TRI-LOCK GRIPTION 1012-04-060Recalls & reported problems

Summary

The FDA's MAUDE database contains 27 adverse event reports that list this exact device (DI 10603295000778), received between Nov 8, 2017 and Mar 5, 2026 — classified as 25 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Biocompatibility” (6 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 18, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 27 reports, in the reporter's own words as published by the FDA.

• InjuryMar 5, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT HAD PERIPROSTHETIC FRACTURE OF THE FEMUR. AFFECTED SIDE- UNKNOWN HIP.

  Patient problems: Limb Fracture

  MAUDE report 24518044 ↗
• MalfunctionMar 27, 2025Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging

  IT WAS REPORTED THAT UPON OPENING THE IMPLANT, IT WAS NOTICED THAT THE PLASTIC HOLDING THE IMPLANT WAS CRACKED AND HAD A HOLE. ANOTHER IMPLANT WAS OPENED, AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO DELAY. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21706036 ↗
• InjuryOct 15, 2024Adverse 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 PELVIC FRACTURE AND INFECTION. THERE WAS A ACETABULAR CUP LOOSENING AT NON-CEMENTED INTERFACE. DOI: (B)(6) 2024. DOR: (B)(6) 2024. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 20451579 ↗
• InjuryJul 27, 2022Adverse Event Without Identified Device or Use Problem; Osseointegration Problem; Adverse Event Without Identified Device or Use Problem; Osseointegration Problem

  PATIENT WHO HAD TOTAL HIP REPLACEMENT PERFORMED IN (B)(6) IN 2013 IS HAVING A FEMORAL SIDE REVISION PERFORMED IN (B)(6) ON (B)(6) 2022. REASON FOR REVISION IS STATED TO BE ¿ASEPTIC LOOSENING¿.

  Patient problems: Inadequate Osseointegration; Insufficient Information

  MAUDE report 15112967 ↗
• InjuryMar 1, 2022Osseointegration Problem; Osseointegration Problem

  REVISION COMPLETED TO ADDRESS LOOSENING OF THE PROSTHESIS. DURING THE SURGERY, THE STEM WAS REMOVED AND DID NOT REQUIRE ANY PARTICULAR MANEUVER FOR EXTRACTION. ONCE THE STEM WAS EXTRACTED, THE OPERATOR NOTICED THE LACK OF THE W / GRIPTION COATING ON THE ANTERIOR PORTION OF THE STEM. THE CANAL WAS WASHED AND CLEANED AND A DIFFERENT FEMORAL STEM WAS IMPLANTED.

  Patient problems: Inadequate Osseointegration

  MAUDE report 13634474 ↗
• InjuryJan 11, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT SUFFERED A PERIPROSTHETIC FRACTURE FOLLOWING THA. THE SURGEON REPAIRED THE FRACTURE AND REMOVED THE TRILOCK STEM AND IMPLANTED A LONGER STEM WITH A COLLAR. THE CUP AND LINER WERE RETAINED. DOI: (B)(6) 2021; DOR: (B)(6) 2021; AFFECTED SIDE: RIGHT HIP.

  Patient problems: Limb Fracture

  MAUDE report 13222728 ↗
• MalfunctionDec 20, 2021Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT THE SURGEON BROACHED UP TO A SIZE 6 TRILOCK BROACH AND WHILE IMPLANTING THE FINAL IMPLANT, THE SIZE 6 STEM WAS SITTING LOANER THAN THE LEVEL OF THE BROACH WHICH INCREASED THE RISK FOR SUBSIDENCE. THE SURGEON THEN ASKED FOR A SIZE 7 AFTER BROACHING UP TO THAT SIZE. THE SALES REPRESENTATIVE REQUESTED THAT THE HOSPITAL WASH AND RETURN THE IMPLANT SO THE SALES REPRESENTATIVE CAN SEND IT IN FOR ANALYSIS. THE EVENT OCCURRED AT 3 PM AND ADDED 5 MINUTES TO THE CASE. THE PATIENT OUTCOME WAS NOT AFFECTED. DOE: (B)(6) 2021. AFFECTED SIDE: UNKNOWN HIP.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13043179 ↗
• InjuryJan 20, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT FELL AND FRACTURED HER FEMUR. DOI: UNKNOWN, DOR: (B)(6) 2021, RIGHT HIP.

  Patient problems: Bone Fracture(s); Fall

  MAUDE report 11201567 ↗
• InjuryJan 4, 2021Fracture; Fracture

  IT WAS REPORTED THAT THE CERAMIC HEAD WAS FRACTURED. PATIENT FELL. NO SURGICAL DELAY. THE ACETABULAR CUP WAS DETERMINED TO BE WELL-FIXED AND WAS NOT REVISED. TRI-LOCK STEM WAS REVISED DUE TO A FRACTURED TRUNNION. DOI: (B)(6) 2013, DOR: (B)(6) 2020, LEFT HIP.

