INBONE 200009901Recalls & reported problems

Summary

The FDA's MAUDE database contains 25 adverse event reports that list this exact device (DI 00840420123831), received between Jul 19, 2021 and Mar 20, 2026 — classified as 22 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Osseointegration Problem” (5 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 25 most recent of 25 reports, in the reporter's own words as published by the FDA.

• InjuryMar 20, 2026Adverse Event Without Identified Device or Use Problem

  THE DIGITAL STRYKER PROPHECY TEAM RECEIVED A CT SCAN INDICATING THAT THE PATIENT MAY REQUIRE A REVISION SURGERY. REVISION PERFORMED DUE TO A POSTOPERATIVE WOUND INFECTION.

  Patient problems: Arthritis; Post Operative Wound Infection

  MAUDE report 24653894 ↗
• InjuryFeb 3, 2026Adverse Event Without Identified Device or Use Problem

  THE DIGITAL STRYKER PROPHECY TEAM RECEIVED A CT SCAN INDICATING THAT THE PATIENT MAY REQUIRE A REVISION SURGERY DUE TO AN INFECTION.

  Patient problems: Unspecified Infection

  MAUDE report 24248698 ↗
• InjuryNov 24, 2025Loss of Osseointegration; Osseointegration Problem; Loss of Osseointegration; Osseointegration Problem

  THE DIGITAL STRYKER PROPHECY TEAM RECEIVED A CT SCAN INDICATING THAT THE PATIENT MAY REQUIRE A REVISION SURGERY DUE TO "ASEPTIC LOOSENING. FOLLOWING IMPLANTATION, LUCENCY RAPIDLY DEVELOPED UNDER THE TALAR IMPLANT. LUCENCY ABOUT THE TIBIAL IMPLANT APPEARED LATER. I SUSPECT THAT NEITHER IMPLANT WAS EVER INGROWN. BOTH TALAR AND TIBIAL COMPONENTS NEED TO BE REVISED. THE TALUS IS A LITTLE THIN AND THE EXISTING CENTRAL PEG ABUTS THE SUBCHONDRAL BONE OF THE SUBTALAR JOINT POSTERIOR FACET."

  Patient problems: Inadequate Osseointegration

  MAUDE report 23632757 ↗
• InjuryNov 21, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  THE STRYKER PROPHECY TEAM HAS RECEIVED A CT SCAN FOR UPCOMING REVISION SURGERY, HOWEVER, THE REASON FOR THE REVISION IS STILL UNKNOWN.

  Patient problems: Insufficient Information

  MAUDE report 23623862 ↗
• InjuryOct 31, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  THE DIGITAL STRYKER PROPHECY TEAM RECEIVED A CT SCAN INDICATING THAT THE PATIENT MAY REQUIRE A REVISION SURGERY FOR REASONS CURRENTLY UNKNOWN.

  Patient problems: Insufficient Information

  MAUDE report 23438836 ↗
• InjuryOct 10, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE DIGITAL STRYKER PROPHECY TEAM RECEIVED A CT SCAN INDICATING THAT THE PATIENT MAY REQUIRE A REVISION SURGERY DUE TO PAIN IN JOINTS.

  Patient problems: Cyst(s); Pain

  MAUDE report 23267241 ↗
• InjuryJun 24, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE DIGITAL STRYKER PROPHECY TEAM RECEIVED A CT SCAN INDICATING THAT THE PATIENT UNDERWENT A DEVICE EXPLANT SURGERY DUE TO INFECTION. THE PATIENT RECEIVED A CEMENT SPACER.

  Patient problems: Post Operative Wound Infection

  MAUDE report 22319177 ↗
• InjuryMay 20, 2025Osseointegration Problem; Osseointegration Problem

  THE DIGITAL STRYKER PROPHECY TEAM RECEIVED A CT SCAN INDICATING THAT THE PATIENT MAY REQUIRE A REVISION SURGERY DUE TO PAIN AND LOOSENING.

