TorxRecalls & reported problems across all models

We found 7 models of Torx by Howmedica Osteonics Corp. in the FDA's device registry (GUDID). Together they are named in 84 adverse event reports in the FDA's MAUDE database, received between Jan 11, 2017 and Jul 1, 2026 — classified as 48 injuries, 36 malfunctions.

The most frequently reported specific device problem is “Fracture” (19 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 Torx problems

Torx models

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

• Torx 2030-6525-1

  Screw, fixation, bone
  27 reports
• Torx 2030-6530-1

  Screw, fixation, bone
  18 reports
• Torx 2030-6535-1

  Screw, fixation, bone
  13 reports
• Torx 2030-6520-1

  Screw, fixation, bone
  9 reports
• Torx 2030-6540-1

  Screw, fixation, bone
  9 reports
• Torx 2030-6516-1

  Screw, fixation, bone
  7 reports
• Torx 2030-6545-1

  Screw, fixation, bone
  1 report

Recent Torx adverse event reports

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

• InjuryJul 1, 2026Degraded

  AS PER MEDWATCH REPORTS MW5188325, MW5188326, MW5188327, MW5188328, MW5188329, MW5188330, MW5188331, MW5188332: REPORTER STATES SHE HAD A COMPLETE HIP REVISION ON (B)(6) 2026 DUE TO HER PREVIOUS HIP IMPLANT LEAKING COBALT INTO HER BLOODSTREAM. REPORTER IS STILL RECOVERING FROM THE REVISION 5 WEEKS AGO AND SHE HAS EXPERIENCED DIFFICULTY WALKING. REPORTER HAD THE INITIAL IMPLANT ON (B)(6) 2012 WITH DR. (B)(6) HOSPITAL. PT STARTED EXPERIENCING EXTREME FATIGUE, HEADACHES, COGNITIVE ISSUES, BODY ACHES, SHORTNESS OF BREATH AFTER MILD ACTIVITY AND JOINT PAIN FOR THE LAST COUPLE OF YEARS. WITHIN THE TIMEFRAME REPORTER ALSO EXPERIENCED CHRONIC FATIGUE SYNDROME. SHE HAD MULTIPLE TESTING DONE SUCH AS X-RAY AND MRI THAT WEREN'T CONCLUSIVE UNTIL SHE HAD A SPECIFIC MRI THAT SHOWED METALS IN BLOODSTREAM AND LAB WORK THAT SHOWED HEAVY METAL DAMAGE. SHE ALSO HAD HER GALLBLADDER REMOVED AND SUSPECTS IT MAY BE DUE TO HEAVY METALS IN BODY. REPORTER STATES THAT SHE HAS SEEN RECALLS ON THESE TYPE OF DEVICES.

  Patient problems: Cognitive Changes; Dyspnea; Fatigue; Headache; Metal Related Pathology; Pain

  MAUDE report 25682839 ↗
• MalfunctionApr 22, 2025Fracture; Fracture

  THE FOLLOWING WAS REPORTED BY THE CUSTOMER: "DURING IMPLANTATION THE SCREW HEAD SNAPPED OFF - UNABLE TO REMOVE REMAINING METAL IMPLANT." FURTHER INFORMATION RECEIVED FROM CUSTOMER 1/4; " THE SURGEON WAS UNABLE TO SAFELY REMOVE THE REMAINING PARTS OF THE SCREW. TO AVOID IT IMPINGING ON THE CUP THE DECISION WAS MADE TO USE A BURR TO ENSURE THE BROKEN SCREW WAS FLUSH. NO LONG LASTING EFFECTS PREDICTED.

  Patient problems: Metal Related Pathology; No Clinical Signs, Symptoms or Conditions

  MAUDE report 21886565 ↗
• InjuryNov 22, 2024Loss of Osseointegration; Loss of Osseointegration

  IT WAS REPORTED THAT THE PATIENT'S RIGHT HIP WAS REVISED DUE TO 'LOOSE ACETABULAR SOCKET.' ALSO REPORTED WERE 'CONTINUED PAIN AND MAINLY GROIN AND LATERAL PAIN¿' SHELL, SCREWS, LINER, AND FEMORAL HEAD WERE REVISED TO A COMPETITOR SHELL, SCREWS, AND LINER, AND A STRYKER LFIT HEAD.

