TRI-LOCK GRIPTION 1012-04-030Recalls & reported problems

Summary

The FDA's MAUDE database contains 43 adverse event reports that list this exact device (DI 10603295000747), received between Jul 7, 2017 and Jan 1, 2025 — classified as 33 injuries, 10 malfunctions.

The most frequently reported specific device problem is “Device-Device Incompatibility” (8 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 43 reports, in the reporter's own words as published by the FDA.

• InjuryJan 1, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT CLAIMS THAT AS A RESULT OF THE PRODUCT, PATIENT EXPERIENCED PAIN AND WAS DIAGNOSED WITH HEMATOLOGICAL DISEASES CAUSED BY THE RELEASE OF METAL IONS. CONSEQUENTLY, PATIENT UNDERWENT REVISION SURGERY, ALTHOUGH FURTHER DETAILS OF THE SECOND SURGERY HAVE NOT BEEN PROVIDED. DOI: 2018. DOR: UNKNOWN, AFFECTED SIDE: UNKNOWN.

  Patient problems: Metal Related Pathology; Pain

  MAUDE report 21051845 ↗
• InjuryApr 25, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE SURGEON HAD TO REMOVE ALL IMPLANTS AND PLACE A SPACER DUE TO INFECTION. DOI: UNKNOWN DOR: (B)(6) 2024 AFFECTED SIDE: RIGHT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 19181420 ↗
• InjuryAug 25, 2023Migration; Migration

  IT WAS REPORTED THAT THE TRILOCK STEM SUBSIDED.

  Patient problems: Insufficient Information

  MAUDE report 17623824 ↗
• InjuryJun 2, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS PC WAS RELATED TO PC-(B)(4) WHICH REPORTS THAT THE LINER CAME OUT AFTER THE REPLACEMENT. THIS PC REPORTS THE SUSPECTED INFECTION AND THE REPLACEMENT SURGERY AFTER THE PRIMARY SURGERY. IT WAS REPORTED THAT ON AN UNKNOWN DATE IN 2015, THE PRIMARY SURGERY WAS PERFORMED. IT IS UNKNOWN IF THE J&J PRODUCTS WERE USED OR NOT. THE REVISION SURGERY WAS PERFORMED ON (B)(6) 2015, DUE TO SUSPECTED INFECTION TO CLEAN AND REPLACE THE LINER AND HEAD. THE EVENT DATE IS UNKNOWN. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Unspecified Infection

  MAUDE report 17049492 ↗
• MalfunctionSep 28, 2022Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT THE SIZE 3 STEM AND BROACH WERE MISMATCHED. FINAL STEM DAY UP IN CANAL AND A NEW ONE WAS NEEDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15500812 ↗
• MalfunctionSep 9, 2022Device-Device Incompatibility; Device-Device Incompatibility

  SIZE 3 BROACH IS MISMATCHED FROM THE SIZE 3 STEM. THE STEM SAT UP DURING ATTEMPTED IMPLANTATION AND A NEW ONE WAS NEEDED. THERE WAS A FIVE MINUTE SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15392072 ↗
• MalfunctionApr 28, 2022Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT THE TRILOCK STEM WOULD NOT SIT FLUSH WITH RESECTED NECK. STEM WAS MUCH BIGGER THAN BROACH. A NEW 3 STD STEM WAS OPENED AND IMPLANTED. THERE WAS A SURGICAL DELAY OF UNKNOWN TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14238074 ↗
• InjuryDec 7, 2021Osseointegration Problem; Osseointegration Problem

  THE PATIENT PRESENTED WITH A PERIPROSTHETIC FEMUR FRACTURE. THERE WAS LOOSENING AT THE BONE TO IMPLANT INTERFACE. STEM & HEAD WERE REMOVED & RECLAIM STEM & BIOLOX HEAD IMPLANTED. DOI : (B)(6) 2021 DOR : (B)(6) 2021 RIGHT SIDE.

