Anthology 71365721Recalls & reported problems
Smith & Nephew, Inc. · ANTHOLOGY INSERTER ANTERIOR SOFT · Class 2
Data updated Oct 13, 2026 from official FDA records · Editorial policy
Quick summary
This Smith & Nephew Anthology anterior soft inserter is used to place hip implants during surgery. Reports mostly describe the threaded tip snapping off during hip surgery, sometimes leaving a fragment inside the patient or attached to the implant, which can delay or require later removal. There are 67 reports, no deaths, and 16 injuries. 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
- 67
- Deaths reported
- 0
- Injuries reported
- 16
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 67 adverse event reports that list this exact device (DI 03596010553409), received between May 24, 2017 and May 1, 2026 — classified as 16 injuries, 51 malfunctions.
The most frequently reported specific device problem is “Break” (46 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
Most reported problems
Device problems
- Break46
- Fracture19
- Flaked1
- Insufficient Device Problem Information1
Patient problems
- No Clinical Signs, Symptoms or Conditions40
- No Consequences Or Impact To Patient10
- No Known Impact Or Consequence To Patient9
- Foreign Body In Patient6
- Injury2
- Device Embedded In Tissue or Plaque1
- Insufficient Information1
- No Information1
Recent adverse event reports
The 25 most recent of 67 reports, in the reporter's own words as published by the FDA.
MalfunctionMay 1, 2026Fracture
IT WAS REPORTED THAT, DURING A THA SURGERY, ONE (1) ANTHOLOGY INSERTER ANT SOFT FRACTURED AT THE TIP WHILE INSERTING THE FEMORAL STEM. THE PROCEDURE WAS PERFORMED, WITHOUT ANY DELAY, USING THE SAME DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25062205 ↗MalfunctionMar 3, 2025Fracture; Fracture
IT WAS REPORTED THAT DURING THR SURGERY, THE TIP OF ONE (1) ANTHOLOGY INSERTER ANT SOFT BROKE OFF WHEN THE INSERTED WAS REMOVED. SURGEON SUCCESSFULLY RETRIEVED THE TIP FROM THE STEM AFTER INSERTION. THE PROCEDURE WAS ABLE TO BE COMPLETED WITH THE SAME DEVICE AFTER A NON-SIGNIFICANT DELAY. PATIENT WAS NOT HARMED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21503671 ↗MalfunctionJan 2, 2025Fracture; Fracture
IT WAS REPORTED THAT, DURING A THR, THE TIP OF AN (1) ANTHOLOGY INSERTER ANT SOFT BROKE OFF. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING THE SAME DEVICE. NO INJURY WAS REPORTED AS A CONSEQUENCE OF THIS ISSUE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21056708 ↗InjuryJul 19, 2024Fracture; Fracture
IT WAS REPORTED THAT DURING A THR SURGERY, WHILE IMPACTING AN ANTHOLOGY SO POROUS SIZE 7 (FEMORAL COMPONENT), THE THREADED TIP OF AN ANTHOLOGY INSERTER ANT SOFT FRACTURED. THE BROKEN TIP WAS LEFT INSIDE THE PATIENT'S BODY ATTACHED TO THE STEM. THE PROCEDURE RESUMED AFTER A SIGNIFICANT DELAY. NO OTHER COMPLICATIONS WERE REPORTED.
