TRI-LOCK GRIPTION 1012-14-090Recalls & reported problems

Summary

The FDA's MAUDE database contains 16 adverse event reports that list this exact device (DI 10603295001119), received between Sep 8, 2017 and Nov 25, 2024 — classified as 15 injuries, 1 malfunction.

The most frequently reported specific device problem is “Loss of Osseointegration” (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 16 most recent of 16 reports, in the reporter's own words as published by the FDA.

• InjuryNov 25, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE SURGEON STATED THE PATIENT FELL FROM 3 FEET ONTO HIS HIP AND BROKE THE PROXIMAL FEMUR. SURGEON ELECTED TO REPLACE THE STEM AND HEAD. DOI: (B)(6) 2014 DOR: (B)(6) 2024. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Fall; Limb Fracture

  MAUDE report 20771508 ↗
• InjuryOct 28, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED, DUE TO ACUTE INFECTION. ALL IMPLANTS WERE REMOVED. DOI: UNKNOWN, DOR: (B)(6) 2024, AFFECTED SIDE: LEFT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 20544455 ↗
• InjuryOct 10, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION RECEIVED: A. WAS THERE A SURGICAL DELAY? IF YES, WHAT IS THE DURATION OF THE DELAY? - NO SURGICAL DELAY, B. WHAT IS THE AFFECTED SIDE INVOLVED IN THIS EVENT? - AFFECTED SIDE WAS LEFT.

  Patient problems: Unspecified Infection

  MAUDE report 20422548 ↗
• InjuryJun 14, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT FELL AND FRACTURED FEMUR, TRILOCK STEM AND HEAD WERE REMOVED, THIS IS NOT A DEFECT IN ANY OF OUR PRODUCTS. THIS WAS DUE TO A DEMENTED PATIENT FALLING. THE ACETABULAR LINER WAS REMOVED AND REVISED TO PINNACLE DUAL MOBILITY. THE STEM WAS REPLACED WITH A ZIMMER ARCOS. NO FURTHER INFORMATION ABOUT THIS CASE. DOI: (B)(6) 2022, DOR: (B)(6) 2022, AFFECTED SIDE: LEFT HIP.

  Patient problems: Fall; Limb Fracture

  MAUDE report 14685327 ↗
• InjuryNov 30, 2020Migration; Migration

  IT WAS REPORTED THAT STEM SUBSIDIZED AND NEEDED REVISION. DOI: UNKNOWN. DOR: (B)(6) 2020; AFFECTED SIDE: LEFT HIP.

  Patient problems: Insufficient Information

  MAUDE report 10920496 ↗
• MalfunctionJul 30, 2020Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging

  IT WAS REPORTED THAT DURING RIGHT HIP ARTHROPLASTY A SIZE 9 HI TRILOCK (1012-14-090 LOT: HY3105) WAS REQUESTED BY THE SURGEON AND UPON OPENING THE UNPERFORATED BOX THE NURSE AND I NOTICED A NEARLY 20CM HOLE IN THE PLASTIC PACKAGING. ANOTHER IMPLANT WAS OPENED ADDING ONLY ABOUT 1-2 MINUTES TO THE CASE. NO PATIENT INFORMATION OR RADIOGRAPHS ARE AVAILABLE AND WILL BE RETURNING THE IMPLANT AND BOX. SURGICAL DELAY: 1 TO 2 MIN.

  Patient problems: No Code Available

  MAUDE report 10344105 ↗
• InjuryJun 18, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PER SURGEON, PATIENT HAS PERIPROSTHETIC FRACTURE. SURGEON LEFT CUP 121732058 L- 8929161, 121725500 L- D18090815, D18081869. SURGEON PUT NEW LINER IN AND REVISION FEMORAL STEM. DOI: (B)(6) 2019. DPR: (B)(6) 2020. AFFECTED SIDE: LEFT HIP.

