Anthology 71365701Recalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 03596010559814), received between Aug 19, 2020 and May 26, 2022 — classified as 12 malfunctions.

The most frequently reported specific device problem is “Defective Device” (4 reports).

2 other recalls cover devices cleared under the same FDA submission (K123598); 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. 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 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 26, 2022Crack; Flaked; Detachment of Device or Device Component; Crack; Flaked; Detachment of Device or Device Component

  IT WAS REPORTED THAT, THE MAGNETS OF THREE (3) ANTHOLOGY SO TR NECK SZ 1-6 WERE FALLING OUT OF THE NECKS. IN ADDITION, THEY ARE CRACKED AND FLACKING OFF. AS THIS WAS NOTICED UPON CLEANING AND STERILIZATION ACTIVITIES, THERE WAS NOT PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14517821 ↗
• MalfunctionMar 16, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT, DURING SET UP OR INSPECTION, THE MAGNETS OF THE ANTHOLOGY SO TR NECK SZ 7 12 WERE FALLING APART. THE PROCEDURE WAS COMPLETED WITHOUT DELAY USING A S+N BACK UP DEVICE. PATIENT WAS NOT HARMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13777205 ↗
• MalfunctionJan 7, 2022Break; Break

  IT WAS REPORTED THAT, AN ANTHOLOGY SO TR NECK SZ 1-6 WAS FOUND BROKEN. AS THIS WAS NOTICE IN A WAREHOUSE, NOT PATIENT WAS INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13192411 ↗
• MalfunctionJun 29, 2021Material Fragmentation; Defective Device; Material Fragmentation; Defective Device

  IT WAS REPORTED THAT, AFTER A TKA SURGERY, THE MAGNETS OF THREE (3) ANTHOLOGY SO TR NECK SZ 1-6, THREE (3) ANTHOLOGY SO TR NECK SZ 7-12, THREE (3) ANTHOLOGY HO TR NECK SZ 1-6 AND THREE (3) ANTHOLOGY HO TR NECK SZ 7-12 ARE BREAKING DOWN AND NOT HOLDING. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT DELAY USING THE SAME DEVICE. PATIENT WAS NOT HARMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12082339 ↗
• MalfunctionJun 29, 2021Material Fragmentation; Defective Device; Material Fragmentation; Defective Device

  IT WAS REPORTED THAT, AFTER A TKA SURGERY, THE MAGNETS OF THREE (3) ANTHOLOGY SO TR NECK SZ 1-6, THREE (3) ANTHOLOGY SO TR NECK SZ 7-12, THREE (3) ANTHOLOGY HO TR NECK SZ 1-6 AND THREE (3) ANTHOLOGY HO TR NECK SZ 7-12 ARE BREAKING DOWN AND NOT HOLDING. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT DELAY USING THE SAME DEVICE. PATIENT WAS NOT HARMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12082338 ↗
• MalfunctionJun 29, 2021Material Fragmentation; Defective Device; Material Fragmentation; Defective Device

  IT WAS REPORTED THAT, AFTER A TKA SURGERY, THE MAGNETS OF THREE (3) ANTHOLOGY SO TR NECK SZ 1-6, THREE (3) ANTHOLOGY SO TR NECK SZ 7-12, THREE (3) ANTHOLOGY HO TR NECK SZ 1-6 AND THREE (3) ANTHOLOGY HO TR NECK SZ 7-12 ARE BREAKING DOWN AND NOT HOLDING. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT DELAY USING THE SAME DEVICE. PATIENT WAS NOT HARMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12082331 ↗
• MalfunctionFeb 2, 2021Crack; Crack

  IT WAS REPORTED THAT DURING STERILIZATION PROCESS THAT THE MAGNETS CRACK AND FLAKE OUT. NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11269356 ↗
• MalfunctionOct 12, 2020Material Disintegration; Material Disintegration

  IT WAS REPORTED DURING THE PROCEDURE, THR, THAT THE COATING ON TRIAL NECKS WEAR OFF, CAUSING THAT THE MAGNET DETACHES FROM THE TRIAL NECK. THE PROCEDURE WAS COMPLETED WITHOUT DELAY, USING THE SAME DEVICE. NO PATIENT INJURY OR OTHER COMPLICATIONS WERE REPORTED. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10667929 ↗
• MalfunctionOct 9, 2020Material Disintegration; Material Disintegration

  IT WAS REPORTED DURING THE PROCEDURE, THR, THAT THE COATING ON TRIAL NECKS WEAR OFF, CAUSING THAT THE MAGNET DETACHES FROM THE TRIAL NECK. THE PROCEDURE WAS COMPLETED WITHOUT DELAY, USING THE SAME DEVICE. NO PATIENT INJURY OR OTHER COMPLICATIONS WERE REPORTED. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10655529 ↗
• MalfunctionOct 9, 2020Material Disintegration; Material Disintegration

  IT WAS REPORTED DURING THE PROCEDURE, THR, THAT THE COATING ON TRIAL NECKS WEAR OFF, CAUSING THAT THE MAGNET DETACHES FROM THE TRIAL NECK. THE PROCEDURE WAS COMPLETED WITHOUT DELAY, USING THE SAME DEVICE. NO PATIENT INJURY OR OTHER COMPLICATIONS WERE REPORTED. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10655457 ↗
• MalfunctionSep 11, 2020Defective Device; Defective Device

  IT WAS REPORTED THAT DURING INSPECTION IN THR PROCEDURE THE ANTHOLOGY SO TR NECK SZ 1-6 WAS FOUND TO BE DAMAGED. IT IS UNKNOWN WHEN THE MALFUNCTION WAS DISCOVERED. A DELAY GREATER THAN 30 MIN WAS REPORTED. IT IS UNKNOWN OF THERE WAS A S&N BACK UP DEVICE TO COMPLETE THE PROCEDURE. NO OTHER COMPLICATIONS WERE REPORTED AT THIS TIME. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10524295 ↗
• MalfunctionAug 19, 2020Crack; Crack

  IT WAS REPORTED THAT THE MAGNET ON THE NECK TRIAL WAS FOUND CRACKED. THIS WAS DISCOVERED AFTER THE CASE. THE PATIENT WAS NOT IMPACTED.

  Patient problems: No Patient Involvement

  MAUDE report 10428419 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K123598. One submission often covers many models, so check the product and lot details in each record.

• Z-0730-2019 · Jan 7, 2019 · Terminated
  SL PLUS MIA DOUBLE OFFSET ADAPTER RIGHT 60/25MM, S&N 75004613
• Z-1008-2017 · Nov 16, 2016 · Terminated
  REFLECTION(R) DEAD BLOW MALLET, REF 71362106, QTY: (1), NON-STERILE, Smith & Nephew, Inc,. Memphis, TN 38116