Persona® The Personalized Knee® 42-5399-018-31Recalls & reported problems
Zimmer, Inc. · Class 2
Quick summary
This Zimmer Persona Personalized Knee implant is used in total knee replacement surgery. The 29 reports mostly describe the surgical peg drill breaking off during drilling; in several the tip snapped and, according to the reports, no fragments were left in the patient and surgery continued. There are no deaths and one injury, and 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
- 28
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 28 adverse event reports that list this exact device (DI 00889024632455), received between Nov 14, 2023 and Jul 30, 2026 — classified as 1 injury, 27 malfunctions.
The most frequently reported specific device problem is “Fracture” (28 reports).
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
- Fracture28
- Mechanical Jam3
- Crack1
Patient problems
- No Clinical Signs, Symptoms or Conditions27
- Foreign Body In Patient1
Recent adverse event reports
The 25 most recent of 28 reports, in the reporter's own words as published by the FDA.
MalfunctionJul 30, 2026Fracture
It was reported that peg drill fractured at the distal extremity. The surgical technique was utilized. No pieces fell inside the patient. There was no surgical delay. Attempts have been made and all available information has been provided.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50088415 ↗MalfunctionJul 22, 2026Fracture
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25906838 ↗MalfunctionJul 20, 2026Fracture
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25874884 ↗MalfunctionJun 17, 2026Fracture
IT WAS REPORTED THAT THE TIP OF A DRILL BROKE OFF. THE SURGICAL TECHNIQUE WAS UTILIZED, THERE WAS NO SURGICAL DELAY, THERE WERE NO FOREIGN BODIES RETAINED. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25535817 ↗MalfunctionMay 7, 2026Fracture
IT WAS REPORTED THAT DURING AN INITIAL TOTAL KNEE ARTHROPLASTY, A DRILL FRACTURED. THERE WAS NO PATIENT IMPACT AND NO ADVERSE EVENTS HAVE BEEN REPORTED AS A RESULT OF THE MALFUNCTION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25117436 ↗MalfunctionMar 31, 2026Fracture
IT WAS REPORTED THAT WHILE DRILLING THE PEGS, THE INSTRUMENT BROKE. NOTHING FELL INTO THE PATIENT. THERE WERE NO FOREIGN BODIES RETAINED. THE SURGICAL TECHNIQUE WAS UTILIZED. THERE WAS NO SURGICAL DELAY. THE SURGERY WAS COMPLETED WITH ANOTHER DEVICE. ATTEMPTS HAVE BEEN MADE AND ALL AVAILABLE INFORMATION HAS BEEN PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24745404 ↗MalfunctionMar 20, 2026Fracture
IT WAS REPORTED THAT THE DRILL BIT FRACTURED WHILE THE SURGEON WAS USING A PEG DRILL. THE SURGICAL TECHNIQUE WAS UTILIZED. NO PIECES FELL INSIDE THE PATIENT. THERE WAS NO SURGICAL DELAY. ATTEMPTS HAVE BEEN MADE AND ALL AVAILABLE INFORMATION HAS BEEN PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24649223 ↗MalfunctionMar 18, 2026Fracture
IT WAS REPORTED THAT A DRILL BIT BROKE DURING DRILLING OF THE TIBIA. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24627589 ↗MalfunctionMar 12, 2026Fracture
IT WAS REPORTED THAT THE DRILL BIT BROKE INTRA-OPERATIVELY WHILE DRILLING TIBIAL PEGS, AND THE PROCEDURE WAS COMPLETED USING A DIFFERENT INSTRUMENT. THERE WAS NO IMPACT TO THE PATIENT. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24584645 ↗MalfunctionFeb 10, 2026Crack; Fracture
IT WAS REPORTED THAT A CRACK WAS FOUND AROUND THE CUTTING FLUTES OF A 0-DEGREE PEG DRILL. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE BEEN MADE; HOWEVER, NO MORE INFORMATION IS AVAILABLE AT THIS TIME.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24303340 ↗MalfunctionFeb 3, 2026Fracture
IT WAS REPORTED THAT DURING DRILLING OF PEG HOLES, THE DRILL BROKE ON THE FOURTH AND FINAL HOLE. THERE WAS NO SURGICAL DELAY, AND THE TIP WAS RETRIEVED FROM THE PATIENT. NO FURTHER INFORMATION HAS BEEN PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24250439 ↗MalfunctionJan 21, 2026Fracture
IT WAS REPORTED THAT THE TIP OF THE DRILL BROKE OFF. THE SURGICAL TECHNIQUE WAS UTILIZED. THERE WAS NO SURGICAL DELAY. NO FOREIGN BODIES WERE RETAINED. ATTEMPTS HAVE BEEN MADE AND ALL AVAILABLE INFORMATION HAS BEEN PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24131924 ↗MalfunctionJan 5, 2026Fracture
IT WAS REPORTED THAT A SMALL PEG DRILL USED FOR TIBIAL PREPARATION BROKE INTRA-OPERATIVELY, AND BOTH PIECES WERE RECOVERED. THE SURGEON ALSO REPORTED THAT A 4-IN-1 BLOCK APPEARED BENT, AND THE SAW WOULD NOT PASS THROUGH A PORTION OF THE BLOCK. THERE WERE NO CONSEQUENCES OR IMPACT TO THE PATIENT. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23961324 ↗MalfunctionNov 6, 2025Fracture; Mechanical Jam; Fracture; Mechanical Jam
NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23487012 ↗InjuryAug 19, 2025Fracture; Fracture
IT WAS REPORTED THAT THE TIP OF A DRILL BIT FRACTURED OFF AND REMAINS IN THE PATIENT¿S TIBIA. THERE IS NO ADDITIONAL INFORMATION AVAILABLE.