  Patient problems: Inadequate Osseointegration; Pain

  MAUDE report 20756058 ↗
• InjuryNov 22, 2024Loss of Osseointegration; Loss of Osseointegration

  IT WAS REPORTED THAT THE PATIENT'S RIGHT HIP WAS REVISED DUE TO 'LOOSE ACETABULAR SOCKET.' ALSO REPORTED WERE 'CONTINUED PAIN AND MAINLY GROIN AND LATERAL PAIN' SHELL, SCREWS, LINER, AND FEMORAL HEAD WERE REVISED TO A COMPETITOR SHELL, SCREWS, AND LINER, AND A STRYKER LFIT HEAD.

  Patient problems: Inadequate Osseointegration; Pain

  MAUDE report 20756053 ↗
• InjuryMar 9, 2023Fracture; Fracture

  A PATIENT WHO UNDERWENT THA ON (B)(6) 2016, COMPLAINED OF RIGHT HIP PAIN. X-RAYS REVEALED THAT THE CUP SIDE WAS PROLAPSED. ONE SCREW (OUT OF THREE) WAS FOUND TO BE BROKEN WHEN THE CUP WAS REMOVED. THE MOLAR FLOOR WAS IN METALLOSIS. THE DOCTOR DECIDED TO LEAVE THE BROKEN SCREW IN PLACE AND PROCEEDED WITH THE OPERATION BECAUSE REMOVING THE ENTIRE SCREW WOULD BE TOO RISKY. AFTER THAT, THE OPERATION WAS COMPLETED AS PLANNED.

  Patient problems: Joint Dislocation; Metal Related Pathology; Pain

  MAUDE report 16513283 ↗
• InjuryFeb 15, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THERE WAS BACKSIDE WEAR-LIKE OSTEOLYSIS AROUND THE SCREW HOLE OF TRIDENT CUP. AN INDENTATION MADE BY THE SCREW HEAD WAS OBSERVED ON THE BACKSIDE OF THE LINER.

  Patient problems: Osteolysis

  MAUDE report 16383279 ↗
• InjuryNov 18, 2022Loss of Osseointegration; Loss of Osseointegration

  IT WAS REPORTED BY THE SALES REP THAT THE SURGEON NOTIFY ON A POSSIBLE REMOVAL CASE DUE TO LOOSENING.

  Patient problems: Inadequate Osseointegration

  MAUDE report 15822611 ↗
• InjuryNov 17, 2022Loss of Osseointegration; Loss of Osseointegration

  IT WAS REPORTED BY THE SALES REP THAT THE SURGEON NOTIFY ON A POSSIBLE REMOVAL CASE DUE TO LOOSENING.

  Patient problems: Inadequate Osseointegration

  MAUDE report 15812797 ↗
• InjuryJun 10, 2022Corroded; Corroded

  LEFT HIP REVISION FOR PAIN, PSEUDO TUMOR, AND ELEVATED COBALT LEVELS. CUP, SCREWS, INSERT, AND HEAD WERE REVISED. COMPETITOR CUP, SCREWS, AND INSERT WERE USED ALONG WITH A STRYKER UNIVERSAL TAPER CERAMIC HEAD. UPDATE BASED ON MEDICAL REVIEW. THE PREOPERATIVE DIAGNOSES AND POSTOPERATIVE DIAGNOSES WERE THE SAME: "PSEUDO-TUMOR LEFT HIP FOLLOWING LEFT TOTAL HIP ARTHROPLASTY. COBALT AND CHROMIUM TOXICITY FOLLOWING LEFT TOTAL HIP ARTHROPLASTY. PAINFUL LEFT HIP. INSTABILITY/SUBLUXATION EVENTS FOLLOWING LEFT TOTAL HIP ARTHROPLASTY. CORROSION IDENTIFIED ON THE SHELL AT THE SCREW HOLES PER THE PROVIDED OP REPORT: "THROUGH THE HOLES ONE COULD SEE EXTENSIVE EVIDENCE FOR CORROSION MATERIAL THROUGH 3 OF THE 4 SCREW HOLES. THIS MATERIAL WAS BLACK AND SEEMED CONSISTENT WITH CORROSION".

