TRI-LOCK GRIPTION 1012-14-070Recalls & reported problems

Summary

The FDA's MAUDE database contains 35 adverse event reports that list this exact device (DI 10603295001096), received between Jul 13, 2015 and Nov 20, 2024 — classified as 33 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (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 16, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 35 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 20, 2024Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT DURING SURGERY ON AN UNKNOWN DATE, THE SURGICAL TEAM HAD TO OPEN NEW STEM IMPLANT. IT WAS MISMATCHED BETWEEN BROACH. OPENED UP NEW BROACHES AND ENCOUNTERED THE SAME ISSUE. ENDED UP OPENING UP A NEW STEM FOR THE PATIENT. SURGERY WAS NOT DELAYED, AND THERE WAS NO PATIENT CONSEQUENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20736830 ↗
• InjuryJan 31, 2024Osseointegration Problem; Osseointegration Problem

  ADDITIONAL INFORMATION RECEIVED: A. WAS THERE A SURGICAL DELAY? WHAT IS THE DURATION OF THE DELAY? NO. B. PLEASE PROVIDE THE LOOSENING INTERFACE. FRACTURE/STEM. C. WERE THERE ANY ADVERSE CONSEQUENCE/S THAT AFFECTED THE PATIENT BECAUSE OF THE REPORTED EVENT? NO.

  Patient problems: Inadequate Osseointegration; Limb Fracture

  MAUDE report 18613224 ↗
• InjuryDec 15, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  LEGAL CLAIM SAYS THE HIP HAS FAILED. UPDATE 6/5/15 MEDICAL RECORDS RECEIVED. A DOI AND DOR WERE PROVIDED. AFTER REVIEW OF THE MEDICAL RECORDS FOR MDR REPORTABILITY, THE PATIENT WAS REVISED ON (B)(6) 2014 FOR DISLOCATIONS, INSTABILITY, MALPOSITIONED CUP, METALLOSIS, AND INFECTION. ALL IMPLANTS WERE REMOVED AND SPACERS WERE PLACED. THE DATE OF REIMPLANTATION WERE PROVIDED. NO. PART/LOT PROVIDED. THE COMPLAINT WAS UPDATED ON: 6/25/2015. UPDATE 7/17/15 MEDICAL RECORDS RECEIVED. AFTER REVIEW OF THE MEDICAL RECORDS FOR MDR REPORTABILITY, THE PATIENT WAS RE-IMPLANTED AFTER THE INFECTION ON (B)(6) 2015. THERE IS NO NEW ADDITIONAL INFORMATION THAT WOULD AFFECT THE EXISTING MDR DECISION. THE COMPLAINT WAS UPDATED ON: 8/4/2015. UPDATE 8/24/15 MEDICAL RECORDS RECEIVED. AFTER REVIEW OF THE MEDICAL RECORDS FOR MDR REPORTABILITY, THE PART/LOT IS BEING UPDATED. THIS COMPLAINT WAS UPDATED ON 9/18/2015. UPDATE 12/15/15 & 1/5/16 MEDICAL RECORDS RECEIVED. THERE IS NO NEW ADDITIONAL INFORMATION THAT WOULD AFFECT THE EXISTING INVESTIGATION. THE COMPLAINT WAS UPDATED ON: JAN 7, 2016. UPDATED 12/02/2016 LITIGATION RECEIVED. THERE IS NO NEW INFORMATION THAT WOULD CHANGE THE EXISTING MDR DECISION. COMPLAINT

  Patient problems: Anxiety; Deformity/ Disfigurement; Depression; Distress; Fatigue; Joint Laxity; Pocket Erosion; Unspecified Infection; Unspecified Tissue Injury

  MAUDE report 18334201 ↗
• InjuryApr 3, 2023Degraded; Adverse Event Without Identified Device or Use Problem; Degraded; Adverse Event Without Identified Device or Use Problem

  UPDATED EVENT DESCRIPTION: DURING THE REVISION PROCEDURE, SIGNIFICANT CLOUDY JOINT EFFUSION CONSISTENT WITH REACTION TO A METAL-ON-METAL BEARING. SMALL AMOUNT OF CORROSION AT THE HEAD NECK JUNCTION ON THE STEM, WELL FIXED COMPONENTS, LARGE ANTERIOR OSTEOPHYTE. THE HIP WAS ASPIRATED OF CLOUDY JOINT FLUID CONSISTENT WITH A METAL-ON-METAL BEARING. THERE WAS SOME SYNOVITIS, CONSISTENT WITH A METAL-ON-METAL BEARING. DOI: (B)(6) 2009, DOR: (B)(6) 2023, AFFECTED SIDE: LEFT HIP.

