TRI-LOCK GRIPTION 1012-14-030Recalls & reported problems

Summary

The FDA's MAUDE database contains 42 adverse event reports that list this exact device (DI 10603295001058), received between Jul 27, 2017 and Jun 10, 2026 — classified as 41 injuries, 1 malfunction.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (6 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 25 most recent of 42 reports, in the reporter's own words as published by the FDA.

• InjuryJun 10, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT REMOVAL OF ALL COMPONENTS IN AN INFECTED TOTAL JOINT WITH AN ACETABULAR FRACTURE. LOOSENING INTERFACE WAS MARKED AS NON-CEMENTED. AFFECTED SIDE: LEFT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 25461445 ↗
• InjuryFeb 13, 2026Osseointegration Problem; Migration

  TRILOCK BPS. SUBSIDENCE. IT WAS STATED THAT THE FEMUR WAS LOOSE. IT¿S A NON CEMENTED IMPLANT. DOI: (B)(6) 2015. DOR: (B)(6) 2026. AFFECTED SIDE: LEFT HIP.

  Patient problems: Inadequate Osseointegration

  MAUDE report 24333486 ↗
• InjuryMay 8, 2025Use of Device Problem; Use of Device Problem

  (B)(6) FIRST REPORT OF RETRIEVALS FOR STATEMENT OF WORK 10 FOR Q1 OF 2025. (B)(6) IS THE RESEARCH LOCATION, AND NOT THE FACILITY OF PLACEMENT. A DEPUY SYNTHES IMPLANT WAS REVISED AND REVIEWED FOR ANALYSIS. REASON FOR REVISION: REVISION DUE TO FEMORAL STEM MALPOSITIONING.

  Patient problems: Insufficient Information

  MAUDE report 21986381 ↗
• InjuryJul 2, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2009, THE PATIENT UNDERWENT A LEFT ASR HIP IMPLANT. THE PATIENT HAD A LEFT ASR HIP REVISION ON (B)(6) 2024 DUE TO SEVERE PAIN AND DISCOMFORT, INCREASED METAL LEVELS IN BLOOD INCLUDING COBALT AND CHROMIUM; PERMANENT INJURIES, EMOTIONAL DISTRESS, DISABILITY, DISFIGUREMENT; ECONOMIC DAMAGES INCLUDING MEDICAL AND HOSPITAL EXPENSES FOR REVISION SURGERY FOLLOWED BY MONITORING, REHABILITATION AND PHARMACEUTICAL COSTS. DOI: (B)(6) 2009; DOR: (B)(6) 2024; LEFT HIP.

  Patient problems: Deformity/ Disfigurement; Discomfort; Distress; Metal Related Pathology; Pain

  MAUDE report 19660251 ↗
• InjuryFeb 20, 2024Osseointegration Problem; Migration; Osseointegration Problem; Migration

  REVISION HIP. TRILOCK BPS WAS UNDERSIZED WHEN IMPLANTED (B)(6) 2018. IT SUBSIDED AND REQUIRED A REVISION. PATIENT HAD A TRILOCK BPS 3 HI STEM , THIS WAS REMOVED AND AN ACTIS 8 STANDARD WAS PLACED. DOI: (B)(6) 2018. DOE: (B)(6) 2024. REASON FOR REVISION SURGERY: LOOSENING-PAIN.

  Patient problems: Pain

  MAUDE report 18740222 ↗
• InjuryJan 10, 2023Fracture; Fracture

  PATIENT WAS REVISED BECAUSE THE NECK (TRUNION) OF THE TRILOCK STEM BROKE. ALL COMPONENTS REMOVED AND A NEW HIP WAS IMPLANTED. THERE WAS NO SURGICAL DELAY. DOI: ON (B)(6) 2017 DOR: ON (B)(6) 2022 AFFECTED SIDE- LEFT HIP.

  Patient problems: Insufficient Information

  MAUDE report 16132991 ↗
• InjuryNov 22, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT HAD A RT THA PERFORMED SOMETIME IN 2007 USING A TRILOCK STEM AND PINNACLE MOM. THE SURGEON WANTED TO DO A RT THA REVISION ON THIS PATIENT BECAUSE HE SAID THE PATIENT STARTED TO COMPLAIN OF PAIN AND HE FELT THE MOM WAS CAUSING THIS. THE SURGEON REMOVED THE METAL LINER AND HEAD. HE THEN TRIALED WITH A 32X50 NEUTRAL TRIAL LINER AND 32 +5 HEAD. HE FELT THAT THE PATIENT WAS UNSTABLE, SO HE DECIDED TO REMOVE THE PINNACLE CUP AS WELL AND CHOSE TO USE BIOMET G7 FOR A DUAL MOBILITY OPTION. DOI: 2007. DOR: (B)(6) 2020. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Adhesion(s); Foreign Body Reaction; Joint Laxity; Metal Related Pathology; Pain

  MAUDE report 15848147 ↗
• InjuryOct 12, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS ADMITTED TO HOSPITAL FOR INFLAMMATORY. SURGERY WAS PERFORMED TO REMOVE METAL ON METAL IMPLANTS, LINER AND HEAD ONLY WAS REMOVED. TRUNNIONS.