  Patient problems: Inadequate Osseointegration; Limb Fracture

  MAUDE report 12954255 ↗
• InjuryOct 8, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS INFECTED, SURGEON ELECTED TO REMOVE IMPLANTS AND DO AN ABX SPACER. DOI: (B)(6) 2017, DOR: (B)(6) 2021, AFFECTED SIDE: RIGHT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 12597911 ↗
• InjurySep 17, 2021Fracture; Osseointegration Problem; Fracture; Osseointegration Problem

  IT WAS REPORTED THAT ON (B)(6) 2013, THE PATIENT UNDERWENT THE THA SURGERY. IN THE SURGERY, OUR COMPANY¿S STEM AND HEAD, STLYKER¿S CUP AND LINER WERE USED. AROUND 2017, THE SURGEON HAD A SUSPECT OF LOOSENING OF THE STEM BUT WAS WATCHING HOW IT WENT. THE PATIENT HAD NO SUBJECTIVE SYMPTOMS. UNTIL 2020, THE POSTOPERATIVE COURSE WAS UNEVENTFUL, AND THE PATIENT HAD BEEN ENJOYING BALLROOM DANCING. SINCE 2020, THE PATIENT'S ADL HAS DECREASED. ON (B)(6) 2021, LOOSENING OF THE STEM WAS CONFIRMED. THE PATIENT HAS PAIN AND HAS DIFFICULTY IN WALKING. ON (B)(6) REVISION SURGERY WAS PERFORMED. IN THE SURGERY, IMPLANTED PRODUCTS WERE REMOVED. WHEN THE REMOVED STEM WAS CHECKED, PEELING OF COATING WAS CONFIRMED. BECAUSE THE STEM WAS COMPLETELY LOOSE, NO CHISEL ETC. WERE USED DURING REMOVAL. DOI: (B)(6)2013, DOR: (B)(6) 2021, UNKNOWN SIDE.

  Patient problems: Ambulation or Postural Difficulties; Inadequate Osseointegration; Pain

  MAUDE report 12487223 ↗
• InjuryMay 19, 2021Osseointegration Problem; Migration; Osseointegration Problem; Migration

  AFTER REVIEW ON MEDICAL RECORDS, IT WAS STATED THAT ON (B)(6) 2021, THE PATIENT HAD A RIGHT TOTAL HIP REVISION TO ADDRESS MECHANICAL COMPLICATIONS, UNEQUAL LEG LENGTH. THE INDICATIONS FOR SURGERY NOTED THE PATIENT HAD A GAIT ABNORMALITY, SUBSIDENCE OF THE HIP STEM, AND LEG LENGTH DISCREPANCY 2 CM. DURING THE PROCEDURE THE SURGEON OBSERVED THAT THE STEM HAD SUBSIDED, BUT WAS WELL FIXED TO THE BONE. DEPUY LINER WAS USED WITH COMPETITOR COMPONENTS DURING THIS PROCEDURE.

  Patient problems: Ambulation or Postural Difficulties; Inadequate Osseointegration; Physical Asymmetry

  MAUDE report 11849267 ↗
• InjuryApr 1, 2021Osseointegration Problem; Osseointegration Problem

  IT WAS REPORTED THAT ON (B)(6) 2012, THE PRIMARY SURGERY WAS PERFORMED VIA THA FOR LEFT HIP WITH THE STEM AND HEAD. ON (B)(6) 2021, THE REVISION SURGERY WAS PERFORMED DUE TO THE LOOSENING OF THE STEM SIDE. IN THE REVISION, THE SURGEON REPLACED THE STEM AND HEAD WITH THE OTHER COMPANY¿S PRODUCT. THE CUP AND LINER HAD NO PROBLEM AND THEY WERE LEFT IN THE PATIENT. THE REVISION SURGERY WAS COMPLETED SUCCESSFULLY WITHOUT ANY SURGICAL DELAY. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Inadequate Osseointegration

  MAUDE report 11605509 ↗
• InjuryAug 13, 2020Loss of Osseointegration; Loss of Osseointegration

  IT WAS REPORTED THAT THE PATIENT HAD A RIGHT THA PERFORMED ON (B)(6) 2020. THE PATIENT WAS DOING GREAT UNTIL SHE TRIPPED ON CARPET AT HOME. FROM THE XRAYS SHE FX HER FEMUR AND HAS A PERIPROSTHETIC FRACTURE. THE SURGEON WANTED TO REMOVE THE TRILOCK STEM AND HEAD, AND PUT IN A CORAIL REVISION STEM WHILE CABLING THE FEMUR. THE SURGEON LIKED THE FINAL RESULT IN REGARDS TO LEG LENGTH, OFFSET, AND NEW STABILITY WITH THE CORAIL REVISION STEM. DOI: (B)(6) 2020, DOR: (B)(6) 2020, RIGHT SIDE.

