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Anthology 71365705Recalls & reported problems

Smith & Nephew, Inc. · ANTHOLOGY INSERTER POSTER HARD · Class 2

Quick summary

This Smith & Nephew Anthology hip inserter has 176 adverse event reports, with no deaths and 36 injuries. The reports mostly describe the inserter breaking, often at its threaded end, and sometimes pieces snapping off inside the implant stem during hip surgery. No recalls name this device.

AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.

Adverse event reports
176
Deaths reported
0
Injuries reported
36
Recalls naming it
0

Summary

The FDA's MAUDE database contains 176 adverse event reports that list this exact device (DI 03596010555663), received between Apr 19, 2017 and May 27, 2026 — classified as 36 injuries, 140 malfunctions.

The most frequently reported specific device problem is “Break” (124 reports).

1 other recall cover devices cleared under the same FDA submission (K113789); 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.

Reports received per month

Nov 2023: 0 reportsDec 2023: 3 reportsJan 2024: 0 reportsFeb 2024: 2 reportsMar 2024: 2 reportsApr 2024: 1 reportsMay 2024: 1 reportsJun 2024: 1 reportsJul 2024: 2 reportsAug 2024: 0 reportsSep 2024: 1 reportsOct 2024: 0 reportsNov 2024: 1 reportsDec 2024: 3 reportsJan 2025: 1 reportsFeb 2025: 1 reportsMar 2025: 0 reportsApr 2025: 0 reportsMay 2025: 1 reportsJun 2025: 1 reportsJul 2025: 2 reportsAug 2025: 1 reportsSep 2025: 0 reportsOct 2025: 0 reportsNov 2025: 1 reportsDec 2025: 2 reportsJan 2026: 0 reportsFeb 2026: 1 reportsMar 2026: 0 reportsApr 2026: 0 reportsMay 2026: 2 reportsJun 2026: 0 reportsJul 2026: 0 reportsAug 2026: 0 reportsSep 2026: 0 reportsOct 2026: 0 reports2024202520263
Last 36 months. The most recent month may be incomplete.

Most reported problems

Device problems

  • Break124
  • Fracture41
  • Insufficient Device Problem Information2
  • Separation Failure2
  • Adverse Event Without Identified Device or Use Problem1
  • Connection Problem1
  • Crack1
  • Damaged Thread1

Patient problems

  • No Clinical Signs, Symptoms or Conditions104
  • No Known Impact Or Consequence To Patient27
  • No Consequences Or Impact To Patient24
  • Foreign Body In Patient8
  • No Patient Involvement6
  • Injury5
  • Device Embedded In Tissue or Plaque4
  • No Information4

Recent adverse event reports

The 25 most recent of 176 reports, in the reporter's own words as published by the FDA.

  • MalfunctionMay 27, 2026Break

    IT WAS REPORTED THAT, DURING A TOTAL HIP REVISION SURGERY, ONE (1) ANTHOLOGY INSERTER POSTER HARD BROKE. IT IS UNKNOWN HOW THE PROCEDURE WAS PERFORMED AND IF THERE WAS ANY DELAY. NO FURTHER COMPLICATIONS WERE REPORTED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 25306385 ↗
  • MalfunctionMay 11, 2026Fracture

    IT WAS REPORTED THAT, DURING A THA SURGERY, UPON IMPACTION OF STEM, THE THREADED END OF ONE (1) ANTHOLOGY INSERTER POSTER HARD SNAPPED OFF INSIDE THE STEM. THE PROCEDURE WAS RESUMED, AFTER A NON-SIGNIFICANT DELAY, USING THE SAME DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 25145278 ↗
  • MalfunctionFeb 2, 2026Break

    IT WAS REPORTED THAT, DURING A TOTAL HIP PROCEDURE. THE PIN WHEEL BROKE FROM THE ANTHOLOGY INSERTER POSTER HARD DURING STEM IMPLANTATION. IT IS UNKNOWN HOW WAS THE PROCEDURE COMPLETED OR IF A DELAY WAS REPORTED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 24240553 ↗
  • MalfunctionDec 29, 2025Fracture; Fracture

