S-ROM 53-4106Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10603295171713), received between Aug 21, 2020 and Sep 27, 2024 — classified as 1 injury, 2 malfunctions.

The most frequently reported specific device problem is “Break” (1 report).

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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 27, 2024Entrapment of Device; Improper or Incorrect Procedure or Method; Entrapment of Device; Improper or Incorrect Procedure or Method

  IT WAS REPORTED THAT ON THE PATIENT UNDERWENT A HIP REPLACEMENT SURGERY FOR OSTEOARTHRITIS OF THE HIP. THE PATIENT HAD PREVIOUSLY UNDERGONE CHIARI PELVIC OSTEOTOMY, AND HER MEDULLARY CAVITY WAS THIN/NARROW AND OSTEOSCLEROSIS OF THE PROXIMAL TRABECULAR BONE WAS SIGNIFICANT. A DISTAL REAMER EXCAVATED THE MEDULLARY CAVITY TO 7 MM. THE CONE REAMER THAT WAS USED WAS A "12B", BUT BONE HARDENING MADE REAMING IMPOSSIBLE, SO THE CONE REAMER WAS USED IN DRILL MODE AFTER SHAVING WITH AN AIR TOME. AT THAT TIME, THE PILOT SHAFT HAD BEEN ATTACHED TO THE CONE REAMER BY MISTAKE. AFTER ROTATING THE CONE REAMER REPEATEDLY IN DRILL MODE AND STOPPING IT ABOUT 10 TIMES, THE PILOT SHAFT BECAME DISCONNECTED WHEN THE CONE REAMER WAS REMOVED. THE PILOT SHAFT MAY HAVE LOOSENED A LITTLE DURING USE, BUT THE PILOT SHAFT SHOULD BE TIGHTENED UP WHEN ROTATED IN FORWARD ROTATION, SO THE CAUSE OF THE PILOT SHAFT COMING OFF IS UNKNOWN. RADIOGRAPHS CONFIRMED THAT THE PILOT SHAFT HAD FALLEN TO 14 CM BELOW THE CALCAR, OR THE DISTAL THIRD OF THE FEMUR. ABOUT THREE-QUARTERS OF THE PILOT SHAFT FELL INTO A SPOT WHERE THE MEDULLARY CAVITY HAD WIDENED PAST THE ISTHMUS. THE SURGEON LIFTED AND TAPPED THE FEMUR, BUT THE PILOT S

  Patient problems: Foreign Body In Patient; No Clinical Signs, Symptoms or Conditions

  MAUDE report 20320563 ↗
• MalfunctionSep 11, 2020Scratched Material; Scratched Material

  BREAKAGE. IT WAS REPORTED THAT DURING THE HIP REPLACEMENT OPERATION,WHEN DID THE "PROXIMAL REAMING", BREAKAGE OCCURRED AT THE THREADED JUNCTION OF THE DISTAL GUIDE ROD AND THE CONICAL REAMER. IT IS NOT KNOWN WHETHER THERE ARE METAL DEBRIS IN THE FRACTURE SITE REMAINED IN THE PATIENT. ANOTHER DEVICE WAS USED TO COMPLETE THE OPERATION. THE OPERATION DELAYED ABOUT 40 MINS. THE PATIENT WAS STABLE AND LEFT FROM HOSPITAL NOW.

  Patient problems: No Code Available

  MAUDE report 10523388 ↗
• InjuryAug 21, 2020Break; Break

  BREAKAGE. IT WAS REPORTED THAT THE PATIENT WAS GIVEN THE RIGHT TOTAL HIP ARTHROPLASTY OPERATION ON (B)(6) 2017. THE DEVICE WAS BROKEN OFF, COULD NOT REMOVE THE BROKEN PART. 3-6 MONTHS AFTER OPERATION, THE PATIENT WAS WITH IONIZATION REACTION, 2ND OPERATION WAS GIVEN TO REMOVE THE BROKEN PART. NOW THE PATIENT IS STABLE.

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

  MAUDE report 10436704 ↗