TRI-LOCK GRIPTION 1012-14-080Recalls & reported problems

Summary

The FDA's MAUDE database contains 25 adverse event reports that list this exact device (DI 10603295001102), received between Sep 14, 2017 and Jan 12, 2026 — classified as 25 injuries.

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

• InjuryJan 12, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THERE WAS INFECTION IN PATIENT'S HIP. IMPLANTS WERE EXTRACTED AND A TEMPORARY SPACER WAS IMPLANTED TO REMOVE INFECTION. DOI: UNKNOWN, DOR: (B)(6) 2025, AFFECTED SIDE: UNKNOWN.

  Patient problems: Unspecified Infection

  MAUDE report 24041652 ↗
• InjuryJun 26, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD A HEMI HIP IMPLANTED (B)(6) 2025 BY THE SURGEON AT THE REPORTED HOSPITAL. THE PATIENT FELL WHILE LEAVING HIS SHOP WHICH RESULTED IN A PERI PROSTHETIC HIP FRACTURE. THE SURGEON REMOVED THE HEMI HIP COMPONENTS, REDUCED THE FRACTURE THEN USED FOUR CABLES TO SECURE THE FEMUR. THE SURGEON THEN USED RECLAIM FEMORAL STEM AND NEW UNIPOLAR HEAD WITH NEW SLEEVE. REDUCED THE HIP AND CLOSED IN NORMAL FASHION. DOI: (B)(6) 2025. DOR: (B)(6) 2025. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Fall; Limb Fracture

  MAUDE report 22339607 ↗
• InjuryNov 19, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED,, DUE TO PERI PROSTHETIC FRACTURE OF FEMUR. STEM AND HEAD REMOVED. NEW STEM AND HEAD IMPLANTED. DOI: (B)(6) 2024. DOR: (B)(6) 2024. AFFECTED SIDE: LEFT HIP.

  Patient problems: Limb Fracture

  MAUDE report 20726808 ↗
• InjuryAug 28, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED DUE TO ACUTE INFECTION. UNKNOWN SURGICAL DELAY. DOI: (B)(6) 2024. DOR: (B)(6) 2024. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 20088312 ↗
• InjuryOct 25, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  UPDATED EVENT DESCRIPTION: PATIENT HAS ELEVATED ION LVL. ELEVATED ESR. SUSPICION FOR INFECTED LEFT THA W/ A PSOAS ABSCESS. SNYNOVIUM WAS COMPRISED OF INFLAMMATORY GREY TISSUE FOUND ON CUP- SPOT WELDS. MILD BONE LOSS. WIDE CAPSULUTOMY TO RESECT THE INFLAMMATORY TISSUE AND THE HIP WAS UNSTABLE. A CYST IN THE SUPERIOR WEIGHT - BEARING AREA WAS CURETTED FREE OF SOFT TISSUE. PIRIFORMIS AND GLUTEUS MAXIMUS INSERTION WERE REPAIRED. DOI: (B)(6) 2008. DOR: (B)(6) 2013. LEFT HIP.

  Patient problems: Abscess; Cyst(s); Inflammation; Insufficient Information; Joint Laxity; Metal Related Pathology; Unspecified Tissue Injury

  MAUDE report 18000532 ↗
• InjuryJun 17, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS 2 DAYS POST-OP AND WAS WITH HER PT PRACTICING A "GET IN AND OUT OF CAR MOVEMENT" WHEN SHE EXPERIENCED A PERIPROSTHETIC FRACTURE. PATIENT WAS BROUGHT BACK TO SURGERY WHERE THE 36X+8.5 CERAMIC HEAD AND 8 HI TRILOCK STEM WERE REMOVED. A RECLAIM STEM WAS PLACED WITH 5 CABLES AND A TROCHANTERIC CLAW CABLE AND A 36+5 CERAMIC HEAD. DOI: MAY 31,2022. DOR: (B)(6) 2022. AFFECTED SIDE: LEFT HIP.

  Patient problems: Limb Fracture

  MAUDE report 14734114 ↗
• InjuryOct 26, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DEPUY HIP IMPLANTS WERE EXTRACTED DUE TO INFECTION.

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 10733316 ↗
• InjuryOct 22, 2020Corroded; Corroded

  THE PATIENT WAS REVISED TO ADDRESS A PAINFUL HIP. DOI: (B)(6) 2009; DOR: (B)(6) 2019 (LEFT HIP).

  Patient problems: Adhesion(s); Foreign Body Reaction; Hypersensitivity/Allergic reaction; Inflammation; Limited Mobility Of The Implanted Joint; No Code Available; Osteolysis; Pain; Rash; Swelling/ Edema; Test Result

  MAUDE report 10718983 ↗
• InjuryJul 28, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PERI PROSTHETIC GC OBSERVED ON POST-OP X-RAY. DECIDED TO GO BACK IN WITH CABLES AND RECLAIM. DOI: (B)(6) 2020, DOR: (B)(6) 2020, LEFT HIP.