    IT WAS REPORTED THAT DURING A THR SURGERY, THE THREADED PORTION OF THE ANTHOLOGY INSERTER POSTER HARD BROKE CLEAN OFF INTO THE STEM. UPON TRYING TO CONTINUE TO REMOVE THE FEMORAL HEAD THE ENTIRE STEM CAME OUT, SO THERE WAS NO NEED TO TRY AND REMOVE THE BROKEN PIECE. NOTHING FELL INTO THE WOUND. NO DELAY OR INJURY TO PATIENT WAS REPORTED. THERE IS NO OTHER INFORMATION AVAILABLE.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 23908755 ↗
  • MalfunctionDec 23, 2025Fracture; Fracture

    IT WAS REPORTED THAT, DURING A THA SURGERY, THE THREAD IN PART OF THE ANTHOLOGY INSERTER POSTER HARD BROKE OFF DURING IMPLANTATION. THE PROCEDURE WAS PERFORMED, AFTER A NON-SIGNIFICANT DELAY, USING AN EQUIVALENT S+N BACK-UP. NO FURTHER COMPLICATIONS WERE REPORTED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 23878605 ↗
  • MalfunctionNov 24, 2025Break; Break

    IT WAS REPORTED THAT DURING A THR REVISION SURGERY, THE THREADS OF ONE (1) ANTHOLOGY INSERTER POSTER HARD BROKE ON CAPTURE BAR. THE PROCEDURE WAS COMPLETED, AFTER NO DELAY, USING A STRYKER INSERT AS A COMPETITOR DEVICE. NO INJURY WAS REPORTED AS A CONSEQUENCE OF THIS ISSUE.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 23631094 ↗
  • MalfunctionAug 6, 2025Fracture; Fracture

    IT WAS REPORTED THAT DURING A THR SURGERY, ONE (1) ANTHOLOGY INSERTER POSTER HARD BROKE OFF IN ONE (1) REDAPT SLVLS MONO STEM 240MM SZ 14 HO DURING FINAL IMPLANTATION. THE PROCEDURE WAS RESUMED, AFTER A NON-SIGNIFICANT DELAY, WITH 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 22724026 ↗
  • InjuryJul 31, 2025Fracture; Fracture

    IT WAS REPORTED THAT DURING A HIP REVISION PROCEDURE, THE THREADED TIP OF THE ANTHOLOGY INSERTER POSTER HARD BROKE, WHICH BECAME STUCK IN THE STEM AND REMAINED CONNECTED TO THE STEM. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING THE SAME DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.

    Patient problems: Device Embedded In Tissue or Plaque; Foreign Body In Patient

    MAUDE report 22678217 ↗
  • MalfunctionJul 3, 2025Fracture; Fracture

    IT WAS REPORTED THAT, DURING A THR SURGERY, THE SCREW PORTION OF THE ANTHOLOGY INSERTER POSTER HARD BROKE OFF IN THE ANTHOLOGY STEM IMPLANT. THE SURGERY WAS COMPLETED, AFTER A NON-SIGNIFICANT DELAY, WITH THE SAME REPORTED DEVICE. NO INJURIES WERE REPORTED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 22392036 ↗
  • MalfunctionJun 9, 2025Damaged Thread; Damaged Thread

    IT WAS REPORTED THAT, DURING A THR SURGERY, THE THREADS OF ONE (1) ANTHOLOGY INSERTER POSTER HARD BECAME STRIPPED AFTER IMPACTING THE STEM. THE PROCEDURE WAS COMPLETED AFTER A SIGNIFICANT DELAY WITH A CHANGE IN SURGICAL TECHNIQUE. THE INSERTER WAS USED TO FINISH THE CASE, BUT DID NOT THREAD IT ON THE STEM. NO INJURIES WERE REPORTED AS A RESULT, PATIENT IS FINE.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 22167808 ↗
  • InjuryMay 9, 2025Fracture; Fracture

    IT WAS REPORTED THAT DURING A TOTAL HIP REPLACEMENT (THR), THE TIP OF ONE (1) ANTHOLOGY INSERTER POSTER HARD BROKE OFF IN THE STEM WHILE ATTEMPTING TO REMOVE THE STEM FOR DEEPER REAMING. THE BROKEN TIP WAS LEFT IN THE STEM. THE PROCEDURE WAS RESUMED AFTER A SURGICAL DELAY OF LESS THAN 30 MINUTES USING A SMITH & NEPHEW BACK-UP DEVICE. NO INJURY WAS REPORTED AS A CONSEQUENCE OF THIS ISSUE.

