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Anthology 71365706Recalls & reported problems

Smith & Nephew, Inc. · ANTHOLOGY INSERTER POSTERIOR SOFT · Class 2

All models of ANTHOLOGY (69)

Data updated Oct 18, 2026 from official FDA records · Editorial policy

Adverse event reports
21
Deaths reported
0
Injuries reported
3
Recalls naming it
0

Summary

The FDA's MAUDE database contains 21 adverse event reports that list this exact device (DI 03596010555670), received between Oct 1, 2018 and Jul 29, 2025 — classified as 3 injuries, 18 malfunctions.

The most frequently reported specific device problem is “Break” (12 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 18, 2026.

Reports received per month

Nov 2023: 0 reportsDec 2023: 1 reportsJan 2024: 0 reportsFeb 2024: 0 reportsMar 2024: 0 reportsApr 2024: 0 reportsMay 2024: 0 reportsJun 2024: 0 reportsJul 2024: 0 reportsAug 2024: 0 reportsSep 2024: 0 reportsOct 2024: 0 reportsNov 2024: 0 reportsDec 2024: 0 reportsJan 2025: 0 reportsFeb 2025: 1 reportsMar 2025: 0 reportsApr 2025: 0 reportsMay 2025: 0 reportsJun 2025: 0 reportsJul 2025: 1 reportsAug 2025: 0 reportsSep 2025: 0 reportsOct 2025: 0 reportsNov 2025: 0 reportsDec 2025: 0 reportsJan 2026: 0 reportsFeb 2026: 0 reportsMar 2026: 0 reportsApr 2026: 0 reportsMay 2026: 0 reportsJun 2026: 0 reportsJul 2026: 0 reportsAug 2026: 0 reportsSep 2026: 0 reportsOct 2026: 0 reports2024202520261
Last 36 months. The most recent month may be incomplete.

Most reported problems

Device problems

  • Break12
  • Fracture9

Patient problems

  • No Clinical Signs, Symptoms or Conditions16
  • No Consequences Or Impact To Patient2
  • Foreign Body In Patient1
  • No Information1
  • No Known Impact Or Consequence To Patient1

Recent adverse event reports

The 21 most recent of 21 reports, in the reporter's own words as published by the FDA.

  • MalfunctionJul 29, 2025Fracture; Fracture

    IT WAS REPORTED THAT DURING A THR SURGERY, THE TIP OF THE ANTHOLOGY INSERTER POST SOFT BROKE OFF. THE PIECE THAT BROKE OFF DID NOT FALL INTO THE WOUND. IT WAS REMOVED FROM THE STEM INSERTION POINT BY VARIOUS OTHER MEDICAL INSTRUMENTATION. IT WAS ONE PIECE THAT WAS REMOVED. THE PROCEDURE WAS RESUMED, WITHOUT ANY SURGICAL DELAY, USING A S+N BACK-UP DEVICE. PATIENT WAS NOT INJURED AS CONSEQUENCE OF THIS PROBLEM.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 22647152 ↗
  • MalfunctionFeb 18, 2025Fracture; Fracture

    IT WAS REPORTED THAT, DURING THR SURGERY, WHILE INSERTING THE STEM, THE TIP OF ONE (1) ANTHOLOGY INSERTER POST SOFT BROKE OFF. ALL PIECES WERE RETRIEVED BY HAND. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING A S+N BACK-UP DEVICE. NO INJURY WAS REPORTED AS A CONSEQUENCE OF THIS ISSUE.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 21399919 ↗
  • MalfunctionDec 5, 2023Fracture; Fracture

    IT WAS REPORTED THAT DURING THR SURGERY, WHILE ATTEMPTING TO REMOVE ANTHOLOGY STEM FROM FEMUR, WHEN THE DIMPLE UNDER THE CALCAR OF THE STEM WAS HIT, THE SMALL NUB OF AN ANTHOLOGY INSERTER POST SOFT BROKE OFF. SURGERY WAS RESUMED WITHOUT ANY DELAY WITH A S+N BACK-UP DEVICE. PATIENT WAS NOT HARMED AS CONSEQUENCE OF THE PROBLEM.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 18267509 ↗
  • MalfunctionOct 30, 2023Fracture; Fracture

