NA 2588-87-000Recalls & reported problems

Summary

The FDA's MAUDE database contains 52 adverse event reports that list this exact device (DI 10603295148036), received between Apr 3, 2018 and Sep 30, 2026 — classified as 52 malfunctions.

The most frequently reported specific device problem is “Material Deformation” (21 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 25 most recent of 52 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 30, 2026Material Deformation

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50945675 ↗
• MalfunctionSep 30, 2026Material Deformation

  It was reported that the Femoral Extractors devices had visible burs and bends found during inspection. There was no patient or user harm. There was no significant delay.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50945674 ↗
• MalfunctionSep 30, 2026Material Deformation

  It was reported that the Femoral Extractors devices had visible burs and bends found during inspection. There was no patient or user harm. There was no significant delay.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50945673 ↗
• MalfunctionSep 30, 2026Material Deformation

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50945663 ↗
• MalfunctionSep 30, 2026Material Deformation

  It was reported that the Femoral Extractors devices had visible burs and bends found during inspection. There was no patient or user harm. There was no significant delay.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50945661 ↗
• MalfunctionSep 24, 2026Device-Device Incompatibility; Material Deformation; Illegible Information

  It was reported that using a knee extraction tool during surgery to impact our femoral trial, the surgeon noted that the tip of our device was bent and not hooking onto the trial like usual. We opened two other handles and had the same issue. The surgeon would like these replaced for our instrument sets.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50878053 ↗
• MalfunctionSep 24, 2026Device-Device Incompatibility; Material Deformation; Illegible Information

  It was reported that using a knee extraction tool during surgery to impact our femoral trial, the surgeon noted that the tip of our device was bent and not hooking onto the trial like usual. We opened two other handles and had the same issue. The surgeon would like these replaced for our instrument sets.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50878052 ↗
• MalfunctionSep 24, 2026Device-Device Incompatibility; Material Deformation; Illegible Information

  It was reported that using a knee extraction tool during surgery to impact our femoral trial, the surgeon noted that the tip of our device was bent and not hooking onto the trial like usual. We opened two other handles and had the same issue. The surgeon would like these replaced for our instrument sets.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50878051 ↗
• MalfunctionJan 9, 2026Break

  OYSTER SHUCK BROKE OFF MIDWAY THROUGH BANGING THE FEMORAL PROSTHESIS OFF. PART OF IT BROKE OFF. NO FRAGMENTS IN PATIENT AND IT GOT THROWN AWAY ACCIDENTALLY. WAS SURGERY DELAYED DUE TO THE REPORTED EVENT? NO, ACTION TAKEN WHEN EVENT OCCURRED? PIECE WAS THROWN OUT, WAS PROCEDURE SUCCESSFULLY COMPLETED? YES, WERE FRAGMENTS GENERATED? YES, IF YES, WERE THEY REMOVED EASILY WITHOUT ADDITIONAL INTERVENTION? YES, PATIENT STATUS/ OUTCOME / CONSEQUENCES, 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-02620996. 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 24023340 ↗
• MalfunctionSep 30, 2024Material Deformation; Material Deformation

  ADDITIONAL INFORMATION WAS RECEIVED: THE METAL IS DEFORMED. IT DID NOT HAVE ANY ADVERSE EFFECT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20333149 ↗
• MalfunctionSep 23, 2024Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT THE INSTRUMENT TIP IS WORN DOWN.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 20277867 ↗
• MalfunctionSep 19, 2024Crack; Crack

  IT WAS REPORTED THAT ON (B)(6) 2024 , THE PATIENT UNDERWENT A SURGERY VIA THA FOR STEROIDAL OSTEONECROSIS OF THE FEMUR. THE SURGEON USES THE FEMORAL EXTRACTOR IN QUESTION FOR DRIVING A CUP INTO THE PROPER LOCATION. DURING THE SURGERY, THE BEAK PART OF THE TIP OF THE FEMORAL EXTRACTOR CRACKED BY THE IMPACT OF HAMMERING. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH NO SURGICAL DELAY. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Insufficient Information

  MAUDE report 20255223 ↗
• MalfunctionAug 15, 2024Break; Failure to Cut; Break; Failure to Cut

  THIS INSTRUMENT IS COMPOSED OF 1 PART. THE TIP OF THE INSTRUMENT IS BLUNT AND HAS METAL BITS FALLING OFF. THE PRODUCT DAMAGE DOCUMENTED IN THIS PC HAS BEEN IDENTIFIED DURING LOAN KIT INSPECTION, BY THE LOAN KIT TECHNICIAN. THE EVENT DATE AND ALERT DATE ARE THE DATE THAT THE INSPECTION TOOK PLACE. THERE IS NO SURGEON, PROCEDURE, OR PATIENT DETAILS AVAILABLE. NO FURTHER INFORMATION CAN BE OBTAINED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19991948 ↗
• MalfunctionJan 11, 2024Break; Break