  Patient problems: Inadequate Osseointegration; Pain

  MAUDE report 22056645 ↗
• InjuryMar 26, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  THE DIGITAL STRYKER PROPHECY TEAM RECEIVED A CT SCAN INDICATING THAT THE PATIENT WAS EXPERIENCING PAIN AND MAY REQUIRE A REVISION SURGERY FOR REASONS THAT ARE NOT AVAILABLE AT THE TIME OF THIS REPORT.

  Patient problems: Implant Pain; Pain

  MAUDE report 21701434 ↗
• InjuryFeb 18, 2025Biocompatibility; Biocompatibility

  THE PATIENT REPORTED EXPERIENCING A SEVERE ALLERGIC REACTION AND INFECTION RELATED TO THE METAL COMPONENTS IN A STRYKER PRODUCT. THEY ALSO ALLEGE CHRONIC FOOT PAIN CAUSED BY THE IMPLANTS AND HAVE REQUESTED AN ANKLE AMPUTATION, STATING THEY DO NOT BELIEVE THEY ARE A SUITABLE CANDIDATE FOR AN ANKLE PROSTHESIS. POSTOPERATIVELY, THE PATIENT¿S PRIMARY CARE PHYSICIAN EXAMINED THE ANKLE AND NOTED SIGNS CONSISTENT WITH INFECTION. THE PATIENT WAS SUBSEQUENTLY PRESCRIBED ANTIBIOTICS. DURING A FOLLOW-UP WITH THE SURGEON, THEY WERE ADVISED TO USE NUMBER TWO COMPRESSION SOCKS. THE PATIENT IS CURRENTLY SEEKING ADDITIONAL MEDICAL OPINIONS REGARDING NEXT STEPS AND HAS MENTIONED IDENTIFYING A SURGEON WHO MAY BE ABLE TO PERFORM THE ANKLE AMPUTATION.

  Patient problems: Ambulation or Postural Difficulties; Discomfort; Fever; Implant Pain; Unspecified Infection; Wound Dehiscence; Wound Odor

  MAUDE report 21392568 ↗
• InjuryFeb 3, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE DIGITAL STRYKER PROPHECY TEAM RECEIVED A CT SCAN INDICATING THAT THE PATIENT MAY REQUIRE A REVISION SURGERY DUE TO INFECTION.

  Patient problems: Unspecified Infection

  MAUDE report 21294602 ↗
• InjuryApr 9, 2024Use of Device Problem; Adverse Event Without Identified Device or Use Problem; Use of Device Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED IT WAS REPORTED THAT TWO IMPLANTS WERE FOUND TO BE DEFECTIVE DURING A PRIMARY PROPHECY INBONE CASE. THE TIBIA FRACTURED AS A RESULT OF THE REPEATED IMPACT TO THE TIBIAL PLATE AND STEM. ARTHREX PLATES AND SCREWS WERE USED TO MANAGE THE FRACTURE AS WELL AS BONE CEMENT TO HELP FIXATE THE INBONE STEM. NEW IMPLANTS WERE USED TO COMPLETE THE CASE SUCCESSFULLY. THERE WAS A 90 MINUTE DELAY.

  Patient problems: Bone Fracture(s)

  MAUDE report 19071610 ↗
• InjuryFeb 16, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE DIGITAL STRYKER PROPHECY TEAM RECEIVED A CT SCAN INDICATING THAT THE PATIENT UNDERWENT A DEVICE EXPLANT SURGERY DUE TO INFECTION CAUSED BY SEPTIC ARTHRITIS FROM THE SPINE THAT TRAVELED THROUGHOUT THE LOWER EXTREMITIES OF HER BODY. THE PATIENT RECEIVED A CEMENT SPACER. THE INFECTION WAS DISCOVERED DURING THE PURULENT DRAINAGE FROM THE LATERAL ASPECT OF THE ANKLE.

  Patient problems: Arthritis; Post Operative Wound Infection; Unspecified Infection

  MAUDE report 18727665 ↗
• InjuryFeb 16, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS WALKING WITH A LIMP, HAS PAIN, SWELLING IN ANKLE AND IN UNABLE TO WALK. THE PATIENT TOLD THE DOCTOR AND WAS PROVIDED SUPPORT HOSE AND THOSE DIDN'T MAKE A DIFFERENCE. PATIENT REQUIRES A WHEELCHAIR AT TIMES TO MOVE AROUND.