Patient problems: Device Embedded In Tissue or Plaque; Foreign Body In Patient
MAUDE report 19780198 ↗MalfunctionJul 15, 2024Fracture; Fracture
IT WAS REPORTED THAT, DURING A THR SURGERY, WHEN IMPACTING THE ANTHOLOGY STEM IMPLANT THE TIP OF THE ANTHOLOGY INSERTER ANT SOFT CAME OFF. THE PROCEDURE WAS COMPLETED, 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 19740847 ↗MalfunctionJul 11, 2024Fracture; Fracture
IT WAS REPORTED THAT, WHILE IMPACTING THE IMPLANT IN A THA SURGERY, THE TIP OF ONE (1) ANTHOLOGY INSERTER ANT SOFT BROKE OFF. NO PIECES FELL INTO THE WOUND. THERE PROCEDURE WAS COMPLETED, WITHOUT ANY DELAY, WITH THE SAME DEVICE. NO INJURY WAS REPORTED AS A CONSEQUENCE OF THIS ISSUE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19721417 ↗MalfunctionMay 15, 2024Fracture; Fracture
IT WAS REPORTED THAT, DURING A THR, THE TIP OF ONE (1) ANTHOLOGY INSERTER ANT SOFT BROKE OFF. ALL PIECES WERE RECOVERED. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING A S+N BACK-UP DEVICE. PATIENT WAS NOT HARMED AS A CONSEQUENCE OF THIS PROBLEM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19322432 ↗InjuryMar 25, 2024Fracture; Fracture
IT WAS REPORTED THAT DURING A THR SURGERY, THE NIPPLE TIP OF THE ANTHOLOGY INSERTER ANT SOFT DEVICE GOT FRACTURED AND WAS LEFT INSIDE THE PATIENT WITHOUT NOTICE. THE SURGEON WAS NOT AWARE OF IT, UNTIL AFTER 6 WEEKS, DURING A POST-OP APPOINTMENT. THE PIECE DISLODGED FROM WHERE IT ORIGINALLY BROKE OFF (TREADS ON THE PROXIMAL PART OF THE IMPLANT). NO SYMPTOMS WERE REPORTED. SURGERY TO REMOVE THE BROKEN INSTRUMENT HAS NOT BEEN CONFIRMED YET. CURRENT HEALTH STATUS OF PATIENT IS UNKNOWN.
Patient problems: Foreign Body In Patient
MAUDE report 18974151 ↗MalfunctionFeb 26, 2024Fracture; Fracture
IT WAS REPORTED THAT, DURING THR SURGERY, WHILE INSERTING THE IMPLANT. THE TIP OF ANTHOLOGY INSERTER ANT SOFT BROKE OFF. ALL PIECES WERE RETRIEVED. NOTHING FELL INTO THE PATIENT. 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 18784038 ↗MalfunctionJan 7, 2024Fracture; Fracture
IT WAS REPORTED THAT, DURING A THR SURGERY, THE TIP OF AN ANTHOLOGY INSERTER ANT SOFT BROKE OFF AND ALL PIECES WERE RECOVERED WITH LONG TWEEZERS. THE PROCEDURE WAS RESUMED, AFTER A NON-SIGNIFICANT DELAY, WITH 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 18461357 ↗MalfunctionDec 27, 2023Break; Break
IT WAS REPORTED THAT DURING THR SURGERY THE ANTHOLOGY INSERTER ANT SOFT BROKE. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING A S+N BACK-UP DEVICE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18397355 ↗MalfunctionSep 18, 2023Fracture; Fracture
IT WAS REPORTED THAT, DURING A THR, AN ANTHOLOGY INSERTER ANT SOFT BROKE WHEN TRYING TO REMOVE THE STEM, ALL PIECES WERE RECOVERED. 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 17764249 ↗MalfunctionAug 4, 2023Fracture; Fracture
IT WAS REPORTED THAT, DURING A THR WHILE ATTEMPTING TO EXTRACT THE STEM, THE TIP OF ONE (1) ANTHOLOGY INSERTER ANT SOFT BROKE. THE PROCEDURE WAS RESUMED, AFTER A NON-SIGNIFICANT DELAY, WITH 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 17466946 ↗MalfunctionJul 11, 2023Fracture; Fracture
IT WAS REPORTED THAT, DURING A THR SURGERY, THE TIP ON A ANTHOLOGY INSERTER ANT SOFT BROKE OFF. THE BROKEN PIECE WAS RECOVERED. IT IS UNKNOWN HOW THE PROCEDURE WAS COMPLETED. NO PATIENT HARM OR DELAY WAS REPORTED AS A CONSEQUENCE OF THIS PROBLEM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17302832 ↗MalfunctionOct 23, 2022Fracture; Fracture
IT WAS REPORTED THAT THE TIP OF AN ANTHOLOGY INSERTER ANTERIOR SOFT IS BROKEN. AS THIS WAS NOTICED UPON INSPECTION, THERE WAS NOT PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15656589 ↗MalfunctionSep 9, 2022Fracture; Fracture
