S-ROM 53-5801Recalls & reported problems

Summary

The FDA's MAUDE database contains 20 adverse event reports that list this exact device (DI 10603295172710), received between Apr 24, 2018 and Mar 5, 2026 — classified as 20 malfunctions.

The most frequently reported specific device problem is “Device-Device Incompatibility” (12 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 20 most recent of 20 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 5, 2026Device-Device Incompatibility

  IT WAS REPORTED THAT NORMAL WEAR AND TEAR, SLEEVE INTRODUCER BUTTON DOES NOT LOCK ON TO SLEEVE INTRODUCER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24519226 ↗
• MalfunctionJan 5, 2026Device-Device Incompatibility

  IT WAS REPORTED THAT DURING A TOTAL HIP REPLACEMENT PROCEDURE, THE SLEEVE HANDLE WOULD NOT STAY ON THE SLEEVE INTRODUCER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23967007 ↗
• MalfunctionMar 24, 2025Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A THA SURGERY FOR OSTEOARTHRITIS OF THE LEFT HIP. DURING THE SURGERY, THE INTRODUCER SLEEVE BODY AND HANDLE WERE DETACHED EASILY. EVENTUALLY, THE HANDLE SLIPPED OUT AND BECAME UNCLEAN, SO THE INTRODUCER SLEEVE BODY HAD TO BE REMOVED BY STRIKING IT FROM THE OPPOSITE DIRECTION WITH A BONE FRAGMENT HAMMER. THE SURGERY WAS COMPLETED SUCCESSFULLY WITHIN 30 MINUTES DELAY. THERE WAS NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21679942 ↗
• MalfunctionFeb 11, 2025Device-Device Incompatibility; Mechanical Jam; Device-Device Incompatibility; Mechanical Jam

  IT WAS REPORTED THAT THE SLEEVE INSERTER BUTTON WOULD NOT STAY IN UP POSITION. THE EVENT DID NOT HAPPEN IN SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21357875 ↗
• MalfunctionDec 21, 2023Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT THE LOCKING BUTTON IS WORN OUT ON SLEEVE INTRODUCER HANDLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18371332 ↗
• MalfunctionOct 3, 2023Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT THE SLEEVE TRIAL WOULD NOT FIT ONTO THE SLEEVE INSERTER PROPERLY. THERE WAS NO SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17859717 ↗
• MalfunctionDec 15, 2021Break; Break

  SLEEVE TRIAL INTRODUCER HANDLE TOP BROKE OFF ON REMOVAL BROKE INTO TWO PIECES. BOTH RECOVERED FROM THE PATIENT. NO DELAY TO SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13012868 ↗
• MalfunctionOct 19, 2021Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON (B)(6) 2021, THE PATIENT UNDERWENT THE THA SURGERY FOR OA. THE SLEEVE INTRODUCER BODY AND INTRODUCER HANDLE WERE NOT WELL CONNECTED, AND THE SLEEVE INTRODUCER AND INTRODUCER HANDLE SEPARATED WHEN A SLEEVE TRIAL WAS REMOVED. THE SAME EVENT OCCURRED WHEN A SLEEVE WAS REMOVED. THERE WAS NO PROBLEM IN ASSEMBLING THE SLEEVE INTRODUCER AND INTRODUCER HANDLE. THE SURGERY WAS COMPLETED WITHIN 30 MINUTES DELAY. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Insufficient Information

  MAUDE report 12657499 ↗
• MalfunctionJul 27, 2021Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT WHEN ATTEMPTING TO FIT SLEEVE INTRODUCING INSTRUMENT TO THE SLEEVE DRIVER HANDLE, THE SURGEON HAD DIFFICULTY FITTING THE SIZE 12, AND RELEASING IT OFF THE DRIVER HANDLE. THE SIZE 14 DID NOT FIT ONTO THE HANDLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12232289 ↗
• MalfunctionJun 17, 2021Unintended Movement; Unintended Movement

  IT WAS REPORTED THAT ON (B)(6) 2021 THE PATIENT UNDERWENT THA WITH INSTRUMENTS IN QUESTION. WHEN THE SURGEON TRIED TO INSERT THE SLEEVE, THE BUTTON AT THE FITTING AREA BETWEEN THE INTRODUCER BODY AND THE HANDLE WAS LOOSE. WHEN THE SURGEON TRIED TO REMOVE THE INTRODUCER, THE BODY REMAINED. THE SURGERY WAS COMPLETED SUCCESSFULLY AND THERE WAS ABOUT 10 MIN SURGICAL DELAY. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Insufficient Information

  MAUDE report 12016788 ↗
• MalfunctionNov 13, 2020Device-Device Incompatibility; Naturally Worn; Device-Device Incompatibility; Naturally Worn

  SROM HANDLE SLEEVE DRIVER DISENGAGING FROM SROM INTRODUCER SLEEVE BODY DUE TO WEAR OF BOLT ON THE HANDLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10835863 ↗
• MalfunctionOct 23, 2020Device-Device Incompatibility; Device-Device Incompatibility

