CRF II - RADIAL PROSTHESISRecalls & reported problems across all models

We found 4 models of CRF II - RADIAL PROSTHESIS by Tornier in the FDA's device registry (GUDID). Together they are named in 20 adverse event reports in the FDA's MAUDE database, received between Mar 1, 2017 and Oct 17, 2024 — classified as 19 injuries, 1 malfunction.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (8 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. 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

Most reported CRF II - RADIAL PROSTHESIS problems

CRF II - RADIAL PROSTHESIS models

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

• CRF II - RADIAL PROSTHESIS DTJ006

  PROSTHESIS, ELBOW, HEMI-, RADIAL, POLYMER
  8 reports
• CRF II - RADIAL PROSTHESIS DTJ019

  PROSTHESIS, ELBOW, HEMI-, RADIAL, POLYMER
  6 reports
• CRF II - RADIAL PROSTHESIS DTJ022

  PROSTHESIS, ELBOW, SEMI-CONSTRAINED, CEMENTED
  5 reports
• CRF II - RADIAL PROSTHESIS DTJ008

  PROSTHESIS, ELBOW, HEMI-, RADIAL, POLYMER
  1 report

Recent CRF II - RADIAL PROSTHESIS adverse event reports

The 15 most recent reports across all models, in the reporter's own words as published by the FDA.

• InjuryOct 17, 2024Positioning Failure; Adverse Event Without Identified Device or Use Problem; Positioning Failure; Adverse Event Without Identified Device or Use Problem

  AS REPORTED: "WELBOW STUDY SUBJECT : (B)(6). DURING THE SURGERY INVOLVING THE CRF II IMPLANT, AN INTRA-OPERATIVE COMPLICATION WAS OBSERVED. THE PATIENT EXPERIENCED A DEFECT IN THE RADIAL BONE CUT. THIS EVENT WAS REPORTED AS A SERIOUS ADVERSE EVENT THAT REQUIRED INTERVENTION TO PREVENT LIFE-THREATENING ILLNESS OR INJURY, OR PERMANENT IMPAIRMENT OR DAMAGE. IN MEDICAL OBSERVATION: INDICATION TO REPEAT THE CUT OF AT LEAST 3MM, CEMENTATION OF A NEW STEM, REINSERTION OF THE EXTERNAL COLLATERAL PLANE, PROCEDURE: CHANGE OF LEFT RADIAL HEAD PROSTHESIS, 3MM CUT, REINSERTION OF EXTERNAL COLLATERAL PLANE. THIS RECORD IS COVERING THIS INTRA-OP COMPLICATION. MANAGEMENT IN THE OPERATING ROOM ON (B)(6) 2024 FOR ARTHROPLASTY OF THE RADIAL HEAD AND REINSERTION OF THE LATERAL PLANE ON ANCHOR. POST-OPERATIVE FOLLOW-UP RADIOGRAPHS SHOWED TOO MUCH PROSTHETIC CROWDING. NEED FOR REVISION SURGERY TO CUT THE NECK OF THE RADIUS AND REIMPLANT A NEW PROSTHESIS. A NEW CRF II IMPLANT WAS USED. STRYKER REFERENCE # (B)(4) IS COVERING THIS REVISION SURGERY."

  Patient problems: Perforation

  MAUDE report 20468780 ↗
• InjuryOct 16, 2024Malposition of Device; Adverse Event Without Identified Device or Use Problem; Malposition of Device; Adverse Event Without Identified Device or Use Problem

