TRI-LOCK GRIPTION 1012-04-020Recalls & reported problems

Summary

The FDA's MAUDE database contains 23 adverse event reports that list this exact device (DI 10603295000730), received between Oct 11, 2017 and Aug 1, 2025 — classified as 17 injuries, 6 malfunctions.

The most frequently reported specific device problem is “Corroded” (4 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 23 most recent of 23 reports, in the reporter's own words as published by the FDA.

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

  IT WAS REPORTED THAT THERE WAS PERI PROSTHETIC FRACTURE. THE STEM, AND HEAD WERE REMOVED AND LINER WAS EXCHANGED. THE DATE OF ORIGINAL SURGERY WAS UNKNOWN. DOI: UNKNOWN, DOR: (B)(6) 2025, AFFECTED SIDE: RIGHT HIP.

  Patient problems: Limb Fracture

  MAUDE report 22688649 ↗
• InjuryJan 10, 2025Degraded; Degraded

  LITIGATION RECORDS RECEIVED. PATIENT ALLEGES MALFUNCTIONING, FAILURE, MECHANICAL LOOSENING OF THE INTERNAL PROSTHETIC JOINT, SQUEAKING SOUNDS, HIP PAIN , CLICKING, IMBALANCE, DIFFICULTY WALKING. IT BAND CORROSION AND FOUND A POLYETHYLENE FAILURE DUE TO A FRACTURE OF THE LOCKING MECHANISM. ECCENTRIC SUPERIOR POSITION OF THE FEMORAL HEAD RELATIVE TO THE ACETABULUM IS CONSISTENT WITH POLYETHYLENE WEAR. CALCIFIED UTERINE FIBROID. CONSISTENT WITH POSTERIOR IMPINGEMENT TRUNNION INTACT WITH A FEW MINOR SCRATCHES. WAS FOUND TO HAVE A DISSOCIATED ACETABULAR LINER. FEMORAL COMPONENT SHOWED SIGNIFICANT STRIPE WEAR. BLACK FILM TO THE ANTERIOR ASPECT, POSTERIOR CAPSULE AND SOME OF THE ABDUCTOR MUSCULATURE. DOI: (B)(6) 2021, DOR: (B)(6) 2023, RIGHT HIP. ON (B)(6) 2021 THE PATIENT HAD A RIGHT TOTAL HIP ARTHROPLASTY TO ADDRESS OSTEOARTHRITIS. DEPUY PRODUCTS WERE IMPLANTED DURING THIS SURGERY. ON (B)(6) 2023 RADIOGRAPHS NOTE THE PATIENT WAS STATUS POST RIGHT TOTAL HIP ARTHROPLASTY WITH THE INDICATIONS FOR RIGHT HIP JOINT PAIN. ECCENTRIC SUPERIOR POSITION OF THE FEMORAL HEAD RELATIVE TO THE ACETABULUM IS CONSISTENT WITH POLYETHYLENE WEAR. ON (B)(6) 2023, MEDICAL RECORDS NOTE THE PATIENT HAS CATASTRO

  Patient problems: Ambulation or Postural Difficulties; Foreign Body Reaction; Joint Laxity; Limb Fracture; Loss of Range of Motion; Pain; Swelling/ Edema

  MAUDE report 21124862 ↗
• MalfunctionAug 25, 2022Device-Device Incompatibility; Device-Device Incompatibility

  SIZE 2 STEM WAS LARGER THAN SIZE 2 BROACH, SO THE STEM SAT UP. ANOTHER WAS NEEDED. NO SURGICAL DELAY. NO ADVERSE AFFECTS ON THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15292675 ↗
• MalfunctionNov 15, 2021Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT THE SURGEON WAS USING TRILOCK RASPS, STARTED WITH STARTER BROACH, UP TO SIZE 2. HE TRIED TO PUT THE SIZE 2 IMPLANT AND THE STEM STAYED VERY PROUD THAN THE BROACH. HE FINALLY PUT A SIZE 1 IMPLANT. THERE WAS A FIVE MINUTE SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12813827 ↗
• MalfunctionNov 9, 2021Device-Device Incompatibility; Device-Device Incompatibility

