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MG II® 5120-85Recalls & reported problems

Zimmer, Inc. · Class 1

Adverse event reports
15
Deaths reported
0
Injuries reported
3
Recalls naming it
0

Summary

The FDA's MAUDE database contains 15 adverse event reports that list this exact device (DI 00889024186804), received between Aug 27, 2020 and Nov 18, 2025 — classified as 3 injuries, 12 malfunctions.

The most frequently reported specific device problem is “Fracture” (14 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

Nov 2023: 0 reportsDec 2023: 1 reportsJan 2024: 0 reportsFeb 2024: 0 reportsMar 2024: 1 reportsApr 2024: 1 reportsMay 2024: 1 reportsJun 2024: 1 reportsJul 2024: 0 reportsAug 2024: 0 reportsSep 2024: 1 reportsOct 2024: 1 reportsNov 2024: 0 reportsDec 2024: 0 reportsJan 2025: 1 reportsFeb 2025: 0 reportsMar 2025: 0 reportsApr 2025: 0 reportsMay 2025: 0 reportsJun 2025: 0 reportsJul 2025: 0 reportsAug 2025: 0 reportsSep 2025: 0 reportsOct 2025: 1 reportsNov 2025: 1 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

  • Fracture14
  • Mechanical Jam1

Patient problems

  • No Clinical Signs, Symptoms or Conditions12
  • Foreign Body In Patient3
  • No Known Impact Or Consequence To Patient1

Recent adverse event reports

The 15 most recent of 15 reports, in the reporter's own words as published by the FDA.

  • MalfunctionNov 18, 2025Fracture; Fracture

    IT WAS REPORTED THAT THE DRILL FRACTURED DURING SURGERY. THE SURGICAL TECHNIQUE WAS UTILIZED. THERE WAS NO IMPACT TO THE PATIENT. NO FOREIGN BODIES WERE RETAINED IN THE PATIENT. THERE WAS NO SURGICAL DELAY. THE SURGERY WAS COMPLETED WITH A SECOND DEVICE. ATTEMPTS HAVE BEEN MADE AND ALL AVAILABLE INFORMATION HAS BEEN PROVIDED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 23586981 ↗
  • InjuryOct 20, 2025Fracture; Fracture

    IT WAS REPORTED THAT DURING A KNEE PROCEDURE, THE DRILL BIT FRACTURED. THE FRACTURED FRAGMENT WAS UNABLE TO BE REMOVED AND WAS LEFT IN THE PATIENT'S FEMUR. NO ADDITIONAL INTERVENTION OR PATIENT IMPACT HAS BEEN REPORTED AS A RESULT OF THE RETAINED FRAGMENT. IT WAS REPORTED THAT ALL AVAILABLE INFORMATION HAS BEEN PROVIDED.

    Patient problems: Foreign Body In Patient

    MAUDE report 23343108 ↗
  • MalfunctionJan 21, 2025Fracture; Fracture

    IT WAS REPORTED THAT THE DRILL BIT BROKE WHILE THE PROPER TECHNIQUES WERE BEING USED. THERE WAS NO CONSEQUENCES OR IMPACT TO THE PATIENT.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 21197865 ↗
  • MalfunctionOct 1, 2024Fracture; Fracture

    NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 20344855 ↗
  • MalfunctionSep 5, 2024Fracture; Fracture

    IT WAS REPORTED THAT A DRILL BIT FRACTURED DURING USE WITH A CUT BLOCK 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 20150588 ↗
  • MalfunctionJun 17, 2024Fracture; Fracture

    IT WAS REPORTED THE DRILL BIT BROKE WHEN CHECKING NOTCH IN CUT BLOCK. NO PATIENT INVOLVEMENT WAS REPORTED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 19554137 ↗
  • MalfunctionMay 1, 2024Fracture; Fracture

    NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 19221693 ↗
  • InjuryApr 4, 2024Fracture; Fracture

    NO FURTHER EVENT INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.

    Patient problems: Foreign Body In Patient

    MAUDE report 19041619 ↗
  • MalfunctionMar 14, 2024Fracture; Fracture

    IT WAS REPORTED THAT THE DRILL TIP FRACTURED WHILE THE SURGEON WAS DRILLING. NOTHING FELL IN THE PATIENT AND THERE WAS NO HARM TO THE PATIENT. THERE IS NO ADDITIONAL INFORMATION AVAILABLE.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 18903425 ↗
  • MalfunctionDec 22, 2023Fracture; Fracture

    NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 18382652 ↗
  • MalfunctionJul 13, 2023Fracture; Fracture

    NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 17315788 ↗
  • MalfunctionFeb 15, 2022Fracture; Fracture

    NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 13533502 ↗
  • MalfunctionJun 9, 2021Fracture; Fracture

    NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 11969225 ↗
  • InjuryMay 26, 2021Fracture; Fracture

    IT WAS REPORTED DURING A LEFT TOTAL KNEE PROCEDURE, THE INSTRUMENT FRACTURED. BROKEN PIECE REMAINS IN THE PATIENT. PIECE WILL NOT BE REMOVED AT THIS TIME. THERE WAS NO DELAY OR HARM TO THE PATIENT. NO ADDITIONAL INFORMATION.

    Patient problems: Foreign Body In Patient

    MAUDE report 11886923 ↗
  • MalfunctionAug 27, 2020Mechanical Jam; Mechanical Jam

    NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

    Patient problems: No Clinical Signs, Symptoms or Conditions; No Known Impact Or Consequence To Patient

    MAUDE report 10459901 ↗

Other BIT, DRILL devices

All BIT, DRILL devices →

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