  AS REPORTED: "WELBOW STUDY SUBJECT : (B)(6). DURING THE SURGERY INVOLVING THE CRF II IMPLANT, AN INTRA-OPERATIVE COMPLICATION WAS OBSERVED. THE PATIENT EXPERIENCED A DEFECT IN THE RADIAL BONE CUT. THIS EVENT WAS REPORTED AS A SERIOUS ADVERSE EVENT THAT REQUIRED INTERVENTION TO PREVENT LIFE-THREATENING ILLNESS OR INJURY, OR PERMANENT IMPAIRMENT OR DAMAGE. IN MEDICAL OBSERVATION: INDICATION TO REPEAT THE CUT OF AT LEAST 3MM, CEMENTATION OF A NEW STEM, REINSERTION OF THE EXTERNAL COLLATERAL PLANE, PROCEDURE: CHANGE OF LEFT RADIAL HEAD PROSTHESIS, 3MM CUT, REINSERTION OF EXTERNAL COLLATERAL PLANE. STRYKER REFERENCE # (B)(4) IS COVERING THIS INTRA-OP COMPLICATION. MANAGEMENT IN THE OPERATING ROOM ON (B)(6) 2024 FOR ARTHROPLASTY OF THE RADIAL HEAD AND REINSERTION OF THE LATERAL PLANE ON ANCHOR. POST-OPERATIVE FOLLOW-UP RADIOGRAPHS SHOWED TOO MUCH PROSTHETIC CROWDING. NEED FOR REVISION SURGERY TO CUT THE NECK OF THE RADIUS AND REIMPLANT A NEW PROSTHESIS. A NEW CRF II IMPLANT WAS USED. THIS RECORD IS COVERING THIS REVISION SURGERY."

  Patient problems: Implant Pain; Insufficient Information

  MAUDE report 20462823 ↗
• InjuryOct 16, 2024Malposition of Device; Adverse Event Without Identified Device or Use Problem; Malposition of Device; Adverse Event Without Identified Device or Use Problem

  AS REPORTED: "WELBOW STUDY SUBJECT : (B)(6). DURING THE SURGERY INVOLVING THE CRF II IMPLANT, AN INTRA-OPERATIVE COMPLICATION WAS OBSERVED. THE PATIENT EXPERIENCED A DEFECT IN THE RADIAL BONE CUT. THIS EVENT WAS REPORTED AS A SERIOUS ADVERSE EVENT THAT REQUIRED INTERVENTION TO PREVENT LIFE-THREATENING ILLNESS OR INJURY, OR PERMANENT IMPAIRMENT OR DAMAGE. IN MEDICAL OBSERVATION: INDICATION TO REPEAT THE CUT OF AT LEAST 3MM, CEMENTATION OF A NEW STEM, REINSERTION OF THE EXTERNAL COLLATERAL PLANE, PROCEDURE: CHANGE OF LEFT RADIAL HEAD PROSTHESIS, 3MM CUT, REINSERTION OF EXTERNAL COLLATERAL PLANE. STRYKER REFERENCE # (B)(4) IS COVERING THIS INTRA-OP COMPLICATION. MANAGEMENT IN THE OPERATING ROOM ON (B)(6) 2024 FOR ARTHROPLASTY OF THE RADIAL HEAD AND REINSERTION OF THE LATERAL PLANE ON ANCHOR. POST-OPERATIVE FOLLOW-UP RADIOGRAPHS SHOWED TOO MUCH PROSTHETIC CROWDING. NEED FOR REVISION SURGERY TO CUT THE NECK OF THE RADIUS AND REIMPLANT A NEW PROSTHESIS. A NEW CRF II IMPLANT WAS USED. THIS RECORD IS COVERING THIS REVISION SURGERY."

  Patient problems: Implant Pain; Insufficient Information

  MAUDE report 20462421 ↗
• 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 20451843 ↗
• 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 RECORD CORRESPONDS TO THIS EVENT ABOVE. 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 EVENT COR

  Patient problems: Subluxation

  MAUDE report 20200608 ↗
• 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 ↗
• InjurySep 12, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  SUBJECT: (B)(6) ((B)(6) 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 (B)(4) AND (B)(4). 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) AND (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 RECORD COVERS THIS EV

  Patient problems: Subluxation

  MAUDE report 20200580 ↗
• InjurySep 12, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  SUBJECT: (B)(6) ((B)(6) 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 (B)(4) AND (B)(4). 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 RECORD CORRESPONDS TO THIS EVENT. 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 20200565 ↗
• 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 ↗
• 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 19366918 ↗
• 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 19040000 ↗
• 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 ↗

Other Tornier products

• Tornier Flex Shoulder System91 models · 791 reports
• Blueprint Mixed Reality8 models · 0 reports · 9 recalls
• AEQUALIS REVERSED II46 models · 405 reports
• AEQUALIS REVERSED41 models · 258 reports
• FLEX SHOULDER SYSTEM35 models · 194 reports
• Tornier Perform Anatomic Glenoid25 models · 81 reports
• Aequalis Ascend Flex30 models · 79 reports
• AEQUALIS15 models · 56 reports