NA 2598-07-480Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 10603295148463), received between Jul 5, 2018 and Oct 22, 2025 — classified as 8 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 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.

• MalfunctionOct 22, 2025No Apparent Adverse Event; No Apparent Adverse Event

  THE FOLLOWING DEVICES WERE RECEIVED FOR ANALYSIS. THERE WAS NO PRODUCT MALFUNCTION OR PATIENT HARM REPORTED WITH THE RETURNED DEVICES.

  Patient problems: Insufficient Information

  MAUDE report 23359433 ↗
• MalfunctionJun 10, 2025Break; Break

  IT WAS REPORTED THAT PATIENT UNDERWENT TOTAL HIP REPLACEMENT ON (B)(6) 2025. THE TIP OF THE SUMMIT STRAIGHT IMPACTOR WAS MISSING COMPLETELY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22176819 ↗
• MalfunctionApr 24, 2025Break; Entrapment of Device; Break; Entrapment of Device

  IT WAS REPORTED THAT A TIP OF A FEMORAL STEM IMPACTOR BROKE OFF DURING A TOTAL HIP REPLACEMENT SURGERY, AND IT WAS VERIFIED BY X-RAY/C-ARM POST OPERATIVELY. THE PIECE WAS NOT RETRIEVED AND DID NOT DELAY CASE. STERILE PROCESSING REALIZED IT WAS BROKEN AND THEY USED C-ARM TO CONFIRM IT WAS LEFT IN THE SHOULDER OF THE IMPLANT.

  Patient problems: Foreign Body In Patient

  MAUDE report 21900545 ↗
• MalfunctionAug 30, 2022Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT STERILIZATION WAS UNABLE TO GET THE UNIVERSAL HANDLE AND STEM INSERTER APART. NO SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15321043 ↗
• MalfunctionMar 30, 2021Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON (B)(6) 2021, THE PATIENT UNDERWENT BILATERAL THA SURGERY FOR OSTEOARTHRITIS WITH THE INSERTER IN QUESTION. DURING THE SURGERY, PROCEDURES FOR ONE SIDE WAS COMPLETED WITHOUT ANY PROBLEMS. HOWEVER, WHEN THE SURGEON USED THE INSERTER FOR ANOTHER SIDE, THE INSERTER GOT DISCONNECTED AND HE COULD NOT INSERT A STEM. HE REMOVED THE STEM AND CHANGED RASP SIZE TO USE A BIGGER ONE. THE SURGERY WAS COMPLETED SUCCESSFULLY. THE SURGERY WAS DELAYED BY LESS THAN 30 MINUTES. AFTER THE SURGERY, THEY CHECKED THE INSERTER AND CONFIRMED THAT THEY DIDN'T ASSEMBLE WELL. THE SURGEON COMMENTED THAT THE CONNECTING PARTS OF THE DEVICE HAVE OBVIOUS DEFECTS. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Insufficient Information

  MAUDE report 11588825 ↗
• MalfunctionOct 24, 2019Device-Device Incompatibility; Device-Device Incompatibility

  STUCK TOGETHER.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9233198 ↗
• MalfunctionSep 18, 2018Failure to Disconnect; Failure to Disconnect

  IT WAS REPORTED THAT THE TWO PIECES WERE FOUND IN INSTRUMENT PAN STUCK TOGETHER.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7885279 ↗
• MalfunctionJul 5, 2018Material Discolored; Material Discolored

  PRODUCTS PRESENTED OXIDATION. IN THE EMAIL RECEIVED, CAME A LIST OF PRODUCTS SEPARATED BY BOX. THIS COMPLAINT REFERS TO THE PRODUCTS OF (B)(6) HOSPITAL IN BOX 2. PRODUCT: 257003050, LOT: MT40695. PRODUCT: 257003100, LOT: MT44718. PRODUCT: 257003150, LOT: MT47132. PRODUCT: 257003250, LOT: MT47299. PRODUCT: 257003350, LOT: MT45600. PRODUCT: 257003400, LOT: MT44738.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7663453 ↗