  THE FEM EXTRACTOR TIP IS DAMAGED. PATIENT STATUS/ OUTCOME / CONSEQUENCES: WAS OTHER MEDICAL INTERVENTION (E.G. X-RAYS, ADDITIONAL PROCEDURES, PRESCRIPTIONS, OTC, REVISION) REQUIRED? UNKNOWN. IS THE PATIENT PART OF A CLINICAL STUDY? UNKNOWN. (B)(4). DEVICE PROPERTY OF: NONE. DEVICE IN POSSESSION OF: NONE. (B)(4). DEVICE PROPERTY OF: NONE. DEVICE IN POSSESSION OF: NONE. (B)(4). DEVICE PROPERTY OF: NONE. DEVICE IN POSSESSION OF: NONE. (B)(4). 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 18496254 ↗
• MalfunctionDec 28, 2023Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT THE DEVICE WAS DAMAGED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18408859 ↗
• MalfunctionDec 19, 2023Break; Break

  IT WAS REPORTED THAT THE FIRST TIME INSTRUMENT WAS USED AND A SOME METAL BROKE OFF FROM THE END/SIDE OF THE INSTRUMENT. THE FRAGMENT WAS REMOVED THE PATIENT AND THE INSTRUMENT WAS NOT USED ANY FURTHER. WAS SURGERY DELAYED DUE TO THE REPORTED EVENT? NO. WAS PROCEDURE SUCCESSFULLY COMPLETED? UNKNOWN. WERE FRAGMENTS GENERATED? UNKNOWN. IF YES, WERE THEY REMOVED EASILY WITHOUT ADDITIONAL INTERVENTION? UNKNOWN. PATIENT STATUS/ OUTCOME / CONSEQUENCES. WAS OTHER MEDICAL INTERVENTION (E.G. X-RAYS, ADDITIONAL PROCEDURES, PRESCRIPTIONS, OTC, REVISION) REQUIRED: UNKNOWN. IS THE PATIENT PART OF A CLINICAL STUDY UNKNOWN. (B)(4): 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 18356015 ↗
• MalfunctionNov 27, 2023Break; Break

  IT WAS REPORTED THAT HE FEMORAL EXTRACTOR IS DAMAGED ON TIP; UNSAFE TO USE FOR FUTURE CASES. THE PRODUCT DAMAGE DOCUMENTED IN THIS PC HAS BEEN IDENTIFIED DURING LOAN KIT INSPECTION, BY THE LOAN KIT TECHNICIAN. THE EVENT DATE AND ALERT DATE ARE THE DATE THAT THE INSPECTION TOOK PLACE. THERE IS NO SURGEON, PROCEDURE, OR PATIENT DETAILS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18208786 ↗
• MalfunctionNov 16, 2023Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT THE DISTAL TIP WAS HEAVILY DEFORMED FROM BEING USED. NO SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18149290 ↗
• MalfunctionJul 28, 2023Naturally Worn; Naturally Worn

  FEMORAL EXTRACTORS (DUCK BILLS) HAVE BECOME WORN AND NEED TO BE REPLACED. NO PATIENT CONSEQUENCE OR SURGICAL DELAY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17414092 ↗
• MalfunctionJul 28, 2023Naturally Worn; Naturally Worn

  FEMORAL EXTRACTORS (DUCK BILLS) HAVE BECOME WORN AND NEED TO BE REPLACED. NO PATIENT CONSEQUENCE OR SURGICAL DELAY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17414019 ↗
• MalfunctionJul 28, 2023Naturally Worn; Naturally Worn

  FEMORAL EXTRACTORS (DUCK BILLS) HAVE BECOME WORN AND NEED TO BE REPLACED. NO PATIENT CONSEQUENCE OR SURGICAL DELAY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17413894 ↗
• MalfunctionJul 28, 2023Naturally Worn; Naturally Worn

  FEMORAL EXTRACTORS (DUCK BILLS) HAVE BECOME WORN AND NEED TO BE REPLACED. NO PATIENT CONSEQUENCE OR SURGICAL DELAY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17413875 ↗
• MalfunctionMar 20, 2023Break; Material Deformation; Break; Material Deformation

  IT WAS REPORTED THE THAT THE SLAP HAMMER THREADS (CROSS THREADED) AND OSTEOTOME HEAD (BENT, CHIPPED) WERE IDENTIFIED AS DAMAGED BY CSSD STAFF. NO SURGEON AFFILIATED WITH EVENT. ALL THREE INSTRUMENTS ARE PART OF A CONSIGNMENT SET. SURGERY WAS NOT DELAYED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16572285 ↗
• MalfunctionMar 16, 2023Material Deformation; Material Deformation

  IT WAS REPORTED THE TIP OF THE INSTRUMENT IS BENT/DAMAGED. NO ADVERSE AFFECTS ON THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16554268 ↗
• MalfunctionJan 27, 2023Break; Break

  IT WAS REPORTED THAT A PIECE OF THE EXTRACTOR BROKE OFF DURING USE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16254331 ↗