Anthology 71365807Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 03596010559883), received between Oct 9, 2020 and Aug 17, 2022 — classified as 11 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. 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 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 17, 2022Degraded; Material Fragmentation; Degraded; Material Fragmentation

  IT WAS REPORTED THAT, BOTH BUMPERS ON THE ANTHOLOGY SO TR NECK SZ 7-12 AND ANTHOLOGY HO TR NECK SZ 7-12 WERE EITHER WEARING OFF OR COMPLETELY WORN OFF CAUSING DEBRIS IN SET. 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 15245680 ↗
• MalfunctionAug 17, 2022Material Erosion; Material Erosion

  IT WAS REPORTED THAT, BOTH BUMPERS ON THE ANTHOLOGY SO TR NECK SZ 7-12 AND ANTHOLOGY HO TR NECK SZ 7-12 WERE EITHER WEARING OFF OR COMPLETELY WORN OFF CAUSING DEBRIS IN SET. 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 15245219 ↗
• MalfunctionMar 16, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE MAGNETS OF A ANTHOLOGY HO TR NECK SZ 7-12 ARE FALLING APART. NO CASE INVOLVED; THEREFORE, THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13777278 ↗
• MalfunctionMar 10, 2022Break; Break

  IT WAS REPORTED THAT THE ANTHOLOGY HO TR NECK SIZE 7-12 WAS BROKEN. IT IS UNKNOWN WHETHER THIS PROBLEM WAS NOTICED IN A SURGICAL ENVIRONMENT OR NOT; THEREFORE, PATIENT INVOLVEMENT HAS NOT BEEN CONFIRMED.

  Patient problems: Insufficient Information

  MAUDE report 13722787 ↗
• MalfunctionJan 7, 2022Break; Break

  IT WAS REPORTED THAT, AN ANTHOLOGY HO TR NECK SZ 7-12 WAS DISCOVERED TO BE BROKEN. AS THIS WAS NOTICED UPON FIELD INSPECTION, THERE WAS NOT PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13192346 ↗
• 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 12082337 ↗
• 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 12082333 ↗
• 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 12082329 ↗
• 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 10667971 ↗
• 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 10655573 ↗
• 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 Known Impact Or Consequence To Patient

  MAUDE report 10655506 ↗

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