Anthology 71365801Recalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 03596010559876), received between Oct 9, 2020 and May 26, 2022 — classified as 13 malfunctions.

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

Most reported problems

Recent adverse event reports

The 13 most recent of 13 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 HO 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 14518059 ↗
• 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 HO 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 14517873 ↗
• MalfunctionMar 16, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE MAGNETS OF AN ANTHOLOGY HO TR NECK SZ 1-6 ARE FALLING APART. NO CASE INVOLVED; THEREFORE, THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13777415 ↗
• MalfunctionJan 7, 2022Break; Break

  IT WAS REPORTED THAT, AN ANTHOLOGY HO 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 13195257 ↗
• MalfunctionJul 30, 2021Break; Break

  IT WAS REPORTED THAT, DURING STERILIZATION, A ANTHOLOGY HO TR NECK SZ 1-6 AND A ANTHOLOGY SO TR NECK SZ 7-12 WERE NOTICED TO HAVE A LAYER OF THE MAGNETS UNDER EACH ONE CHIPPED 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 12250824 ↗
• 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 12082351 ↗
• 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 12082348 ↗
• 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 12082346 ↗
• MalfunctionApr 28, 2021Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT THE BLACK COATING OF THE ANTHOLOGY HO TRIAL NECK SIZE 1-6 IS CHIPPING OFF FROM THE MAGNET IS LOCATED. THERE WAS NO CASE INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11742457 ↗
• MalfunctionFeb 2, 2021Crack; Crack

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11269395 ↗
• 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 10667943 ↗
• 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 10655552 ↗
• MalfunctionOct 9, 2020Material Disintegration; Naturally Worn; Material Disintegration; Naturally Worn

  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 Clinical Signs, Symptoms or Conditions; No Known Impact Or Consequence To Patient

  MAUDE report 10655466 ↗

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