TRI-LOCK GRIPTION 1012-14-020Recalls & reported problems

Summary

The FDA's MAUDE database contains 28 adverse event reports that list this exact device (DI 10603295001041), received between Sep 1, 2017 and Apr 30, 2026 — classified as 28 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (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 28 reports, in the reporter's own words as published by the FDA.

• InjuryApr 30, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS REVISED DUE TO SEPTIC WASHOUT. EXCHANGED HEAD AND LINER. AFFECTED SIDE: UNKNOWN.

  Patient problems: Sepsis

  MAUDE report 25046077 ↗
• InjuryJul 2, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  MEDICAL RECORDS WERE RECEIVED: DATE OF REVISION WILL BE ON (B)(6) 2024.

  Patient problems: Insufficient Information

  MAUDE report 19660871 ↗
• InjuryJun 13, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2022, THE PATIENT UNDERWENT THE BHA SURGERY OF RIGHT HIP FOR FEMORAL NECK FRACTURE. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH NO SURGICAL DELAY. AFTER SURGERY, ON (B)(6) 2022, THE PATIENT FELL DURING A REHABILITATION AND A FRACTURE AROUND THE STEM OCCURRED. ON THE SAME DAY, THE STEM WAS EXTRACTED AND REPLACED IN A REVISION SURGERY. THE SURGEON COMMENTED THAT THE CAUSE OF THE FRACTURE WAS THE PATIENT'S FALL. NO FURTHER INFORMATION IS AVAILABLE. DOI: (B)(6) 2022. DOR: (B)(6) 2022. RIGHT HIP.

  Patient problems: Fall; Limb Fracture

  MAUDE report 14679989 ↗
• InjuryOct 29, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PRIMARY SURGERY WAS PERFORMED ON (B)(6) 2020 VIA THA FOR THE PATIENT¿S RIGHT HIP JOINT. IT WAS REPORTED THAT THE PATIENT FELL AND THE FRACTURE AROUND THE STEM OCCURRED IN WALKING AT THE HOSPITAL ON (B)(6) 2020. THE REVISION SURGERY WAS PERFORMED ON (B)(6) 2020 BY REPLACING THE STEM. THE ACETABULAR SIDE IMPLANTS WERE REMAINED. THE SURGEON WRAPPED A CABLE AROUND THE PATIENT¿S FEMUR AND COMPLETED THE REVISION SURGERY. IT WAS UNKNOWN WHETHER THERE WAS ANY SURGICAL DELAY. NO FURTHER INFORMATION IS AVAILABLE.

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

  MAUDE report 10755503 ↗
• InjuryOct 13, 2020Unintended Movement; Migration; Unintended Movement; Migration

  THE PRIMARY SURGERY WAS PERFORMED ON (B)(6) 2020 VIA THA. AFTER THE SURGERY, A FRACTURE AROUND THE STEM OCCURRED DUE TO FALLING FROM A BED IN THE HOSPITAL. THE SURGEON FOLLOWED UP ON IT, BUT THE SINKING OF THE STEM WAS NOT GETTING BETTER. THE SURGEON PLANNED THE REVISION SURGERY BY REPLACING THE STEM ON (B)(6) 2020. NO FURTHER INFORMATION IS AVAILABLE.

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

  MAUDE report 10673544 ↗
• InjurySep 11, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PINNACLE MEDICAL RECORDS RECEIVED. AFTER REVIEW OF MEDICAL RECORDS THE PATIENT WAS REVISED TO DUE TO FAILED HIP. PATIENT'S HISTORY REPORTED OF PAIN, EL AND POSSIBLE BONE LOSS AROUND HIS FEMUR. REVISION NOTES REPORTED, THERE WAS A SMALL AMOUNT OF FLUID IN THE CAPSULE AND NECROTIC MATERIAL BUT NO MAJOR METAL STAINING. THERE WAS AN EARLY AGE OF TRUNNIONOSIS NOTED IN THE HEAD. COBALT AND CHROMIUM LEVELS WERE BELOW 7 PPB. DOI: (B)(6) 2009 - DOR: (B)(6) 2019 (LEFT HIP). PLEASE SEE (B)(4) FOR THE RIGHT HIP.