    IT WAS REPORTED THAT, DURING A THR SURGERY, THE TIP OF ONE (1) ANTHOLOGY INSERTER POST SOFT BROKE OFF. NO PATIENT HARM. ALL PIECES WERE RETRIEVED BY HAND, NOTHING WAS LEFT ON THE PATIENT. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING A S+N BACK-UP DEVICE. PATIENT WAS NOT INJURED AS CONSEQUENCE OF THIS PROBLEM.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 18035922 ↗
  • InjuryFeb 23, 2023Fracture; Fracture

    IT WAS REPORTED THAT, SEVERAL WEEKS LATER AFTER A THR ON (B)(6) 2022, IT WAS NOTICED THAT THE TIP OF ONE (1) ANTHOLOGY INSERTER POST SOFT BROKE OFF INTO THE FINAL IMPLANT AND WAS FOUND FLOATING IN THE PATIENT'S PROXIMAL FEMUR BY THE GREATER TROCHANTER. THE TIP HAS NOT BEEN REMOVED FROM THE PATIENT YET, SURGERY IS BEING SCHEDULED. THE PATIENT IS NOT EXPERIENCING ANY HEALTH ISSUES.

    Patient problems: Foreign Body In Patient

    MAUDE report 16431922 ↗
  • MalfunctionOct 4, 2022Fracture; Fracture

    IT WAS REPORTED THAT DURING A THR, THE TIP OF A ANTHOLOGY INSERTER POST SOFT BROKE OFF WHEN PUTTING IN THE STEM. SURGERY WAS PERFORMED, WITHOUT ANY DELAY, WITH A S+N BACK-UP DEVICE INSTEAD. PATIENT WAS NOT INJURED AS CONSEQUENCE OF THIS PROBLEM.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 15535474 ↗
  • MalfunctionSep 13, 2022Break

    IT WAS REPORTED THAT DURING THR, THE TIP OF THE ANTHOLOGY INSERTER POST SOFT BROKE OFF THE END. THE SURGERY ENDED WITH THE SAME DEVICE. NO INJURY OR DELAY REPORTED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 15415255 ↗
  • MalfunctionSep 9, 2022Fracture; Fracture

    IT WAS REPORTED THAT, DURING SET AND INSPECTION FOR A THR, IT WAS FOUND THAT THE TIP OF AN ANTHOLOGY INSERTER POST SOFT WAS BROKEN OFF. THE PROCEDURE WAS PERFORMED, WITHOUT DELAY, USING A S+N BACK-UP DEVICE. SINCE INCIDENT OCCURRED BEFORE PROCEDURE, PATIENT WAS NOT YET INVOLVED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 15396327 ↗
  • MalfunctionJun 11, 2022Break; Break

    IT WAS REPORTED THAT, DURING A REVISION SURGERY, THE ANTHOLOGY INSERTER ANT SOFT AND THE ANTHOLOGY INSERTER POST SOFT BROKE WHILE REMOVING AN ANTHOLOGY STEM. THE PROCEDURE WAS FINISHED WITH A SMITH AND NEPHEW BACK UP DEVICE WITHOUT DELAY. THE PATIENT WAS NOT HARMED BEYOND THE REPORTED PROBLEM.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 14671881 ↗
  • MalfunctionApr 27, 2022Fracture; Fracture

    IT WAS REPORTED THAT THE TIP OF AN ANTHOLOGY INSERTER POSTERIOR SOFT BROKE OFF. AS THIS WAS NOTICED UPON INSPECTION, THERE WAS NO PATIENT INVOLVEMENT.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 14228576 ↗
  • MalfunctionFeb 1, 2022Break; Break

    IT WAS REPORTED THAT AN ANTHOLOGY INSERTER POSTERIOR SOFT IS BROKEN. AS THIS WAS NOTICED UPON FIELD INSPECTION, THERE WAS NO PATIENT INVOLVEMENT.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 13412799 ↗
  • InjuryDec 17, 2021Break; Break