  DR IMPLANTED THE 2 STANDARD TRILOCK BPS. HE FELT IT WAS TOO PROUD. VOICED IMPLANT MAY BE TOO BIG. WANTED A NEW STEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12779096 ↗
• InjuryOct 6, 2021Osseointegration Problem; Migration; Osseointegration Problem; Migration

  THE PATIENT WAS REVISED TO ADDRESS SUBSIDENCE AND LOOSENING OF THE FEMORAL STEM AT THE BONE TO IMPLANT INTERFACE. LEFT FEMUR. DOI: (B)(6) 2019, DOR: (B)(6) 2021, AFFECTED SIDE: LEFT HIP.

  Patient problems: Inadequate Osseointegration

  MAUDE report 12584580 ↗
• InjuryJun 22, 2021Osseointegration Problem; Osseointegration Problem

  STEM WAS LOOSE. REVISION SURGERY REQUIRED.

  Patient problems: Inadequate Osseointegration

  MAUDE report 12041832 ↗
• InjuryJun 15, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED TO ADDRESS INFECTED HIP; REMOVED ALL COMPONENTS, PERFORMED I&D AND RE-IMPLANTED TOTAL HIP. DOI: (B)(6) 2020; DOR: (B)(6) 2020; LEFT SIDE.

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 10154980 ↗
• InjuryMar 27, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AFTER A REVIEW OF THE MEDICAL RECORD, THE PATIENT PREOPERATIVE VISIT ON OCT 15, 2019, HAS REPORTED OF BILATERAL PAIN. LABORATORY TEST RESULT SHOWS ELEVATED COBALT LEVEL. NO REVISION OPERATIVE NOTE REPORTED FOR THE LEFT HIP. DOI: (B)(6) 2011, DOR: NONE REPORTED, (LEFT HIP). PLEASE SEE (B)(4) FOR THE RIGHT HIP REVISION.

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

  MAUDE report 9890698 ↗
• InjuryMar 27, 2020Corroded; Degraded; Corroded; Degraded

  AFTER REVIEW OF THE MEDICAL RECORD, THE PATIENT WAS REVISED TO ADDRESS METALLOSIS STATUS POST RIGHT TOTAL HIP ARTHROPLASTY. REVISION POST OPERATIVE NOTE REPORTED OF BROWNISH CLEAR CAPSULAR FLUID AND THERE WAS SOME STAINING OF THE TRUNNION. LABORATORY TEST RESULT SHOWS ELEVATED COBALT LEVEL. DOI: (B)(6) 2010, DOR: (B)(6) 2019, RIGHT HIP.

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

  MAUDE report 9890578 ↗
• InjuryFeb 13, 2020Loss of Osseointegration; Loss of Osseointegration

  IT WAS REPORTED THAT THE PATIENT FELL, WHICH ATTRIBUTED TO THE LOOSENING CONSTRUCT. THE FEMORAL STEM HAS BEEN REPORTED AT THIS TIME FOR THE LOOSENING. DOI: UNKNOWN. DOR: (B)(6) 2020; AFFECTED SIDE: UNKNOWN.

  Patient problems: Inadequate Osseointegration; No Code Available

  MAUDE report 9706101 ↗
• InjuryAug 7, 2019Corroded; Corroded

  CLINICAL NOTIFICATION RECEIVED FOR RIGHT HIP REVISION TO ADDRESS ADVERSE LOCAL TISSUE REACTION . DOI: (B)(6) 2009; DOR: (B)(6) 2019, (RIGHT HIP).

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

  MAUDE report 8869692 ↗
• InjuryJul 23, 2019Corroded; Degraded; Corroded; Degraded

  PINNACLE CLAIM LETTER RECEIVED. CLAIM LETTER ALLEGES INJURY AND ADVERSE METAL DEBRIS. DOI: (B)(6) 2009 - DOR: SCHEDULED ON (B)(6) 2019, (RIGHT HIP).

