TRI-LOCK GRIPTION 1012-04-080Recalls & reported problems

Summary

The FDA's MAUDE database contains 16 adverse event reports that list this exact device (DI 10603295000792), received between Aug 31, 2017 and Oct 10, 2024 — classified as 15 injuries, 1 malfunction.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (2 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 16 most recent of 16 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 10, 2024Device Markings/Labelling Problem; Wrong Label; Device Markings/Labelling Problem; Wrong Label

  ADDITIONAL INFORMATION WAS RECEIVED AND STATED THAT THE IMPLANT SIZE WAS SMALLER THAN NORMAL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20420428 ↗
• InjuryOct 8, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS REVISED DUE TO INFECTION. PATIENT UNDERWENT REMOVAL PROCEDURE ON (B)(6) 2024.

  Patient problems: Unspecified Infection

  MAUDE report 20403038 ↗
• InjuryJan 10, 2023Use of Device Problem; Use of Device Problem

  PATIENT WAS REVISED DUE TO REPEATED ANTERIOR HIP DISLOCATION FOLLOWING POSTERIOR THA. HIP WAS CONVERTED TO PINNACLE DUAL MOBILITY WITH A HIGH OFFSET REVISION STEM. NO ADDITIONAL INFORMATION. DOI: (B)(6) 2022, DOR: (B)(6) 2022, AFFECTED SIDE: LEFT HIP.

  Patient problems: Joint Dislocation

  MAUDE report 16131860 ↗
• InjuryDec 5, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT RECEIVED STAGE 1 OF A 2-STAGE RIGHT HIP REVISION TO TREAT PAIN, INFLAMMATION, AND INFECTION. ALL DEVICES WERE REMOVED AND AN ANTIBIOTIC SPACER WAS PLACED. THE PROCEDURE WAS COMPLETED WITHOUT COMPLICATIONS. DO1: 2012. DOR: (B)(6) 2022. RIGHT HIP.

  Patient problems: Inflammation; Pain; Unspecified Infection

  MAUDE report 15917664 ↗
• InjuryOct 28, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD A FALL IN HOSPITAL DAY OF PRIMARY SURGERY. PATIENT ALSO HAD A FALL APPROXIMATELY ONE YEAR POST OP FROM HIS TRACTOR. NO OTHER TRAUMAS OR COMORBIDITIES. STEM WAS EASILY REMOVED AND REPLACED WITH A LONG CORAIL STEM. NO SURGICAL DELAY. NO OTHER INFORMATION IS AVAILABLE. DOI: (B)(6) 2017. DOR: (B)(6) 2022. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Fall

  MAUDE report 15690807 ↗
• InjuryJul 22, 2022Degraded; Adverse Event Without Identified Device or Use Problem; Degraded; Adverse Event Without Identified Device or Use Problem

  PINNACLE MOM LITIGATION RECORDS RECEIVED. LITIGATION ALLEGES HEAVY METAL POISONING DUE TO ELEVATED METAL IONS RESULTING TO INJURY TO THE MUSCLES, TISSUES, METALLOSIS, SCAR TISSUE FORMATION, LIMITED ADL, EMOTIONAL TRAUMA, DISTRESS AND PAIN DOI: (B)(6) 2009, DOR: (B)(6) 2022, HIP UNKNOWN.

  Patient problems: Adhesion(s); Ambulation or Postural Difficulties; Depression; Discomfort; Distress; Fibrosis; Foreign Body Reaction; Hypersensitivity/Allergic reaction; Inflammation; Joint Laxity; Loss of Range of Motion; Metal Related Pathology; Muscular Rigidity; Osteolysis; Pain; Scar Tissue; Swelling/ Edema; Unspecified Tissue Injury

  MAUDE report 15084487 ↗
• InjuryMay 19, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REMOVAL OF IMPLANTS FROM ORIGINAL SURGERY ON (B)(6) 2022 AND COMPLETE WASH OUT DUE TO INFECTION. DOI: (B)(6) 2022; DOR: (B)(6) 2022; UNKNOWN SIDE.

  Patient problems: Unspecified Infection

  MAUDE report 14434159 ↗
• InjuryMay 21, 2021Osseointegration Problem; Osseointegration Problem

  THE PATIENT WAS REVISED TO ADDRESS HIP PAIN AND LOOSENING OF THE FEMORAL STEM AT THE BONE TO IMPLANT INTERFACE. AFTER BEING SEEN A FEW TIMES, THE SURGEON TOOK AN X-RAY IMAGE OF THE RIGHT HIP AND NOTICED THAT RADIOGRAPHICALLY IT LOOKED LIKE THE STEM HAD BEEN TOGGLING. DUE TO THIS AND THE PATIENT'S LEVEL OF PAIN, HE DECIDED TO REVISE THE STEM. DURING THE REVISION, THEY USED A BURR AND A SMALL OSTEOTOME BEFORE DR. (B)(6) (WHO WAS ALSO SCRUBBED IN) USED THE SUMMIT STEM EXTRACTOR AND SLAP HAMMER TO REMOVE THE STEM. IT CAME OUT EASIER THAN BOTH DOCTORS HAD EXPECTED AND THE SURGEON MADE A COMMENT THAT THE STEM WAS LOOSE. DOI: (B)(6) 2019. DOR: (B)(6) 2021; AFFECTED SIDE: RIGHT HIP.

  Patient problems: Inadequate Osseointegration; Pain

  MAUDE report 11863580 ↗
• InjuryApr 26, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD INFECTED HIP; REMOVED ALL COMPONENTS; PERFORMED I&D AND RE-IMPLANTED NEW COMPONENTS. DOI: (B)(6) 2021, DOR: (B)(6) 2021, AFFECTED SIDE: RIGHT HIP.