  Patient problems: Foreign Body Reaction; Hypersensitivity/Allergic reaction; Inflammation

  MAUDE report 15586930 ↗
• InjuryOct 3, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PLAINTIFF FACT SHEET AND MEDICAL RECORD RECEIVED. PATIENT ALLEGES DISCOMFORT, LOUD SQUEAKING SOUND, ANXIETY, EXTREME STRESS, FEAR, EMOTIONAL DISTRESS, ELEVATED METAL ION, PSEUDOTUMOR. DOI: (B)(6) 2022. DOR: UNKNOWN. (LEFT HIP).

  Patient problems: Anxiety; Discomfort; Distress; Hypersensitivity/Allergic reaction

  MAUDE report 15527758 ↗
• InjuryJun 1, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PC WAS CREATED TO CAPTURES THE BLOOD CLOT THAT OCCURRED AFTER THE INITIAL SURGERY. DOI: (B)(6) 2019. DOR: (B)(6) 2021. RIGHT HIP.

  Patient problems: Embolism/Embolus

  MAUDE report 14565855 ↗
• InjuryMay 26, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  MEDICAL RECORDS RECEIVED. IT WAS REPORTED THAT PATIENT COMPLAINED OF PAIN, WEAKNESS, STIFFNESS, LIMITED WALKING, SCAR AND DIFFICULTY WALKING. PATIENT TAKING ELIQUIS FOR A MONTH TO PREVENT BLOOD CLOTS AS SHE HAD SUFFERED BLOOD CLOT FORM INITIAL SURGERY. DOI: (B)(6) 2019, DOR: NONE REPORTED, RIGHT HIP.

  Patient problems: Ambulation or Postural Difficulties; Embolism/Embolus; Loss of Range of Motion; Muscular Rigidity; Pain; Scar Tissue

  MAUDE report 14514439 ↗
• InjuryMay 7, 2022Use of Device Problem; Use of Device Problem

  CLAIM LETTER RECEIVED. PATIENT WAS REVISED DUE TO FAILED TOTAL RIGHT HIP REPLACEMENT. BOTH SURGERIES WERE PERFORMED AT HOSPITAL FOR SPECIAL SURGERY IN NYC. DOI: (B)(6) 2019. DOR: (B)(6) 2021. RIGHT HIP.

  Patient problems: Discomfort; Embolism/Embolus; Foreign Body Reaction; Joint Laxity; Pain; Swelling/ Edema; Unspecified Musculoskeletal problem

  MAUDE report 14318202 ↗
• InjuryApr 18, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REVISION COMPLETED DUE TO INSTABILITY. DOI: (B)(6) 2019. DOR: (B)(6) 2022. AFFECTED SIDE: LEFT HIP.

  Patient problems: Joint Laxity

  MAUDE report 14138612 ↗
• InjuryMar 25, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REVISION COMPLETED DUE TO INFECTION. ALL IMPLANTS WERE REMOVED AND REPLACED WITH ANTIBIOTIC BEADS. DOI: (B)(6) 2016; DOR: (B)(6) 2022; AFFECTED SIDE: LEFT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 13901400 ↗
• InjuryFeb 8, 2022Degraded; Adverse Event Without Identified Device or Use Problem; Degraded; Adverse Event Without Identified Device or Use Problem

  REVISION COMPLETED TO REMOVE ASR HIP AND SLEEVE. METAL ION LEVELS WERE ELEVATED.

  Patient problems: Anxiety; Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Deformity/ Disfigurement; Discomfort; Distress; Emotional Changes; Foreign Body Reaction; Hypersensitivity/Allergic reaction; Metal Related Pathology; Necrosis; Pain; Swelling/ Edema

  MAUDE report 13480755 ↗
• InjuryDec 15, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT FELL, AND IT WAS FOUND THAT THE PATIENT HAD A FRACTURE AROUND THE STEM. THE REVISION SURGERY WILL BE PERFORMED ON (B)(6) 2021, AND THE SURGEON WILL FIX THE PLATE. NO FURTHER INFORMATION HAS BEEN MADE AVAILABLE.