  Patient problems: Foreign Body Reaction; Joint Laxity; Metal Related Pathology

  MAUDE report 14655839 ↗
• InjuryJun 10, 2022Corroded; Corroded

  LEFT HIP REVISION FOR PAIN, PSEUDO TUMOR, AND ELEVATED COBALT LEVELS. CUP, SCREWS, INSERT, AND HEAD WERE REVISED. COMPETITOR CUP, SCREWS, AND INSERT WERE USED ALONG WITH A STRYKER UNIVERSAL TAPER CERAMIC HEAD. UPDATE BASED ON MEDICAL REVIEW. THE PREOPERATIVE DIAGNOSES AND POSTOPERATIVE DIAGNOSES WERE THE SAME: "PSEUDO-TUMOR LEFT HIP FOLLOWING LEFT TOTAL HIP ARTHROPLASTY. COBALT AND CHROMIUM TOXICITY FOLLOWING LEFT TOTAL HIP ARTHROPLASTY. PAINFUL LEFT HIP. INSTABILITY/SUBLUXATION EVENTS FOLLOWING LEFT TOTAL HIP ARTHROPLASTY. CORROSION IDENTIFIED ON THE SHELL AT THE SCREW HOLES PER THE PROVIDED OP REPORT: "THROUGH THE HOLES ONE COULD SEE EXTENSIVE EVIDENCE FOR CORROSION MATERIAL THROUGH 3 OF THE 4 SCREW HOLES. THIS MATERIAL WAS BLACK AND SEEMED CONSISTENT WITH CORROSION."

  Patient problems: Foreign Body Reaction; Joint Laxity; Metal Related Pathology

  MAUDE report 14655766 ↗
• InjuryMar 17, 2022Fracture; Fracture

  THIS PI IS FOR THE 2017 HIP REVISION OF UNKNOWN REASON. ITS REPORTED BY THE ATTORNEY, THROUGH THE FILING OF A LAWSUIT, THAT THE PLAINTIFF UNDERWENT REVISION RIGHT TOTAL HIP ARTHROPLASTY ON (B)(6) 2017, WHERE SHE WAS IMPLANTED WITH A STRYKER HIP SYSTEM. ITS FURTHER ALLEGED THAT THE PATIENTS RIGHT HIP HAD TO BE REVISED AGAIN ON (B)(6) 2018 DUE TO ACETABULAR COMPONENT LOOSENING. UPDATE ON 22-FEB-2022 PER CLINICIAN REVIEW: ON (B)(6) 2017, A 'RIGHT REVISION TOTAL HIP ARTHROPLASTY' WAS PERFORMED FOR A 'PRE- AND POST-OPERATIVE DIAGNOSIS OF ASEPTIC LOOSENING RIGHT TOTAL HIP ARTHROPLASTY'. THE OPERATIVE REPORT NOTES, ACETABULAR COMPONENT WAS GROSSLY LOOSE, SCREW WAS BROKEN, DISTAL END OF SCREW, REMAINED DEEP IN THE BONE.

  Patient problems: Inadequate Osseointegration

  MAUDE report 13796000 ↗
• InjuryFeb 4, 2022Fracture; Unstable; Fracture; Unstable

  IT WAS REPORTED THROUGH THE FILING OF A LAWSUIT THAT ALLEGEDLY THE PATIENT WAS IMPLANTED WITH AN LFIT ANATOMIC COCR V40 FEMORAL HEAD ON HIS RIGHT HIP ON OR ABOUT (B)(6) 2014 AND WAS REVISED ON (B)(6) 2019. IT IS FURTHER ALLEGED THAT HE SUFFERED INJURIES AS A RESULT OF IMPLANTATION AND EXPLANTATION OF THE DEVICE(S) AT ISSUE, DEVICE RECALL AND EXCESSIVE LEVELS OF CHROMIUM AND COBALT IN HIS BLOOD. UPDATE 1: "ACCORDING TO THE (B)(6) 2019 REVISION OPERATIVE REPORT, HE HAD PERSISTENT PAIN AND WAS REVISED 5 YEARS AGO. AT SURGERY HIS ACETABULAR COMPONENT WAS FOUND TO BE IN RETROVERSION. A NEW STRYKER ACETABULAR COMPONENT WAS PLACED ALONG WITH NEW STRYKER HEAD ON HIS ACCOLADE STEM." UPDATE 2: AS PER MED REVIEW AND REVISION NOTES: ADD IN 2 SCREWS FOR LOOSENING AND 1 BONE SCREW ALSO FRACTURED.