  Patient problems: Ambulation or Postural Difficulties; Implant Pain; Swelling/ Edema

  MAUDE report 18721137 ↗
• InjuryNov 3, 2023Loss of Osseointegration; Adverse Event Without Identified Device or Use Problem; Loss of Osseointegration; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD POST TRAUMATIC ARTHRITIS FROM A PRIOR PILON FRACTURE. THE DISTAL TIBIAL BONE WAS RATHER SOFT AT THE TIME OF SURGERY- THE TALAR COMPONENT COLLAPSED INTO SOME VALGUS. THE PATIENT HAD A TIBIAL PERIPROSTHETIC FRACTURE THAT REQUIRED SURGERY. THE PATIENT CONTINUES TO HAVE DISCOMFORT. THE PHYSICIAN IS PLANNING TO REVISE THE PATIENT WITH LONGER TIBIAL STEM FOR ADDED STABILITY. THE PHYSICIAN PLANS TO HAVE A NAIL BACK UP IN CASE THE BONE IS TOO SOFT AND UNABLE TO REVISE. DURING A LATER CONVERSATION THE PHYSICIAN REPORTED THAT THE IMPLANT COMPONENTS WERE NOT THE CAUSE OF THE FAILURE, IT WAS THE PATIENT'S POOR QUALITY OF BONE. THEY PLAN ON REVISING IN THE NEAR FUTURE BUT THE PATIENT IS CURRENTLY HAVING CARDIAC ISSUES AND HAS NOT BEEN CLEARED BY CARDIOLOGY.

  Patient problems: Bone Fracture(s); Discomfort; Inadequate Osseointegration

  MAUDE report 18069709 ↗
• InjurySep 18, 2023Osseointegration Problem; Migration; Osseointegration Problem; Migration

  THE DIGITAL STRYKER PROPHECY TEAM RECEIVED A CT SCAN INDICATING THAT THE PATIENT MAY REQUIRE A REVISION SURGERY DUE TO LOOSENING OF THE TIBIA.

  Patient problems: Inadequate Osseointegration

  MAUDE report 17770292 ↗
• MalfunctionSep 15, 2023Device Difficult to Setup or Prepare; Device Difficult to Setup or Prepare

  IT WAS REPORTED THAT DURING A PRIMARY IMPLANT PROCEDURE THE SURGEON COULD NOT GET THE MORSE TAPER TO SEAT WITH THESE 2 IMPLANTS. THEY PROCEEDED TO REMOVE THE TIBIAL TRAY AND STEMS, THEN TRIED TO SEAT THE MORSE TAPER ON THE BACK TABLE WHICH DID NOT WORK EITHER. AFTER SEVERAL TRIES AND 90 MINUTE DELAY, THE SURGEON OPENED NEW IMPLANTS AND THE MORSE TAPER SEATED FINE. THEY HAD TO REMOVE AND OPEN DIFFERENT IMPLANT. THEY REPLACED WITH ANOTHER 16MM BASE STEM, DIFFERENT LOT NUMBER AND IT WORKED FINE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17760943 ↗
• InjuryAug 18, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A TOTAL ANKLE REPLACEMENT. THE PATIENT HAD AN INFECTION, THE TOTAL ANKLE WAS EXPLANTED AND A CEMENT SPACER WAS INSERTED. THE PATIENT WAS WASHED OUT AND A POLY EXCHANGE WAS DONE ALONG WITH ANTIBIOTICS.

  Patient problems: Unspecified Infection

  MAUDE report 17575926 ↗
• InjuryApr 5, 2023Osseointegration Problem; Migration; Osseointegration Problem; Migration

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A TOTAL ANKLE REPLACEMENT. ALLEGEDLY, THERE WAS POSTERIOR SUBSIDENCE OF THE TIBIAL IMPLANT. THE PATIENT WILL CONTINUE TO BE MONITORED AND NO FURTHER INTERVENTION WILL BE PERFORMED.