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

  MAUDE report 10334144 ↗
• InjuryFeb 18, 2020Corroded; Corroded

  PATIENT WAS REVISED TO ADDRESS PAIN. DOI: UNKNOWN; DOR: (B)(6) 2017; AFFECTED SIDE: UNKNOWN.

  Patient problems: Hypersensitivity/Allergic reaction; Inflammation; No Code Available; Pain; Test Result

  MAUDE report 9720866 ↗
• InjuryDec 20, 2019Fracture; Fracture

  IT WAS REPORTED THAT THE PATIENT HAS BEEN A CHRONIC DISLOCATER. PATIENT SAID THEY WERE WALKING AND DISLOCATED AND THE STEM (TRILOCK) BROKE AT THE TRUNION. PRODUCT IS IN HOSPITAL HANDS. I AM TRYING TO GET IT TO SEND IN. ( NOT SURE IF ALLOWED). DOI: (B)(6) 2017; DOR: (B)(6) 2019; RIGHT HIP.

  Patient problems: No Code Available

  MAUDE report 9504163 ↗
• InjuryOct 22, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PINNACLE CLAIM SUBMISSION FORM AND MEDICAL RECORDS RECEIVED VIA CD SHIPMENT LAST 04 APR 2019. AFTER REVIEW OF MEDICAL RECORDS, THE PATIENT WAS REVISED TO ADDRESS FAILED LEFT TOTAL HIP REPLACEMENT, HIP INSTABILITY, METALLOSIS AND BONE LOSS. PATIENT HAS EXPERIENCED PAIN, TENDERNESS, LIMITATIONS IN RANGE OF MOTION, WEAKNESS AND RECURRENT DISLOCATION EPISODES IN THE PAST. BLOOD COBALT AND CHROMIUM ION LEVELS WERE ALSO NOTED TO BE ELEVATED. MRI SHOWED EVIDENCE OF POSSIBLE PSEUDOTUMOR SECONDARY TO METALLOSIS. EMERGENCY ROOM NOTES ON (B)(6) 2017 NOTES THAT THE PATIENT'S LEFT LOWER EXTREMITY WAS SLIGHTLY SHORTENED. INTRAOPERATIVELY, THERE WAS PRESENCE OF METAL DEBRIS THROUGHOUT THE ENTIRE HIP, THE APPEARANCE OF WHICH MIMICKED THAT OF COAL DUST. WHEN THE LEG WAS IN A NEUTRAL POSITION AND SLIGHTLY ABDUCTED, EXTERNAL ROTATION CREATED AN IMPINGEMENT ON THE POSTERIOR SOFT TISSUES WHERE A CLUMP OF METALLOSIS AND TISSUE RESTED. THERE WAS MINIMAL OSTEOLYSIS AROUND THE FEMUR. THERE WAS BONE LOSS BEHIND THE CUP. DOI: (B)(6) 2008; DOR: (B)(6) 2018; (LEFT HIP).

  Patient problems: Discomfort; Foreign Body Reaction; Joint Disorder; Limited Mobility Of The Implanted Joint; No Code Available; Osteolysis; Pain; Test Result; Weakness

  MAUDE report 9218441 ↗
• InjuryOct 8, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT PRESENT TO SURGEON ROOMS 3 YEARS POST TOTAL HIP REPLACEMENT WITH PAIN. ON X-RAY THERE WAS AN AREA IN THE REGION OF THE DISTAL PORTION OF THE STEM WHERE BONE HAD WAS MISSING? REASON. REVISION SURGERY WAS PERFORMED. A FROZEN SECTION WAS TAKEN DURING THE PROCEDURE WHICH RULED OUT INFECTION BUT STILL UNKNOWN CAUSE. STEM WAS REVISED. PATIENT STATUS / OUTCOME / CONSEQUENCES? YES. PATIENT CONSEQUENCE DESCRIPTION / WAS THERE A CLINICAL OUTCOME EXPERIENCED BY THE PATIENT (INFECTION, INFLAMMATION, ETC.)? PAIN. WAS OTHER MEDICAL INTERVENTION (E.G. X-RAYS, ADDITIONAL PROCEDURES, PRESCRIPTIONS, OTC, REVISION) REQUIRED: YES. IF YES, DESCRIBE: REVISION SURGERY.

