TRI-LOCK GRIPTION 1012-14-040Recalls & reported problems

Summary

The FDA's MAUDE database contains 58 adverse event reports that list this exact device (DI 10603295001065), received between Nov 10, 2014 and Dec 22, 2025 — classified as 54 injuries, 4 malfunctions.

The most frequently reported specific device problem is “Osseointegration Problem” (9 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 58 reports, in the reporter's own words as published by the FDA.

• InjuryDec 22, 2025Osseointegration Problem; Migration; Osseointegration Problem; Migration

  PATIENT WAS REVISED DUE TO LOOSENING OF THE FEMORAL STEM AT THE BONE TO IMPLANT INTERFACE. REVISION OF TRILOCK FOR SUBSIDENCE. DOI: UNKNOWN, DOR: ON (B)(6) 2025, AFFECTED SIDE: RIGHT HIP.

  Patient problems: Inadequate Osseointegration

  MAUDE report 23871419 ↗
• InjuryNov 17, 2025Osseointegration Problem; Osseointegration Problem

  IT WAS REPORTED THAT THE PATIENT WAS REVISED DUE TO LOOSENING OF THE FEMORAL STEM AT THE BONE TO IMPLANT INTERFACE. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Inadequate Osseointegration

  MAUDE report 23573035 ↗
• InjuryOct 30, 2025Use of Device Problem; Use of Device Problem

  IT WAS REPORTED THAT THERE WAS PINNACLA INLAY WITH MASSIVE WEAR DUE TO MALPOSITION OF THE TRI-LOCK STEM. IT POSSIBLE TO IDENTIFY THE HEAD.

  Patient problems: Insufficient Information

  MAUDE report 23423801 ↗
• InjurySep 17, 2025Adverse 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 A PERIPROSTHETIC FRACTURE. AFFECTED SIDE - LEFT HIP.

  Patient problems: Limb Fracture

  MAUDE report 23075003 ↗
• InjuryDec 2, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT HAD REVISION FOR PERIPROSTHETIC FRACTURE. DOI: (B)(6) 2024. DOR: (B)(6) 2024. AFFECTED SIDE- LEFT HIP.

  Patient problems: Limb Fracture

  MAUDE report 20825826 ↗
• InjuryJan 10, 2023Osseointegration Problem; Osseointegration Problem

  THE PATIENT WAS REVISED DUE TO LOOSENING OF FEMORAL STEM AT THE BONE TO IMPLANT INTERFACE. NO SURGICAL DELAY WAS REPORTED. DOI: (B)(6) 2018; DOR: (B)(6) 2022; AFFECTED SIDE: LEFT HIP.

  Patient problems: Inadequate Osseointegration

  MAUDE report 16129905 ↗
• InjurySep 9, 2022Migration; Migration

  PATIENT WAS REVISED DUE TO THE FEMORAL STEM SUBSIDENCE AND MOVEMENT. THERE WAS NO REPORTED LOOSENING. IT WAS UNKNOWN IF ANY SURGICAL DELAY. DOI: (B)(6) 2017, DOR: (B)(6) 2022, AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Insufficient Information

  MAUDE report 15392674 ↗
• InjuryJul 20, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED TO ADDRESS INFECTION. DOI: (B)(6) 2009. DOR: (B)(6) 2016 . RIGHT HIP.

  Patient problems: Ambulation or Postural Difficulties; Anxiety; Depression; Distress; Loss of Range of Motion; Numbness; Pain; Unspecified Infection

  MAUDE report 15064977 ↗
• InjuryJul 5, 2022Fracture; Migration; Fracture; Migration

  IT WAS REPORTED THAT ON (B)(6), 2022, THE PATIENT UNDERWENT THE BIPOLAR HIP ARTHROPLASTY WITH THE TRILOCK FOR THE RIGHT HIP JOINT. THE SURGERY WAS COMPLETED SUCCESSFULLY WITHOUT ANY SURGICAL DELAY. AFTER THE SURGERY, THE FRACTURE OF THE FEMORAL STEM OCCURRED DUE TO MULTIPLE FALLS AT THE HOSPITAL, AND THE STEM SANK. THEREFORE, A REVISION SURGERY WAS PERFORMED ON (B)(6),2022. THE IMPLANTS WERE REMOVED, AND THE STEM WAS REPLACED WITH OTHER COMPANY¿S STEM. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Fall

  MAUDE report 14914793 ↗
• InjuryDec 30, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REVISION COMPLETED DUE TO INFECTION. DOI: (B)(6) 2017; DOR: (B)(6) 2021; RIGHT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 13118355 ↗
• InjuryAug 31, 2021Osseointegration Problem; Migration; Osseointegration Problem; Migration

