TRI-LOCK GRIPTION 1012-04-070Recalls & reported problems

Summary

The FDA's MAUDE database contains 31 adverse event reports that list this exact device (DI 10603295000785), received between Feb 23, 2018 and Nov 18, 2025 — classified as 29 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Fracture” (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 25 most recent of 31 reports, in the reporter's own words as published by the FDA.

• InjuryNov 18, 2025Naturally Worn; Naturally Worn

  PATIENT UNDERWENT REVISION SURGERY FOR METAL ON METAL PINNACLE / TRILOCK FRETTING CAUSING PSEUDO TUMOR. REMOVAL OF METAL LINER AND METAL HEAD WAS DONE WITH REPLACEMENT TO POLY LINER AND TS CERAMIC HEAD. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Hypersensitivity/Allergic reaction

  MAUDE report 23586752 ↗
• InjuryAug 13, 2024Osseointegration Problem; Osseointegration Problem

  IT WAS REPORTED THAT THE PATIENT WAS REVISED DUE TO PERIPROSTHETIC FRACTURE. THERE WAS A FEMORAL STEM LOOSENING. DOI: UNKNOWN. DOR:(B)(6) 2024. AFFECTED SIDE: LEFT HIP.

  Patient problems: Inadequate Osseointegration; Limb Fracture

  MAUDE report 19974143 ↗
• MalfunctionJul 18, 2024Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT THE SIZE 7 STEM WAS SITTING UP FROM THE SIZE 7 BROACH SO HAD TO OPEN A NEW STEM. SURGERY WAS DELAYED 2 MINUTES DUE TO THE REPORTED EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19770094 ↗
• InjuryJul 11, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE STEM AND HEAD WERE REVISED DUE TO PERIPROSTHETIC FRACTURE AFTER A FALL. DOI: UNKNOWN. DOR: (B)(6) 2024. AFFECTED SIDE: LEFT HIP.

  Patient problems: Fall; Limb Fracture

  MAUDE report 19726183 ↗
• InjuryJul 27, 2022Fracture; Fracture

  THE PATIENT, WHILE STANDING, HAS HAD A SUDDEN STRUCTURAL FAILURE. AT THE EMERGENCY ROOM IT WAS DIAGNOSED A RUPTURE OF THE STEM AT NECK LEVEL. A REVISION SURGERY HAS BEEN PLANNED FOR ON (B)(6) 2022.

  Patient problems: Insufficient Information

  MAUDE report 15112636 ↗
• InjuryMar 29, 2022Adverse 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 METALLOSIS. ULTAMET METAL LINER/HEAD. THE HIP JOINT WAS BLACK AND GREEN WITH METAL DEBRIS. ADDITIONAL INFORMATION EVENT IN THE DER REPORTED OSTEOLYSIS. PRODUCT ISSUES WAS SUSPECTED AND CONTRIBUTED TO THE EVENT. DOI: UNKNOWN: DOR: (B)(6) 2021: LEFT HIP.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Discomfort; Distress; Fatigue; Hypersensitivity/Allergic reaction; Inflammation; Loss of Range of Motion; Metal Related Pathology; Necrosis; Pain; Scar Tissue; Swelling/ Edema; Unspecified Tissue Injury

  MAUDE report 13937600 ↗
• InjuryMay 25, 2021Osseointegration Problem; Migration; Osseointegration Problem; Migration

  IT WAS REPORTED THAT TRILOCK STEM APPEARS TO HAVE SUBSIDED ON X-RAY FILMS. SURGEON STARTED STEM APPEARS TO BE UNDERSIZED. IN THE ADDITIONAL EVENT INFORMATION REPORTED LOOSENING OF THE STEM TO BONE-IMPLANT INTERFACE . DOI: (B)(6) 2019; DOR: (B)(6) 2021: HIP UNKNOWN.