  Patient problems: Injury; No Code Available; Pain

  MAUDE report 9168945 ↗
• InjuryJun 25, 2019Loss of Osseointegration; Biocompatibility; Osseointegration Problem; Loss of Osseointegration; Biocompatibility; Osseointegration Problem

  LITIGATION PAPERS ALLEGE THAT THE PATIENT HAS HAD TWO REVISIONS BECAUSE OF ELEVATED METAL ION LEVELS. UPDATE: RECORDS INDICATE THAT THE PATIENT WAS REVISED ON (B)(6) 2011 BECAUSE OF DISLOCATION AND METALLOSIS, AND AGAIN ON (B)(6) 2011 BECAUSE OF DISLOCATION WITH A LOOSE CUP. UPDATE: IN ADDITION TO WHAT WAS PREVIOUSLY REPORTED, PPF ALLEGES INFECTION AND METAL WEAR. DOI: (B)(6) 2009, DOR: (B)(6) 2011 (RIGHT HIP) FIRST REVISION.

  Patient problems: Inadequate Osseointegration; No Code Available; Test Result; Tissue Damage; Unspecified Infection

  MAUDE report 8730739 ↗
• InjuryApr 22, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED TO ADDRESS PAIN. DOI: (B)(6) 2018; DOR: (B)(6) 2019. LEFT HIP.

  Patient problems: No Code Available; Pain

  MAUDE report 8536764 ↗
• InjuryApr 11, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED BECAUSE OF METAL SENSITIVITY. DOI: UNKNOWN DOR: (B)(6) 2011. UPDATE: LITIGATION ALLEGES METALLOSIS AND HIP IMPLANT FAILURE. UPDATE RECORDS INDICATE THAT THE PATIENT WAS REVISED BECAUSE OF A PSEUDOTUMOR. UPDATE IN ADDITION TO WHAT WERE PREVIOUSLY ALLEGED, PPF ALLEGES METAL WEAR AND ELEVATED METAL IONS. DOI: (B)(6) 2009 - DOR: (B)(6) 2011 (RIGHT HIP).

  Patient problems: Hypersensitivity/Allergic reaction; No Code Available; Test Result; Tissue Damage

  MAUDE report 8505481 ↗
• InjuryMar 6, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PFS ALLEGES LACK OF MOBILITY, SWELLING, DISCOMFORT, EMOTIONAL DISTRESS AND UNABLE TO WALK FOR A LONG PERIOD OF TIME. MEDICAL RECORDS HAS NO REVISION NOTES PROVIDED. DOI: (B)(6) 2010. DOR: (B)(6) 2014. RIGHT HIP.

  Patient problems: Ambulation or Postural Difficulties; Discomfort; Limited Mobility Of The Implanted Joint; No Code Available; Pain; Swelling; Test Result; Tissue Damage

  MAUDE report 8394170 ↗
• InjuryJan 30, 2019Malposition of Device; Malposition of Device

  THE PRIMARY SURGERY WAS PERFORMED ON (B)(6) 2018 VIA THA. IT WAS REPORTED THAT THE REVISION SURGERY WAS SCHEDULED TO BE PERFORMED ON (B)(6) 2019 BY REPLACING THE STEM (P/N: 101214080), THE HEAD (P/N: 136521000), THE CUP (P/N: 121730060), THE LINER (P/N: 122432060) DUE TO FREQUENT DISLOCATION. NO FURTHER INFORMATION WAS PROVIDED BY THE HOSPITAL.

  Patient problems: No Code Available

  MAUDE report 8288439 ↗
• InjuryNov 14, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  LITIGATION ALLEGES INFECTION AFTER FIRST REVISION. AFTER REVIEW OF MEDICAL RECORDS, PATIENT WAS REVISED TO ADDRESS RIGHT PERIPROSTHETIC HIP INFECTION, SYNOVITIS, ABSCESS AND COMPLEX WOUND ON RIGHT HIP. REVISION NOTES REPORTED THAT THERE WAS SOME GROSSLY PURULENT MATERIAL.

  Patient problems: Abscess; No Code Available; Unspecified Infection

  MAUDE report 8070404 ↗
• InjuryNov 13, 2018Fracture; Loose or Intermittent Connection; Appropriate Device Problem Term/Code Not Available; Fracture; Loose or Intermittent Connection; Appropriate Device Problem Term/Code Not Available

  THE PATIENT WAS REVISED TO ADDRESS PERIPROSTHETIC FRACTURE OF THE HIP SECONDARY TO A FALL. THE STEM WAS INDICATED TO BE LOOSE AT THE BONE TO IMPLANT INTERFACE.

