NA 71369715Recalls & reported problems

Summary

The FDA's MAUDE database contains 16 adverse event reports that list this exact device (DI 03596010555618), received between May 31, 2019 and Mar 18, 2024 — classified as 4 injuries, 12 malfunctions.

The most frequently reported specific device problem is “Break” (10 reports).

4 other recalls cover devices cleared under the same FDA submission (K121393); they may or may not involve this specific model.

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 16 most recent of 16 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 18, 2024Break; Break

  IT WAS REPORTED THAT DURING A THR, THE INSIDE TAB BROKE THEREFORE, THE MI TRIAL FEM HEAD 32 +0 DID NOT STAY ON THE NECK ANYMORE. SURGERY WAS PERFORMED, WITHOUT ANY DELAY, WITH A BACK-UP DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18926734 ↗
• MalfunctionSep 7, 2023Fracture; Fracture

  IT WAS REPORTED THAT DURING A THR SURGERY, THE MI TRIAL FEM HEAD 32 +0 INNER GRIPPING TABS BROKE OFF, HEAD WILL NO LONGER ATTACH TO NECK. PIECES FELL INTO THE PATIENT AND WERE RETRIEVED. THE PROCEDURE WAS RESUMED AFTER A NON-SIGNIFICANT DELAY WITH A S+N BACK-UP DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED AS A CONSEQUENCE OF THIS PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17698994 ↗
• InjuryNov 2, 2022Off-Label Use; Off-Label Use

  IT WAS REPORTED THAT, DURING A THR, A MI TRIAL FEM HEAD 32 +0 CAME OFF AND GOT STUCK INSIDE THE PATIENT. EVEN THOUGH ATTEMPTS WERE MADE TOWARDS RETRIEVING THE DEVICE, THEY WERE UNSUCCESSFUL. FINALLY, THE TRIAL WAS LEFT INSIDE THE PATIENT DUE TO THE PATIENT'S ANATOMY. SURGERY WAS RESUMED, WITH A BACKUP DEVICE, BUT IT REMAINS UNSPECIFIED IF THERE WAS A DELAY. NO COMPLICATIONS WERE REPORTED.

  Patient problems: Foreign Body In Patient

  MAUDE report 15715036 ↗
• MalfunctionMay 12, 2022Break; Break

  IT WAS REPORTED THAT ONE MI TRIAL FEM HEAD 36 -3, ONE MI TRIAL FEM HEAD 36 +0 AND ONE MI TRIAL FEM HEAD 32 +0 HAVE INNER FLANGES THAT HAVE BROKEN AWAY PREVENTING THE TRIAL HEAD FROM SEATING ON THE FEMORAL TRIAL/STEM. SURGICAL REPROCESSING HAS DISCARDED. NO CASE INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14377619 ↗
• InjuryMar 25, 2022Break; Break

  IT WAD REPORTED THAT, DURING A THR SURGERY, THE MI TRIAL FEM HEAD 32 +0 BROKE INSIDE PATIENT. ALL PIECES WERE RETRIEVED. SURGERY WAS RESUMED, WITHOUT ANY DELAY, USING THE SAME DEVICE. PATIENT WAS NOT HARMED BEYOND THE REPORTED PROBLEM. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13910633 ↗
• MalfunctionMar 23, 2022Break; Break

  IT WAS REPORTED THAT THE INNER BUSHING OF A MI TRIAL FEMORAL HEAD 32MM +0 IS BROKEN AND WOULD NO LONGER FIT ON TRIALS. AS THIS WAS NOTICED IN A NON-SURGICAL ENVIRONMENT, THERE WAS NOT ANY PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13870319 ↗
• InjuryFeb 28, 2022Break; Break

  IT WAS REPORTED THAT FOLLOWING TRIALING AND AFTER HIP WAS DISLOCATED DURING A THR SURGERY, A FRAGMENT OF THE MI TRIAL FEM HEAD 32 +0 BROKE OFF WHILE INSIDE THE PATIENT. THE PROCEDURE WAS COMPLETED, WITHOUT DELAY, USING THE SAME DEVICE. PATIENT WAS NOT HARMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13620396 ↗
• MalfunctionJan 18, 2022Break; Naturally Worn; Break; Naturally Worn

  IT WAS REPORTED THAT THE MI TRIAL FEM HEAD 32 +0 WAS DAMAGED. IT WAS FOUND TO BE BROKEN AND WORN. AS THIS WAS NOTICED UPON FIELD INSPECTION, THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13282364 ↗
• MalfunctionJul 29, 2021Break; Break