  Patient problems: Inadequate Osseointegration

  MAUDE report 11880894 ↗
• InjuryJan 13, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  LITIGATION RECORD RECEIVED. PATIENT ALLEGES PAIN, EXCESSIVE COBALT AND CHROMIUM, ABRASION, AND EMOTIONAL DISTRESS FOR ECONOMIC LOSS AS WELL AS PUNITIVE DAMAGES.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Cyst(s); Foreign Body Reaction; Pain

  MAUDE report 11165017 ↗
• InjuryOct 14, 2020Degraded; Naturally Worn; Degraded; Naturally Worn

  OFFICE NOTES(B)(6)2021 INDICATED THAT THE PATIENT EXPERIENCED A DISLOCATION POST THE (B)(6)2020 REVISION THAT WAS TREATED WITH CLOSED REDUCTION. IT WAS NOTED THERE WAS PAIN WITH THE DISLOCATION, BUT IT IS IMPROVING SINCE THE CLOSED REDUCTION. IT IS ALSO NOTED THAT HIS LEFT HIP IS SQUEAKY AND SORE. OFFICE NOTES (B)(6) 2021 INDICATE THE PATIENT IS CONTINUING TO EXPERIENCE PAIN, STIFFNESS, HIP SQUEAKING, AND DIFFICULTY AMBULATING. OBSERVATION AND CONTINUED STRENGTH TRAINING ARE THE ONLY INTERVENTIONS AT THIS TIME.

  Patient problems: Abscess; Ambulation or Postural Difficulties; Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Foreign Body Reaction; Hypersensitivity/Allergic reaction; Inflammation; Limb Fracture; Muscular Rigidity; No Code Available; Pain; Physical Asymmetry; Swelling/ Edema

  MAUDE report 10680160 ↗
• InjuryApr 1, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  UNF AND MEDICAL RECORDS RECEIVED. AFTER REVIEW OF MEDICAL RECORDS, IT INDICATED THAT THE PATIENT HAS A METAL ON METAL HIP IMPLANT. NO ALLEGATIONS WERE REPORTED. DOI: (B)(6) 2009. DOR: NONE REPORTED, (RIGHT HIP).

  Patient problems: No Code Available; Test Result

  MAUDE report 9911162 ↗
• InjuryApr 1, 2020Degraded; Degraded

  UNF AND MEDICAL RECORDS RECEIVED. AFTER REVIEW OF MEDICAL RECORDS, PATIENT WAS REVISED TO ADDRESS FAILED LEFT TOTAL HIP REPLACEMENT DUE TO METALLOSIS, ARTICULAR SURFACE WEAR, AND CORROSION. IT WAS INDICATED THAT THE PATIENT HAS ELEVATED METAL LINES AND SIGNS OF CORROSION AND WEAR OF ARTICULAR SURFACE OF PREVIOUSLY PLACED METAL-ON-METAL HIP REPLACEMENT. OPERATIVE FINDINGS STATED FAILED LEFT TOTAL HIP REPLACEMENT METAL-ON-METAL CONSTRUCT DUE TO BOTH TRUNNIONOSIS AND METALLOSIS. THERE WAS NO SIGNIFICANT OSTEOLYSIS IN THE ACETABULAR SHELL AND FEMORAL STEM WAS WELL FIXATED WITH NO MECHANICAL COMPROMISE OF THE LOCKING MECHANISM OR TRUNNION. THIS WAS DESPITE SOME ELEMENT OF TRUNNIONOSIS AND SOME BACK SITE CORROSION AND METALLOSIS. THERE WAS NO PSEUDOTUMOR: THE PROCEDURE INCORPORATED SYNOVECTOMY OF THE JOINT, REMOVAL OF THE FEMORAL AND ACETABULAR BEARING SURFACE COMPONENT, AND REVISION OF BOTH THESE COMPONENTS. DOI: (B)(6) 2009; DOR: (B)(6) 2019 (LEFT HIP).