IT WAS REPORTED THAT DURING A THR, THE TIP OF AN ANTHOLOGY INSERTER ANT SOFT BROKE. NO PIECES FELL INTO PATIENT. 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 15393830 ↗MalfunctionAug 23, 2022Fracture; Fracture
IT WAS REPORTED THAT WHILE PUTTING THE TRAY TOGETHER WE NOTICED THE TIP OF ANTHOLOGY INSERTER ANT SOFT WAS BROKE OFF. NO CASE INVOLVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15274494 ↗MalfunctionJul 22, 2022Fracture; Fracture
IT WAS REPORTED THAT DURING A THR SURGERY WHILE IMPACTING THE ANTHOLOGY INSERTER ANT SOFT STEM INSERTER WITH MALLET, THE TIP OF THE INSERTER BROKE OFF. THE PROCEDURE WAS COMPLETED, WITHOUT DELAY, USING A S+N BACK-UP DEVICE. NO FURTHER COMPLICATION WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15090115 ↗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 14671880 ↗MalfunctionMay 5, 2022Break; Break
IT WAS REPORTED THAT, DURING A THR SURGERY, THE TIP OF ANTHOLOGY INSERTER ANT SOFT BROKE. NO PIECES FELL INTO 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 14285829 ↗MalfunctionApr 26, 2022Break; Break
IT WAS REPORTED THAT, DURING SURGERY, THE TIP OF THE ANTHOLOGY INSERTER ANT SOFT BROKE. NO PIECES FELL INTO 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 14213926 ↗MalfunctionApr 23, 2022Break; Break
IT WAS REPORTED THAT THE TIP OF AN ANTHOLOGY INSERTER ANT SOFT BROKE OFF. AS THIS WAS NOTICED UPON FIELD INSPECTION, NO PATIENT WAS INVOLVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14191059 ↗MalfunctionApr 7, 2022Break; Break
IT WAS REPORTED THAT, DURING A THR SURGERY, THE TIP OF AN ANTHOLOGY INSERTER ANTERIOR SOFT BROKE. NO PIECES FELL INTO PATIENT. SURGERY 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 14048178 ↗MalfunctionMar 9, 2022Break; Break
IT WAS REPORTED THAT, DURING A THR SURGERY, THE SURGEON BROKE THE TIP OF AN ANTHOLOGY INSERTER ANT SOFT, TRYING TO GET THE HEAD OFF THE STEM. THE REVISION SURGERY WAS COMPLETED, THE DEVICES EXPLANTED WERE NOT FROM SMITH AND NEPHEW. THE PROCEDURE WAS FINISHED WITHOUT DELAY, USING THE SAME DEVICE. NO OTHER COMPLICATION WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13710790 ↗InjuryFeb 23, 2022Break; Break
IT WAS REPORTED THAT, DURING A THR SURGERY, THE TIP OF WORKING END OF AN ANTHOLOGY INSERTER ANT SOFT SNAPPED OFF. SURGERY WAS FINISHED WITHOUT ANY DELAY, WITH A SN BACK-UP DEVICE. NO HARM TO THE PATIENT OR FURTHER COMPLICATIONS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13583418 ↗
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 · TerminatedModular 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
- BIOLOX DELTA 1365-32-310Depuy Orthopaedics, Inc. · Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented551 reports
- PINNACLE ALTRX 1221-36-052Depuy Orthopaedics, Inc. · Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented481 reports
- BIOLOX DELTA 1365-32-320Depuy Orthopaedics, Inc. · Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented1 death314 reports
- BIOLOX DELTA 1365-36-720Depuy Orthopaedics, Inc. · Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented1 death189 reports
- DJO SURGICAL 400-03-362Encore Medical, L.P. · Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented187 reports
- Anthology 71365705Smith & Nephew, Inc. · Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented176 reports
- BIOLOX DELTA 1365-40-710Depuy Orthopaedics, Inc. · Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented170 reports
- PINNACLE GRIPTION 1217-32-054Depuy Orthopaedics, Inc. · Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented169 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 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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