  Patient problems: Distress; Foreign Body Reaction; Loss of Range of Motion; Metal Related Pathology; Pain; Scar Tissue; Swelling/ Edema; Synovitis; Unspecified Musculoskeletal problem

  MAUDE report 16663503 ↗
• InjuryJan 5, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO LEG LENGTH DISCREPANCY. THERE WAS NO SURGICAL DELAY. DOI: (B)(6) 2017. DOR:(B)(6) 2022. AFFECTED SIDE : LEFT HIP.

  Patient problems: Physical Asymmetry

  MAUDE report 16101628 ↗
• InjuryAug 16, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT IS S/P THA AND SUFFERED A FALL. SHE HAS A PERIPROSTHETIC FRACTURE. HER TRILOCK WAS REMOVED AND A SOLUTION 10IN WAS PLACED. NO BROKEN INSTRUMENTS, NO DELAYS. DOI: (B)(6) 2017; DOR: (B)(6) 2022; AFFECTED SIDE: RIGHT HIP.

  Patient problems: Fall; Limb Fracture

  MAUDE report 15232650 ↗
• MalfunctionAug 4, 2022Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping

  IT WAS REPORTED THAT INTRAOPERATIVELY DURING PRIMARY HIP-TEP UNKNOWN SIDE PLASTIC PARTICLES WERE FOUND TO BE ATTACHED TO THE IMPLANT. ANOTHER IMPLANT WAS AVAILABLE AND SURGERY WAS COMPLETED WITHOUT ISSUES. NO PATIENT HARM. SURGERY DELAY ABOUT 5 MINUTES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15163185 ↗
• InjuryApr 7, 2021Degraded; Degraded

  ASR MEDICAL RECORDS RECEIVED. AFTER REVIEW OF THE MEDICAL RECORDS THE PATIENT WAS REVISED DUE TO FAILED MOM THA WITH PSEUDOTUMOR AND ELEVATED METAL IONS. OPERATIVE NOTE CONFIRMED PSEUDOTUMOR AND CORROSION NOTED AT THE TRUNNION. DOI: (B)(6) 2009; DOR: (B)(6) 2020: LEFT HIP.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Hypersensitivity/Allergic reaction

  MAUDE report 11628828 ↗
• InjuryNov 9, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED DUE TO PAINFUL LEFT HIP. DOI: (B)(6) 2016, DOR: OCT 27, 2020, LEFT HIP.

  Patient problems: No Code Available; Pain

  MAUDE report 10810386 ↗
• InjuryJan 30, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PCF AND MEDICAL RECORDS RECEIVED. AFTER REVIEW OF MEDICAL RECORDS, PATIENT WAS REVISED TO ADDRESSED CHRONIC INFECTED LEFT TOTAL HIP ARTHROPLASTY, POST IRRIGATION AND DEBRIDEMENT, MULTIPLE MEDICAL COMORBIDITIES INCLUDING MARFAN SYNDROME AND PLOYSUBSTANCE ABUSE.. OPERATIVE NOTES INDICATED SIGNIFICANT REDNESS AND SWELLING OF THE LEFT HIP, IT WAS ACUTE INFECTION. IRRIGATION, DEBRIDEMENT AND PLOYETHYLENE EXCHANGE AND PLACEMENT OF ANTIBIOTIC BEADS WAS THEN PERFORMED. THERE WAS A SIGNIFICANT AMOUNT OF SEROUS APPEARING FLUID IN THE SUBCUTANEOUS TISSUES. THE UNDERLYING INTERARTICULAR PORTION OF THE JOINT SHOWED OBVIOUS DEEP INFECTION. ADDED CUP AND STEM TO CAPTURE THE NEW ALLEGATION. DOI: (B)(6) 2016 (LINER & HEAD); DOI: (B)(6) 2016 (CUP & STEM); DOR: (B)(6) 2016 LEFT HIP. PLEASE SEE (B)(4) LEFT HIP 1ST REVISION.