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

  MAUDE report 9911108 ↗
• InjuryMar 17, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PINNACLE CLAIM SUBMISSION FORM ALLEGES PAIN, OSTEOLYSIS, METALLOSIS AND ELEVATED METAL IONS. AFTER REVIEW OF MEDICAL RECORDS PATIENT WAS REVISED TO ADDRESS METALOSIS LEFT HIP. REVISION NOTES REPORTED THAT THERE WAS EVIDENCE OF METALOSIS. THERE WAS LOBULAR SYNOVIUM WHICH WAS GRAY IN COLOR. DOI: (B)(6) 2010; DOR: (B)(6) 2018 (LEFT HIP). THE PATIENT HAS BILATERAL HIP IMPLANTS, PLEASE SEE (B)(4) FOR THE RIGHT HIP.

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

  MAUDE report 9843240 ↗
• InjuryJan 14, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING INSERTION OF FEMORAL IMPLANT, THE FEMUR CRACKED, AND SO THE SURGEON APPLIED AN ORTHOPEDIC CABLE. THERE WAS A 10-MINUTE SURGICAL DELAY ATTRIBUTED TO THE CASE. DOE: (B)(6) 2019, (UNKNOWN HIP).

  Patient problems: Bone Fracture(s); No Code Available; Not Applicable

  MAUDE report 9587182 ↗
• InjuryJan 3, 2020Migration or Expulsion of Device; Migration or Expulsion of Device

  IT WAS REPORTED THAT THE PATIENT WAS DOING FINE AFTER SURGERY THEN HAD PAIN. X-RAY SHOWED SHE CRACKED HER FEMUR AND STEM SUBSIDED. FEMUR WAS CABLED AND A REVISION CORAIL STEM WAS IMPLANTED.

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

  MAUDE report 9545382 ↗
• MalfunctionDec 4, 2019Patient-Device Incompatibility; Patient-Device Incompatibility

  IT WAS REPORTED THAT THE SURGEON WAS USING TRILOCK FOR A BIPOLAR CASE. BROACHED ACCORDINGLY TO TECHNIQUE GUIDE UP TO A SIZE 7. WHEN IMPLANTING A SIZE 7 IMPLANT , THE IMPLANT WOULD NOT ADVANCE INTO FEMUR ALL THE WAY PHYSICIAN RE-BROACHED AND STILL WOULD NOT ADVANCE. WE HAD TO WASTE THE 7 AND IMPLANT SIZE 6. THOUGHT THE SIZE 7 IMPLANT WAS LARGE THAN ACTUAL SIZE. DOE: UNKNOWN. UNKNOWN AFFECTED SIDE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9412129 ↗
• InjuryOct 18, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PF ALLEGES DIFFICULTY WALKING AND LIMITED MOBILITY. AFTER REVIEW OF MEDICAL RECORDS, PATIENT WAS REVISED TO ADDRESS PAINFUL RIGHT HIP METAL ON METAL TOTAL HIP REPLACEMENT AND PARTIAL GLUTEUS MEDIUS TENDON AVULSION. REVISION NOTE REPORTED ADHESIONS, GLUTEUS MEDIUS TENDON WAS NOT ATTACHED TO THE TROCHANTER AND ACETABULAR COMPONENTS WERE CONFIRMED TO BE WELL FIXED INTO 45 DEGREES OF ABDUCTION AND 20 DEGREES OF ANTEVERSION; AND IT WAS ALSO STATED THAT THERE WAS NO EVIDENT TRUNIONOSIS.

  Patient problems: Adhesion(s); Ambulation or Postural Difficulties; Foreign Body Reaction; Hypersensitivity/Allergic reaction; Limited Mobility Of The Implanted Joint; No Code Available; Pain; Test Result

  MAUDE report 9207666 ↗
• InjuryOct 16, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PPF ALLEGES DIFFICULTY WALKING AND LIMITED MOBILITY.