  Patient problems: Fall; Foreign Body Reaction; Joint Laxity; Pain

  MAUDE report 11107983 ↗
• InjuryNov 5, 2020Migration; Migration

  IT WAS REPORTED THAT PATIENT HAD PERIPROSTHETIC HIP FRACTURE AND HER STEM SUBSIDED. DOI: (B)(6) 2020, DOR: (B)(6) 2020, AFFECTED SIDE: LEFT HIP.

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

  MAUDE report 10792338 ↗
• InjurySep 2, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING INSERTION OF FEMORAL STEM SURGEON NOTED SMALL CRACK IN FEMUR. SURGEON PLACED ORTHOPEDIC CABLE. DOI: UNKNOWN. DOR: (B)(6) 2020; UNKNOWN AFFECTED SIDE.

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

  MAUDE report 10482366 ↗
• InjuryApr 22, 2019Biocompatibility; Biocompatibility

  PPF ALLEGES METAL WEAR, METALLOSIS AND ELEVATED METAL IONS.

  Patient problems: Pain; Test Result; Tissue Damage

  MAUDE report 8536361 ↗
• InjuryApr 2, 2019Biocompatibility; Adverse Event Without Identified Device or Use Problem; Biocompatibility; Adverse Event Without Identified Device or Use Problem

  PPF ALLEGES ELEVATED METAL IONS. DOI: (B)(6) 2009 - DOR: (B)(6) 2012 (RIGHT HIP).

  Patient problems: Osteolysis; Pain; Test Result; Tissue Damage; Weakness

  MAUDE report 8473204 ↗
• InjuryMar 15, 2019Biocompatibility; Adverse Event Without Identified Device or Use Problem; Biocompatibility; Adverse Event Without Identified Device or Use Problem

  PPF ALLEGES ELEVATED METAL IONS. DOI: (B)(6) 2009, DOR: (B)(6) 2014, (LEFT HIP).

  Patient problems: Test Result

  MAUDE report 8424072 ↗
• InjuryMar 1, 2019Biocompatibility; Adverse Event Without Identified Device or Use Problem; Biocompatibility; Adverse Event Without Identified Device or Use Problem

  UPDATE REC¿D 10/30/2013- REVISION OPERATIVE NOTES INDICATED "ADVERSE LOCAL TISSUE REACTION TO METAL ON METAL BEARING." UPDATE AD 10 JUL 2018- RECEIPT OF PPF AND STICKER SHEETS. IN ADDITION TO WHAT WAS PREVIOUSLY ALLEGED, PPF ALLEGES METAL WEAR AND ELEVATED METAL IONS.

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

  MAUDE report 8381481 ↗
• InjuryFeb 8, 2019Degraded; Adverse Event Without Identified Device or Use Problem; Degraded; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED TO ADDRESS PAIN SECONDARY TO INFECTION. UPDATE REC'D 1/11/2016 - LITIGATION PAPERS ALLEGE THE PATIENT SUFFERED FROM PAIN AND DISCOMFORT, SWELLING IN HIS LEG AND DIFFICULTY SLEEPING. THE COMPLAINT WAS UPDATED ON 1/15/2016. MDR DECISIONS WERE REVERSED DUE TO THE PENDING LITIGATION. UPDATE AD 12 JUN 2018 RECEIPT OF PPF, STICKER SHEETS AND MEDICAL RECORDS. IN ADDITION TO WHAT WERE PREVIOUSLY ALLEGED, PPF ALLEGES PSEUDOTUMOR AND METAL WEAR/METALLOSIS. AFTER REVIEW OF MEDICAL RECORDS IT WAS CONFIRMED THAT THE PATIENT WAS REVISED DUE TO ACUTE HEMATOGENOUS INFECTION. REVISION NOTES INDICATED THAT THE PATIENT HAD BEEN DEVELOPING FEVER AND A SMALL AMOUNT OF BLACK CORROSION MATERIAL WAS NOTED ON THE TRUNNION AT THE BASE. STEM WAS ADDED DUE TO THE ALLEGED CORROSION. DOI: (B)(6) 2010 - DOR: (B)(6) 2015 (LEFT HIP).

  Patient problems: Discomfort; Fever; No Code Available; Pain; Swelling; Tissue Damage; Unspecified Infection

  MAUDE report 8320122 ↗
• InjuryFeb 1, 2019Biocompatibility; Adverse Event Without Identified Device or Use Problem; Biocompatibility; Adverse Event Without Identified Device or Use Problem

  PPF ALLEGES ELEVATED METAL IONS, METAL WEAR AND METALLOSIS. DOI: (B)(6) 2009, DOR: FEB 16, 2017, (RIGHT HIP).

  Patient problems: Discomfort; Pain; Swelling; Test Result; Tissue Damage

  MAUDE report 8296149 ↗
• InjuryJan 4, 2019Biocompatibility; Biocompatibility

  LITIGATION ALLEGES THAT THE PATIENT SUFFERS FROM PAIN, DISCOMFORT, BURNING SENSATION, AND DIFFICULTY AMBULATING. UPDATE REC'D 5/21/2013 - PFS AND MEDICAL RECORDS RECEIVED. THIS COMPLAINT IS FOR THE RIGHT HIP. AFTER REVIEW OF THE MEDICAL RECORDS/REVISION OPERATIVE NOTE THERE WAS CORROSION ON THE TRUNNION NOTED. UPDATE AD 05 MAY 2018: RECEIPT OF PPF AND STICKER SHEETS RECEIVED. PPF ALLEGES ELEVATED METAL IONS.