  THE PATIENT WAS REVISED TO ADDRESS LOOSENING OF THE STEM AT THE BONE TO IMPLANT INTERFACE. THE STEM WAS ALSO SUBSIDED. PATIENT HAD A FALL WHICH MAY HAVE CONTRIBUTED TO THE LOOSENING. DOI: (B)(6) 2012. DOR: (B)(6) 2021. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Fall; Inadequate Osseointegration

  MAUDE report 12395804 ↗
• InjuryAug 6, 2021Degraded; Degraded

  IT WAS REPORTED THAT THE PATIENT HAD PINNACLE METAL ON METAL. LARGE PSEUDO-TUMOR, TISSUE DAMAGE AND ABDUCTOR ISSUES. METAL LINER WAS REMOVED AND REDUCED TO POLY WITH TS CERAMIC HEAD. DOI: (B)(6) 2010, DOR: (B)(6) 2019, LEFT HIP.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Discomfort; Foreign Body Reaction; Hypersensitivity/Allergic reaction; Limb Fracture; Necrosis; Osteolysis

  MAUDE report 12287430 ↗
• InjuryJun 7, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION RECEIVED INDICATED THAT THE CORRECT AFFECTED SIDE WAS THE RIGHT HIP.

  Patient problems: Loss of Range of Motion; Pain; Unspecified Tissue Injury

  MAUDE report 11952097 ↗
• InjuryJun 7, 2021Adverse Event Without Identified Device or Use Problem; Osseointegration Problem; Adverse Event Without Identified Device or Use Problem; Osseointegration Problem

  SURGEON CONFIRMATION FORM RECEIVED. PATIENT WAS REVISED TO ADDRESS IMPLANT LOOSENING, PAIN, DISCOMFORT, AND SORENESS. PATIENT EXPERIENCED A "STABBING PAIN" IMMEDIATELY AFTER PRIMARY SURGERY. THE PATIENT ALLEGES THE BONE DID NOT ATTACH TO THE PROSTHESIS SO THE STEM WOBBLED IN THE FEMUR. THE PATIENT ALLEGES THAT IT SHOULD HAVE BEEN POINTED OUT THAT THE PROSTHESIS NEEDS TO BE IMPLANTED WITH CEMENT. DOI: (B)(6) 2018 - (B)(6) 2021 (RIGHT HIP).

  Patient problems: Discomfort; Inadequate Osseointegration; No Clinical Signs, Symptoms or Conditions; Pain

  MAUDE report 11946330 ↗
• InjuryFeb 3, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CONSUMER CLAIM LETTER RECEIVED. THERE IS A PROBLEM WITH METAL ON POLY HIP REPLACEMENT SYSTEM. THE PATIENT EXPERIENCED PAIN, SEVERE ANEMIA DUE TO COBALT METAL POISONING WITH COBALT LEVELS REACHING 9.7 AND CHROMIUM REACHING 1.2 (NO UNITS OF MEASUREMENT PROVIDED. THE PATIENT WAS ORIGINALLY IMPLANTED WITH METAL ON POLY. THE PATIENT WAS REVISED (B)(6) 2020. THE HEAD/LINER WERE REVISED. PATIENT STATED THAT AFTER THE REVISION, THEIR COBALT LEVELS DROPPED AND THEY WERE CURED OF THEIR ANEMIA. DOI: (B)(6) 2016 DOR: (B)(6) 2020 RIGHT HIP.

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

  MAUDE report 11272463 ↗
• InjuryJan 11, 2021Degraded; Degraded

  THE PATIENT MADE AN APPOINTMENT TO HIS DOCTOR AFTER NOTICING A BUMP ON HIS THIGH. DURING THE SURGERY, PSEUDOTUMORS WERE REMOVED. PATIENT WAS REVISED TO ADDRESSED BILATERAL HIP MECHANICAL FAILURE OF TOTAL HIP ARTHROPLASTY WITH PSEUDOTUMOR FORMATION FROM METAL ON METAL. THERE WAS ALSO SOME CORROSION ON THE TRUNNION THAT WAS REMOVED USING A SPONGE IN SALINE. DOI: 2011, DOR: (B)(6) 2018, LEFT HIP.