  Patient problems: Ambulation or Postural Difficulties; Discomfort; Foreign Body Reaction; Hypersensitivity/Allergic reaction; Limited Mobility Of The Implanted Joint; Pain; Test Result

  MAUDE report 9198303 ↗
• InjuryMay 15, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  TRILOCK STEM REVISED DUE TO PERIPROSTHETIC FRACTURE. REASON FOR REVISION SURGERY. PERIPROSTHETIC FRACTURE,

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

  MAUDE report 8611496 ↗
• InjuryMay 8, 2019Biocompatibility; Adverse Event Without Identified Device or Use Problem; Biocompatibility; Adverse Event Without Identified Device or Use Problem

  LITIGATION ALLEGES THAT DUE TO METALLOSIS AND FAILURE OF OSSEOINTEGRATION OF THE PINNACLE DEVICE, PATIENT UNDERWENT REVISION ON BOTH SIDES. UPDATE: IN ADDITION TO WHAT WERE PREVIOUSLY ALLEGED, PPF ALLEGES COMPONENT FRACTURE, METAL WEAR, METALLOSIS, AND ELEVATED METAL IONS. DOI: (B)(6) 2009; DOR: (B)(6) 2011; (RIGHT HIP).

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

  MAUDE report 8590767 ↗
• InjuryFeb 15, 2019Corroded; Corroded

  COMPLAINT DESCRIPTION: LITIGATION ALLEGES PATIENT SUFFERS FROM PAIN, DISCOMFORT, SWELLING IN HER LEG, AND DIFFICULTY SLEEPING. UPDATE: PATIENT WAS REVISED DUE TO PAIN AND A PSEUDOTUMOR. UPDATE: IN ADDITION TO WHAT WERE PREVIOUSLY ALLEGED, PPF ALLEGES PSEUDOTUMOR, METAL WEAR, METALLOSIS, AND ELEVATED METAL IONS. AFTER REVIEW OF MEDICAL RECORDS, PATIENT WAS REVISED TO ADDRESS PAIN DUE TO INTERNAL ORTHOPAEDIC PROSTHETIC DEVICE, INITIAL ENCOUNTER. REVISION NOTES STATED OF SCAR TISSUE AND REMNANTS OF PSEUDOTUMOR CAPSULE. THERE WAS SOME MILD CORROSION ON THE ARTICULATION WHICH WAS REMOVED WITH A BOVIE SCRATCH PAD. DOI: (B)(6) 2009; DOR: (B)(6) 2016; (RIGHT HIP).

  Patient problems: Discomfort; No Code Available; Pain; Scar Tissue; Swelling; Test Result; Tissue Damage

  MAUDE report 8343744 ↗
• InjuryFeb 7, 2019Fracture; Osseointegration Problem; Migration; Fracture; Osseointegration Problem; Migration

  IT WAS REPORTED THAT ONE MONTH AGO, PATIENT WAS OUT FROM HIS TOTAL HIP REPLACEMENT. HE WAS LEAVING A RESTAURANT WALKING UNASSISTED AND FELL RESULTING IN A PERIPROSTHETIC FRACTURE OF HIS FEMUR. THE STEM AND HEAD WERE REMOVED AND REPLACED WITH NEW COMPONENTS.

  Patient problems: Fall; Hip Fracture; Inadequate Osseointegration; No Code Available

  MAUDE report 8315733 ↗
• InjuryJan 30, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED DUE TO PAIN.

  Patient problems: No Code Available; Pain

  MAUDE report 8288687 ↗
• InjuryJan 24, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT REVISED DUE TO INFECTION.

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 8273780 ↗
• InjuryJan 4, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT FELL AND BROKE HER FEMUR. DURING THE OPEN REDUCTION AND INTERNAL FIXATION (ORIF), THE SURGEON NOTICED A HEMATOMA AND SOME FLUID IN THE JOINT. THE SURGEON DECIDED TO DO A HEAD AND LINER EXCHANGE. DOI: (B)(6) 2018; DOR: (B)(6) 2018; UNKNOWN HIP.

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

  MAUDE report 8217721 ↗
• InjuryDec 19, 2018Biocompatibility; Biocompatibility

  LITIGATION ALLEGES PATIENT EXPERIENCED SEVERE PAIN, DISCOMFORT, AND SWELLING. UPDATE 29 JUN 2018 RECEIPT OF PPF AND STICKER SHEETS. IN ADDITION TO WHAT PREVIOUSLY ALLEGED, PPF ALLEGED ELEVATED METAL IONS.

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

  MAUDE report 8180981 ↗