  Patient problems: No Code Available; Test Result

  MAUDE report 8216926 ↗
• InjuryNov 29, 2018Break; Appropriate Device Problem Term/Code Not Available; Break; Appropriate Device Problem Term/Code Not Available

  THE PATIENT WAS REVISED TO ADDRESS BROKEN FEMUR.

  Patient problems: Bone Fracture(s)

  MAUDE report 8117242 ↗
• InjuryOct 30, 2018Device Dislodged or Dislocated; Appropriate Device Problem Term/Code Not Available; Device Dislodged or Dislocated; Appropriate Device Problem Term/Code Not Available

  PPF AND STICKERS SHEETS RECEIVED. PPF ALLEGES ABDUCTOR MUSCLE REPAIR, DISLOCATION, AND INFECTION.

  Patient problems: Tissue Damage; Unspecified Infection

  MAUDE report 8021097 ↗
• InjuryOct 4, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT BROKE HER HIP SOMEHOW WHILE RECOVERING AT HOME FROM HER TOTAL HIP SURGERY. WE REPLACED HER TRILOCK SYSTEM WITH AN AML.

  Patient problems: No Code Available

  MAUDE report 7933549 ↗
• InjurySep 25, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED DUE TO BONE FRACTURE. IT IS UNKNOWN WHEN THE FRACTURE OCCURRED, BUT IT WAS STATED BY THE SURGEON THAT THE FRACTURE OCCURRED AFTER THE PATIENT WAS DISCHARGED FROM THE HOSPITAL.

  Patient problems: Hip Fracture; No Code Available

  MAUDE report 7907596 ↗
• InjurySep 11, 2018Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  REASON FOR ORIGINAL COMPLAINT: BILATERAL PATIENT. LITIGATION ALLEGES THAT PATIENT EXPERIENCED DEBILITATING PAIN, DISCOMFORT, AND SORENESS IN THE AREA OF HIP IMPLANT, THEREBY, NEGATIVELY AFFECTING ABILITY TO PERFORM ACTIVITIES OF DAILY LIVING. ADDITIONALLY, IT IS ALLEGED THAT METAL IONS AND PARTICLES HAVE BEEN RELEASED INTO PATIENT'S BLOOD, TISSUE AND BONE SURROUNDING THE IMPLANT. UPDATE AD 27 APRIL 2018: (B)(4) HAS BEEN RE-OPENED UNDER (B)(4) DUE TO THE RECEIPT OF PPF AND STICKER SHEETS. THERE IS NO NEW ALLEGATION AND REVISION REPORTED. ADDED STEM DUE TO PREVIOUSLY ALLEGED METAL IONS AND PARTICLES HAVE BEEN RELEASED INTO PATIENT'S BLOOD. ADDED LAWYER AND LAW FIRM. UPDATED DOI. DOI: (B)(6) 2010 - DOR: NOT REPORTED (LEFT HIP).

  Patient problems: Discomfort; Pain; Test Result

  MAUDE report 7866636 ↗
• InjuryAug 30, 2018Naturally Worn; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Naturally Worn; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information

  LITIGATION ALLEGES THAT PATIENT EXPERIENCED SEVERE AND PERMANENT INJURIES, CONSCIOUS PAIN AND SUFFERING. DOI: (B)(6) 2008; DOR: NONE REPORTED; (UNKNOWN SIDE). PATIENT IS A RESIDENT OF (B)(6). UPDATE 05/21/2012 PLAINTIFF'S PRELIMINARY DISCLOSURE (PPD) FORM AND IMPLANT LOG RECEIVED WHICH IDENTIFIED PART/LOT INFORMATION AND THE PATIENT'S DATE OF BIRTH. PRODUCT UPDATED AND FEMORAL HEAD ADDED. MDR DECISION TREE COMPLETED AND APPROPRIATE MDRS SUBMITTED. PPD W/LOG ATTACHED TO THE FILE. THERE IS NO NEW INFORMATION THAT WOULD CHANGE THE OUTCOME OF THE INVESTIGATION. (B)(6). UPDATE AD 7 AGG 2018: (B)(4) HAS BEEN RE-OPENED UNDER (B)(4) DUE TO RECEIPT OF A DER. IT WAS REPORTED THAT THE LEFT HIP ASR CUP REVISED - PAINFUL LEFT HIP WITH ELEVATED CHROMIUM LEVELS. DOI: (B)(6) 2008; DOR: (B)(6) 2018; LEFT HIP.

  Patient problems: Adhesion(s); Discomfort; Edema; Foreign Body Reaction; Host-Tissue Reaction; Hypersensitivity/Allergic reaction; Injury; No Code Available; Not Applicable; Pain; Test Result

  MAUDE report 7832295 ↗
• InjuryJul 19, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

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

  Patient problems: Bone Fracture(s); Not Applicable

  MAUDE report 7702711 ↗