NA 9599-10-000Recalls & reported problems

Summary

The FDA's MAUDE database contains 23 adverse event reports that list this exact device (DI 10603295231585), received between Jul 9, 2018 and May 13, 2026 — classified as 23 malfunctions.

The most frequently reported specific device problem is “Break” (16 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 23 most recent of 23 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 13, 2026Break

  IT WAS REPORTED THAT THE CERAMIC INSERTER BROKEN DURING INSERTION WHILE IN USE WITH THE ANTERIOR CORAIL/ TRI-LOCK WHERE A PIECE OF THE EXTREMITIES TOOL STAY LOCKED INTO STEM IMPLANTED. WAS SURGERY DELAYED DUE TO THE REPORTED EVENT? UNKNOWN. WAS PROCEDURE SUCCESSFULLY COMPLETED? UNKNOWN. WERE FRAGMENTS GENERATED? UNKNOWN. IF YES, WERE THEY REMOVED EASILY WITHOUT ADDITIONAL INTERVENTION? UNKNOWN. PATIENT STATUS/ OUTCOME / CONSEQUENCES -NO PATIENT INVOLVEMENT. WAS OTHER MEDICAL INTERVENTION (E.G. X-RAYS, ADDITIONAL PROCEDURES, PRESCRIPTIONS, OTC, REVISION) REQUIRED: UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25160181 ↗
• MalfunctionJun 23, 2025Break; Device-Device Incompatibility; Break; Device-Device Incompatibility

  IT WAS REPORTED THAT THE CERAMIC INSERTER TIPS HAVE SPLITS IN THE PLASTIC FROM THE LONER GRIPS TO THE LINERS. DAMAGE DUE TO WEAR AND TEAR. NO DELAY TO SURGERY. NO IMPACT ON PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22306506 ↗
• MalfunctionJun 23, 2025Break; Device-Device Incompatibility; Break; Device-Device Incompatibility

  IT WAS REPORTED THAT THE CERAMIC INSERTER TIPS HAVE SPLITS IN THE PLASTIC FROM THE LONER GRIPS TO THE LINERS. DAMAGE DUE TO WEAR AND TEAR. NO DELAY TO SURGERY. NO IMPACT ON PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22306494 ↗
• MalfunctionJun 23, 2025Break; Device-Device Incompatibility; Break; Device-Device Incompatibility

  IT WAS REPORTED THAT THE CERAMIC INSERTER TIPS HAVE SPLITS IN THE PLASTIC FROM THE LONER GRIPS TO THE LINERS. DAMAGE DUE TO WEAR AND TEAR. NO DELAY TO SURGERY. NO IMPACT ON PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22306461 ↗
• MalfunctionJun 23, 2025Break; Device-Device Incompatibility; Break; Device-Device Incompatibility

  IT WAS REPORTED THAT THE CERAMIC INSERTER TIPS HAVE SPLITS IN THE PLASTIC FROM THE LONER GRIPS TO THE LINERS. DAMAGE DUE TO WEAR AND TEAR. NO DELAY TO SURGERY. NO IMPACT ON PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22306436 ↗
• MalfunctionJan 14, 2025Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A TOTAL HIP REPLACEMENT, AND THE ACETABULAR LINER POPPED OFF THE SUCTION CUP AND FELL ON THE FLOOR. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Insufficient Information

  MAUDE report 21151516 ↗
• MalfunctionNov 14, 2024Structural Problem; Structural Problem

  IT WAS REPORTED THAT THE INSTRUMENT BROKE DURING HIP SURGERY ON NOVEMBER 6, 2024. THE SUCTION PART IS NOT WORKING AS IT SHOULD. THE INSTRUMENT DID NOT BREAK IN HALF, NO DELAYS WERE CAUSED, NOTHING WAS LEFT IN THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20685247 ↗
• MalfunctionSep 13, 2024Break; Break

  IT WAS REPORTED THAT UPON INSPECTION THE FOLLOWING PARTS WERE FOUND. REPLACEMENT SUCTION CUP - RIPPED

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20216535 ↗
• MalfunctionJun 21, 2024Break; Crack; Break; Crack

  IT WAS REPORTED THAT THE SUCTION CUP HAD A SPLIT IN IT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19581252 ↗
• MalfunctionFeb 18, 2024Break; Break

  IT WAS REPORTED THAT SUCTION RUBBER TIP SPLIT ON APPLICATION ONTO HANDLE. DID THE PATIENT EXPERIENCE AN ADVERSE EVENT SUCH AS INFECTION, NON-UNION, ALLERGIC REACTION, OSTEOPOROSIS, OVERLOADING, PAIN, DEGENERATIVE DISEASES, BLEEDING OR OOZING? --> NO, DID THE PATIENT REQUIRE REVISION SURGERY OR HARDWARE REMOVAL? --> NO, IF NO, WAS THERE ANY ADDITIONAL MEDICAL INTERVENTION REQUIRED SUCH AS X-RAYS, ADDITIONAL PROCEDURES, PRESCRIPTIONS?--> NO, PATIENT STATUS/ OUTCOME / CONSEQUENCES --> NO, PATIENT CONSEQUENCE DESCRIPTION/WAS THERE A CLINICAL OUTCOME EXPERIENCED BY THE PATIENT (INFECTION, INFLAMMATION, ETC.)?--> NO, WAS OTHER MEDICAL INTERVENTION (E.G. X-RAYS, ADDITIONAL PROCEDURES, PRESCRIPTIONS, OTC, REVISION) REQUIRED: --> NO, IS THE PATIENT PART OF A CLINICAL STUDY --> UNKNOWN, IP-01970675 DEVICE PROPERTY OF -->NONE, DEVICE IN POSSESSION OF -->NONE, IP-01970676 DEVICE PROPERTY OF -->NONE, DEVICE IN POSSESSION OF -->NONE BY CHECKING THIS BOX I CERTIFY THAT ALL INFORMATION THAT ARE KNOWN/AVAILABLE HAS BEEN DISCLOSED. IF ANY NEW INFORMATION WILL BE MADE AVAILABLE, THE ADDITIONAL INFORMATION WILL BE SUBMITTED THROUGH CST.--> TRUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18728582 ↗
• MalfunctionFeb 18, 2024Break; Break