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

  MAUDE report 10403419 ↗
• MalfunctionMay 28, 2020Inadequacy of Device Shape and/or Size; Appropriate Device Problem Term/Code Not Available; Inadequacy of Device Shape and/or Size; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT THE SURGEON BROACHED UP TO A 3 BROACH AND IMPLANTED A SIZE 3 THRILOCK STD. IT SAT PROUD AND AFTER REBROACHING IT STILL SAT PROUD. HE THEN REMOVED THE STEM AND BROACHED UP TO A 4 THEN IMPLANTED A NEW SIZE 3. THIS DELAYED THE CASE ABOUT 5-10 MINUTES BUT WAS NOT DETRIMENTAL TO THE OUTCOME. I WILL WASH AND RETURN THE IMPLANT IN QUESTION. DOE: (B)(6) 2020 AFFECTED SITE: UNKNOWN

  Patient problems: No Code Available; Not Applicable

  MAUDE report 10097531 ↗
• InjuryMar 3, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PCF AND MEDICAL RECORDS. AFTER REVIEW OF MEDICAL RECORDS PATIENT WAS REVISED TO ADDRESSED INFECTED RIGHT TOTAL HIP ARTHROPLASTY, METALLOSIS AND ADVERSE LOCAL TISSUE REACTION. OPERATIVE NOTES INDICATED SEVERE PURULENT IN INTRAARTICULAR AREA AS WELL AS THE REGION BETWEEN THE ADDUCTOR TENDONS AND FASCIA LATA. A POCKET OF PUS ANTERIOR TO THE ACETABULUM. THERE WAS EXTENSIVE OSTEOLYSIS INVOLVING BOTH ACETABULUM AND PROXIMAL FEMUR. THERE IS NO EROSION IN ADDUCTOR TENDONS AS INSERTED TO THE GREATER TROCHANTER. TRUNNIONOSIS WITH BLACK MATERIAL ABOUT THE HEAD AND NECK JUNCTION. A FATTY LARGE LYTIC LESION ON THE MEDIAL NECK OF FEMUR WAS NOTED. DEBRIDEMENT OF PSEUDOTUMOR AND SOFT TISSUES WERE PERFORMED AS WELL AS THE NECROTIC BONE. DOI: (B)(6) 2010; DOR: (B)(6) 2018 RIGHT HIP.

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

  MAUDE report 9779452 ↗
• InjuryDec 20, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REVISED TO ADDRESS RIGHT ACETABULAR OSTEOLYSIS, PAIN, DISCOMFORT AND ELEVATED METAL IONS. OPERATIVE NOTE REPORTED CUP COMPONENT WAS NON MODULAR, SOME CENTRAL VOIDS, SUPERIOR BONE STOCK, AND ANTERIOR AND POSTERIOR COLUMNS. DOI: (B)(6) 2008; DOR: (B)(6) 2019; RIGHT HIP.

  Patient problems: Discomfort; Osteolysis; Pain; Test Result

  MAUDE report 9506699 ↗
• InjuryDec 19, 2019Loss of Osseointegration; Osseointegration Problem; Loss of Osseointegration; Osseointegration Problem

  IT WAS REPORTED THAT THE PATIENT FELL RESULTING IN A PERI-­-PROSTHETIC FRACTURE OF THE PROXIMAL FEMUR. FEMORAL COMPNENT & FEMORAL HEAD WERE REMOVED, FRACTURE REDUCED, CABLES PLACED & RECLAIM FEMORAL STEM INSERTED. DOI: (B)(6) 2019; DOR; (B)(6) 2019; LEFT HIP.

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

  MAUDE report 9499137 ↗
• MalfunctionNov 8, 2019Inadequacy of Device Shape and/or Size; Device-Device Incompatibility; Inadequacy of Device Shape and/or Size; Device-Device Incompatibility

  DR COMPLAINED THAT THE BROACH WAS SITTING SIGNIFICANTLY LOWER THAN THE FINAL IMPLANT. HE USED ANOTHER STEM AND IT DID THE SAME THING SO HE REQUESTED A 3RD IMPLANT.

