CRF II - RADIAL PROSTHESIS DTJ006Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 03700386901218), received between Apr 4, 2023 and Oct 15, 2024 — classified as 8 injuries.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (4 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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• InjuryOct 15, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED: "WELBOW STUDY SUBJECT (B)(6). ONE MONTH AFTER THE SURGERY INVOLVING THE CRF II IMPLANT, HETEROTOPIC OSSIFICATION WITH NEUROPATHIC PAIN WAS OBSERVED. IT WAS OBSERVED A NEUROPATHIC PAIN STARTING FROM THE ELBOW AND RADIATING THROUGH THE RIGHT UPPER LIMB. TO ADDRESS THIS ISSUE REHABILITATION AND PHYSICAL THERAPY WERE REQUIRED."

  Patient problems: Extraskeletal ossification; Implant Pain

  MAUDE report 20451800 ↗
• InjurySep 12, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  SUBJECT: (B)(6) (ELBOW CLINICAL STUDY). FEW DAYS AFTER THE SURGERY INVOLVING THE CRF II IMPLANT, A DISLOCATION OF THE ELBOW (IN THE EVENT OF MAJOR INSTABILITY) WAS OBSERVED. IT WAS OBSERVED A AVULSION OF THE REATTACHMENT ANCHOR OF THE LATERAL LIGAMENTOUS PLAN RESULTED IN POSTERIOR DISLOCATION OF THE RADIAL HEAD. THIS EVENT WAS REPORTED AS A SERIOUS ADVERSE EVENT ¿REQUIRED INTERVENTION TO PREVENT LIFE-THREATENING ILLNESS OR INJURY, OR PERMANENT IMPAIRMENT OR DAMAGE TO ADDRESS THIS ISSUE, THREE INTERVENTIONS WERE REQUIRED: ON (B)(6) 2022: RE-OPERATION WITHOUT IMPLANT CHANGE: LIGAMENT RECONSTRUCTION USING HALF OF THE FLEXOR CARPI RADIALIS TENDON. THIS RECORD CORRESPONDS TO THIS EVENT ABOVE. ON (B)(6) 2022: RE-OPERATION WITHOUT IMPLANT CHANGE: LIGAMENT RECONSTRUCTION USING THE CONTROLATERAL PALMARIS LONGUS TENDON (BECAUSE OF RECURRENCE OF POSTEROLATERAL RADIAL DISLOCATION AFTER THE FIRST LIGAMENT). THIS EVENT CORRESPONDS TO (B)(4). ON (B)(6) 2022: RE-OPERATION WITHOUT IMPLANT CHANGE: LIGAMENT RECONSTUCTION (BECAUSE OF PERSISTENCE OF THE POSTEROLATERAL RADIAL HEAD DISLOCATION) THIS EVENT WAS RESOLVED WITHOUT SEQUELAE AFTER LAST INTERVENTION. THIS EVENT CORRESPONDS TO (B)(4).

  Patient problems: Subluxation

  MAUDE report 20200670 ↗
• InjurySep 12, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  SUBJECT: (B)(6) (WELBOW CLINICAL STUDY). FEW DAYS AFTER THE SURGERY INVOLVING THE CRF II IMPLANT, A DISLOCATION OF THE ELBOW (IN THE EVENT OF MAJOR INSTABILITY) WAS OBSERVED. IT WAS OBSERVED A AVULSION OF THE REATTACHMENT ANCHOR OF THE LATERAL LIGAMENTOUS PLAN RESULTED IN POSTERIOR DISLOCATION OF THE RADIAL HEAD. THIS EVENT WAS REPORTED AS A SERIOUS ADVERSE EVENT ¿REQUIRED INTERVENTION TO PREVENT LIFE-THREATENING ILLNESS OR INJURY, OR PERMANENT IMPAIRMENT OR DAMAGE TO ADDRESS THIS ISSUE, THREE INTERVENTIONS WERE REQUIRED : ON (B)(6) 2022 : RE-OPERATION WITHOUT IMPLANT CHANGE : LIGAMENT RECONSTRUCTION USING HALF OF THE FLEXOR CARPI RADIALIS TENDON. THIS EVENT CORRESPONDS TO 20243724469 AND 20243724470. ON 12 JUL 2022 : RE-OPERATION WITHOUT IMPLANT CHANGE : LIGAMENT RECONSTRUCTION USING THE CONTROLATERAL PALMARIS LONGUS TENDON (BECAUSE OF RECURRENCE OF POSTEROLATERAL RADIAL DISLOCATION AFTER THE FIRST LIGAMENT). THIS RECORD CORRESPONDS TO THIS EVENT. ON 13 JUL 2022 : RE-OPERATION WITHOUT IMPLANT CHANGE : LIGAMENT RECONSTRUCTION (BECAUSE OF PERSISTENCE OF THE POSTEROLATERAL RADIAL HEAD DISLOCATION) THIS EVENT WAS RESOLVED WITHOUT SEQUELAE AFTER LAST INTERVENTION. THIS EVENT CORRESPOND

