BIOSTOP 5463-12-000Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 10603295174561), received between Feb 21, 2019 and Mar 6, 2025 — classified as 4 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Fracture” (2 reports).

1 FDA recall record name this device's identifier, 1 still open.

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 18, 2026.

Recalls naming this device

1. Dec 19, 2022Class IIOpen, Classified

   All lots of BIOSTOP G Bioresorbable Cement Restrictor are being removed as a precautionary measure because tested endotoxin levels were higher than recommended by the current FDA regulatory guidance. In general, endotoxins have a potential to initiate inflammatory responses, ranging from a mild fever to potentially impact or damage to vital organs.

   Z-0951-2023 · Root cause: Process control · Recall details · FDA record ↗

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.

• InjuryMar 6, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT UNDERWENT REVISION SURGERY, REQUIRING EXTENSIVE DEBRIDEMENT. EXTENSIVE BONE EROSION WAS NOTED ON THE MEDIAL AND LATERAL FEMORAL CONDYLES AS WELL AS ALONG THE MEDIAL TIBIAL PLATEAU REQUIRING BONE GRAFTING TO CORRECT. GRANULATION TISSUE INDICATIVE OF LOOSENING WAS NOTED. THE FEMORAL AND TIBIAL SIDES WERE NOTED TO BE LOOSE - INTERFACE NOT IDENTIFIED. THE PATELLA WAS REMOVED AND UNDERNEATH SMALL CYSTS WERE IDENTIFIED AND REMOVED BEFORE REPLACING. A FRACTURE OF THE FEMORAL STEM AND THE CONNECTING SCREW OCCURRED WITHOUT TRAUMA. THE CONNECTING SCREW BETWEEN THE FEMORAL SHIELD AND THE FEMORAL SHAFT IS AFFECTED. THE REVISION WENT SMOOTHLY.

  Patient problems: Bone Notching; Pocket Erosion; Unspecified Tissue Injury

  MAUDE report 21536917 ↗
• InjuryFeb 15, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REMOVAL OF ALL DELTA XTEND IMPLANTS DUE TO INFECTION. SURGEON DID ORIGINAL OPERATION IN 2020 AND FIRST REVISION 2 MONTHS LATER FOR DISLOCATION. NO SURGICAL DELAY.

  Patient problems: Unspecified Infection

  MAUDE report 18717396 ↗
• MalfunctionJul 8, 2021Fracture; Fracture

  WE HAD A BIOSTOP CEMENT RESTRICTOR BREAK INTO TWO PIECES AND COULD ONLY PARTIALLY BE REMOVED DURING HIP REPLACEMENT SURGERY ON THE 15TH JUNE. THE SURGERY WAS SUCCESSFULLY COMPLETED AFTER A 20 MINUTE DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12134825 ↗
• InjuryOct 8, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REVISION REVERSE TOTAL SHOULDER: (B)(6) HOSPITAL, (B)(6) 2019. THIS WAS THE 2ND REVISION ON THIS PATIENT DUE TO CHRONIC DISLOCATION. PRIMARY IMPLANT DONE IN 2017 AND FIRST REVISION IN MID-2018. ORIGINAL CASE WAS A FRACTURED HUMERUS, AND THE FIRST REVISION WAS DONE DUE TO DISLOCATION. THE PATIENT ENDED UP AFTER FIRST REVISION WITH SPACER PLUS 38/9 POLY. THE SURGEON SAID PATIENT HAD FALLEN AGAIN AND REQUIRED RE REVISION. THE ORIGINAL PLAN WAS TO CONVERT TO HEMI WITH A CTA HEAD AS HE THOUGHT THE GLENOID COMPONENTS WOULD BE LOOSE, BUT AFTER OPENING THE BASE PLATE WAS SECURE SO HE UPSIZED THE HEAD TO A 42 AND PUT IN A 6 STANDARD POLY AND IT WASN'T DISLOCATING AT ALL. THE SURGEON SAID REVISION HAD NOTHING TO DO WITH THE IMPLANT, HE FELT THE PATIENT HAD DELTOID INSUFFICIENCY AND HAD SEVERE INFECTION ISSUES FOR MANY YEARS. FEMALE PATIENT, INITIAL: R., DOB: (B)(6) 1950.

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 9166364 ↗
• MalfunctionJul 12, 2019Fracture; Difficult to Remove; Connection Problem; Fracture; Difficult to Remove; Connection Problem

  AT THE MOMENT OF THE PLACEMENT OF BIOSTOP PLUG NUMBER 12 AFTER HAVING CORRECTLY PREPARED THE MEDULLARY CANAL, THE SURGEON INTRODUCES THE CAP WITH THE CORRESPONDING SETTER. IT IS CAUGHT IN THE CANAL, BUT IN AN ATTEMPT BY THE SURGEON TO REMOVE THE PLUG FROM THE CAP, IT DECAPITATED. WHEN THIS SITUATION OCCURRED, ANOTHER BIOSTOP NUMBER 14 PLUG WAS OPENED, SINCE THE PREVIOUS ONE HAD BROKEN, BUT WHEN PLACING THIS NEW IMPLANT, THE SAME ISSUE HAPPENED. SURGERY: RTC HYBRID, PINNACLE / C-STEM.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8785818 ↗
• InjuryFeb 21, 2019Loss of or Failure to Bond; Loss of or Failure to Bond

  IT WAS REPORTED THAT PATIENT PRESENTED WITH HIP PAIN AND INSTABILITY. CT REVEALED SOME OSTEOLYSIS BEHIND CUP. INITIAL PLAN WAS TO REMOVE CUP AND ASSESS DAMAGE. UPON DISLOCATION, FOUND STEM WAS LOOSE. STEM WAS REMOVED EASILY BY HAND. OPTED TO PUT IN RECLAIM REVISION STEM AND SWAP OUT THE LINER IN THE CUP TO A DURALOC CONSTRAINED. CUP WAS LEFT IN DUE TO SOLID FIXATION. THE LOOSENING WAS AT BONE TO CEMENT INTERFACE. DOI: UNKNOWN; DOR: (B)(6) 2019, RIGHT HIP.

  Patient problems: No Code Available; Osteolysis; Pain

  MAUDE report 8357433 ↗