TRI-LOCK GRIPTION 1012-04-005Recalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 10603295000716), received between Oct 27, 2017 and Jun 4, 2024 — classified as 11 injuries, 1 malfunction.

The most frequently reported specific device problem is “Biocompatibility” (1 report).

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 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• InjuryJun 4, 2024Degraded; Degraded

  PATIENT HAD AN ASR HIP IMPLANT ON HER LEFT HIP AND WAS REVISED DUE TO LOSS OF MOVEMENT, SUBSEQUENT SURGERIES, TISSUE DAMAGE, TISSUE DESTRUCTION, METALLOSSIS, CORROSION, PAIN AND SUFFERING, EXCESSIVE LEVELS OF CHROMIUM AND COBALT. DOI: (B)(6) 2009. DOR: (B)(6) 2023. LEFT HIP.

  Patient problems: Foreign Body Reaction; Hypersensitivity/Allergic reaction; Loss of Range of Motion; Metal Related Pathology; Pain; Unspecified Tissue Injury

  MAUDE report 19458186 ↗
• InjuryJan 5, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO INFECTION. THERE WAS NO SURGICAL DELAY. DOI: UNKNOWN. DOR: (B)(6) 2022. AFFECTED SIDE: UNKNOWN HIP.

  Patient problems: Unspecified Infection

  MAUDE report 16103377 ↗
• InjuryJun 9, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED TO ADDRESS UNSTABLE HIP. SURGEON CHANGED STEM AND CUP. NO SURGICAL DELAY REPORTED. DOI: (B)(6) 2021; DOR: (B)(6) 2021; LEFT HIP.

  Patient problems: Joint Laxity

  MAUDE report 11967529 ↗
• InjuryJan 8, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED FOR A FEMORAL FRACTURE. IT WAS THOUGHT THE PATIENT PROBABLY HAD A FRACTURE UNKNOWN AT THE TIME OF THE ORIGINAL SURGERY ON (B)(6) 2019. PATIENT WAS REVISED TO AN AML STEM. FEMALE AND IT WAS THE RIGHT SIDE. WAS SURGERY DELAYED DUE TO THE REPORTED EVENT? --> NO, WAS PROCEDURE SUCCESSFULLY COMPLETED? --> YES, WERE FRAGMENTS GENERATED? --> NO, IF YES, WERE THEY REMOVED EASILY WITHOUT ADDITIONAL INTERVENTION? --> UNKNOWN, PATIENT STATUS/ OUTCOME / CONSEQUENCES --> YES, PATIENT CONSEQUENCE DESCRIPTION/WAS THERE A CLINICAL OUTCOME EXPERIENCED BY THE PATIENT (INFECTION, INFLAMMATION, ETC.)?--> PROX FEMUR FX PROBABLY FROM THE ORIGINAL SURGERY A COUPLE WEEKS AGO. MOST LIKELY AN UNSEEN INTRAOP FRACTURE AT THE TIME OF PRIMARY IMPLANTATION., WAS OTHER MEDICAL INTERVENTION (E.G. X-RAYS, ADDITIONAL PROCEDURES, PRESCRIPTIONS, OTC, REVISION) REQUIRED: --> UNKNOWN, IS THE PATIENT PART OF A CLINICAL STUDY --> UNKNOWN, (B)(6). DEVICE PROPERTY OF -->HOSPITAL, DEVICE IN POSSESSION OF -->NONE, (B)(6). DEVICE PROPERTY OF -->HOSPITAL, DEVICE IN POSSESSION OF -->NONE. BY CHECKING THIS BOX I CERTIFY THAT ALL INFORMATION THAT ARE KNOWN/AVAILABLE HAS BEEN DISCLOSED. IF ANY NEW INFORMATION WI

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

  MAUDE report 9565346 ↗
• InjuryJul 3, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PRIMARY SURGERY WAS PERFORMED ON (B)(6) 2019 VIA BHA BY USING TRI-LOCK. IT WAS REPORTED THAT THE REMOVAL SURGERY WAS PERFORMED ON (B)(6) 2019 BY EXPLANTING THE BIPOLAR CUP (P/N: 856742), THE STEM (P/N: 101204005), THE HEAD (P/N: 136513000) DUE TO POSTOPERATIVE INFECTION. THE SURGERY WAS COMPLETED WITHOUT A SURGICAL DELAY. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 8759883 ↗
• InjuryJun 28, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  LITIGATION ALLEGES THAT THE HIP BECAME DETACHED, DISCONNECTED, CREATED METALLIC DEBRIS, AND/OR LOOSENED FROM THE PATIENT¿S ACETABULUM, CAUSED PAIN AND INHIBITED THE PATIENT¿S ABILITY TO WALK. DOI: (B)(6) 2009, DOR: (B)(6) 2013, (RIGHT HIP).