  Patient problems: Subluxation

  MAUDE report 20200619 ↗
• InjurySep 12, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  SUBJECT: (B)(6) (WELBOW CLINICAL STUDY) FEW DAYS AFTER THE SURGERY INVOLVING THE CRF II IMPLANT, A DISLOCATION OF THE ELBOW (IN THE EVENT OF MAJOR INSTABILITY) WAS OBSERVED. IT WAS OBSERVED A AVULSION OF THE REATTACHMENT ANCHOR OF THE LATERAL LIGAMENTOUS PLAN RESULTED IN POSTERIOR DISLOCATION OF THE RADIAL HEAD. THIS EVENT WAS REPORTED AS A SERIOUS ADVERSE EVENT ¿REQUIRED INTERVENTION TO PREVENT LIFE-THREATENING ILLNESS OR INJURY, OR PERMANENT IMPAIRMENT OR DAMAGE TO ADDRESS THIS ISSUE, THREE INTERVENTIONS WERE REQUIRED : ON 27 JUN 2022 : RE-OPERATION WITHOUT IMPLANT CHANGE : LIGAMENT RECONSTRUCTION USING HALF OF THE FLEXOR CARPI RADIALIS TENDON. THIS EVENT CORRESPONDS TO 20243724469 AND 20243724470. ON 12 JUL 2022 : RE-OPERATION WITHOUT IMPLANT CHANGE : LIGAMENT RECONSTRUCTION USING THE CONTROLATERAL PALMARIS LONGUS TENDON (BECAUSE OF RECURRENCE OF POSTEROLATERAL RADIAL DISLOCATION AFTER THE FIRST LIGAMENT). THIS EVENT CORRESPONDS TO 20243733255 AND 20243733256. ON 13 JUL 2022 : RE-OPERATION WITHOUT IMPLANT CHANGE : LIGAMENT RECONSTRUCTION (BECAUSE OF PERSISTENCE OF THE POSTEROLATERAL RADIAL HEAD DISLOCATION) THIS EVENT WAS RESOLVED WITHOUT SEQUELAE AFTER LAST INTERVENTION. THIS R

  Patient problems: Subluxation

  MAUDE report 20200593 ↗
• InjuryMay 21, 2024Unstable; Device Dislodged or Dislocated; Unstable; Device Dislodged or Dislocated

  AS REPORTED: "DISLOCATION OF THE ELBOW (IN THE EVENT OF MAJOR INSTABILITY) PROSTHESIS PLACEMENT ON (B)(6) 2022, SUBLUXATION NOTED ON THE VISIT OF (B)(6) 2022, PROSTHESIS CHANGE ON (B)(6) 2022. TO ADDRESS THIS MATTER COMPREHENSIVELY, A CORRECTIVE RE-OPERATION WAS CONDUCTED. THIS INVOLVED THE EXTRACTION OF THE EXISTING IMPLANT AND THE SUBSEQUENT RE-IMPLANTATION OF A NEW PROSTHESIS."