  Patient problems: Ambulation or Postural Difficulties; Pain

  MAUDE report 13452977 ↗
• InjuryFeb 4, 2022Fracture; Unstable; Fracture; Unstable

  IT WAS REPORTED THROUGH THE FILING OF A LAWSUIT THAT ALLEGEDLY THE PATIENT WAS IMPLANTED WITH AN LFIT ANATOMIC COCR V40 FEMORAL HEAD ON HIS RIGHT HIP ON OR ABOUT (B)(6) 2014 AND WAS REVISED ON (B)(6) 2019. IT IS FURTHER ALLEGED THAT HE SUFFERED INJURIES AS A RESULT OF IMPLANTATION AND EXPLANTATION OF THE DEVICE(S) AT ISSUE, DEVICE RECALL AND EXCESSIVE LEVELS OF CHROMIUM AND COBALT IN HIS BLOOD. UPDATE 1: "ACCORDING TO THE (B)(6) 2019 REVISION OPERATIVE REPORT, HE HAD PERSISTENT PAIN AND WAS REVISED 5 YEARS AGO. AT SURGERY HIS ACETABULAR COMPONENT WAS FOUND TO BE IN RETROVERSION. A NEW STRYKER ACETABULAR COMPONENT WAS PLACED ALONG WITH NEW STRYKER HEAD ON HIS ACCOLADE STEM." UPDATE 2: AS PER MED REVIEW AND REVISION NOTES : ADD IN 2 SCREWS FOR LOOSENING AND 1 BONE SCREW ALSO FRACTURED.

  Patient problems: Ambulation or Postural Difficulties; Pain

  MAUDE report 13452936 ↗
• InjuryJun 17, 2021Loss of Osseointegration; Loss of Osseointegration

  IT WAS REPORTED THROUGH THE FILING OF A LAWSUIT THAT ALLEGEDLY THE PATIENT WAS IMPLANTED WITH AN LFIT ANATOMIC COCR V40 FEMORAL HEAD ON HIS LEFT HIP ON OR ABOUT (B)(6) 2011 AND WAS REVISED ON (B)(6) 2019. IT IS FURTHER ALLEGED THAT HE SUFFERED INJURIES AS A RESULT OF IMPLANTATION AND EXPLANTATION OF THE DEVICE AT ISSUE, DEVICE RECALL AND EXCESSIVE LEVELS OF CHROMIUM AND COBALT IN HIS BLOOD. UPDATE: HEAD DISASSOCIATION. UPDATE: METALLOSIS, LOOSE ACETABULAR COMPONENT.

  Patient problems: Ambulation or Postural Difficulties; Inadequate Osseointegration; Metal Related Pathology

  MAUDE report 12015114 ↗
• MalfunctionMar 30, 2021Fracture; Osseointegration Problem; Fracture; Osseointegration Problem

  IT WAS REPORTED THAT THE PATIENT'S RIGHT HIP WAS REVISED DUE TO SHELL LOOSENING AND MIGRATION, AND A BROKEN SCREW. THERE WAS NO KNOWN CAUSE OR CONTRIBUTOR FOR THE LOOSENING OR MIGRATION. THERE ARE NO ALLEGATIONS AGAINST ANY OTHER IMPLANTS. A 50D CLUSTER HOLE SHELL AND TORX BONE SCREW WERE REVISED TO A 58F TRITANIUM SHELL WITH HEX SCREWS. REP CONFIRMED THAT NO FURTHER INFORMATION WOULD BE RELEASED BY THE HOSPITAL OR SURGEON.

  Patient problems: Inadequate Osseointegration

  MAUDE report 11590094 ↗

Other Howmedica Osteonics Corp. products

• Triathlon608 models · 3,524 reports · 15 recalls
• Scorpio107 models · 113 reports · 28 recalls
• Trident160 models · 1,280 reports · 2 recalls
• Accolade57 models · 1,228 reports
• Duracon58 models · 65 reports · 16 recalls
• LFIT23 models · 852 reports
• TRIDENT II42 models · 188 reports · 12 recalls
• INSTRUMENT131 models · 290 reports · 7 recalls