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

  MAUDE report 10521439 ↗
• InjuryJun 4, 2020Inadequacy of Device Shape and/or Size; Unintended Movement; Migration; Inadequacy of Device Shape and/or Size; Unintended Movement; Migration

  THE PRIMARY SURGERY WAS PERFORMED ON (B)(6) 2014 VIA THA FOR THE PATIENT¿S RIGHT HIP JOINT. AFTER THE SURGERY, THE PATIENT HAD A PAIN BECAUSE THE STEM (P/N: 101214020)¿S SINKING TOWARD VALGUS OCCURRED, AND THIS CAUSED TO FORM THE PEDESTAL AT THE DISTAL POINT OF THE STEM AND THE DISTAL POINT OF THE STEM TOUCHED CORTEX BONE. IT WAS REPORTED THAT THE REVISION SURGERY WAS PERFORMED ON (B)(6) 2020 BY REPLACING THE STEM, THE LINER (P/N: 122432052) AND THE HEAD (P/N: 136532330) DUE TO THE PAIN. A CUP WAS REMAINED IN THE BODY. THE REVISION SURGERY WAS COMPLETED WITH 210 MINUTES DELAY. THE SURGEON THOUGHT THAT THIS EVENT WAS CAUSED BY A MISTAKE OF THE CHOICE OF THE STEM¿S SIZE AT THE PRIMARY SURGERY. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Code Available; Not Applicable; Pain

  MAUDE report 10120888 ↗
• InjuryApr 1, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  UNF AND MEDICAL RECORDS RECEIVED. AFTER A REVIEW OF THE MEDICAL RECORD, THE PATIENT WAS REVISED TO ADDRESS FAILED RIGHT TOTAL HIP REPLACEMENT SECONDARY TO METALLOSIS. REVISION OPERATIVE NOTES REPORTED THAT METALLOSIS WAS NOTED IN THE HIP CAPSULE. PATIENT CLINIC VISIT NOTE ON (B)(6) 2019, REPORTED A HIGH COBALT LEVEL. DOI: (B)(6) 2009; DOR: (B)(6) 2019; RIGHT HIP. PLEASE SEE (B)(4) FOR THE LEFT HIP REVISION.

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

  MAUDE report 9912940 ↗
• InjuryDec 27, 2019Loss of Osseointegration; Osseointegration Problem; Loss of Osseointegration; Osseointegration Problem

  IT WAS REPORTED THAT THE PATIENT HAD A LEFT THA REPLACEMENT DONE ON (B)(6) 2019. THE SURGEON SAID THAT WHILE THE PATIENT WAS DOING PHYSICAL THERAPY, SHE FRACTURED. THE SURGEON NEEDED TO DO FEMORAL REVISION AND CABLE THE FRACTURE. THE SURGEON REMOVED THE TRILOCK STEM, CABLED THE FRACTURE, AND BROACHED AND THEN IMPLANTED A CORAL REVISION STEM. HE TRAILED AND WAS HAPPY WITH THE LEG LENGTHS AND OFFSETS. IT WAS ALSO INDICATED THAT THERE WAS LOOSENING OF THE STEM AT THE BONE TO IMPLANT INTERFACE. DOI: (B)(6) 2019; DOR: (B)(6) 2019; LEFT HIP.

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

  MAUDE report 9526524 ↗
• InjuryDec 12, 2019Loss of Osseointegration; Osseointegration Problem; Loss of Osseointegration; Osseointegration Problem

  THE PATIENT WAS REVISED TO ADDRESS LOOSENING FEMORAL STEM AT THE BONE TO IMPLANT INTERFACE. DOI: (B)(6) 2017; DOR: (B)(6) 2019; RIGHT HIP.

  Patient problems: Inadequate Osseointegration; No Code Available

  MAUDE report 9457374 ↗
• InjuryJul 3, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AFTER REVIEW OF MEDICAL RECORDS THE PATIENT WAS REVISED TO ADDRESS FAILURE RIGHT HIP. THERE'S A MANAGEABLE PAIN AND SKIN ABRASION NOTED. OPERATIVE NOTE REPORTED FLUID FROM JOINT APPEARED SOMEWHAT BENIGN AND A SIGNIFICANT FLEXION CONTRACTURE WAS PRESENT TO HIS KNEE, LENGTHENING OF THE LEG WAS NOT POSSIBLE DUE TO RESTRICTION IN THE SOFT TISSUES. DOI: (B)(6) 2009; DOR: (B)(6) 2016; RIGHT HIP.