  Patient problems: Hypersensitivity/Allergic reaction

  MAUDE report 11146789 ↗
• InjuryDec 4, 2020Osseointegration Problem; Osseointegration Problem

  THE PATIENT WAS REVISED DUE TO ADDRESS FEMUR FRACTURE AND LOOSENING OF THE TRILOCK STEM AT IMPLANT TO BONE INTERFACE, AND REPLACED WITH CORAIL REVISION STEM. DOI: (B)(6) 2020. DOR: (B)(6) 2020. LEFT HIP.

  Patient problems: Bone Fracture(s); Inadequate Osseointegration

  MAUDE report 10949377 ↗
• MalfunctionSep 8, 2020Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  IT WAS REPORTED THAT THE STEM WOULD NOT GO DOWN. BROACH WAS BURIED. OPENED A 2ND STEM. SURGERY DELAY: 10 MIN.

  Patient problems: No Code Available

  MAUDE report 10503012 ↗
• InjuryAug 26, 2020Naturally Worn; Naturally Worn

  NEW UNITY RECORD CREATED IN ORDER TO UPDATE LEGACY COMPLAINT NUMBER (B)(4). LITIGATION PAPERS ALLEGE PAIN, DIFFICULTY ENGAGING IN ACTIVITIES OF DAILY LIVING, FURTHER DETERIORATING OF THE HIP JOINT, DAMAGE TO SURROUNDING TISSUES, WILL BE REQUIRED TO UNDERGO AN EXPLANTATION SURGERY WHICH WILL INVOLVE SIGNIFICANT FINANCIAL EXPENSES, PAIN AND SUFFERING AND PHYSICAL DISFIGUREMENT. DOI: (B)(6) 2009 - DOR: NONE REPORTED (RIGHT HIP). UPDATE: 8 DEC 2017: CLAIM LETTER RECEIVED. CLAIM LETTER ALLEGES INJURY TO THE PATIENT. ADDED COMPLAINANT INFORMATION. DOI: (B)(6) 2009-DOR: (B)(6) 2017 (RIGHT HIP).

  Patient problems: Cyst(s); Foreign Body Reaction; Hypersensitivity/Allergic reaction; Injury; No Code Available; Pain

  MAUDE report 10455532 ↗
• InjuryAug 10, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED DUE TO INFECTION. EVERYTHING EXPLANTED AND PROSTALAC SPACER WAS IMPLANTED. NO FURTHER PATIENT INFORMATION AVAILABLE. DOI: UNKNOWN, DOR: (B)(6) 2020, RIGHT HIP.

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 10385975 ↗
• InjuryAug 4, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THERE WAS A REVISION OF THA, REMOVAL OF RECALLED ASR ACETABULAR COMPONENTS. PATIENT EXPERIENCED PAIN AND OSTEOLYSIS. CLINICAL FINDINGS ALSO INDICATED INFLAMMATION. THERE WAS REPORTED DELAY DUE TO EXPLANT OF ACETABULAR AND FEMORAL DEVICES. FEMORAL DEVICE REMOVED AS A RESULT OF OSTEOLYTIC RESORPTION & COMPROMISED FIXATION AFTER REVIEW OF MEDICAL RECORDS, PATIENT WAS REVISED TO ADDRESS LEFT HIP REPLACEMENT WITH METALLOSIS, PAIN AND INCREASED LEVEL OF COBALT AND CHROMIUM. OPERATIVE NOTES REPORTED, A COPIOUS AMOUNT OF METALLOSIS DEBRIS WAS ENCOUNTERED IN THE JOINT. THE TRUNNION WAS NOTED TO HAVE A GREAT DEAL OF METALLOSIS. RADIOGRAPHS SHOWED A SMALL AMOUNT OF LYSIS AND MRI SHOWED METALLOSIS. ADDED MEDICAL HISTORY, PATIENT HARM AND AFFECTED SIDE. DOI: (B)(6) 2009; DOR: (B)(6) 2018 UNKNOWN HIP.

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

  MAUDE report 10362093 ↗
• InjuryFeb 24, 2020Migration; Migration

  AFTER REVIEW OF MEDICAL RECORDS PATIENT WAS REVISED TO ADDRESSED METALLOSIS RIGHT HIP STATUS POST RIGHT METAL ON METAL TOTAL HIP REPLACEMENT. OPERATIVE NOTES INDICATED SUBSEQUENT RECENT X-RAYS DEMONSTRATED OF SUBSIDENCE OVERTIME OF FEMORAL STEM RESULTING TO 1 CM LIMB LENGTH DISCREPANCY. NO FLUID ACCUMULATION WAS NOTED OTHER THAN BENIGN APPEARING SYNOVIAL FLUID AT THE ARTHROTOMY. THE TRUNNION WAS NOTED TO HAVE NO MORE THAN FOCAL SURFACE CORROSION. THE CORROSION WAS VERY MINIMAL AS WAS THE CASE WITH THE FEMORAL HEAD. ATTENTION WAS ON THE CUP, THERE WAS SOME FIBROUS TISSUE WHICH HAD GROWN IN FROM ONE OF THE UNUSED SCREW HOLES, OTHERWISE THE ARTICULATION WAS UNREMARKABLE. THE TRUNNION WAS NOTED TO BE INTACT AND NO CORROSION WAS PRESENT.