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

  MAUDE report 10167238 ↗
• InjuryApr 27, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ASR XL LITIGATION RECORDS RECEIVED. LITIGATION ALLEGES INJURY, METALLOSIS AND IMPLANT FAILURE. AFTER REVIEW OF MEDICAL RECORDS, THE PATIENT WAS REVISED DUE TO METAL HYPERSENSITIVITY AND OSTEOLYSIS. OPERATIVE NOTES REPORTED THAT THERE WAS EVIDENCE OF A PSEUDOCAPSULE OR CYSTIC MASS EXTENDING INTO THE PERITROCHANTERIC SPACE INTO THE JOINT. THERE WAS EVIDENCE OF METALLOSIS AT THE TRUNNION, AFTER INSPECTION THERE WERE NO VISIBLE DAMAGE TO THE FEMORAL TRUNNION. ASSESSMENT OF THE ACETABULAR BONE DEMONSTRATED A LARGE CYSTIC LESION. THERE WAS ALSO A SECONDARY CONTAINING OSTEOLYTIC LESION IN THE POSTERIOR COLUMN EXTENDING INTO THE ISCHIUM. DOI: (B)(6) 2009 : DOR: (B)(6) 2017 (LEFT HIP).

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

  MAUDE report 10002510 ↗
• InjuryMar 11, 2020Degraded; Degraded

  PCF AND MEDICAL RECORDS RECEIVED. AFTER REVIEW OF MEDICAL RECORDS, PATIENT UNDERGONE PHYSICAL EXAMINATION LAST (B)(6) 2017. RECENT LABS REVEAL COBALT INCREASED FROM 20.2 TO 25. CHROMIUM IS STABLE AT 11. IT WAS 10 BEFORE. THE PATIENT HAS SIGNIFICANT FUNCTIONAL DEFICITS, RECENT VISUAL PROBLEM, TROCHANTER TENDERNESS, PAIN IN ROTATION OF THE LEG, LEG LENGTH DISCREPANCY, AND SEVERE RIGHT HIP STIFFNESS. THE PATIENT AMBULATES WITH AN ANTALGIC TRENDELENBURG GAIT AND MOVES ABOUT AT A MODERATE PACE. MEDICAL RECORDS ALSO STATED AN OSTEOLYSIS IN THE RIGHT ACETABULUM WITH METAL ON METAL IMPLANT. PATIENT WAS REVISED TO ADDRESS RIGHT FAILED TOTAL HIP ARTHROPLASTY, METAL ON METAL REACTION, OSTEOLYSIS, GRANULOMA, ELEVATED ION COUNTS, AND MILD TAPER CORROSION. OPERATIVE NOTES STATED NO EVIDENCE OF INFECTION. SURGEON PERFORMED EXTENSIVE DEBRIDEMENT ON GRANULOMA TISSUE. DOI: (B)(6) 2009. DOR: (B)(6) 2017; RIGHT HIP.

  Patient problems: Discomfort; Foreign Body Reaction; Granuloma; Limited Mobility Of The Implanted Joint; No Code Available; Osteolysis; Pain; Visual Impairment

  MAUDE report 9818750 ↗
• InjurySep 22, 2019Corroded; Degraded; Loose or Intermittent Connection; Loss of Osseointegration; Osseointegration Problem; Loosening of Implant Not Related to Bone-Ingrowth; Corroded; Degraded; Loose or Intermittent Connection; Loss of Osseointegration; Osseointegration Problem; Loosening of Implant Not Related to Bone-Ingrowth

  PPF ALLEGES LOOSENING OF STEM. CORRECTED.

  Patient problems: Discomfort; Inadequate Osseointegration; Limited Mobility Of The Implanted Joint; No Code Available; Pain

  MAUDE report 9102251 ↗
• InjuryJun 14, 2019Corroded; Corroded

  PINNACLE LITIGATION RECORDS RECEIVED. LITIGATION ALLEGES DIFFICULTY WALKING, PAIN, DISCOMFORT, COMPLETE LOSS OF MOBILITY, INJURY, LOSS OF RANGE OF MOTION AND MENTAL ANGUISH. DOI: (B)(6) 2009; DOR: (B)(6) 2017; RIGHT HIP.

