VERSABOND 71271440Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 03596010507372), received between Oct 1, 2018 and Dec 14, 2021 — classified as 2 injuries, 4 malfunctions.

The most frequently reported specific device problem is “Clumping in Device or Device Ingredient” (1 report).

1 other recall cover devices cleared under the same FDA submission (K022688); 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 16, 2026.

Most reported problems

Recent adverse event reports

The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• InjuryDec 14, 2021Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

  IT WAS REPORTED THAT, DURING SURGERY, A VERSABOND AB 40 GRAMS F2 WAS USED EVEN THOUGH IT EXPIRED ON (B)(6) 2021. THIS WAS NOTICED AFTER USE IN PATIENT. SURGERY HAD BEEN COMPLETED, WITHOUT ANY DELAY, WITH THE SAME DEVICE. NO HARM TO THE PATIENT OR FURTHER COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13004795 ↗
• MalfunctionMar 23, 2020Failure to Back-Up; Failure to Back-Up

  IT WAS REPORTED THAT DURING A TOTAL KNEE ARTHROPLASTY SURGEON COMPLAINED ABOUT THE FLAKY TEXTURE OF THE RADIOPAQUE BONE CEMENT. THE SECOND PACKAGE OPENED GAVE THE SAME RESULT. IN ORDER TO OVERCOME THIS PROBLEM, THE SURGEONS HAD TO USE SYNICEM 1G BONE CEMENT.

  Patient problems: No Information

  MAUDE report 9869676 ↗
• MalfunctionJan 13, 2020Clumping in Device or Device Ingredient; Clumping in Device or Device Ingredient

  IT WAS REPORTED THAT DURING SURGERY, THE CEMENT DID NOT MIX IN A REGULAR AND HOMOGENEOUS WAY AS USUAL IN THE CONTAINER, IT WAS NOT USED DUE TO THE ABNORMAL CONSISTENCY (IT TURNED LUMPY AND YELLOW). INSTEAD, COMPETITOR CEMENT WAS USED TO PERFORM THE SURGERY. IT IS UNKNOWN IF THERE WERE ANY DELAYS IN THE SURGERY. NO PATIENT INJURIES WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9580176 ↗
• MalfunctionJan 13, 2020Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT THE CEMENT DID NOT MIX IN A REGULAR AND HOMOGENEOUS WAY AS USUAL IN THE CONTAINER, DOCTOR DID NOT WANT TO USE THE PRODUCT BECAUSE OF THE ABNORMAL CONSISTENCY. A SECOND CEMENT PACKAGE WAS OPENED AND MIXED IN ITS INDICATED CONTAINER, WHICH ALSO HAS AN ABNORMAL CONSISTENCY. BOTH TURNED LUMPY AND YELLOW. A THIRD CEMENT WAS OPENED WITH THE SAME LOT NUMBER THAT WAS MIXED IN A USUAL WAY AND WAS USED IN THE PATIENT. THE DEVICE WILL NOT BE RETURNED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9580152 ↗
• MalfunctionJan 3, 2020Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT THE CEMENT DID NOT MIX IN A REGULAR AND HOMOGENEOUS WAY AS USUAL IN THE CONTAINER, DOCTOR DID NOT WANT TO USE THE PRODUCT BECAUSE OF THE ABNORMAL CONSISTENCY. A SECOND CEMENT PACKAGE WAS OPENED AND MIXED IN ITS INDICATED CONTAINER, WHICH ALSO HAS AN ABNORMAL CONSISTENCY. BOTH TURNED LUMPY AND YELLOW. A THIRD CEMENT WAS OPENED WITH THE SAME LOT NUMBER THAT WAS MIXED IN A USUAL WAY AND WAS USED IN THE PATIENT. THE DEVICE WILL NOT BE RETURNED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9545434 ↗
• InjuryOct 1, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT A REVISION SURGERY WAS PERFORMED DUE TO FAILURE OF THE DEVICE. SWELLING WAS REPORTED.

  Patient problems: Injury; Joint Swelling

  MAUDE report 7924873 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K022688. One submission often covers many models, so check the product and lot details in each record.

• Z-0933-2021 · Dec 18, 2020 · Terminated
  VERSABOND AB 40 GRAMS FORMULATION 2, antibiotic infused bone cement, Product Number: 71271440 - Product Usage: VERSABOND is a medium viscosity bone cement which can be used for hip