  Patient problems: Fall; Limb Fracture

  MAUDE report 13011434 ↗
• InjuryOct 28, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE REVISION WAS DUE TO DISPLACEMENT AND FRACTURE OF POLY LINER. DOI: (B)(6) 2019, DOR: (B)(6) 2020, AFFECTED SIDE: LEFT HIP.

  Patient problems: Ambulation or Postural Difficulties; Fatigue; Inflammation; Pain; Physical Asymmetry; Swelling/ Edema

  MAUDE report 12712502 ↗
• InjurySep 30, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2021, THE PATIENT WITH SHELL-ALLERGY UNDERWENT THE THA SURGERY. DURING THE SURGERY, THE BLOOD PRESSURE OF THE PATIENT DECREASED, AND SHE WAS IN THE SHOCK STAT, AND THEN SHE ALMOST HAD CARDIAC ARREST TWICE (THE FIRST TIME WAS DURING RASPING, THE SECOND TIME IS DURING SUTURING). AFTER THE SUTURING, THE SURGEON PERFORMED A CARDIAC CATHETERIZATION, BUT A BLOOD CLOT HAS NOT APPEARED, AND THE CAUSE OF THIS PROBLEM REMAINS UNKNOWN. THE SURGERY WAS COMPLETED SUCCESSFULLY WITHOUT ANY SURGICAL DELAY. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Bradycardia; Low Blood Pressure/ Hypotension

  MAUDE report 12558868 ↗
• InjuryApr 14, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2016: PATIENT UNDERWENT A REVISION AFTER EXPERIENCING GRINDING/SQUEAKING AND DISLOCATION WITH SUSPECTED INLAY DISASSOCIATION. PATIENT WAS NOTED TO BE PAIN AND SYMPTOM FREE. X-RAY SHOWED DECENTRALIZED FEMORAL HEAD. REVISION OPERATIVE NOTE INDICATED SYNOVITIS, TROCHANTERIC BURSITIS, AND METALLOSIS. DISLOCATION AND DISASSOCIATION WERE CONFIRMED. THERE WERE SIGNS OF IMPLANT IMPINGEMENT, BUT IT WAS NOTED TO BE SECONDARY TO THE GRINDING AFTER THE DISASSOCIATION. THE FEMORAL HEAD AND ACETABULAR LINER WERE REVISED. RIGHT SIDE AFFECTED. DOI: (B)(6) 2015, DOR: (B)(6) 2016 - REVISION OF INLAY.

  Patient problems: Foreign Body Reaction; Inflammation; Pain; Synovitis

  MAUDE report 11664943 ↗
• InjuryApr 8, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A. PLEASE INDICATE THE AFFECTED SIDE THE AFFECTED HIP WAS ON THE LEFT SIDE B. CAN YOU PLEASE CONFIRM IF THERE WAS REALLY A LOOSENING OF THE STEM? I CANNOT SAY DEFINITIVELY IF THERE WAS LOOSENING OR NOT. THE SURGEON DID WORK FOR A WHILE TO FREE THE STEM, BUT HE DID NOT STATE IF IT WAS LOOSE. THERE APPEARED TO BE SOME PROXIMAL BONE LOSS. I DO NOT HAVE ANY OF THE OTHER ITEMS REQUESTED AS THE SURGEON STATED THAT THE PATIENT HAD CONTACTED AN ATTORNEY AND WANTED ALL INFORMATION AND EXPLANTED PRODUCTS.

  Patient problems: Adhesion(s); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Depression; Discomfort; Distress; Foreign Body Reaction; Loss of Range of Motion; Metal Related Pathology; Muscular Rigidity; Osteolysis; Pain; Pocket Erosion; Scar Tissue; Swelling/ Edema; Synovitis; Unspecified Tissue Injury

  MAUDE report 11638804 ↗
• InjuryAug 17, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AFTER REVIEW OF THE MEDICAL RECORDS THE PATIENT WAS REVISED TO ADDRESS FAILED THA WITH METALLOSIS AND ELEVATED METAL IONS RESULTING TO HIP PAIN. OPERATIVE NOTE REPORTED SYNOVECTOMY, REMOVAL OF DEBRIS AND SCAR TISSUE. LAB RESULT SHOWS ABOVE 7PPB. DOI: (B)(6), 2009; DOR: (B)(6) 2020; LEFT HIP.