  Patient problems: Cyst(s); Edema; Foreign Body Reaction; Injury; Necrosis; No Code Available; Osteolysis; Pain; Test Result

  MAUDE report 8815653 ↗
• InjuryJun 28, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT HAD IMPLANTS EXTRACTED DUE TO INFECTION. ORIGINAL IMPLANT DATE UNKNOWN. DOI: UNKNOWN, DOR: (B)(6) 2019, LEFT HIP.

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 8746052 ↗
• InjuryMar 20, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PINNACLE PPF AND MEDICAL RECORDS RECEIVED. PPF ALLEGES PSEUDOTUMOR, METAL WEAR AND METALLOSIS AND ELEVATED METAL IONS. AFTER REVIEW OF MEDICAL RECORDS, PATIENT WAS REVISED TO ADDRESS LEFT TOTAL HIP ARTHROPLASTY, METAL ON METAL ADVERSE REACTION OR PSEUDOTUMOR. CLINICAL NOTES STATED THAT PATIENT EXPERIENCED DISLOCATIONS AND PERSISTENT INSTABILITY. DOI: (B)(6) 2009, DOR: (B)(6) 2014, (LEFT HIP). BILATERAL PATIENT SEE (B)(4) FOR RIGHT HIP.

  Patient problems: Test Result; Tissue Damage

  MAUDE report 8436963 ↗
• MalfunctionNov 5, 2018Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  DR (B)(6) BROACHES TO A 2 AND INSERTED A SIZE 2 IMPLANT. FELT THE IMPLANT WAS TOO PROUD. HE THEN BROACHED TO A 3 AND FELT THE IMPLANT WAS STILL PROUD. HE THEN ASKED FOR A NEW SIZE 2. PATIENT CONSEQUENCE? :NO. IS THE INFORMATION BEING SUBMITTED FOR THIS COMPLAINT ALL THE DETAILS THAT ARE KNOWN/AVAILABLE REGARDING THIS EVENT? : YES.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8039273 ↗
• InjuryAug 31, 2018Corroded; Degraded; Appropriate Device Problem Term/Code Not Available; Corroded; Degraded; Appropriate Device Problem Term/Code Not Available

  THE PATIENT WAS REVISED DUE TO INCREASED METAL ION LEVELS. DEPUY TRILOCK WITH TRI SPIKE ASR SHELL REVISION. DOI: UNKNOWN; DOR: (B)(6) 2018; RIGHT HIP.

  Patient problems: Edema; Host-Tissue Reaction; Inflammation; Injury; Limited Mobility Of The Implanted Joint; Memory Loss/Impairment; Pain; Swelling; Test Result; Unspecified Infection

  MAUDE report 7837327 ↗
• InjuryAug 6, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  THE PATIENT WAS REVISE DUE TO FEMUR FRACTURE. DOI: UNKNOWN; DOR: (B)(6) 2018. LEFT HIP.