  Patient problems: Abrasion; No Code Available; Pain; Tissue Damage

  MAUDE report 8758616 ↗
• InjuryMay 2, 2019Biocompatibility; Biocompatibility

  PATIENT WAS REVISED TO ADDRESS ELEVATED CHROMIUM AND COBALT LEVELS AND PSEUDOTUMOR FORMATION. PROGRESSIVE DISCOMFORT WAS ALSO NOTED. REVISION NOTES REPORTED PSEUDOTUMOR IN THE GLUTEUS MEDIUS AREA. DOI: (B)(6) 2008, DOR: (B)(6) 2017, (RIGHT HIP).

  Patient problems: Test Result; Tissue Damage

  MAUDE report 8573432 ↗
• InjuryApr 10, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  LITIGATION ALLEGES PAIN, DISCOMFORT AND METALLOSIS. UPDATE: THE REVISION OPERATIVE NOTE INDICATED PAIN, SYNOVITIS, AND FINE WEAR MARKINGS BETWEEN THE LINER/CUP. THE CUP WAS NOTED TO BE SOMEWHAT ANTEVERTED, BUT NO MENTION OF MALPOSITIONING AND THE CUP WASN'T REVISED. UPDATE: IN ADDITION TO WHAT WERE PREVIOUSLY ALLEGED, PPF ALLEGES PSEUDOTUMOR AND ELEVATED METAL IONS. AFTER REVIEW OF MEDICAL RECORDS, PATIENT WAS REVISED TO ADDRESS PAINFUL FAILED METAL ON METAL RIGHT TOTAL HIP ARTHROPLASTY. REVISION NOTES REPORTED SYNOVITIS AND THICKENING OF THE ENVELOPE OF SOFT TISSUE AROUND THE JOINT. IT WAS ALSO MENTIONED THAT THE CUP WAS ANTEVERTED. DOI: (B)(6) 2008; DOR: (B)(6) 2012; (RIGHT HIP).

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

  MAUDE report 8500736 ↗
• InjuryApr 9, 2019Biocompatibility; Biocompatibility

  PPF ALLEGES METAL WEAR AND ELEVATED METAL IONS.

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

  MAUDE report 8496060 ↗
• InjuryMar 18, 2019Loss of Osseointegration; Loss of Osseointegration

  THE PPF AND STICKER SHEETS RECORD RECEIVED. PPF ALLEGES PSEUDO TUMOR, LOOSENING OF STEM AND ELEVATED METAL IONS AFTER FIRST REVISION. DOI: (B)(6) 2009 (STEM), DOI: (B)(6) 2011 (HEAD), DOR: NONE REPORTED (RIGHT HIP).

  Patient problems: Inadequate Osseointegration; Test Result; Tissue Damage

  MAUDE report 8429082 ↗
• InjuryJan 7, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PPF ALLEGED ELEVATED METAL IONS.

  Patient problems: No Code Available; Test Result

  MAUDE report 8223246 ↗
• InjuryJan 7, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PPF ALLEGED ELEVATED METAL IONS.

  Patient problems: No Code Available; Test Result

  MAUDE report 8223068 ↗
• InjuryDec 19, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT REVISED FOR PAIN, HAS COBALT CHROME LEVEL OF 35. PPF ALLEGES METAL WEAR AND METALLOSIS. DOI: (B)(6) 2008 - DOR: (B)(6) 2011 (RIGHT HIP).

  Patient problems: No Code Available; Pain; Test Result

  MAUDE report 8178473 ↗
• InjuryAug 16, 2018Failure to Osseointegrate; Failure to Osseointegrate

  PPF AND STICKER SHEETS RECEIVED. PPF ALLEGES DISLOCATION W/ CLOSED REDUCTION, INFECTION, LOOSENING OF STEM, AND ELEVATED METAL IONS. DOI: B)(6) 2017 - DOR: NONE REPORTED (RIGHT HIP).