Patient problems: Foreign Body In Patient
MAUDE report 22839382 ↗MalfunctionJul 30, 2025Fracture; Fracture
IT WAS REPORTED DURING KNEE ARTHROPLASTY THAT WHILE THE SURGEON WAS DRILLING THE PEGS FOR THE TIBIAL BASE PLATE, THE DRILL FRACTURED. NO ADVERSE EVENTS WERE REPORTED AS A RESULT OF THIS MALFUNCTION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22663138 ↗MalfunctionJul 18, 2025Fracture; Fracture
NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22541516 ↗MalfunctionJun 30, 2025Fracture; Fracture
IT WAS REPORTED THAT THE TIP OF THE DRILL FRACTURED WHILE DOING THE LAST DRILL HOLE. THE BROKEN PIECE WAS LOCATED AND NO FOREIGN BODIES WERE RETAINED; NO PIECES FELL INTO THE PATIENT. THE SURGICAL TECHNIQUE WAS UTILIZED. THERE WAS NO SURGICAL DELAY. ANOTHER DEVICE WAS NOT NEEDED TO COMPLETE THE SURGERY. ATTEMPTS HAVE BEEN MADE AND ALL AVAILABLE INFORMATION HAS BEEN PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22356824 ↗MalfunctionJun 19, 2025Fracture; Fracture
IT WAS REPORTED THAT THE TIP OF A DRILL BIT FRACTURED OFF. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE BEEN MADE; HOWEVER, NO MORE INFORMATION IS AVAILABLE AT THIS TIME.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22289704 ↗MalfunctionApr 23, 2025Fracture; Fracture
IT WAS REPORTED THAT DURING A TOTAL KNEE PROCEDURE, THE TIP OF THE DRILL BIT FRACTURED. THERE WAS NO PATIENT IMPACT AND NO ADVERSE EVENTS HAVE BEEN REPORTED AS A RESULT OF THE MALFUNCTION. IT WAS REPORTED THAT ALL AVAILABLE INFORMATION HAS BEEN PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21890907 ↗MalfunctionMar 11, 2025Fracture; Fracture
NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21571997 ↗MalfunctionJan 8, 2025Fracture; Mechanical Jam; Fracture; Mechanical Jam
NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21101979 ↗MalfunctionDec 2, 2024Fracture; Fracture
NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20825004 ↗MalfunctionMar 14, 2024Fracture; Fracture
IT WAS REPORTED THAT A DRILL BIT FRACTURED DURING PLACEMENT OF THE TIBIAL TRAY AS PART OF A KNEE PROCEDURE. NO ADVERSE EVENTS HAVE BEEN REPORTED AS A RESULT OF THE MALFUNCTION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18909065 ↗MalfunctionDec 20, 2023Fracture; Fracture
NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18365174 ↗
Other Prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer + additive/metal/polymer + additive devices
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- ATTUNE 1506-70-007Depuy (Ireland) · Prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer + additive/metal/polymer + additive1 recall2 deaths74 reports
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- ATTUNE 1516-40-605Depuy (Ireland) · Prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer + additive/metal/polymer + additive120 reports
- ATTUNE 1506-70-006Depuy (Ireland) · Prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer + additive/metal/polymer + additive1 recall70 reports
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.