    Patient problems: Foreign Body In Patient

    MAUDE report 21997585 ↗
  • InjuryFeb 4, 2025Fracture; Fracture

    IT WAS REPORTED THAT DURING A REVISION SURGERY TO EXCHANGE NON SMITH AND NEPHEW DEVICES, AN ANTHOLOGY INSERTER POSTER HARD BROKE AND REMAINED INSIDE THE STEM INSERTED INTO THE PATIENT. ADDITIONALLY, WHEN USING TWO (2) ACCORD DUAL ENDED HEX DRIVERS TO TIGHTEN THE SCREW HEAD OF TWO (2) ACC 2.0MM COCR CABLE W/CLAMP, THE LATER WERE ROLLED. THERE WAS A SIGNIFICANT DELAY, AND THE PROCEDURE WAS FINISHED USING A SMITH & NEPHEW BACK UP. PATIENT WAS NOT HARMED.

    Patient problems: Foreign Body In Patient

    MAUDE report 21301622 ↗
  • MalfunctionJan 13, 2025Fracture; Fracture

    IT WAS REPORTED THAT, DURING A THR SURGERY, WHILE INSERTING THE FINAL IMPLANT (REDAPT STEM), THE END OF THE THREADED TIP OF ONE (1) ANTHOLOGY INSERTER POSTER HARD BROKE OFF INSIDE THE IMPLANTED STEM. THE PROCEDURE WAS RESUMED USING THE SAME DEVICE. IT IS UNKNOWN IF THERE WAS ANY SURGICAL DELAY. NO FURTHER COMPLICATIONS WERE REPORTED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 21139387 ↗
  • MalfunctionDec 27, 2024Fracture; Fracture

    IT WAS REPORTED THAT, DURING A THR, THE TOP PIECE FOR SCREWING OF A (1) ANTHOLOGY INSERTER POSTER HARD FLEW OFF, WHEN HIT WITH A MALLET. THE PROCEDURE WAS RESUMED WITHOUT ANY DELAY, BUT IT IS UNKNOWN IF THERE WAS A BACK-UP DEVICE AVAILABLE. NO INJURY WAS REPORTED AS A CONSEQUENCE OF THIS ISSUE.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 21026235 ↗
  • MalfunctionDec 6, 2024Break; Break

    IT WAS REPORTED THAT, DURING A THR SURGERY, THE ANTHOLOGY INSERTER POSTER HARD BROKE. THE SURGERY WAS COMPLETED, WITHOUT ANY DELAY, BUT IT IS UNKNOWN HOW. NO INJURIES WERE REPORTED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 20873207 ↗
  • MalfunctionDec 6, 2024Fracture; Fracture

    IT WAS REPORTED THAT DURING A THR, THE FLANGE ON END OF ONE (1) ANTHOLOGY INSERTER POSTER HARD BROKE OFF ON IMPACTION. 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 20861170 ↗
  • MalfunctionNov 25, 2024Fracture; Separation Failure; Fracture; Separation Failure

    IT WAS REPORTED THAT DURING A THR, THE TIP OF THE SCREW OF AN ANTHOLOGY INSERTER POSTER HARD BROKE OFF AND GOT STUCK IN THE ANTHOLOGY AFIT SO POR PL HA SZ 7. IT IS UNKNOWN IF ANY PIECES FELL INTO THE PATIENT. THERE WAS NO DELAY AND, BUT IT IS UNKNOWN HOW THE PROCEDURE WAS FINISHED. PATIENT WAS NOT HARMED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 20773705 ↗
  • MalfunctionSep 25, 2024Fracture; Fracture

    IT WAS REPORTED THAT, DURING STEM IMPLANTATION IN A THR SURGERY, THE TOP OF ONE (1) ANTHOLOGY INSERTER POSTER HARD BROKE OFF. IT IS UNKNOWN HOW THE PROCEDURE WAS FINISHED. THERE WAS NO SURGICAL DELAY OR REPORTED PATIENT INJURY AS A RESULT OF THIS ISSUE.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 20304186 ↗
  • InjuryJul 29, 2024Fracture; Fracture

    IT WAS REPORTED THAT DURING A HIP STEM REVISION, THE ANTHOLOGY INSERTER POSTER HARD TIP BROKE WHILE DETACHING FROM THE STEM. THE THREADS BROKE OFF AND WERE IRRETRIEVABLE BECAUSE THEY BROKE EVEN WITH THE TOP OF THE STEM. SURGEON WAS UNCONCERNED ABOUT THE INCIDENT AND SAID THAT THE THREADS WOULD STAY THREADED INSIDE OF THE STEM. PROCEDURE WAS PERFORMED, WITHOUT ANY DELAY, WITH THE SAME DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.

