N/A 74018902Recalls & reported problems

Summary

The FDA's MAUDE database contains 121 adverse event reports that list this exact device (DI 00885556697962), received between May 21, 2019 and Apr 23, 2026 — classified as 29 injuries, 92 malfunctions.

The most frequently reported specific device problem is “Break” (74 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 121 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 23, 2026Fracture

  IT WAS REPORTED THAT, DURING TKA SURGERY, ONE (1) OUTER-GRIP LOCKING FEM IMPLANT IMPACTOR BROKE OFF ATTEMPTING TO REMOVE IT FROM FEMUR. IT IS UNKNOWN IF ANY PIECE FELL INSIDE THE PATIENT. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING AN EQUIVALENT S+N BACK-UP. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24972194 ↗
• MalfunctionApr 5, 2026Break

  IT WAS REPORTED THAT, DURING A TKA SURGERY, ONE (1) OUTER-GRIP LOCKING FEM IMPLANT IMPACTOR WAS DAMAGED AFTER IMPACTING THE FINAL FEMORAL IMPLANT. THE PROCEDURE WAS PERFORMED, AFTER A NON-SIGNIFICANT DELAY, USING AN EQUIVALENT S+N BACK-UP. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24787051 ↗
• MalfunctionMar 25, 2026Fracture

  IT WAS REPORTED THAT, DURING A TKA SURGERY, ONE (1) OUTER-GRIP LOCKING FEM IMPLANT IMPACTOR BROKE OFF UPON STARTING TO IMPACT THE FEMUR. THE PIECE THAT BROKE OFF WAS RETRIEVED FROM INSIDE THE SURGICAL SITE. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING THE SAME DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24687587 ↗
• MalfunctionMar 5, 2026Break

  IT WAS REPORTED THAT, DURING A TKA SURGERY, THE WELD OF A OUTER-GRIP LOCKING FEM IMPLANT IMPACTOR BROKE AT THE BOTTOM OF THE LOCKING KNOB. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING AN EQUIVALENT S+N BACK-UP. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24525102 ↗
• MalfunctionFeb 5, 2026Fracture

  IT WAS REPORTED THAT, DURING A TKA SURGERY, THE TIP OF THE PRONG THAT HOLDS THE IMPLANT ON ONE (1) OUTER-GRIP LOCKING FEM IMPLANT IMPACTOR BROKE OFF. THE PROCEDURE WAS PERFORMED, WITHOUT ANY DELAY, USING AN EQUIVALENT S+N BACK- UP. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24271182 ↗
• MalfunctionJan 12, 2026Detachment of Device or Device Component

  IT WAS REPORTED THAT, DURING A TKA SURGERY THE PIN OF ONE (1) OUTER-GRIP LOCKING FEM IMPLANT IMPACTOR FELL OUT AND THE HEAD FELL OFF THE IMPACTOR. THE PROCEDURE WAS RESUMED, AFTER A NON-SIGNIFICANT DELAY, USING AN EQUIVALENT S+N BACK-UP DEVICE. NO ADDITIONAL ANESTHETIC WAS REQUIRED. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24036491 ↗
• MalfunctionDec 29, 2025Fracture; Fracture

  IT WAS REPORTED THAT, DURING A TKA SURGERY, THE SPRING OF THE OUTER-GRIP LOCKING FEM IMPLANT IMPACTOR BROKE DURING IMPACTING. NO FRAGMENTS FELL INTO THE PATIENT. THE PROCEDURE WAS PERFORMED, WITHOUT ANY DELAY, USING AN EQUIVALENT S+N BACK- UP. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23906239 ↗
• MalfunctionNov 13, 2025Fracture; Fracture

  IT WAS REPORTED THAT, DURING A TKA SURGERY, AN OUTER-GRIP LOCKING FEM IMPLANT IMPACTOR BROKE DURING IMPACTION. THE SURGERY WAS COMPLETED, AFTER A NON-SIGNIFICANT DELAY, WITH AN EQUIVALENT S+N BACK-UP PRODUCT. IT IS UNKNOWN IF ANY PIECE FELL INSIDE THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23542194 ↗
• MalfunctionDec 17, 2024Fracture; Fracture

  IT WAS REPORTED THAT DURING A TKA, THE DISTAL METAL CLASP OF A OUTER-GRIP LOCKING FEM IMPLANT IMPACTOR BROKE DURING IMPACTION. THERE WAS NO DELAY AND THE PROCEDURE WAS FINISHED USING THE SAME DEVICE. PATIENT WAS NOT HARMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20952483 ↗
• MalfunctionDec 1, 2024Fracture; Fracture