  Patient problems: Not Applicable

  MAUDE report 9296335 ↗
• MalfunctionNov 8, 2019Inadequacy of Device Shape and/or Size; Device-Device Incompatibility; Inadequacy of Device Shape and/or Size; Device-Device Incompatibility

  DR COMPLAINED THAT THE BROACH WAS SITTING SIGNIFICANTLY LOWER THAN THE FINAL IMPLANT. HE USED ANOTHER STEM AND IT DID THE SAME THING SO HE REQUESTED A 3RD IMPLANT.

  Patient problems: Not Applicable

  MAUDE report 9296334 ↗
• InjuryOct 17, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PPF ALLEGES PAIN AND MOTION LIMITATION.

  Patient problems: Limited Mobility Of The Implanted Joint; Pain; Unspecified Infection

  MAUDE report 9203476 ↗
• InjuryAug 15, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  STUDY ID: (B)(6). ADVERSE EVENT: FOOT DROP. ADVERSE EVENT DATE: (B)(6) 2015. DATE OF ONSET: (B)(6) 2015. DATE OF ACTION TAKEN: N/A. RELATIONSHIP TO THE STUDY DEVICE: NO RELATIONSHIP. RELATIONSHIP TO THE STUDY PROCEDURE: DEFINITE. FINAL OUTCOME: ONGOING. RANDOMIZED TO: TRILOCK SHORT STEM. TYPE OF RE-OPERATION: NO RE-OPERATION. ACTION TAKEN: NONE.

  Patient problems: No Code Available

  MAUDE report 8897411 ↗
• MalfunctionApr 10, 2019Loss of Osseointegration; Loss of Osseointegration

  PPF ALLEGES LOOSENING OF STEM, METAL WEAR AND METALLOSIS. AFTER REVIEW OF MEDICAL RECORDS, PATIENT UNDERWENT LEFT PRIMARY TOTAL HIP ARTHROPLASTY TO ADDRESS DEGENERATIVE JOINT DISEASE LEFT HIP. DOI: (B)(6) 2011; DOR: NONE REPORTED; (LEFT HIP).

  Patient problems: Inadequate Osseointegration; Pain; Tissue Damage

  MAUDE report 8500117 ↗
• MalfunctionJan 31, 2019Device-Device Incompatibility; Device-Device Incompatibility

  THE SURGEON SAW THE BROACH TO IMPLANT MISMATCH AS TOO DRASTIC AND THOUGHT IT RISKED FRACTURING THE FEMUR. HE REQUESTED A NEW IMPLANT AND TO HAVE THE INITIAL IMPLANT AND CORRESPONDING BROACH TO BE SENT IN FOR TESTING. ACTION TAKEN-NEW SIZE 3 STD IMPLANT OPENED. IT AFFECTED THE LENGTH OF THE CASE BY ADDING 5-7 MINUTES BUT DID NOT AFFECT THE PATIENT OUTCOME.

  Patient problems: No Code Available

  MAUDE report 8293803 ↗
• InjuryJan 15, 2019Biocompatibility; Biocompatibility

  PPF ALLEGES ELEVATED METAL IONS. DOI: (B)(6) 2009 - DOR: (B)(6) 2011 (LEFT HIP).

  Patient problems: Discomfort; Limited Mobility Of The Implanted Joint; Pain; Test Result

  MAUDE report 8247704 ↗
• InjuryJan 2, 2019Biocompatibility; Adverse Event Without Identified Device or Use Problem; Biocompatibility; Adverse Event Without Identified Device or Use Problem

  PFS AND MEDICAL RECORDS RECEIVED. THIS COMPLAINT IS LEGAL. MEDICAL RECORDS SHOW THE PATIENT HAD HIS RIGHT HIP REPLACED ON (B)(6) 2008. THE PATIENT WENT THROUGH ALCOHOL WITHDRAWS AT THE HOSPITAL AND FELL AND FRACTURED (NONDISPLACED) HIS ANTERIOR ACETABULUM TO PUBIC RAMUS. THE EXACT DATE OF THE FALL IS UNKNOWN. UPDATE AD (B)(4) 2018: RECEIPT OF PPF AND STICKER SHEETS RECORD. IN ADDITION TO WHAT WERE PREVIOUSLY ALLEGED, PPF ALLEGES METAL WEAR, METALLOSIS AND ELEVATED METAL IONS.

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

  MAUDE report 8208168 ↗