  Patient problems: Inadequate Osseointegration; Insufficient Information; Limb Fracture

  MAUDE report 16682972 ↗
• InjuryMar 10, 2023Osseointegration Problem; Migration; Osseointegration Problem; Migration

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A TOTAL ANKLE REPLACEMENT. ALLEGEDLY, THE PATIENT MAY NEED TO UNDERGO A REVISION SURGERY DUE TO PAIN AND LOOSENING OF THE TIBIA STEM OF THE PROSTHESIS. NO OPERATING HAS BEEN DONE. THE PATIENT HAS BEEN GOING THROUGH PHYSICAL THERAPY WITH NO POSITIVE RETURNS.

  Patient problems: Implant Pain; Inadequate Osseointegration

  MAUDE report 16522441 ↗
• MalfunctionDec 9, 2022Device Difficult to Setup or Prepare; Detachment of Device or Device Component; Device Difficult to Setup or Prepare; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE PATIENT WAS UNDERGOING A TOTAL ANKLE REPLACEMENT DUE TO ANKLE ARTHRITIS. DURING THE PROCEDURE IT WAS NOTED THAT THE INVISION TIBIA SIZE 3 +4 COMPONENT WAS CONNECTED TO THE SIZE 16 BASE STEM. ALL THE INDICATORS SHOWED IT WAS CONNECTED, THEN IMPACTED INTO THE TIBIA. FROM THERE THE TIBIA COMPONENT DETACHED FROM THE BASE STEM. THIS HAPPENED THREE TIMES. ON THE FOURTH TIME THE SURGEON USED CEMENT TO SECURE IN PLACE. ADDITIONALLY, IT WAS REPORTED; THE PROCEDURE WAS EXTENDED HOWEVER THE LENGTH OF THE EXTENSION IS UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15950265 ↗
• InjuryJun 27, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD AN INFECTION AND UNDERWENT A PROCEDURE TO REMOVE THE IMPLANT. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME.

  Patient problems: Unspecified Infection

  MAUDE report 14836755 ↗
• InjuryFeb 14, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING A REVISION SURGERY THE PATIENT SUFFERED AN ANTERIOR MIDLINE FRACTURE OF THE TIBIA UPON IMPLANTATION OF THE TIBIAL STEMS. THE SURGEON USED A PLATE AND SCREWS TO TREAT THE FRACTURE. THE SURGEON EXPECTS THE PATIENT TO RECOVER WELL AND WILL PROCEED WITH NON-WEIGHT BEARING FOR 8 WEEKS.

  Patient problems: Bone Fracture(s)

  MAUDE report 13524935 ↗
• MalfunctionJan 6, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  DURING A REVISION TAR INTERVENTION THERE WAS A DISASSOCIATION BETWEEN THE TIBIAL TRAY AND THE BASE STEM PIECE WHILE TRIALING FOR THE PE INSERT THICKNESS. SURGICAL TECHNIQUE WAS FOLLOWED AS DESCRIBED, MORSE TAPER LOCKING BETWEEN THE 2 COMPONENTS WAS TESTED AS DESCRIBED IN TECHNIQUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13181671 ↗
• InjuryJul 19, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A TOTAL ANKLE SURGICAL PROCEDURE. ALLEGEDLY, THE BASE STEM WAS DROPPED ON THE FLOOR AND THE HOSPITAL WOULD NOT PROCESS DUE TO THE IFU INSTRUCTIONS. THIS WAS THE ONLY 16MM BASE STEM IN THE KIT, AS ONLY ONE OF THIS SIZE IS STANDARD IN THE KIT. THE 18MM STEM WOULD NOT FIT ON THE TIBIA TRAY THAT WAS NEEDED, SO THERE WAS NO BACK UP AVAILABLE. A CEMENT SPACER WAS PUT INTO THE JOINT SPACE AND THE PATIENT HAD TO UNDERGO A SECOND SURGICAL PROCEDURE THE FOLLOWING DAY.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 12193508 ↗