TO MAKE AWARE, IMPACTOR WILL NOT RELEASE FROM THE HANDLE. THE INSTRUMENT WORKED FINE IN SURGERY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10690132 ↗
• MalfunctionJan 31, 2018Break; Break

  IT WAS REPORTED THAT THE FEMORAL IMPACTOR BROKE. NO SURGICAL DELAY. ALL PIECES RETRIEVED

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7230170 ↗