  Patient problems: Edema; No Code Available; Unspecified Infection

  MAUDE report 9647667 ↗
• InjuryJan 30, 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 LEFT TOTAL HIP ARTHROPLASTY. OPERATIVE NOTES INDICATED OF INCREASING PAIN AND SOME REDNESS ABOUT THE INCISION, HAD FALL AND NOTICING SOME DRAINAGE. UPON INCISION, THERE WAS OBVIOUS DEEP INFECTION INTO THE FEMORAL ACETABULAR COMPONENT. DOI: (B)(6) 2016; DOR: (B)(6) 2016; LEFT HIP.

  Patient problems: No Code Available; Pain; Unspecified Infection

  MAUDE report 9647636 ↗
• InjuryDec 12, 2019Corroded; Degraded; Corroded; Degraded

  PATIENT ALLEGES INJURY, ECONOMIC LOSS, PAIN AND MENTAL ANGUISH.

  Patient problems: Foreign Body Reaction; Hypersensitivity/Allergic reaction; No Code Available; Pain; Pocket Erosion; Test Result

  MAUDE report 9459730 ↗
• InjuryNov 19, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REVISION DUE TO INFECTION.

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 9343331 ↗
• InjuryOct 18, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED TO ADDRESS PERIPROSTHETIC FRACTURE OF THE PROXIMAL FEMUR 2 WEEKS AFTER INDEX ARTHROPLASTY. REMOVED TRILOCK STEM AND IMPLANTED RECLAIM. DOI: UNKNOWN; DOR: (B)(6) 2019; (LEFT HIP).

  Patient problems: No Code Available

  MAUDE report 9209529 ↗
• InjuryJun 12, 2019Corroded; Degraded; Corroded; Degraded

  ADDITIONAL INFORMATION RECEIVED: PATIENT REPORTS FATIGUE AND WALKING DIFFICULTY.

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

  MAUDE report 8692778 ↗
• InjuryMay 3, 2019Biocompatibility; Adverse Event Without Identified Device or Use Problem; Biocompatibility; Adverse Event Without Identified Device or Use Problem

  LITIGATION ALLEGES THAT THE PATIENT SUFFERS FROM PAIN, DISCOMFORT, INFLAMMATION, AND DIFFICULTY AMBULATING. UPDATE AD 14 AUG 2018: RECEIPT OF PPF AND MEDICAL RECORDS. IN ADDITION TO WHAT WERE PREVIOUSLY ALLEGED, PPF ALLEGES ELEVATED METAL IONS, METAL WEAR AND METALLOSIS. AFTER REVIEW OF MEDICAL RECORDS, THERE WAS NO REVISION NOTES PROVIDED. ADDED STEM DUE TO HIGH METAL IONS.

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

  MAUDE report 8577547 ↗
• InjuryApr 18, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE TRILOCK BPS AND PINNACLE METAL ON METAL SHELL AND LINER REMOVED FOR INFECTION. DOI: UNKNOWN. DOR: (B)(6) 2019; RIGHT HIP.

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 8529118 ↗
• InjuryApr 5, 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) 2010 - DOR: (B)(6) 2013 (RIGHT HIP).

  Patient problems: Discomfort; Inflammation; Limited Mobility Of The Implanted Joint; Pain; Test Result; Tissue Damage; Unspecified Infection

  MAUDE report 8486468 ↗
• InjuryMar 26, 2019Corroded; Adverse Event Without Identified Device or Use Problem; Corroded; Adverse Event Without Identified Device or Use Problem

  LITIGATION ALLEGES EXTREME PAIN, DISCOMFORT, WALKING DIFFICULTY AND MOBILITY LIMITATIONS. DOI: (B)(6) 2010; DOR: (B)(6) 2017; RIGHT HIP.

  Patient problems: Discomfort; Limited Mobility Of The Implanted Joint; No Code Available; Pain; Swelling; Test Result

  MAUDE report 8452812 ↗
• InjuryFeb 5, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PPF ALLEGES ABDUCTOR MUSCLE REPAIR AND ELEVATED METAL IONS AFTER FIRST REVISION.

