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 · TerminatedSL PLUS MIA DOUBLE OFFSET ADAPTER RIGHT 60/25MM, S&N 75004613
- Z-1008-2017 · Nov 16, 2016 · TerminatedREFLECTION(R) DEAD BLOW MALLET, REF 71362106, QTY: (1), NON-STERILE, Smith & Nephew, Inc,. Memphis, TN 38116
Other Prosthesis, hip, femoral component, cemented, metal devices
- GENESIS II 71440005Smith & Nephew, Inc. · Prosthesis, hip, femoral component, cemented, metal599 reports
- NA 71364073Smith & Nephew, Inc. · Prosthesis, hip, femoral component, cemented, metal436 reports
- Peri-Loc 71173377Smith & Nephew, Inc. · Prosthesis, hip, femoral component, cemented, metal401 reports
- R3 71368569Smith & Nephew, Inc. · Prosthesis, hip, femoral component, cemented, metal398 reports
- NA 71364006Smith & Nephew, Inc. · Prosthesis, hip, femoral component, cemented, metal197 reports
- NA 71364011Smith & Nephew, Inc. · Prosthesis, hip, femoral component, cemented, metal176 reports
- Accord 71360046Smith & Nephew, Inc. · Prosthesis, hip, femoral component, cemented, metal171 reports
- REFLECTION 71362279Smith & Nephew, Inc. · Prosthesis, hip, femoral component, cemented, metal155 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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