  Patient problems: Joint Laxity; Subluxation

  MAUDE report 19366919 ↗
• InjuryApr 4, 2024Malposition of Device; Malposition of Device

  AS REPORTED: "FOLLOWING THE SURGICAL INTERVENTION FOR THE RADIAL HEAD CRF II IMPLANT, THE PATIENT EXPERIENCED POSTOPERATIVE COMPLICATIONS, INCLUDING ELBOW STIFFNESS AND IMPLANT MISPOSITIONING. ACCORDING TO THE SURGEON, THIS EVENT HAS A CAUSAL RELATIONSHIP WITH THE SURGERY PROCEDURE BUT IS NOT RELATED TO THE IMPLANT. TO ADDRESS THIS MATTER COMPREHENSIVELY, A CORRECTIVE RE-OPERATION WAS CONDUCTED ON (B)(6) 2020. THIS INVOLVED THE EXTRACTION OF THE EXISTING IMPLANT AND THE SUBSEQUENT RE-IMPLANTATION OF A NEW PROSTHESIS. THE PROCEDURE SUCCESSFULLY RECTIFIED THE COMPLICATIONS, AND THE PATIENT'S CONDITION WAS RESOLVED WITHOUT SEQUELAE."

  Patient problems: Loss of Range of Motion

  MAUDE report 19039996 ↗
• InjuryMar 1, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED: "POST OPERATIVE COMPLICATION: BONE CYST / OSTEOLYSIS / BONE RESORPTION SEVERE PAIN OF THE LEFT ELBOW POSTERO-LATERAL. PARTIAL LOSS OF RANGE OF MOTION." UPDATE FOLLOWING CLINICAL TEAM FEEDBACK: "TWO YEARS POST-SURGERY, THE PATIENT ENCOUNTERED INTENSE PAIN IN THE POSTERO-LATERAL REGION OF THE LEFT ELBOW, ACCOMPANIED BY A PARTIAL LOSS OF RANGE OF MOTION. SUBSEQUENT TO A FOLLOW-UP VISIT, A BONE CYST WAS CONCLUSIVELY DIAGNOSED MARKING A SIGNIFICANT ADVERSE EVENT (SAE) ¿PERMANENT IMPAIRMENT OF A BODY STRUCTURE OR FUNCTION¿. ACCORDING TO THE SURGEON, THIS EVENT HAS A CAUSAL RELATIONSHIP TO THE IMPLANT AND A POSSIBLE RELATIONSHIP TO THE SURGERY. TO ADDRESS THIS, REVISION SURGERY WAS PERFORMED ON (B)(6) 2024 TO REMOVE THE PROSTHESIS, BUT WITHOUT ANY REPLACEMENT. THE EVENT WAS RESOLVED WITHOUT SEQUELAE ON (B)(6) 2024. THE REMOVAL OF THE PROSTHESIS RESULTED IN COMPLETE ALLEVIATION OF PAIN, RENDERING THE LEFT ELBOW PAIN-FREE, STABLE, AND FULLY RESTORED TO ITS FULL RANGE OF MOTION."

  Patient problems: Cyst(s); Implant Pain; Loss of Range of Motion; Osteolysis

  MAUDE report 18817474 ↗
• InjuryApr 4, 2023Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  IT WAS REPORTED THAT THE PATIENT HAD PAIN FROM THE INITIAL IMPLANTATION OF AN ELBOW PROSTHESIS 4 MONTHS PRIOR. THE SURGEON ANALYZED THAT THE PROSTHESIS WAS OVERSTUFFED AND HAD CREATED PAIN ON THE HUMERAL CARTILAGE. REVISION WAS PERFORMED WITH A MOPYC HEAD SMALL, NECK MEDIUM AND STEM SMALL. SURGEON HAD DIFFICULTLY TO REMOVE CEMENT FROM BONE SHAFT, BUT AFTER THIS STEP IMPLANTATION OF THE MOPYC WAS EASY.

  Patient problems: Implant Pain

  MAUDE report 16673628 ↗