  Patient problems: Inadequate Osseointegration

  MAUDE report 8064885 ↗
• InjuryAug 16, 2018Loss of Osseointegration; Osseointegration Problem; Appropriate Device Problem Term/Code Not Available; Loss of Osseointegration; Osseointegration Problem; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT THE PATIENT WAS EXPERIENCING PAIN FOR THE LAST 2 YEARS FROM A TOTAL HIP. HE HAD A SIZE 8 TRILOCK HIGH OFFSET AND 56 PINNACLE CUP WITH METAL ON METAL INSERT AND 40 -2 12/14 TAPER HEAD. THE CUP HAD 2 SCREWS IN IT ONE LOOKING LIKE A 45MM AND THE OTHER 20MM. UPON OPENING THE HIP A MASSIVE PSEUDO TUMOR WAS FOUND ENCAPSULATING THE FEMUR. AFTER DISLOCATING AND REMOVE THE FEMORAL HEAD MORE PSEUDO TUMOR WAS REMOVED ALL AROUND THE ACETABULUM. SURROUNDING THE TRILOCK STEM WAS MASSIVE BONE LOSS ON THE LATERAL SHOULDER OF FEMUR INTO THE GREATER TROCHANTER ALONG WITH THE ANTERIOR AND POSTERIOR FEMUR. THE FEMUR WAS INGROWN MEDIALLY HOWEVER WITH SUCH BONE LOSS WAS SLAP HAMMERED OUT EASILY. WE PROCEEDED TO THE ACETABULUM WHERE WE REMOVED METAL INSERT AND SCREWS TO TEST CUP STABILITY AND IN-GROWTH. THE COMPONENT DEFINITELY HAD LYSIS AROUND THE SOCKET HOWEVER SEEMED STABLE ENOUGH TO PROCEED. THE FEMUR WAS PREPARED AND WE IMPLANTED 3 SCREWS INTO THE EXISTING SOCKET WITH A NEW LINER AND CERAMIC HEAD. IT WAS INDICATED THAT THE STEM WAS LOOSE AT BONE TO IMPLANT INTERFACE. DOI: UNKNOWN; DOR: (B)(6) 2018; RIGHT HIP.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Foreign Body Reaction; Hypersensitivity/Allergic reaction; Inadequate Osseointegration; Injury; No Code Available; Osteolysis; Pain; Tissue Damage; Unspecified Tissue Injury

  MAUDE report 7788743 ↗
• InjuryAug 16, 2018Fracture; Fracture

  IT WAS REPORTED THAT INITIALLY THE PATIENT HAD A TRILOCK STEM WITH AN ASR CUP. THE ASR CUP WAS REVISED A FEW YEARS AGO AND A PINNACLE CUP WITH A 40 +15.5 METAL HEAD WAS IMPLANTED. THE PATIENT WAS REVISED TO REMOVE A TRILOCK STEM WHICH HAD A TRUNION THAT FRACTURED OFF ALONG WITH THE 40 MM HEAD ATTACHED TO IT. A BIOMET ARCOS STEM WAS THEN IMPLANTED. DOI: (B)(6) 2011- HEAD; DOI: (B)(6) 2009 - STEM; DOR: JUL 18, 2018; RIGHT HIP.

  Patient problems: Ambulation or Postural Difficulties; No Known Impact Or Consequence To Patient

  MAUDE report 7788595 ↗
• InjuryJun 19, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED TO ADDRESS PERIPROSTHETIC FRACTURE BELOW THE STEM DUE TO FALL. DOI: (B)(6) 2018; DOR: (B)(6) 2018; RIGHT HIP.

  Patient problems: Bone Fracture(s); Fall; Not Applicable

  MAUDE report 7613343 ↗
• InjuryJun 19, 2018Loss of Osseointegration; Insufficient Device Problem Information; Loss of Osseointegration; Insufficient Device Problem Information

  PATIENT WAS REVISED AND CONFIRMED TO HAVE FEMORAL STEM LOOSENING.

  Patient problems: Inadequate Osseointegration; Not Applicable; Pain

  MAUDE report 7613158 ↗
• InjurySep 14, 2017Corroded; Degraded; Adverse Event Without Identified Device or Use Problem; Appropriate Device Problem Term/Code Not Available; Corroded; Degraded; Adverse Event Without Identified Device or Use Problem; Appropriate Device Problem Term/Code Not Available

  15 AUG 2017: DER RECEIVED. IT STATES THAT THE PATIENT UNDERWENT REVISION SURGERY FOR A PAINFUL HIP. PATIENT HAD FLUID COLLECTION ON MRI AND ELEVATED COBALT CHROMIUM LEVELS. ASR COMPONENTS WERE REMOVED AND COMPETITOR IMPLANTS WERE USED TO REPLACE THEM. UPDATE AUG 16 & 17, 2017: CLAIM LETTER AND LITIGATION RECORDS RECEIVED. CLAIM LETTER AND LITIGATION ALLEGES PAIN AND SUFFERING, AND ELEVATED METAL IONS. ADDED COMPLAINANT INFORMATION.

  Patient problems: Edema; No Code Available; Osteolysis; Pain

  MAUDE report 6864631 ↗