PRO-DENSE™ 87SR0100Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00889797072762), received between Jul 28, 2021 and Oct 14, 2022 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Device Difficult to Setup or Prepare” (3 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.

Most reported problems

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 14, 2022Difficult to Insert; Device Difficult to Setup or Prepare; Difficult to Insert; Device Difficult to Setup or Prepare

  IT WAS REPORTED THAT THE 10CC PRODENSE UNIT WAS MIXED AND UPON DELIVERY WOULD NOT EXIT THE DELIVERY NEEDLE AFTER 4 MINUTES WHEN FILLING SCREW TRACKS IN THE HIP AFTER HARDWARE WAS REMOVED. 2 OF THE THREE SCREW HOLES WERE FILLED BEFORE THE PRODENSE WOULD NOT EXIT THE DELIVERY NEEDLE. ONE SCREW HOLE WAS NOT FILLED WITH PRODENSE. THIS RESULTED IN A 3-4 MINUTE DELAY IN SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15606339 ↗
• MalfunctionMar 3, 2022Coagulation in Device or Device Ingredient; Device Difficult to Setup or Prepare; Coagulation in Device or Device Ingredient; Device Difficult to Setup or Prepare

  IT WAS REPORTED THAT DURING THE PROCEDURE THE PHYSICIAN MIXED MONOMER INTO MIXER AND MATERIAL, MIXED FOR 30 SECS HORIZONTAL, SWITCHED CAPS AND WENT TO DELIVER AFTER ALL ATTACHMENTS CONNECTED AND MATERIAL WAS HARD BEFORE THE 5 MINS MARK. THE SURGICAL STAFF DID THIS PROCESS TWICE WITH ANOTHER 10CC AND ANOTHER LOT NUMBER AND WHILE ATTEMPTING INJECTION THE MATERIAL HARDENED PREVENTING THE INJECTION. THEY OPENED A SECOND BATCH OF PRODENSE AND THAT DID THE EXACT SAME THING. THE STAFF CONVERTED TO CERAMENT TO FINISH THE CASE. THE SUBSTITUTE (CERAMENT) WAS ONLY 5CC¿S AND THEY NEEDED A TOTAL OF 15-20CC¿S FOR THE CASE. A SURGICAL DELAY WAS REPORTED; HOWEVER THE LENGTH OF THE DELAY WAS NOT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13664050 ↗
• MalfunctionMar 3, 2022Coagulation in Device or Device Ingredient; Device Difficult to Setup or Prepare; Coagulation in Device or Device Ingredient; Device Difficult to Setup or Prepare

  IT WAS REPORTED THAT DURING THE PROCEDURE THE PHYSICIAN MIXED MONOMER INTO MIXER AND MATERIAL, MIXED FOR 30 SECS HORIZONTAL, SWITCHED CAPS AND WENT TO DELIVER AFTER ALL ATTACHMENTS CONNECTED AND MATERIAL WAS HARD BEFORE THE 5 MINS MARK. THE SURGICAL STAFF DID THIS PROCESS TWICE WITH ANOTHER 10CC AND ANOTHER LOT NUMBER AND WHILE ATTEMPTING INJECTION THE MATERIAL HARDENED PREVENTING THE INJECTION. THEY OPENED A SECOND BATCH OF PRODENSE AND THAT DID THE EXACT SAME THING. THE STAFF CONVERTED TO CEREMENT TO FINISH THE CASE. THE SUBSTITUTE (CEREMENT) WAS ONLY 5CC¿S AND THEY NEEDED A TOTAL OF 15-20CC¿S FOR THE CASE. A SURGICAL DELAY WAS REPORTED; HOWEVER THE LENGTH OF THE DELAY WAS NOT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13664041 ↗
• MalfunctionJul 28, 2021Material Too Rigid or Stiff; Material Too Rigid or Stiff

  IT WAS REPORTED THAT THE PRODENSE HARDENED TOO QUICKLY AND WAS NOT ABLE TO BE INJECTED INTO THE PATIENT. THERE WAS A BACKUP SOLUTION FROM ANOTHER COMPANY THAT WAS ABLE TO BE USED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12237496 ↗