  Patient problems: Discomfort; Foreign Body Reaction; Injury; Limited Mobility Of The Implanted Joint; Loss of Range of Motion; No Code Available; Pain; Weakness

  MAUDE report 8700742 ↗
• InjuryJan 25, 2019Loss of Osseointegration; Loss of Osseointegration

  IT WAS REPORTED THAT THE PATIENT SUSTAINED A PERIPROSTHETIC FEMUR FRACTURE. IT WAS ALSO INDICATED THAT THERE WAS LOOSENING OF THE STEM AT BONE TO IMPLANT INTERFACE. THE PATIENT WAS BROUGHT TO THE OPERATING ROOM FOR FRACTURE REDUCTION AND FEMORAL. STEM AND HEAD EXCHANGE.

  Patient problems: Inadequate Osseointegration; No Code Available

  MAUDE report 8277262 ↗
• InjuryDec 13, 2018Loss of Osseointegration; Loss of Osseointegration

  LITIGATION ALLEGES PATIENT HAS SUFFERED EXTREME PAIN IN HIP, CAUSING DIFFICULTY AMBULATING AND SLEEPING. AFTER RECEIVING THE PINNACLE, PATIENT LEARNED THAT THE DEVICE WAS FAILING AND RELEASING METAL IONS INTO THE BODY. PPF ALLEGES LOOSENING OF THE STEM. DOI: (B)(6) 2009; DOR: (B)(6) 2013 (LEFT HIP).

  Patient problems: Inadequate Osseointegration; No Code Available; Pain

  MAUDE report 8161261 ↗
• InjuryApr 17, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DER STATES THAT THE PATIENT FELL AND RESULTED TO A PERI-PROSTHETIC FRACTURE. THE SURGEON REVISED IT TO A LONGER STEM AND PLACED CABLES. DOI: (B)(6) 2018; DOR: (B)(6) 2018; RIGHT HIP.

  Patient problems: Bone Fracture(s); Not Applicable

  MAUDE report 7435971 ↗
• InjuryDec 12, 2017Loss of Osseointegration; Loss of Osseointegration

  REVISION DUE TO MECHANICAL LOOSENING OF THE DEPUY STEM. BONE TO IMPLANT LOOSENING INTERFACE. MEDICAL RECORDS HAVE BEEN REVIEWED. PRIMARY PROCEDURE NOTES (B)(6) 2013 INDICATE THE PATIENT RECEIVED A RIGHT HIP CONVERSION TO TOTAL HIP ARTHROPLASTY, ANTERIOR APPROACH, DUE TO RIGHT HIP AVASCULAR NECROSIS. PROCEDURE WAS COMPLETED WITHOUT COMPLICATION INDICATED BY THE SURGEON. REVISION NOTES (B)(6) 2014 INDICATE THE PATIENT RECEIVED A REVISION TOTAL HIP ARTHROPLASTY DUE TO MECHANICAL LOOSENING, RIGHT TOTAL HIP. THE SURGEON INDICATED THAT THE STEM WAS VISUALIZED AND THERE WERE NO CLEAR SIGNS OF LOOSENING, FIBROUS TISSUE WAS REMOVED AND AN EXTRACTOR WAS USED TO DISLODGE THE STEM. POST-OP DIAGNOSIS DOES INDICATE MECHANICAL LOOSENING. PROCEDURE WAS COMPLETED WITHOUT COMPLICATION INDICATED BY THE SURGEON.

  Patient problems: Inadequate Osseointegration; Pain

  MAUDE report 7108332 ↗
• InjurySep 8, 2017Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  AUG 11, 2017: MEDICAL RECORDS RECEIVED. AFTER REVIEW OF THE MEDICAL RECORDS FOR THE MDR REPORTABILITY, PATIENT WAS REVISED DUE TO PAIN. REVISION NOTES REPORTED MILD TRUNNION CORROSION, NO METALLOSIS. THIS COMPLAINT WAS UPDATED ON: AUG 18, 2017

  Patient problems: Pain

  MAUDE report 6853217 ↗