  IT WAS REPORTED THAT, THE INNER FLANGE OF A MI TRIAL FEM HEAD 32 +0 HAS BROKEN, PREVENTING THE TRIAL HEAD FROM SEATING ON THE STEM CORRECTLY. AS THIS WAS NOTICED IN A NON-SURGICAL ENVIRONMENT, THERE WAS NOT ANY PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12250781 ↗
• MalfunctionApr 18, 2021Loose or Intermittent Connection; Naturally Worn; Loose or Intermittent Connection; Naturally Worn

  IT WAS REPORTED THAT, THREE 32 +0 TRIAL HEADS ARE WORN AND WILL NOT ARTICULATE WITH THE FEMORAL STEM SECURELY. NO CASE REPORTED; THEREFORE, THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11683508 ↗
• MalfunctionApr 18, 2021Loose or Intermittent Connection; Naturally Worn; Loose or Intermittent Connection; Naturally Worn

  IT WAS REPORTED THAT, THREE 32 +0 TRIAL HEADS ARE WORN AND WILL NOT ARTICULATE WITH THE FEMORAL STEM SECURELY. NO CASE REPORTED; THEREFORE, THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11683507 ↗
• MalfunctionApr 18, 2021Loose or Intermittent Connection; Naturally Worn; Loose or Intermittent Connection; Naturally Worn

  IT WAS REPORTED THAT, THREE 32 +0 TRIAL HEADS ARE WORN AND WILL NOT ARTICULATE WITH THE FEMORAL STEM SECURELY. NO CASE REPORTED; THEREFORE, THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11683506 ↗
• MalfunctionNov 13, 2020Break; Break

  IT WAS REPORTED THAT THE 32 +0 MM TRIAL HEAD WILL NOT SEAT ON TRIAL STEM AS INNER FLANGE HAS BROKE OFF NOT ALLOWING THE TRIAL HEAD TO SEAT. NO CASE INVOLVED. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Patient Involvement

  MAUDE report 10836830 ↗
• InjuryOct 7, 2020Break; Break

  IT WAS REPORTED THAT DURING THR SURGERY, THE PLASTIC FLANGE ON UNDERSIDE OF MI TRIAL FEMORAL HEAD 32 +0 BROKE OFF WHILE USING INSIDE THE PATIENT. THE TRIAL HEAD WILL NOT SEAT ON TRUNION AND MUST BE REPLACED. THE PROCEDURE WAS FINISHED USING A SMITH AND NEPHEW BACK UP DEVICE, WITH A SURGICAL DELAY OF LESS THAN 30 MINUTES AND NO INJURY TO THE PATIENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10642666 ↗
• MalfunctionOct 1, 2020Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT THE MECHANISM WHICH HOLDS THE HEAD TO THE TRIAL NECK BROKE OFF, RENDERING THE HEAD UNUSABLE. AS NOTICED IN THE MDRD, NO CASE WAS INVOLVED.

  Patient problems: No Patient Involvement

  MAUDE report 10614194 ↗
• MalfunctionMay 31, 2019Break; Break

  IT WAS REPORTED THAT WHEN TRIALING FOR FEMORAL STEM SIZE,  ONE OF THE ¿FLANGES¿ INSIDE THE 32MM +0 TRIAL HEAD BROKE OFF. DELAY FROM 1-30MIN WAS REPORTED AND BACK-UP DEVICE WAS AVAILABLE. NO INJURY OR PATIENT IMPACT INVOLVED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8660894 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K121393. One submission often covers many models, so check the product and lot details in each record.

• Z-0878-2020 · Dec 16, 2019 · Open, Classified
  LEGION AP Cutting Block Size 4, REF 71434409; LEGION AP Cutting Block Size 6, REF 71434411; LEGION AP Cutting Block Size 7, REF 71434412; LEGION AP Cutting Block Size 8, REF 714344
• Z-0200-2019 · Sep 18, 2018 · Terminated
  Smith+Nephew Orthopaedic Division LEGION A/P FEMORAL CUTTING BLOCK, SIZE 6 REF 71434411, QTY: (1) The LEGION AP Femoral Cutting Block is a reusable surgical instrument used to mak
• Z-2163-2018 · May 4, 2018 · Terminated
  smith&nephew GENESIS(R) II TIBIAL Punch, 13 MM, REF 71440408, QTY: (1)
• Z-1902-2018 · Apr 9, 2018 · Terminated
  smith&nephew 5o (5 degree) GENESIS(R) II VALGUS BUSHING, REF CATALOG NUMBER 71440014 The GENESIS II Knee System Components are indicated for rheumatoid arthritis; post-traumatic a