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
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 · 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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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