  IT WAS REPORTED THAT, DURING A TKA SURGERY, THE INSERTER TAB OF A OUTER-GRIP LOCKING FEM IMPLANT IMPACTOR BROKE OFF WHEN INSERTING FEMUR. ALL PIECES WERE RECOVERED BY HAND. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, WITH A CHANGE IN THE SURGICAL TECHNIQUE. NO INJURY WAS REPORTED AS A CONSEQUENCE OF THIS ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20815716 ↗
• MalfunctionNov 22, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT, DURING A TKA WHEN IMPACTING THE IMPLANT, ONE (1) OUTER-GRIP LOCKING FEM IMPLANT IMPACTOR HAD THE SPIRING AND PIN MISSING, WHERE THE FEMORAL IMPACTOR BUMPER SNAPS INTO PLACE. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING A S+N BACK-UP DEVICE. NO INJURY WAS REPORTED AS A CONSEQUENCE OF THIS ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20760141 ↗
• MalfunctionNov 7, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT, DURING A TKA SURGERY, ONE (1) OUTER-GRIP LOCKING FEM IMPLANT IMPACTOR HAD A PIN FALL OUT DURING IMPACTION, IT DID NOT FALL INTO THE PATIENT. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING THE SAME DEVICE. NO INJURY WAS REPORTED AS A CONSEQUENCE OF THIS ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20630383 ↗
• MalfunctionOct 29, 2024Break; Break

  IT WAS REPORTED THAT, DURING A TKA, THE LOCKING MECHANISM OF ONE (1) OUTER-GRIP LOCKING FEM IMPLANT IMPACTOR WAS NOTICED TO BE BROKEN. THE PROCEDURE WAS RESUMED, AFTER A NON-SIGNIFICANT DELAY, WITH A S+N BACK-UP DEVICE. PATIENT WAS NOT HARMED AS A CONSEQUENCE OF THIS PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20556662 ↗
• InjuryOct 23, 2024Fracture; Fracture

  IT WAS REPORTED THAT, DURING FINAL X-RAY FOR TKA SURGERY AND AFTER ONE (1) OUTER-GRIP LOCKING FEM IMPLANT IMPACTOR WAS USED NORMALLY TO HIT THE FEMORAL COMPONENT, IT WAS NOTICED THAT THERE WAS A PIECE OF METAL IN THE PATIENT. IT IS UNKNOWN IF/HOW THE PROBLEM WAS RESOLVED OR WHAT WAS THE PATIENT OUTCOME.

  Patient problems: Foreign Body In Patient

  MAUDE report 20517766 ↗
• InjuryOct 14, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER A TKA SURGERY WAS PERFORMED ON (B)(6) 2024, IT WAS FOUND A PIECE OF METAL IN A POLY EXCHANGE AND WASH OUT PROCEDURE. THIS ADVERSE EVENT WAS TREATED BY A REVISION SURGERY ON (B)(6) 2024, IN WHICH AN OUTER-GRIP LOCKING FEM IMPLANT IMPACTOR WAS EXCHANGED. PATIENT'S CURRENT HEALTH STATUS IS UNKNOWN.

  Patient problems: Insufficient Information

  MAUDE report 20446508 ↗
• MalfunctionAug 7, 2024Positioning Failure; Fracture; Positioning Failure; Fracture

  IT WAS REPORTED THAT, DURING A TKA SURGERY, FIVE (5) OUTER-GRIP LOCKING FEM IMPLANT IMPACTOR WILL NOT CLASP ONTO THE FEMORAL IMPLANT SUFFICIENTLY DUE TO NOB MALFUNCTION. THE SURGERY WAS COMPLETED, WITHOUT ANY DELAY, WITH A S+N BACK-UP DEVICE. NO INJURIES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19933441 ↗
• MalfunctionJul 30, 2024Break; Fracture; Break; Fracture

  IT WAS REPORTED THAT DURING A TKA SURGERY, THE SIDE METAL PRONGS OF ONE (1) OUTER-GRIP LOCKING FEM IMPLANT IMPACTOR, WHICH HOLDS ONTO THE SIDE OF THE IMPLANT, BROKE. THE PROCEDURE RESUMED, WITHOUT ANY DELAY, USING THE SAME DEVICE. NO INJURY WAS REPORTED AS A CONSEQUENCE OF THIS ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19862301 ↗
• MalfunctionJun 17, 2024Detachment of Device or Device Component; Mechanics Altered; Detachment of Device or Device Component; Mechanics Altered