  Patient problems: Test Result; Tissue Damage

  MAUDE report 8304619 ↗
• InjuryDec 11, 2018Biocompatibility; Biocompatibility

  PATIENT WAS REVISED TO ADDRESS PAIN. PPF ALLEGES ELEVATED METAL IONS, METAL WEAR AND METALLOSIS. DOI: (B)(6) 2010 - DOR: (B)(6) 2012; (RIGHT HIP).

  Patient problems: Pain; Test Result; Tissue Damage

  MAUDE report 8150037 ↗
• InjuryDec 6, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT REVISED FOR METAL SENSITIVITY AND OSTEOLYSIS. UPDATE IN ADDITION TO WHAT WERE PREVIOUSLY ALLEGED, PPF ALLEGES CONSTRAINED LINER, METAL WEAR, METALLOSIS AND ELEVATED METAL IONS. DOI: (B)(6) 2009 - DOR: (B)(6) 2011 (LEFT HIP).

  Patient problems: Hypersensitivity/Allergic reaction; No Code Available; Osteolysis; Test Result; Tissue Damage

  MAUDE report 8137320 ↗
• InjuryNov 30, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  LITIGATION ALLEGES ELEVATED METAL IONS. DOI: (B)(6) 2009 - DOR: NONE REPORTED (LEFT HIP).

  Patient problems: Discomfort; Pain; Test Result

  MAUDE report 8119381 ↗
• InjuryJul 23, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  LITIGATION ALLEGES THAT PATIENT EXPERIENCED SERIOUS PHYSICAL INJURY, HARM AND DAMAGES. DOI: (B)(6) 2008 - DOR: (B)(6) 2012; (RIGHT HIP). DOI: (B)(6) 2009 - DOR: (B)(6) 2012; (LEFT HIP). THE SALES REP HAS REPORTED THE REVISION SURGERY FOR THE RIGHT SIDE. PATIENT WAS REVISED TO ADDRESS INCREASING COBALT AND CHROMIUM LEVELS. PPF AND STICKER SHEETS WERE RECEIVED. PPF ALLEGES PSEUDOTUMOR. THE LAWYER AND LAW FIRM NAME ARE UPDATED. ADDED STEM FOR THE PREVIOUSLY ALLEGES INCREASING COBALT AND CHROMIUM LEVELS. DOI: (B)(6) 2009 - DOR: (B)(6) 2012; (LEFT HIP).

  Patient problems: Not Applicable; Test Result; Tissue Damage

  MAUDE report 7710052 ↗
• InjuryJul 3, 2018Material Discolored; Insufficient Device Problem Information; Material Discolored; Insufficient Device Problem Information

  PINNACLE LITIGATION RECEIVED. LITIGATION ALLEGES SEVERE PAIN, WHICH AFFECTS HIS ABILITY TO WALK AND SIT. RADIOGRAPH SHOWED OSTEOLYSIS AND SHOWED A LARGE FLUID COLLECTION WITH DEBRIS CONSISTENT WITH A GRANULOMATOUS PSEUDOTUMOR SECONDARY TO METAL REACTION. IT WAS ALSO REPORTED THAT THERE WAS MILD AMOUNT OF FLUID AND SOME BROWNISH STAINING OF THE SYNOVIAL TISSUES THROUGHOUT, BUT NO SIGNIFICANT PSEUDOTUMOR. DOI: (B)(6) 2008: DOR: (B)(6) 2016; (RIGHT HIP). THIS COMPLAINT IS LINKED TO (B)(4); (LEFT HIP). UPDATE 4 JUN 2018 PINNACLE PPF RECEIVED. IN ADDITION TO WHAT WERE PREVIOUS ALLEGED, PPF ALLEGES ELEVATED METAL IONS. HOWEVER, IT WAS PREVIOUSLY CONFIRMED THAT THE BLOOD LEVELS FOR METAL IONS WERE BELOW 7(NO UNIT PROVIDED). SHALL THERE BE NEW INFORMATION

  Patient problems: Foreign Body Reaction; Limited Mobility Of The Implanted Joint; Loss of Range of Motion; Osteolysis; Pain; Test Result; Tissue Damage

  MAUDE report 7660155 ↗