  IT WAS REPORTED THAT SUCTION RUBBER TIP SPLIT ON APPLICATION ONTO HANDLE. DID THE PATIENT EXPERIENCE AN ADVERSE EVENT SUCH AS INFECTION, NON-UNION, ALLERGIC REACTION, OSTEOPOROSIS, OVERLOADING, PAIN, DEGENERATIVE DISEASES, BLEEDING OR OOZING? --> NO, DID THE PATIENT REQUIRE REVISION SURGERY OR HARDWARE REMOVAL? --> NO, IF NO, WAS THERE ANY ADDITIONAL MEDICAL INTERVENTION REQUIRED SUCH AS X-RAYS, ADDITIONAL PROCEDURES, PRESCRIPTIONS?--> NO, PATIENT STATUS/ OUTCOME / CONSEQUENCES --> NO, PATIENT CONSEQUENCE DESCRIPTION/WAS THERE A CLINICAL OUTCOME EXPERIENCED BY THE PATIENT (INFECTION, INFLAMMATION, ETC.)?--> NO, WAS OTHER MEDICAL INTERVENTION (E.G. X-RAYS, ADDITIONAL PROCEDURES, PRESCRIPTIONS, OTC, REVISION) REQUIRED: --> NO, IS THE PATIENT PART OF A CLINICAL STUDY --> UNKNOWN, IP-01970675 DEVICE PROPERTY OF -->NONE, DEVICE IN POSSESSION OF -->NONE, IP-01970676 DEVICE PROPERTY OF -->NONE, DEVICE IN POSSESSION OF -->NONE BY CHECKING THIS BOX I CERTIFY THAT ALL INFORMATION THAT ARE KNOWN/AVAILABLE HAS BEEN DISCLOSED. IF ANY NEW INFORMATION WILL BE MADE AVAILABLE, THE ADDITIONAL INFORMATION WILL BE SUBMITTED THROUGH CST.--> TRUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18728580 ↗
• MalfunctionFeb 22, 2023Break; Break

  IT WAS REPORTED THE IMPACTORS ARE DAMAGED. NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16421474 ↗
• MalfunctionFeb 22, 2023Break; Break

  ADDITIONAL INFORMATION RECEIVED INDICATED THAT THE ISSUE WAS DISCOVERED DURING ROUTINE INSTRUMENT INSPECTIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16420317 ↗
• MalfunctionFeb 22, 2023Break; Break

  ADDITIONAL INFORMATION RECEIVED INDICATED THAT THE ISSUE WAS DISCOVERED DURING ROUTINE INSTRUMENT INSPECTIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16420312 ↗
• MalfunctionFeb 22, 2023Break; Break

  ADDITIONAL INFORMATION RECEIVED STATES THAT THERE WAS NO SURGICAL DELAY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16420291 ↗
• MalfunctionMay 25, 2022Break; Naturally Worn; Break; Naturally Worn

  SUCTION CUP SPLIT. NO SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14495796 ↗
• MalfunctionMay 13, 2022Material Discolored; Naturally Worn; Material Discolored; Naturally Worn

  IT HAS BEEN REPORTED THAT THESE INSTRUMENTS ARE OLD AND DISCOLORED SO REQUIRE REPLACING UNDER FAIR WEAR AND TEAR AFTER A KIT INSPECTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14401101 ↗
• MalfunctionMay 13, 2022Material Discolored; Naturally Worn; Material Discolored; Naturally Worn

  IT HAS BEEN REPORTED THAT THESE INSTRUMENTS ARE OLD AND DISCOLORED SO REQUIRE REPLACING UNDER FAIR WEAR AND TEAR AFTER A KIT INSPECTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14401100 ↗
• MalfunctionJan 17, 2022Crack; Naturally Worn; Crack; Naturally Worn

  INSTRUMENTS ARE BROKEN DUE TO GENERAL WEAR AND TEAR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13266381 ↗
• MalfunctionJan 17, 2022Crack; Naturally Worn; Crack; Naturally Worn

  INSTRUMENTS ARE BROKEN DUE TO GENERAL WEAR AND TEAR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13266379 ↗
• MalfunctionDec 2, 2021Break; Break

  ADDITIONAL INFORMATION INDICATED THAT THE ITEM HAS SPLIT. IT IS NOT IN 2 PIECES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12916835 ↗
• MalfunctionNov 19, 2021Break; Break

  959910000 SUCTION TIP SPLIT, IDENTIFIED BY CSSD, NIL PATIENT DETAILS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12848467 ↗
• MalfunctionJul 9, 2018Suction Problem; Material Integrity Problem; Suction Problem; Material Integrity Problem

  IT WAS REPORTED THAT THE T HANDLE WOULD NOT LOCK ON THE REAMER. THE SUCTION TIP HAD A SMALL TEAR IN IT AND HAD PROBLEM GETTING THE SUCTION ON THE LINER.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7670332 ↗