    Patient problems: Foreign Body In Patient

    MAUDE report 19852555 ↗
  • InjuryJul 15, 2024Fracture; Fracture

    IT WAS REPORTED THAT, DURING IMPLANT IMPACTION IN A THR SURGERY, THE TIP OF ONE (1) ANTHOLOGY INSERTER POSTER HARD FRACTURED AND REMAINED THREADED INTO ONE (1) REDAPT SLVLS MONO STEM 300MM SZ 21 HO. AS THE BROKEN TIP IS THREADED, IT WAS UNABLE TO BE REMOVED. IT IS STILL INSERTED INTO THE TOP OF THE IMPLANTED STEM AND SURGERY FOR REMOVAL IS REPORTEDLY NOT REQUIRED. NO OTHER PIECES FELL INTO THE WOUND. THE PROCEDURE WAS RESUMED, AFTER A NON-SIGNIFICANT DELAY, USING THE SAME DEVICE. NO INJURY WAS REPORTED AS A CONSEQUENCE OF THIS ISSUE AND THE PATIENT HAS NOT EXPERIENCED ANY SYMPTOMS AFTER THE PROCEDURE.

    Patient problems: Device Embedded In Tissue or Plaque; Foreign Body In Patient

    MAUDE report 19745601 ↗
  • MalfunctionJun 23, 2024Fracture; Fracture

    IT WAS REPORTED THAT DURING A THR SURGERY, THE TIP OF THE ANTHOLOGY INSERTER POSTER HARD BROKE OFF WHEN INSERTING. THE PROCEDURE WAS PERFORMED, AFTER NO DELAY, USING THE SAME DEVICE. PATIENT WAS NOT HARMED AS CONSEQUENCE OF THIS PROBLEM.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 19591628 ↗
  • MalfunctionMay 22, 2024Fracture; Fracture

    IT WAS REPORTED THAT, WHILE INSERTING THE STEM DURING A THR SURGERY, THE TIP OF ONE (1) ANTHOLOGY INSERTER POSTER HARD BROKE OFF. NO BROKEN PIECES FELL INSIDE THE PATIENT, AND THEY WERE ALL RETRIEVED FROM THE SITE. 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 19372724 ↗
  • MalfunctionApr 9, 2024Fracture; Fracture

    IT WAS REPORTED THAT DURING A THR SURGERY THE THREADS OF ONE (1) ANTHOLOGY INSERTER POSTER HARD SNAPPED OFF WHEN TRYING TO INSERT THE IMPLANT. THE PROCEDURE WAS RESUMED, AFTER A NON-SIGNIFICANT DELAY, WITH 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 19075969 ↗
  • MalfunctionMar 25, 2024Fracture; Fracture

    IT WAS REPORTED THAT, DURING A STEM REMOVAL SURGERY, THE TIP OF ONE (1) ANTHOLOGY INSERTER POSTER HARD BROKE OFF. IT IS UNKNOWN IF PIECES OF THE INSTRUMENT FELL INTO THE PATIENT. IT IS UNKNOWN HOW SURGERY WAS COMPLETED, BUT THERE WAS NO DELAY AS CONSEQUENCE OF THIS PROBLEM.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 18976066 ↗
  • MalfunctionMar 1, 2024Fracture; Fracture

    IT WAS REPORTED THAT DURING A THR SURGERY, THE ANTHOLOGY INSERTER POSTER HARD FIXATION THREAD BROKE DURING THE IMPACT OF THE FEMORAL STEM. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING THE SAME DEVICE. PATIENT WAS NOT HARMED AS CONSEQUENCE OF THIS PROBLEM.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 18816500 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K113789. One submission often covers many models, so check the product and lot details in each record.

  • Z-0945-2017 · Nov 15, 2016 · Terminated
    Modular SMF(TM) The Modular SMF(TM) and Modular REDAPT(TM) Hip Systems are indicated for individuals undergoing primary and revision surgery where other treatments or devices have

Other Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented devices

All Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented devices →

Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.