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

  MAUDE report 10413811 ↗
• InjuryJul 2, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PINNACLE CLAIM SUBMISSION FORM AND MEDICAL RECORDS RECEIVED. PINNACLE CLAIM FORM HAS NO ALLEGATION PROVIDED. AFTER REVIEW OF MEDICAL RECORDS THE PATIENT WAS REVISED TO ADDRESS ABSCESS AND POSSIBLE INFECTION. OPERATIVE NOTE REPORTED PURULENT MATERIAL. MECHANICAL SCRUB AND THOROUGH I AND D WAS PERFORMED. DOI: (B)(6) 2009; DOR: (B)(6) 2013; RIGHT HIP.

  Patient problems: Abscess; No Code Available; Unspecified Infection

  MAUDE report 10224602 ↗
• InjuryJun 6, 2019Naturally Worn; Naturally Worn

  PINNACLE CLAIM SUBMISSION FORM AND MEDICAL RECORDS RECEIVED. AFTER REVIEW OF MEDICAL RECORDS, THE PATIENT WAS REVISED TO ADDRESS A LARGE FLUID COLLECTION AND METAL-ON-METAL TRUNNION REACTION. REVISION NOTE REPORTED AN EXTENSIVE AMOUNT OF JOINT FLUID, DAMAGED ANTERIOR ASPECT OF THE ABDUCTOR MUSCLE, NECROTIC-APPEARING BONE AND TISSUE, AND AN 8MM RING OF BLACK TRUNNION WEAR AT THE BASE OF THE HEAD. AN EXTENDED TROCHANTERIC OSTEOTOMY WAS DONE TO REMOVE THE STEM; HOWEVER, A DISTAL PORTION BROKE OFF AS IT WAS VERY WELL FIXED TO THE FEMORAL COMPONENT. A CABLE WAS PLACED DISTAL TO THE OSTEOTOMY TO AVOID FURTHER FRACTURE. THE EXTENSIVE DAMAGE FROM THE MOM REACTION REQUIRED AN EXTENDED OPERATING TIME OF 6 HOURS. DOI: (B)(6) 2013; DOR: (B)(6) 2018; RIGHT HIP.

  Patient problems: Injury; Necrosis; No Code Available; Not Applicable; Tissue Damage

  MAUDE report 8674686 ↗
• InjuryMar 15, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  LITIGATION ALLEGES THE PATIENT SUFFERS FROM PAIN AND DISCOMFORT. UPDATE AD 13 JUL 2018. (B)(4) WAS RE-OPENED UNDER (B)(4) DUE TO RECEIPT OF PPF AND MEDICAL RECORDS. IN ADDITION TO WHAT WAS PREVIOUSLY ALLEGED, PPF ALLEGES INFECTION, METAL WEAR, METALLOSIS AND LOOSENING OF THE CUP. STEM, CUP AND SCREW HAS BEEN ADDED TO THE COMPLAINT AND PRODUCT DETAILS WERE PROVIDED. AFTER REVIEW OF MEDICAL RECORDS, , THE PATIENT WAS REVISED DUE TO PAINFUL LEFT HIP, TOTAL HIP ARTHROPLASTY AND PSOAS TENDONITIS.

  Patient problems: Discomfort; No Code Available; Pain; Tissue Damage; Unspecified Infection

  MAUDE report 8424476 ↗
• InjuryJan 17, 2019Corroded; Degraded; Biocompatibility; Corroded; Degraded; Biocompatibility

  LITIGATION ALLEGES THAT THE PATIENT SUFFERS FROM PAIN, DISCOMFORT, INFLAMMATION, AND LARGE AMOUNTS OF TOXIC COBALT-CHROMIUM METAL ION PARTICLES TO BE RELEASED INTO THE BLOOD, TISSUE, AND BONE. UPDATE AD 10 MAY 2018: RECEIPT OF PFS AND MEDICAL RECORDS. IN ADDITION TO PREVIOUS ALLEGATIONS, PFS ALLEGES DIFFICULTY WALKING. AFTER REVIEW OF MEDICAL RECORDS, THE PATIENT WAS REVISED TO ADDRESS PAIN AND ELEVATED METAL IONS. REVISION NOTES REPORTED THAT MINOR CORROSIVE CHANGES WERE NOTED AT THE JUNCTION OF THE TITANIUM NECK WITH THE COBALT-CHROMIUM HEAD.

  Patient problems: Discomfort; Inflammation; No Code Available; Pain; Test Result

  MAUDE report 8258452 ↗