  THE PRIMARY SURGERY WAS PERFORMED ON (B)(6) 2020 VIA THA. DURING THE SURGERY, THE SURGEON INSERTED A SLEEVE WITH THE INTRODUCER SLEEVE BODY CONNECTED THE HANDLE SLEEVE DRIVER. THEN, THE SURGEON TRIED TO REMOVE THE DEVICES WITH A HAMMER, THE CONNECTION POINT OF THE INTRODUCER SLEEVE BODY AND THE HANDLE SLEEVE DRIVER CAME OFF EASILY. THE SURGEON COULD REMOVE THE DEVICES WITH TRYING A FEW TIMES. AFTER THAT, THE NURSE CHECKED THE DEVICES, HE/SHE COULD NOT DISCONNECT THE DEVICES BY HAND. HOWEVER, HE/SHE TRIED TO GET THEM OFF WITH A HAMMER, THE DEVICES CAME OFF EASILY. THE SURGERY WAS COMPLETED WITHIN 30 MINUTES DELAY. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Code Available

  MAUDE report 10726656 ↗
• MalfunctionJul 16, 2020Mechanical Jam; Mechanical Jam

  IT WAS REPORTED THAT THE SROM SLEEVE INTRODUCER HANDLE GETS JAMMED WHEN CONNECTING IT TO THE SLEEVE INTRODUCERS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10283263 ↗
• MalfunctionJul 13, 2020Device-Device Incompatibility; Physical Resistance/Sticking; Device-Device Incompatibility; Physical Resistance/Sticking

  IT WAS REPORTED THAT THE BALL BEARING ON THE INSERTER SHAFT KEEPS GETTING STUCK IN THE OPEN POSITION. WILL NOT LOCK AND ENGAGE CONSISTENTLY. NO SURGICAL DELAY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10267402 ↗
• MalfunctionOct 10, 2019Connection Problem; Device-Device Incompatibility; Material Deformation; Naturally Worn; Connection Problem; Device-Device Incompatibility; Material Deformation; Naturally Worn

  IT WAS REPORTED THAT THE SIZE 16 SLEEVE INTRODUCER AND HANDLE NO LONGER STAY ATTACHED. DOCTOR INDICATES BOTH PARTS WERE WORN AND NEEDED REPLACING. PLEASE SEND REPLACEMENT PARTS TO (B)(4) OFFICE. THERE WAS A 30 SECONDS SURGICAL DELAY.

  Patient problems: Not Applicable

  MAUDE report 9175645 ↗
• MalfunctionMay 23, 2019Device-Device Incompatibility; Scratched Material; Physical Resistance/Sticking; Device-Device Incompatibility; Scratched Material; Physical Resistance/Sticking

  IT WAS REPORTED THAT THE SROM SLEEVE WAS STUCK. NO SURGICAL DELAY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8636973 ↗
• MalfunctionApr 3, 2019Difficult to Remove; Mechanical Jam; Difficult to Remove; Mechanical Jam

  IT WAS REPORTED THAT THE SLEEVE INTRODUCER STUCK ON HANDLE. SURGERY TIME NOT EXTENDED. NOTHING WAS BROKEN-OFF IN THE INSTRUMENTS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8479325 ↗
• MalfunctionAug 13, 2018Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  THE PRIMARY SURGERY WAS PERFORMED ON (B)(6) 2018 VIA THA. AFTER THE TRIAL SLEEVE WAS INSERTED TO THE PATIENT¿S FEMUR, IT WAS REPORTED THAT THE SURGEON FELT DIFFICULTY TO REMOVE THE TRIAL SLEEVE BECAUSE THE CONNECTION PART OF THE SLEEVE INTRODUCER AND INTRODUCER HANDLE WERE DETACHED WHEN THE SURGEON HIT THE CONNECTION PART TO RELEASE WHILE THE TRIAL SLEEVE WAS REMOVED. THE SURGEON ATTEMPTED TO REMOVE THE TRIAL SLEEVE SEVERAL TIMES, AND FINALLY IT WAS REMOVED BY USING ELEVATORS. THE SAME CONDITION WAS OCCURRED (DIFFICULTY TO RELEASE) WHEN THE SLEEVE WAS IMPLANTED TO PATIENT¿S FEMUR. THERE WAS LESS THAN 30MIN. SURGICAL DELAY AND THERE WAS NO ADVERSE CONSEQUENCE TO THE PATIENT. NO FURTHER INFORMATION WAS PROVIDED BY THE HOSPITAL.

  Patient problems: Not Applicable

  MAUDE report 7777438 ↗
• MalfunctionMay 30, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  NEW REP AT (B)(6) MEDICAL CENTER. DURING A CASE, THE SLEEVE DRIVER WAS DISENGAGING FROM SLEEVE BODY USED TO IMPACT THE SLEEVE TRIAL. THE SLEEVE DRIVER DISENGAGED TWICE WILE EXTRACTING THE SLEEVE IMPACTOR BODY. THIS INCIDENT MAYBE ADDED 20 SECONDS TO THE ENTIRE CASE. AFTER THE SURGERY, I EXAMINED THE SLEEVE DRIVER, AND NOTICED THE BUTTON WHICH ENGAGES IN THE BODY WAS WORN. ASKING THAT THIS IS REPLACED AND SHIPPED TO: (B)(6). THE DAMAGED INSTRUMENT WILL BE RETURNED TO (B)(6). LOT CODE: AY0703. P.S: ON THE COMPLAINT TOOL; YOU ARE UNABLE TO ADD THE LOT CODE. THE PRODUCT WON'T ADD/UPLOAD WHEN THE LOT IS ALSO TYPED PATIENT CONSEQUENCE? NO.

  Patient problems: Not Applicable

  MAUDE report 7554206 ↗
• MalfunctionApr 24, 2018Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT THE SROM SLEEVE INSERTER WAS NOT ENGAGING DISTAL PORTION OF THE INSTRUMENT. NO SURGICAL DELAY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7453650 ↗