NA 5789-71Recalls & reported problems
Zimmer, Inc. · Class 1
Data updated Oct 13, 2026 from official FDA records · Editorial policy
Quick summary
This Zimmer surgical tension gauge is used to check knee fit during surgery. The 23 reports mostly describe the gauge tip breaking during surgery, with reports mentioning no pieces left in the patient. There are no deaths and no injuries among the 23 reports. 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
- 22
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 22 adverse event reports that list this exact device (DI 00889024192690), received between Nov 23, 2020 and Dec 29, 2025 — classified as 22 malfunctions.
The most frequently reported specific device problem is “Fracture” (22 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
- Fracture22
- Separation Failure1
Patient problems
- No Clinical Signs, Symptoms or Conditions21
- No Patient Involvement1
Recent adverse event reports
The 22 most recent of 22 reports, in the reporter's own words as published by the FDA.
MalfunctionDec 29, 2025Fracture; Fracture
NO FURTHER EVENT INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23906692 ↗MalfunctionJan 28, 2025Fracture; Fracture
NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21255373 ↗MalfunctionJan 7, 2025Fracture; Fracture
NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21095316 ↗MalfunctionOct 14, 2024Fracture; Fracture
IT WAS REPORTED THAT THE FLEXION GAUGE BROKE DURING GAP TESTING. THERE WAS NO CONSEQUENCES OR IMPACT TO THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20445246 ↗MalfunctionSep 19, 2024Fracture; Fracture
NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20258686 ↗MalfunctionJul 23, 2024Fracture; Fracture
NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19807314 ↗MalfunctionMay 22, 2024Fracture; Fracture
IT WAS REPORTED THE DR PUT TENSION GAUGE IN KNEE TO CHECK FLEXION AND THE 2MM/3MM TENSION GAUGE BROKE OFF AT THE TIP. NO PIECES FELL INTO THE PATIENT. THERE WAS NO PATIENT HARM OR IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19372394 ↗MalfunctionMay 22, 2024Fracture; Fracture
NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19370796 ↗MalfunctionApr 24, 2024Fracture; Fracture
NO FURTHER EVENT INFORMATION AT TIME OF THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19173970 ↗MalfunctionApr 17, 2024Fracture; Fracture
NO FURTHER EVENT INFORMATION AT TIME OF THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19124920 ↗MalfunctionApr 2, 2024Fracture; Separation Failure; Fracture; Separation Failure
IT WAS REPORTED THAT DURING SURGERY, THE CABLE GOT CAUGHT IN THE TENSIONER AND IT WOULDN'T RELEASE AND THE DEVICE FRACTURED. ATTEMPTS HAVE BEEN MADE AND ALL AVAILABLE INFORMATION HAS BEEN PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19020838 ↗MalfunctionMar 28, 2024Fracture; Fracture
IT WAS REPORTED THAT THE TENSION GAUGE BROKE INTO 3 PIECES DURING TRIALING. THERE WAS NO CONSEQUENCES OR IMPACT TO THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18997283 ↗MalfunctionOct 31, 2023Fracture; Fracture
IT WAS REPORTED THE TENSION GAUGE FRACTURED DURING THE PROCEDURE. THE SURGEON ENSURED ALL PIECES WERE RETRIEVED AND THE PATIENT WAS NOT IMPACTED. NO ADDITIONAL INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18038401 ↗MalfunctionJan 25, 2023Fracture; Fracture
IT WAS REPORTED THE TENSION GAUGE FRACTURED DURING USAGE AS PART OF A PROCEDURE. NO ADVERSE EVENTS HAVE BEEN REPORTED AS A RESULT OF THE MALFUNCTION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16240871 ↗MalfunctionJun 3, 2022Fracture; Fracture
IT WAS REPORTED THAT WHILE THE SURGEON WAS PERFORMING A PARTIAL KNEE PROCEDURE, HE PLACED THE TENSION GAUGE INTO THE JOINT AND THE TIP SNAPPED OFF IN THE POSTERIOR CAPSULE. NO PATIENT IMPACT. NO ADDITIONAL INFORMATION AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14594268 ↗MalfunctionMar 23, 2022Fracture; Fracture
IT WAS REPORTED THAT DURING SURGERY THE DOCTOR PUT THE TENSOR GAUGE IN TO TEST THE GAPS AND WHEN HE BROUGHT THE KNEE DOWN INTO EXTENSION, THE FEMORAL AND TIBIAL IMPLANT SNAPPED THE TENSOR GAUGE. ALL FRAGMENTS WERE RETRIEVED
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13862064 ↗MalfunctionFeb 18, 2022Fracture; Fracture
IT WAS REPORTED THAT THE TENSION GAUGE BROKE. THERE WAS NO CONSEQUENCES OR IMPACT TO THE PATIENT. IT WAS REPORTED THAT NO FURTHER INFORMATION IS AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13560100 ↗MalfunctionFeb 3, 2022Fracture; Fracture
IT WAS REPORTED THAT THE TENSOR GAUGE BROKE. THERE WAS NO CONSEQUENCES OR IMPACT TO THE PATIENT. IT WAS REPORTED THAT NO FURTHER INFORMATION IS AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13443347 ↗MalfunctionOct 7, 2021Fracture; Fracture
NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12589453 ↗MalfunctionAug 16, 2021Fracture; Fracture
NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12325161 ↗MalfunctionAug 16, 2021Fracture; Fracture
NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12325156 ↗MalfunctionNov 23, 2020Fracture; Fracture
IT IS REPORTED THAT DURING KIT INSPECTION AT THE ZIMMER BIOMET SPAIN WAREHOUSE, THE TENSION GAUGE WAS IDENTIFIED TO BE BROKEN. THERE WAS NO PATIENT INVOLVEMENT. NO ADVERSE EVENTS WERE IDENTIFIED AS A RESULT OF THIS MALFUNCTION.
Patient problems: No Patient Involvement
MAUDE report 10886201 ↗
Other ORTHOPEDIC MANUAL SURGICAL INSTRUMENT devices
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- EXPRESSEW 214141Medos International Sàrl · ORTHOPEDIC MANUAL SURGICAL INSTRUMENT1,166 reports
- N/A 9560524Medtronic Sofamor Danek, Inc. · ORTHOPEDIC MANUAL SURGICAL INSTRUMENT866 reports
- INHANCE 6500-11-104Depuy (Ireland) · Orthopedic manual surgical instrument831 reports
- INHANCE 6500-11-102Depuy (Ireland) · Orthopedic manual surgical instrument567 reports
- R3 71364450Smith & Nephew, Inc. · ORTHOPEDIC MANUAL SURGICAL INSTRUMENT520 reports
- N/A 9561524Medtronic Sofamor Danek, Inc. · ORTHOPEDIC MANUAL SURGICAL INSTRUMENT494 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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