TRI-LOCK GRIPTION 1012-14-010Recalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 10603295001034), received between Sep 1, 2017 and Oct 25, 2024 — classified as 13 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (3 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 16, 2026.

Most reported problems

Recent adverse event reports

The 13 most recent of 13 reports, in the reporter's own words as published by the FDA.

• InjuryOct 25, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT WASHOUT FOR INFECTION. ORIGINAL DATE OF SURGERY WAS ON (B)(6) 2016, RIGHT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 20531708 ↗
• InjuryOct 16, 2020Loss of Osseointegration; Migration; Loss of Osseointegration; Migration

  IT WAS REPORTED AS REMOVAL OF STEM AND HEAD DUE TO STEM SUBSIDENCE. REPLACED LINER AS WELL. REPLACED STEM WITH A SUMMIT, AND A NEW HEAD AND LINER. IT WAS ALSO INDICATED THAT THERE WAS LOOSENING OF THE STEM AT THE BONE TO IMPLANT INTERFACE. DOI: (B)(6) 2018, DOR: (B)(6) 2020, AFFECTED SIDE: LEFT HIP.

  Patient problems: Inadequate Osseointegration; No Code Available

  MAUDE report 10690391 ↗
• InjuryApr 3, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  UNF AND MEDICAL RECORDS RECEIVED. AFTER A REVIEW OF THE MEDICAL RECORD, THE PATIENT WAS REVISED TO ADDRESS FAILED LEFT HIP REPLACEMENT SECONDARY TO METALLOSIS. REVISION OPERATIVE NOTES REPORTED THAT THE SYNOVIUM WAS STAINED WITH METALLOSIS. IT WAS CONFIRMED THAT THE PATIENT HAS COBALT POISONING DURING THE LEFT HIP REVISION. DOI: (B)(6) 2009. DOR: (B)(6) 2019. LEFT HIP.

  Patient problems: Foreign Body Reaction; No Code Available; Pain; Test Result

  MAUDE report 9921782 ↗
• InjuryMar 27, 2020Corroded; Corroded

  LITIGATION ALLEGES DEFECTIVE AND HAS CAUSED DAMAGE TO HIP JOINT. DOI: (B)(6) 2008, DOR: NOT REPORTED, (UNKNOWN HIP).

  Patient problems: Depression; Foreign Body Reaction; Hypersensitivity/Allergic reaction; Inflammation; Necrosis; No Code Available; Osteolysis; Pain

  MAUDE report 9889502 ↗
• InjuryMar 5, 2020Fitting Problem; Fitting Problem

  CALCAR FRACTURE UPON STEM IMPACTION. SURGEON STATED STEM WAS SITTING UP AND REQUESTED NEW STEM. SURGEON CABLED FRACTURE. NO DELAY.

  Patient problems: Bone Fracture(s)

  MAUDE report 9793996 ↗
• InjuryAug 13, 2019Degraded; Degraded

  PATIENT WAS REVISED TO ADDRESS PAIN. ADDITIONAL INFORMATION RECEIVED VIA PPF AND MEDICAL RECORDS. IN ADDITIONAL TO WHAT WERE PREVIOUSLY ALLEGED, PPF ALLEGES PSEUDOTUMOR, CLUNKING SOUND, INFLAMMATION, DISLOCATION AND DECREASED RANGE OF MOTION. AFTER REVIEW OF MEDICAL RECORDS,PATIENT WAS REVISED TO ADDRESS ADVERSE REACTION TO METAL DEBRIS. OPERATIVE NOTES INDICATED SMALL SPOT OF CORROSION AT THE TRUNNION WITH NO OBVIOUS TRUNNIONOSIS. STEM ADDED TO THE COMPLAINT FOR THE ALLEGED CORROSION. ADDED MEDICAL HISTORY AND PATIENT'S AGE. DOI: (B)(6) 2008; DOR: (B)(6) 2017, LEFT HIP.

