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Anthology 71365707Recalls & reported problems

Smith & Nephew, Inc. · ANTHOLOGY STANDARD OFFSET TRIAL NECK SIZE 7-12 · Class 2

All models of ANTHOLOGY (69)

Data updated Oct 16, 2026 from official FDA records · Editorial policy

Adverse event reports
15
Deaths reported
0
Injuries reported
0
Recalls naming it
0

Summary

The FDA's MAUDE database contains 15 adverse event reports that list this exact device (DI 03596010559845), received between Jul 1, 2020 and Aug 31, 2022 — classified as 15 malfunctions.

The most frequently reported specific device problem is “Break” (5 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

Device problems

  • Break5
  • Material Fragmentation4
  • Defective Device3
  • Detachment of Device or Device Component2
  • Material Disintegration2
  • Crack1
  • Degraded1
  • Difficult to Insert1

Patient problems

  • No Clinical Signs, Symptoms or Conditions12
  • No Known Impact Or Consequence To Patient2
  • No Patient Involvement1

Recent adverse event reports

The 15 most recent of 15 reports, in the reporter's own words as published by the FDA.

  • MalfunctionAug 31, 2022Fracture; Difficult to Insert; Fracture; Difficult to Insert

    IT WAS REPORTED THAT THE ANTHOLOGY SO TR NECK SZ 7-12 IS BROKEN, IT DOES NOT SIT ON BROACH PROPERLY. AS THIS WAS NOTICED UPON FIELD INSPECTION, NO PATIENT WAS INVOLVED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 15326940 ↗
  • 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 15245623 ↗
  • 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 15245162 ↗
  • 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 7-12 WERE FALLING OUT OF THE NECKS. THEY ARE CRACKED APART 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 14518002 ↗
  • MalfunctionMay 6, 2022Break; Break

    IT WAS REPORTED THAT, THE MAGNET OF AN ANTHOLOGY SO TR NECK SZ 7-12 IS BROKEN. AS THIS WAS NOTICED UPON CLEANING AND STERILIZATION ACTIVITIES, THERE WAS NOT PATIENT INVOLVEMENT.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 14309822 ↗
  • 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 13777162 ↗
  • MalfunctionJan 7, 2022Break; Break

    IT WAS REPORTED THAT AN ANTHOLOGY SO TR NECK SIZE 7-12 WAS BROKEN. SINCE THIS WAS NOTICED DURING A FIELD INSPECTION, NO CASE WAS INVOLVED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 13195595 ↗
  • 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 12250818 ↗
  • 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 12082344 ↗
  • 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 12082343 ↗
  • 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 12082341 ↗
  • MalfunctionMay 20, 2021Break; Break

    IT WAS REPORTED THAT DURING SPD, THE MAGNET FELL OUT OF ANTHOLOGY SO TR NECK SIZE 7-12. NO CASE INVOLVED; THEREFORE, NO OTHER COMPLICATIONS WERE REPORTED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 11860131 ↗
  • 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 10667959 ↗
  • 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 10655491 ↗
  • MalfunctionJul 1, 2020Break; Break

    IT WAS REPORTED THAT THE ANTHOLOGY SO TR NECK SIZE 7-12 MAGNET COVER HAVE CHIPPED OFF. 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 Patient Involvement

    MAUDE report 10218023 ↗

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

Other Prosthesis, hip, femoral component, cemented, metal devices

All Prosthesis, hip, femoral component, cemented, metal devices →

Sources and updates

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