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

  MAUDE report 11727891 ↗
• InjuryApr 13, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PPF, PFS AND MEDICAL RECORDS RECEIVED. PPF HAS NO ALLEGATION. PFS ALLEGES PAIN, GAIN WEIGHT, DM, HEART ISSUES, WALKING DIFFICULTY, DECREASE ROM, METALLOSIS AND PATIENT SUSPECT METAL IN BLOOD CAUSED MEMORY IMPAIRMENT. AFTER REVIEW OF MEDICAL RECORDS, NO REVISION WAS SCHEDULED DUE TO DIABETES AND HEART CONDITION AS WELL AS THROAT ISSUE, PATIENT COULD NOT BE INTUBATED AND THAT A REVISION SURGERY WOULD BE OUT OF THE QUESTION. PATIENT ALSO REPORTED CONCERNS ABOUT METALLOSIS. DOI: (B)(6) 2008. DOR: NONE REPORTED. LEFT HIP.

  Patient problems: Ambulation or Postural Difficulties; Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Atrial Fibrillation; Foreign Body Reaction; Ischemic Heart Disease; Loss of Range of Motion; Pain; Pericardial Effusion

  MAUDE report 11661002 ↗
• InjuryNov 13, 2018Migration; Migration

  IT WAS REPORTED THAT LEFT TOTAL HIP FAILED, TRILOCK STEM HAS SUBSIDED. REMOVED STEM, LINER AND HIP BALL.

  Patient problems: No Code Available

  MAUDE report 8064552 ↗
• InjurySep 11, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  THE PATIENT WAS REVISED TO ADDRESS EARLY SIGNS OF INFECTION. THE WOUND WAS IRRIGATED. NEW COMPONENTS WERE IMPLANTED FOLLOWED BY ANTIBIOTIC BEADS. DOI: (B)(6) 2018; DOR: (B)(6) 2018; RIGHT HIP.

  Patient problems: Not Applicable; Unspecified Infection

  MAUDE report 7863783 ↗
• InjuryJul 19, 2018Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  LITIGATION ALLEGES THAT THE PATIENT SUFFERS FROM PAIN. UPDATE (B)(6) 2013 - IT HAS BEEN REPORTED THAT THE PATIENT'S RIGHT HIP WAS REVISED ON (B)(6) 2013 TO ADDRESS A MALPOSITIONED ACETABULAR COMPONENT THOUGHT TO HAVE LED TO INCREASED METAL ION LEVEL. PATIENT ALSO HAD PAIN. UPDATED MAY 29, 2018: (B)(4) HAS BEEN REOPENED UNDER (B)(4) DUE TO RECEIPT OF PPF, MEDICAL RECORDS AND STICKER SHEETS. IN ADDITION TO WHAT WERE PREVIOUSLY ALLEGED, PFF ALLEGES METAL WEAR AND METALLOSIS. AFTER REVIEW OF MEDICAL RECORDS, MEDICAL RECORDS PROVIDED IMPLANT RECORD. DOI: (B)(6) 2009 - DOR: (B)(6) 2013: (RIGHT HIP).

  Patient problems: Pain; Tissue Damage

  MAUDE report 7702641 ↗
• InjuryMar 28, 2018Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  PFS AND MEDICAL RECORDS RECEIVED. PFS ALLEGES CONTINUOUS AND PERSISTENT PAIN, FATIGUE, SLEEP DISTURBANCE, AFFECTING THOUGHT PROCESS, DEPRESSION AND IMPAIRED ACTIVITIES OF DAILY LIVING. AFTER REVIEW OF MEDICAL RECORDS FOR MDR REPORTABILITY, IT WAS STATED THAT THE PATIENT WAS REVISED TO ADDRESS PAIN DUE TO IMPLANT FAILURE. REVISION NOTES STATED THAT THERE WAS A TURBID FLUID CONSISTENT WITH METALLOSIS, TREMENDOUS AMOUNT OF SCAR TISSUE AND ARTHROFIBROSIS. CLINIC VISIT STATED THAT MRI OF THE HIP AND PELVIS DEMONSTRATE SOME RELATIVELY SMALL FLUID COLLECTION AROUND THE GREATER TROCHANTER AND THERE IS TRACE HIP EFFUSION. COBALT ION LEVEL IS ABOVE 7 PPB. DOI: (B)(6) 2010; DOR: (B)(6) 2017; RIGHT HIP.

  Patient problems: Confusion/ Disorientation; Depression; Fatigue; Fibrosis; No Code Available; Not Applicable; Pain; Scar Tissue; Test Result; Tissue Damage; Weakness

  MAUDE report 7376870 ↗
• InjuryOct 11, 2017Insufficient Device Problem Information; Insufficient Device Problem Information

  PATIENT WAS REVISED TO ADDRESS INFECTION.

  Patient problems: Unspecified Infection

  MAUDE report 6940357 ↗
• InjuryAug 31, 2017Fracture; Fracture

  DER STATES THAT THE PATIENT ORIGINAL SURGERY WAS ON (B)(6) 2017. PATIENT FELL DURING INITIAL WEIGHT BEARING THERAPY. RESULTING IN A FRACTURE. IT IS UNKNOWN AT THIS TIME WHETHER THE FRACTURE WAS OF THE PATIENT'S BONE OR THE IMPLANT.

  Patient problems: Bone Fracture(s)

  MAUDE report 6835594 ↗