  Patient problems: Inadequate Osseointegration; Unspecified Infection

  MAUDE report 7788709 ↗
• InjuryJul 10, 2018Material Erosion; Material Erosion

  THE PATIENT WAS REVISED TO ADDRESS SUSPECTED PSEUDOTUMOR, EVIDENCE OF TRUNNION WEAR BETWEEN METAL HEAD AND STEM, TISSUE LOSS AND REVISION OF THE CUP FOR MORE STABILITY. DOI: (B)(6) 2014; DOR: (B)(6) 2018; UNKNOWN HIP.

  Patient problems: Tissue Damage

  MAUDE report 7673873 ↗
• InjuryMay 11, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  LITIGATION ALLEGES THAT THE PATIENT SUFFERS FROM PAIN, DISCOMFORT, LIMITED MOBILITY, AND A CONSTANT LIMP. UPDATE: 11/20/2012 PFS WAS RECEIVED FROM LEGAL, MEDICAL RECORDS WERE RECEIVED FROM LEGAL, AND PART/LOT INFORMATION WAS IDENTIFIED. RECORDS INDICATE THAT THE PATIENT WAS REVISED BECAUSE OF PAIN, METALLOSIS, ELEVATED ION LEVELS, DISLOCATION ISSUES, AND VERTICAL CUP. RECORDS ARE AVAILABLE FOR FURTHER REVIEW. DOR: (B)(6) 2013. UPDATE AD 13 APR 2018: PINNACLE PPF AND MEDICAL RECORDS RECEIVED. IN ADDITION TO WHAT WAS PREVIOUSLY ALLEGED. PPF ALLEGES DISLOCATION WITH OPEN REDUCTION AND METAL WEAR/ METALLOSIS CONFIRMED IN MEDICAL RECORDS. AFTER REVIEW OF MEDICAL RECORDS FOR MDR REPORTABILITY, THE PATIENT WAS REVISED TO ADDRESS PAINFUL LEFT TOTAL HIP REPLACEMENT SECONDARY TO ELEVATED METAL IONS, DISLOCATION, VERTICAL PLACEMENT OF CUP, AND INFLAMMATION. OPERATIVE NOTES REPORTED THERE WAS A MODERATE AMOUNT OF DARK TINGED FLUID CONSISTENT WITH METALLOSIS, A FAIR AMOUNT OF METALLOSIS DEBRIS AROUND THE CUP AND TISSUES. DOI: (B)(6) 2009; DOR: (B)(6) 2013; LEFT HIP.

  Patient problems: Discomfort; Inflammation; Limited Mobility Of The Implanted Joint; No Code Available; Not Applicable; Pain; Tissue Damage

  MAUDE report 7508643 ↗
• InjuryMay 11, 2018Adverse Event Without Identified Device or Use Problem; Appropriate Device Problem Term/Code Not Available; Adverse Event Without Identified Device or Use Problem; Appropriate Device Problem Term/Code Not Available

  PINNACLE PPF AND MEDICAL RECORDS RECEIVED. PFS ALLEGES DISLOCATION AND METALLOSIS. AFTER REVIEW OF MEDICAL RECORDS FOR MDR REPORTABILITY, THE PATIENT WAS REVISED TO ADDRESS METALLOSIS, INFLAMMATION, AND PREVIOUS DISLOCATION. SURGICAL NOTES ALSO REPORTED PRURITUS DUE TO PAIN AND MUSCLE SPASM. BLOOD WORK ALSO DETERMINED THAT PATIENT HAD HIGH METAL LEVELS AND REPORTED THAT THE CUP WAS EXCHANGED WITH FINDINGS OF INFLAMMATION AND MODERATE AMOUNT OF DARK TINGED FLUID WITH CONSISTENT METALLOSIS AND CONSISTENT PAIN. THE PATIENT ALSO HAD AN ANEMIA OF ACUTE BLOOD LOSS NOT NECESSITATING TRANSFUSION. DOI: (B)(6) 2009; DOR: (B)(6) 2012; LEFT HIP.

