BIOSTOPRecalls & reported problems across all models

We found 10 models of BIOSTOP by Depuy Orthopaedics, Inc. in the FDA's device registry (GUDID). Together they are named in 16 adverse event reports in the FDA's MAUDE database, received between Feb 14, 2018 and Mar 6, 2025 — classified as 5 injuries, 11 malfunctions.

The most frequently reported specific device problem is “Fracture” (4 reports).

1 FDA recall record name at least one of these models by its device 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

BIOSTOP recalls

FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.

1. Dec 19, 2022Open, 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 · names 7 of these models · Recall details · FDA record ↗

Most reported BIOSTOP problems

BIOSTOP models

10 models, most reported first. Each model has its own page with its reports, recalls and device details.

• BIOSTOP 5463-12-000

  CEMENT OBTURATOR
  1 recall6 reports
• BIOSTOP 5463-14-000

  Prosthesis, hip, cement restrictor
  1 recall2 reports
• BIOSTOP 5463-08-000

  CEMENT OBTURATOR
  1 recall1 report
• BIOSTOP 5463-16-000

  CEMENT OBTURATOR
  1 recall1 report
• BIOSTOP 5463-18-000

  CEMENT OBTURATOR
  1 recall1 report
• BIOSTOP 5463-10-000

  Prosthesis, hip, cement restrictor
  1 recall0 reports
• BIOSTOP 5463-20-000

  CEMENT OBTURATOR
  1 recall0 reports
• BIOSTOP 5463-60-500

  ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
  3 reports
• BIOSTOP 5463-34-500

  TEMPLATE
  1 report
• BIOSTOP 5463-50-500

  ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
  1 report

Recent BIOSTOP adverse event reports

The 15 most recent reports across all models, 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 ↗
• InjuryApr 2, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REVISION SHOULDER DELTA MOTION POST HUMERAL FRACTURE DUE TO INFECTION INFECTION AND LOOSENING AT THE STEM HUMERAL. THERE WAS NO SURGICAL DELAY.

  Patient problems: Unspecified Infection

  MAUDE report 19018689 ↗
• 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 ↗
• MalfunctionJan 8, 2021Unintended Movement; Unintended Movement

  WHEN THE NURSE WENT TO PUT THERE TRIAL ON THE BIOSTOP INSERTER HANDLE. THERE WAS SOME PLAY AND THE TRIAL FELT LOOSE. IT WAS NEVER LIKE THAT. MOST LIKELY DUE TO OVER USAGE. THE HANDLE SHOULD BE REPLACED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11139365 ↗
• MalfunctionApr 24, 2020Material Twisted/Bent; Material Twisted/Bent

  UPON THE USE OF THE T HANDLE FROM THE BIOSTOP INSTRUMENTS, THE THREADED SCREW ON TIP THAT ENGAGES WITH THE TRIAL, CROSS THREADED TOGETHER. THIS HAPPENED AFTER TRAILING WAS DONE, THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9996104 ↗
• MalfunctionFeb 24, 2020Material Deformation; Material Twisted/Bent; Material Deformation; Material Twisted/Bent

  WHEN OPENING THE CEMENT RESTRICTOR FOR A BIPOLAR CASE THIS MORNING, WE SAW THAT THE CEMENT RESTRICTOR INSERTER WAS BENT. THERE IS A DEPTH GAUGE THAT CAN SLIDE DOWN TO MEASURE THE DEPTH OF INSERTION, BUT IT WASN'T ABLE TO GO PAST HALF WAY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9746372 ↗
• MalfunctionJan 23, 2020Entrapment of Device; Entrapment of Device

  THE METAL RESTRICTOR THAT WAS USED FOR THE PLACEMENT OF THE BIOSTOP PLUG HAS ACCIDENTALLY BEEN LEFT INSIDE THE FEMORAL CANAL.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9623513 ↗
• 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 ↗
• MalfunctionAug 30, 2019Fracture; Fracture

  WE HAD A TOTAL HIP REPLACEMENT (THR) AND IT WAS COMPLICATED AT THE MOMENT OF ADDING THE FINAL PIECE, THE IMPACTOR BROKE. THE SCREWS WERE TRIED TO BE PLACED BUT IT DID NOT HAVE A GOOD GRIP BECAUSE THE PATIENT HAD OSTEOPOROSIS. AND FOR THAT REASON THEY CEMENTED THE LINERS. AND WHEN HE WAS PLACING THE BIOSTOP 18 IT BROKE OFF AND COULD NOT PLACE IT AND PLACED ANOTHER MEASURE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8949493 ↗
• MalfunctionJul 16, 2019Break; Break

  BIOSTOP WAS OPENED AND IT BROKE WHEN PLACED ON THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8792942 ↗
• 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 8785819 ↗
• 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 ↗
• MalfunctionMay 29, 2019Material Twisted/Bent; Material Twisted/Bent

  HOLDING PIECE FOR THE BIO STOP IMPLANT IS BENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8649346 ↗
• 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 ↗

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