  Patient problems: Foreign Body Reaction; Injury; Necrosis; No Code Available

  MAUDE report 9746658 ↗
• InjuryFeb 12, 2020Loss of Osseointegration; Loss of Osseointegration

  IT WAS REPORTED THAT THE PATIENT HAD A TOTAL HIP REPLACEMENT IN 2018 AND HAD POST OPERATIVE PAIN. A BONE SCAN WAS DONE AN INDICATED THAT THE FEMORAL STEM WAS LOOSE. SURGEON WAS ABLE TO REMOVE TRILOCK STEM WITHOUT ANY ISSUES AS WELL AS THE 32+1 CERAMIC HEAD AND 50+4N LINER. LINER WAS REPLACED WITH A 50+4/10. FEMUR WAS THEN PREPPED FOR A 4HI SUMMIT AND A 32+5 CERAMIC HEAD WAS IMPLANTED. {I HAVE PROVIDED ALL INFORMATION AVAILABLE TO ME} DOI: (B)(6) 2018; DOR: (B)(6) 2020; AFFECTED SIDE: LEFT HIP.

  Patient problems: Inadequate Osseointegration; No Code Available; Pain

  MAUDE report 9701238 ↗
• InjuryJan 21, 2020Degraded; Use of Device Problem; Malposition of Device; Degraded; Use of Device Problem; Malposition of Device

  PINNACLE MOM LITIGATION RECORDS RECEIVED. LITIGATION ALLEGES PAIN, DISCOMFORT, EMOTIONAL DISTRESS, DISFIGUREMENT AND INJURIES. IN ADDITION TO WHAT WERE PREVIOUSLY ALLEGED, PPF ALLEGES METAL WEAR, METALLOSIS AND ELEVATED METAL IONS, WHILE PFS ALLEGES NUMBNESS, STIFFNESS, INSTABILITY, WEAKNESS, LIMITED ROM, SOFT TISSUE DESTRUCTION AND ANXIETY. AFTER REVIEW OF MEDICAL RECORDS, THE PATIENT WAS REVISED DUE TO FAILED RIGHT THA, WITH METALLOSIS AND SOFT TISSUE DESTRUCTION. OPERATIVE NOTES REPORTED THAT UPON ENTERING HE INTRA-ARTICULAR SPACES, METALLOSIS DEBRIS WAS EXPELLED AND THERE WAS EVIDENT OF SOME METAL STAINING OF THE SOFT TISSUE. THERE WAS SOME TRUNNION CORROSION AND DEBRIS, BUT THE TRUNNION LOOKED INTACT. THE FEMUR WAS 5-10 DEGREES ANTERVERSION. TTE LINER HAS SOME OLD STAINING BEHIND IT, INCLUDING SOME METALLOSIS AND CORROSION. ADDED STEM AND CUP TO THE COMPLAINT. PRODUCT AND LOT NUMBERS WERE PROVIDED. ADDED SURGEON, MEDICAL HISTORY, PATIENT DOB, AGE, HEIGHT AND WEIGHT. DOI: (B)(6) 2010: DOR: (B)(6) 2018: RIGHT HIP.

  Patient problems: Anxiety; Deformity/ Disfigurement; Discomfort; Foreign Body Reaction; Hypoesthesia; Injury; Limited Mobility Of The Implanted Joint; No Code Available; Pain; Tissue Damage; Weakness

  MAUDE report 9610980 ↗
• InjuryJan 7, 2020Loss of Osseointegration; Osseointegration Problem; Loss of Osseointegration; Osseointegration Problem

  IT WAS REPORTED THAT THE STEM WAS LOOSENED AT BONE TO IMPLANT INTERFACE SO THE SURGEON TOOK THAT AND THE CERAMIC LINER OUT. THE ORIGINAL IMPLANT DATE IS UNKNOWN. DOI: UNKNOWN. DOR: (B)(6) 2019, LEFT HIP.

  Patient problems: Inadequate Osseointegration; No Code Available

  MAUDE report 9558295 ↗