  Patient problems: Discomfort; Inflammation; Injury; Itching Sensation; Limited Mobility Of The Implanted Joint; Muscle Spasm(s); No Code Available; Pain; Tissue Damage

  MAUDE report 7506508 ↗
• InjuryApr 30, 2018Corroded; Degraded; Corroded; Degraded

  ALLEGES THE PATIENT SUFFERS FROM LARGE AMOUNTS OF TOXIC COBALT-CHROMIUM METAL IONS AND PARTICLES TO BE RELEASED INTO THE BLOOD, TISSUE AND BONE, PAIN, DISCOMFORT AND INFLAMMATION.

  Patient problems: Discomfort; Inflammation; Injury; Limited Mobility Of The Implanted Joint; Loss of Range of Motion; No Code Available; Not Applicable; Pain; Tissue Damage

  MAUDE report 7472522 ↗
• InjuryApr 27, 2018Malposition of Device; Osseointegration Problem; Malposition of Device; Osseointegration Problem

  THE PRIMARY SURGERY WAS PERFORMED ON (B)(6) 2017. RIGHT AFTER THE PRIMARY SURGERY, THE PATIENT HAS COMPLAINED THE PAIN FOR A YEAR. THEN, THE SURGEON RECOGNIZED UNDER X-RAY THAT THE STEM WAS IMPLANTED IN VARUS AND THE LOOSENING. THUS, THE REVISION SURGERY WAS PERFORMED ON (B)(6) 2018 BY REPLACING THE STEM AND THE HEAD TO ANOTHER MANUFACTURER¿S PRODUCTS. NO FURTHER INFORMATION WAS PROVIDED BY THE HOSPITAL. DOI: (B)(6) 2017; DOR: (B)(6) 2018; UNKNOWN HIP.

  Patient problems: Inadequate Osseointegration; Not Applicable; Pain

  MAUDE report 7468036 ↗
• InjuryDec 13, 2017Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  NEW UNITY RECORD CREATED IN ORDER TO UPDATE LEGACY COMPLAINT NUMBER (B)(4). LITIGATION ALLEGES THAT PATIENT SUFFERS FROM CONSTANT HIP PAIN, BACK PAIN AND DISCOMFORT. IT IS SOMETIMES NOT POSSIBLE FOR PATIENT TO PERFORM HER ROUTINE DAILY ACTIVITIES DUE TO THE PAIN. THE INCISION SITE AROUND THE HIP IMPLANT SOMETIMES STILL OPENS UP AND BLEEDS YEARS AFTER HER ORIGINAL IMPLANT SURGERY. ADDITIONALLY, IT IS ALLEGED THAT PATIENT HAS ELEVATED METAL ION LEVELS. PATIENT'S PRELIMINARY DISCLOSURE FORM WAS RECEIVED ON 6/29/2012, WHICH PROVIDED PART/LOT INFORMATION. DOI: (B)(6) 2008 - DOR: NONE REPORTED (LEFT HIP). **PATIENT IS A RESIDENT OF (B)(6). UPDATE NOV 15 AND 28, 2017: MEDICAL RECORDS RECEIVED. AFTER REVIEW OF MEDICAL RECORDS FOR THE MDR REPORTABILITY, IN ADDITION TO WHAT WAS PREVIOUSLY REPORTED, THE PATIENT WAS REVISED TO ADDRESS METALLOSIS AND TRUNNIONOSIS. REVISION NOTES REPORTED A METALLOSIS-TYPE FLUID, SIGNIFICANT TRUNNIONOSIS WITH GREY METAL BLACK PARTICLES IN THE FEMORAL HEAD, AND NO REAL INCORPORATION OF BONE INTO THE ACETABULAR SHELL. LABORATORY RESULT FOR COBALT IS ABOVE 7PPB. CLINICAL NOTES REPORTED INABILITY TO BEAR WEIGHT, HISTORY OF WOUND DEHISCENCE, SOFT TISSUE ATROPHY, LIMI

  Patient problems: Foreign Body Reaction; Loss of Range of Motion; Necrosis; Pain; Tissue Damage; Wound Dehiscence

  MAUDE report 7114900 ↗