  Patient problems: Not Applicable

  MAUDE report 7752324 ↗
• InjuryJun 26, 2018Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  LITIGATION PAPERS ALLEGE PATIENT SUFFERED INJUR(IES) INCLUDING BUT NOT LIMITED TO GRINDING, METAL FLAKES IN AND AROUND THE SOCKET, FLUID, PAIN, SWELLING, LIMITED RANGE OF MOTION. IT IS FURTHER ALLEGED PATIENT COULD NOT HAVE KNOWN THAT HE/SHE WAS INJURED BY EXCESSIVE LEVELS OF CHROMIUM AND COBALT UNTIL AFTER THE DATE HE/SHE HAD HIS/HER BLOOD DRAWN AND HE/SHE WAS ADVISED OF THE RESULTS OF SAID BLOOD-WORK. PATIENT HAS NOT YET SCHEDULED AN EXPLANTATION OF THE ASR HIP IMPLANT. DOI: (B)(6) 2009; - DOR: NONE REPORTED; (LEFT SIDE). PATIENT IS A RESIDENT OF (B)(6). (B)(4) EVENT DESCRIPTION ((B)(6) 2017): THE PATIENT WAS REVISED TO ADDRESS MALPOSITIONED ACETABULUM AND CUP WAS GROOSELY LOOSE IN BONE TO IMPLANT INTERFACE. IT WAS STATED THAT THE PATIENT WAS BROUGHT TO OR TO HAVE AN I&D AND REVISE HER LEFT HIP IN SINGLE STAGE. THIS PATIENT HAD A LEFT PRIMARY #2 STD TRILOCK STEM WITH A 46MM/300 ASR ACETABULUM CUP, A 41MM ASR HEAD AND ADAPTOR IMPLANTED ELSEWHERE ON AN UNKNOWN DATE. DOI: UNKNOWN; DOR: (B)(6) 2017, LEFT HIP. UPDATE AD (B)(6) 2018: (B)(4) HAS BEEN RE-OPENED UNDER (B)(4) DUE TO RECEIPT OF MEDICAL RECORDS. AFTER REVIEW OF MEDICAL RECORDS FOR MDR REPORTABILITY IT WAS REPORTED THAT THE P

  Patient problems: Injury; Loss of Range of Motion; No Code Available; Pain; Swelling; Test Result; Tissue Damage

  MAUDE report 7637441 ↗
• MalfunctionJun 14, 2018Defective Device; Defective Device

  THE SURGEON WAS UPSET BECAUSE THERE WAS A SIGNIFICANT MISMATCH BETWEEN THE BROACH AND THE IMPLANT. PATIENT CONSEQUENCE? :YES PATIENT CONSEQUENCE DESCRIPTION:THE CASE TOOK LONGER BECAUSE ADDITIONAL PREP AND ANOTHER PROSTHESIS WAS USED. ACTION TAKEN FOR PROCEDURE: EXTRA BROACHING AND PREP OF THE FEMUR WITH NEW IMPLANT INSERTED. IS THE INFORMATION BEING SUBMITTED FOR THIS COMPLAINT ALL THE DETAILS THAT ARE KNOWN/AVAILABLE REGARDING THIS EVENT? : YES. DOE: (B)(6) 2018; UNKNOWN HIP.

  Patient problems: No Consequences Or Impact To Patient; Not Applicable

  MAUDE report 7600696 ↗
• InjuryDec 12, 2017Insufficient Device Problem Information; Insufficient Device Problem Information

  DER STATES THAT THE PATIENT EXPERIENCED PAIN THREE WEEKS LATER AND CAME INTO THE SURGEON¿S OFFICE IN A WHEEL CHAIR. X-RAYS SHOWED A PERI-PROSTHETIC FRACTURE AND SURGEON BELIEVES THAT THE PATIENT FELL. DOI: (B)(6) 2017; DOR: (B)(6) 2017; RIGHT HIP.

  Patient problems: Bone Fracture(s); Pain

  MAUDE report 7107964 ↗
• MalfunctionNov 14, 2017Defective Device; Defective Device

  COMPLAINT DESCRIPTION: IT WAS REPORTED THAT THE SURGEON FELT THAT THE IMPLANT SIT TOO HIGH AND THE IMPLANT WAS TOO BIG. IT WAS ALSO STATED THAT THEY REMOVED AND REBROACHED AND PLACED A NEW SIZE 2 TRILOC BPS.

  Patient problems: No Consequences Or Impact To Patient; No Information

  MAUDE report 7029187 ↗
• InjuryOct 11, 2017Defective Device; Defective Device

  DER STATES THAT THE SIZE 2 STEM WAS MUCH THICKER THAN THE PROFILE OF THE BROACH. THE SURGEON REQUESTED ANOTHER STEM BECAUSE HE COULD TELL JUST BY LOOKING AT IT THAT IT WAS TOO LARGE. IT SAT OVER A CM PROUD OF THE BROACH.

  Patient problems: No Consequences Or Impact To Patient; No Information

  MAUDE report 6942080 ↗