  Patient problems: Inflammation; Loss of Range of Motion; No Code Available; Pain

  MAUDE report 8887628 ↗
• InjuryJul 15, 2019Migration; Migration

  IT WAS REPORTED THAT THE STEM WAS SUBSIDED AND DOCTOR DECIDED TO REVISE STEM. DOI: UNKNOWN, DOR: (B)(6) 2019, UNKNOWN AFFECTED SIDE.

  Patient problems: No Code Available

  MAUDE report 8790148 ↗
• InjuryJul 12, 2019Loss of Osseointegration; Loss of Osseointegration

  THE PATIENT WAS REVISED DUE TO INFECTION. IT WAS ALSO INDICATED THAT THERE WAS A LOOSENING OF THE FEMORAL STEM AT BONE TO IMPLANT INTERFACE. DOI: (B)(6) 2018; DOR: (B)(6) 2019, RIGHT HIP.

  Patient problems: Inadequate Osseointegration; No Code Available; Unspecified Infection

  MAUDE report 8785040 ↗
• InjuryMay 22, 2019Biocompatibility; Adverse Event Without Identified Device or Use Problem; Biocompatibility; Adverse Event Without Identified Device or Use Problem

  PPF ALLEGES LOOSENING OF CUP, INFECTION, METAL WEAR, METALLOSIS AND ELEVATED METAL IONS. AFTER REVIEW OF MEDICAL RECORDS THE PATIENT WAS REVISED TO ADDRESS FAILED TRUNNION BETWEEN THE ACETABULAR COMPONENT AND THE LINER. REVISION NOTE REPORTED THERE WAS DARK YELLOW TISSUE SURROUNDING THE EDGES OF THE ACETABULAR LINER ENCROACHING UPON THE METALLIC LINER WITHIN THE ACETABULAR. THIS WAS LOOSE AND THEN ONCE THE CUP AND THE COMPONENT SEPARATED, THERE WAS TISSUE IN THIS INTERSPACE BETWEEN THE TWO INDICATING THE LACK OF MOVEMENT BETWEEN THIS TWO METAL BODIES. THERE WAS NO INFECTION INDICATED IN THE REVISION NOTES.

  Patient problems: No Code Available; Pain; Sudden Cardiac Death; Test Result; Tissue Damage; Unspecified Infection

  MAUDE report 8631326 ↗
• InjuryJan 18, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PPF ALLEGES ABDUCTOR MUSCLE REPAIR, METAL WEAR, METALLOSIS AND ELEVATED METAL IONS.

  Patient problems: No Code Available; Test Result; Tissue Damage

  MAUDE report 8260712 ↗
• InjurySep 17, 2018Insufficient Device Problem Information

  PPF AND STICKER SHEETS. IN ADDITION TO WHAT WERE PREVIOUSLY ALLEGED, PPF ALLEGES METAL WEAR/METALLOSIS AND ELEVATED METAL IONS. THE STEM WAS ADDED IN THE IMPACTED PRODUCTS TO ADDRESSED THE ALLEGATION OF ELEVATED METAL IONS AND THE SCREW WAS ALSO ADDED IN THE IMPACTED PRODUCTS AS IT WAS REMOVED DURING THE REVISION SURGERY AS STATED IN THE PREVIOUS MEDICAL RECORDS.

  Patient problems: Discomfort; Not Applicable; Pain; Test Result

  MAUDE report 7880826 ↗
• InjuryAug 16, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  PPF AND STICKER SHEETS RECEIVED. PPF ALLEGES DISLOCATION W/ CLOSED REDUCTION, INFECTION, LOOSENING OF STEM, AND ELEVATED METAL IONS. DOI: (B)(6) 2017 - DOR: NONE REPORTED (LEFT HIP).

  Patient problems: Unspecified Infection

  MAUDE report 7788642 ↗
• InjurySep 1, 2017Insufficient Device Problem Information; Insufficient Device Problem Information

  THE COMPLAINT WAS REVISED TO ADDRESS PERIPROSTHETIC FRACTURE AND LOOSENING OF THE FEMORAL STEM AT THE BONE TO IMPLANT INTERFACE.

  Patient problems: Bone Fracture(s); No Code Available

  MAUDE report 6837396 ↗