    IT WAS REPORTED THAT, DURING THR SURGERY, A THE TIP OF THE ANTHOLOGY INSERTER POST SOFT BROKE OFF IN STEM WHILE IMPACTING FEMORAL COMPONENT. TIP WAS RECOVERED AND IMPACTION CONTINUED WITH ALTERNATE IMPACTOR. DEVICE INSIDE THE PATIENT. 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 13026484 ↗
  • MalfunctionOct 5, 2021Break; Break

    IT WAS REPORTED THAT, THE TIP OF AN ANTHOLOGY INSERTER POST SOFT BROKE OF. IT IS UNKNOWN WHETHER THIS PROBLEM WAS NOTICED IN A SURGICAL ENVIRONMENT OR NOT; THEREFORE, PATIENT INVOLVEMENT HAS NOT BEEN CONFIRMED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 12577448 ↗
  • MalfunctionSep 29, 2021Break; Break

    IT WAS REPORTED THAT THE TIP OF A ANTHOLOGY INSERTER POST SOFT WAS BROKEN OFF IMPACTOR. AS THIS WAS NOTICED UPON FIELD INSPECTION, THERE WAS NOT PATIENT INVOLVEMENT.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 12546135 ↗
  • MalfunctionAug 5, 2021Break; Break

    IT WAS REPORTED THAT, DURING THE SET UP FOR A THR SURGERY, THE TIP OF AN ANTHOLOGY INSERTER POST SOFT BROKE. THIS HAPPENED BEFORE USE IN PATIENT. SURGERY WAS PERFORMED, WITHOUT ANY DELAY, USING A SMITH AND NEPHEW BACK-UP DEVICE INSTEAD. PATIENT WAS NOT INJURED AS CONSEQUENCE OF THIS PROBLEM.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 12285517 ↗
  • MalfunctionJul 15, 2021Break; Break

    IT WAS REPORTED THAT ONE ANTHOLOGY INSERTER POST SOFT ((B)(4)) AND ONE ANTHOLOGY INSERTER ANT SOFT ((B)(4)) HAD THE TIP BROKE. IT IS UNKNOWN WHEN THIS HAPPENED OR IF THERE WAS A PATIENT INVOLVED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 12171142 ↗
  • InjuryMay 12, 2021Fracture; Fracture

    IT WAS REPORTED THAT DURING A THR, THE TIP OF A ANTHOLOGY INSERTER POST SOFT SNAPPED OFF INSIDE THE PATIENT. THERE WAS NO SIGNIFICANT DELAY AND THE PROCEDURE WAS FINISHED USING A SMITH & NEPHEW BACK UP. PATIENT WAS NOT HARMED. 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

    MAUDE report 11812540 ↗
  • MalfunctionDec 2, 2019Break; Break

    IT WAS REPORTED THAT DURING A THR PROCEDURE, TIP OF THE INSTRUMENT BROKE. NO DELAY. BACKUP DEVICE AVAILABLE. NO INJURY OR IMPACT TO PATIENT REPORTED.

    Patient problems: No Information

    MAUDE report 9398595 ↗
  • MalfunctionApr 14, 2019Break; Break

    IT WAS REPORTED THAT DURING SURGERY THE INSTRUMENT'S TIP BROKE OFF. NO INJURY REPORTED. UNKNOWN IF A DELAY OCCURRED OR IF A BACKUP DEVICE WAS AVAILABLE.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 8512567 ↗
  • MalfunctionApr 11, 2019Break; Break

    IT WAS REPORTED THAT THE TIP BROKE DURING IMPACTION OF THE STEM, ALL PIECES WERE REMOVED. BACKUP WAS AVAILABLE. NO DELAY TO PROCEDURE RECORDED.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 8504510 ↗
  • MalfunctionOct 1, 2018Break; Break

    IT WAS REPORTED THAT THE NIPPLE ON THE END OF THIS STEM INSERTER BROKE OFF WHILE INSERTING THE STEM INTO THE PATIENT. DOCTOR WAS ABLE TO GET IT OUT.

    Patient problems: No Known Impact Or Consequence To Patient

    MAUDE report 7924593 ↗

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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