  IT WAS REPORTED THAT DURING A TKA SURGERY, THE HANDLE OF THE OUTER-GRIP LOCKING FEM IMPLANT IMPACTOR NO LONGER HELD THE IMPLANT. FURTHERMORE, THE SNAP RING GOT DETACHED DURING PROCEDURE, THE PIECE WAS RECOVERED FROM THE DRAPES. INTRAOPERATIVE X-RAY WERE PERFORMED TO ENSURE NO METAL PIECES WERE LEFT IN THE PATIENT. THE PROCEDURE WAS PERFORMED, AFTER NO DELAY, USING A S+N BACK-UP DEVICE. PATIENT WAS NOT HARMED AS CONSEQUENCE OF THIS PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19554548 ↗
• MalfunctionMay 21, 2024Fracture; Fracture

  IT WAS REPORTED THAT DURING TKA SURGERY, WHILE IMPACTING THE FINAL FEMUR IMPLANT. THE TIP OF AN OUTER-GRIP LOCKING FEM IMPLANT IMPACTOR BROKE OFF. THE BROKEN OFF PIECE WAS RETRIEVED. THE WOUND WAS IRRIGATED AND NO PIECES WERE LEFT IN THE WOUND. SURGERY WAS RESUMED AFTER A NON-SIGNIFICANT DELAY WITH A CHANGE IN SURGICAL TECHNIQUE. NO INJURIES TO THE PATIENT WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19357976 ↗
• MalfunctionMay 15, 2024Fracture; Detachment of Device or Device Component; Fracture; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A TKA SURGERY, THE IMPACTING PART OF ONE (1) OUTER-GRIP LOCKING FEM IMPLANT IMPACTOR BROKE OFF FROM THE HANDLE. ADDITIONALLY, IT WAS NOTICED THAT ITS SPRING AND BOLT WERE LOST. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING A S+N BACK-UP DEVICE. NO PIECES FELL INTO THE PATIENT AND NO HARM WAS REPORTED AS A CONSEQUENCE OF THIS ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19318908 ↗
• MalfunctionApr 30, 2024Fracture; Fracture

  IT WAS REPORTED THAT, DURING A TKA, THE SIDE GRASPING CLAW OF ONE (1) OUTER-GRIP LOCKING FEM IMPLANT IMPACTOR SHEARED OFF. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING A S+N BACK-UP DEVICE. PATIENT WAS NOT HARMED AS CONSEQUENCE OF THIS PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19217211 ↗
• MalfunctionMar 18, 2024Fracture; Detachment of Device or Device Component; Fracture; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A TKA SURGERY ONE (1) OUTER-GRIP LOCKING FEM IMPLANT IMPACTOR WAS DISASSEMBLED WHEN IMPACTING THE FEMORAL COMPONENT. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING THE SAME DEVICE. NO INJURY WAS REPORTED AS A CONSEQUENCE OF THIS ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18926928 ↗
• MalfunctionFeb 15, 2024Fracture; Fracture

  IT WAS REPORTED THAT, DURING IMPACTION OF FINAL IMPLANT IN A TKA SURGERY, THE IMPACTOR BECAME UNSTABLE AND UPON INSPECTION, THE PART OF THE METAL CLAW BROKE OFF. THE LOOSE PIECE WAS RETRIEVED AND THE JOINT WAS IRRIGATED TO ENSURE NO RESIDUALS WERE LEFT IN THE JOINT. NO X-RAYS WERE TAKEN AND NO PIECES WERE LEFT IN THE JOIN. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING THE SAME DEVICE. PATIENT WAS NOT INJURED AS CONSEQUENCE OF THIS PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18717537 ↗
• MalfunctionFeb 14, 2024Fracture; Fracture

  IT WAS REPORTED THAT DURING A TKA SURGERY, THE OUTER-GRIP LOCKING FEM IMPLANT IMPACTOR BROKE DURING IMPACTION. IT IS UNKNOWN HOW WAS COMPLETED THE PROCEDURE AND IF A DELAY WAS PRESENTED. NO INJURY TO PATIENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18707411 ↗
• MalfunctionFeb 9, 2024Fracture; Fracture

  IT WAS REPORTED THAT, DURING A TKA SURGERY, AN OUTER-GRIP LOCKING FEM IMPLANT IMPACTOR FRACTURED UPON IMPACTION. NO PIECES REMAINED IN THE PATIENT. THE PROCEDURE WAS PERFORMED WITHOUT ANY DELAY. A S+N BACK-UP DEVICE WAS AVAILABLE BUT IT WAS NOT NEEDED. NO INJURY WAS REPORTED AS A CONSEQUENCE OF THIS ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18677621 ↗