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

  MAUDE report 8745104 ↗
• InjuryApr 18, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  LITIGATION ALLEGES THE PATIENT SUFFERS FROM PAIN. UPDATE 9/30/15-PFS AND MEDICAL RECORDS RECEIVED. AFTER REVIEW OF THE MEDICAL RECORDS FOR MDR REPORTABILITY, THE PATIENT WAS REVISED ON (B)(6) 2012 FOR DISLOCATIONS. UPDATE AD 28 MAR 2019: THE RECEIPT OF PPF AND STICKER SHEETS. IN ADDITION TO WHAT WERE PREVIOUSLY ALLEGED, PPF ALLEGES PULMONARY EMBOLISM. ADDED REVISION HOSPITAL, LAW FIRM, AGE AND REVISION SURGEON. UPDATED PATIENT'S IDENTIFIER. AN IMPACTED PRODUCT RECORD FOR THE CUP, SCREW AND STEM WAS ADDED DUE TO ALLEGED PULMONARY EMBOLISM.

  Patient problems: No Code Available; Pain; Pulmonary Embolism

  MAUDE report 8528306 ↗
• InjuryFeb 14, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  LITIGATION ALLEGES THAT THE PATIENT SUFFERS FROM PAIN, DISCOMFORT, AND SWELLING. UPDATE: OPERATIVE NOTES INDICATE THAT THE PATIENT SUFFERED FROM INSTABILITY AND A PSEUDOTUMOR. UPDATE: IN ADDITION TO WHAT WAS PREVIOUSLY ALLEGED, PATIENT ALLEGES METAL WEAR, METALLOSIS AND ELEVATED METAL ION. AFTER REVIEW OF MEDICAL RECORDS, PATIENT WAS REVISED TO ADDRESS DISLOCATION AND ELEVATED CHROMIUM COBALT LEVEL. REVISION NOTE, STATED THERE WAS A THICKENED LINING OF THE LARGE CYST WHICH IS ACROSS BETWEEN BURSITIS AND A TRUE PSEUDOCYST. THERE WAS NO CORROSION AND METALLOSIS NOTED. DOI: (B)(6) 2010; DOR: (B)(6) 2013; (RIGHT HIP).

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

  MAUDE report 8340765 ↗
• InjuryJan 21, 2019Biocompatibility; Biocompatibility

  COMPLAINT DESCRIPTION: JUN 27, 2017: LITIGATION RECEIVED. LITIGATION ALLEGES EROSION OF THE ACETABULUM, FEMUR AND SURROUNDING STRUCTURES, RESULTING IN SEVERE PAIN AND A LIMP, DISLOCATION, METALLOSIS, AND FLUID BUILDUP.

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

  MAUDE report 8263878 ↗
• InjuryAug 16, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  REASON FOR ORIGINAL COMPLAINT-PATIENT WAS REVISED TO ADDRESS INFECTION. PFS AND MEDICAL RECORDS RECEIVED. PFS AND MEDICAL RECORDS REVIEWED FOR MDR REPORTABILITY. PFS REPORTED VOMITING, FLU-LIKE SYMPTOMS, FEVER, SEVERE PAIN, BODY ACHES, RIGHT HIP INFECTION, LEFT HIP EFFECTED MOBILITY WITH SHARP PAINS AND SORENESS, FLUID FOUND IN LEFT HIP, DISCOMFORT, UNABLE TO SIT OR STAND FOR LONG PERIODS OF TIME, UNABLE TO EXERCISE AND DO STRENUOUS ACTIVITIES. REVISION SURGICAL REPORT NOTED INCREASED TEMPERATURE AND POSITIVE ASPIRATION AS REASONS FOR REVISION. PPF AND STICKER SHEETS RECEIVED. IN ADDITION TO WHAT WERE PREVIOUSLY ALLEGED, PPF ALLEGES PSEUDOTUMOR, INFECTION AND METAL WEAR/METALLOSIS. DOI: (B)(6) 2010 - DOR: (B)(6) 2012; (RIGHT HIP).

  Patient problems: Not Applicable; Test Result; Unspecified Infection

  MAUDE report 7790790 ↗
• InjuryJun 12, 2018Migration or Expulsion of Device; Loss of Osseointegration; Migration or Expulsion of Device; Loss of Osseointegration

  SUBJECT ID: (B)(4). CLINICAL ADVERSE EVENT RECEIVED FOR RADIOLUCENT LINE AROUND THE FEMORAL COMPONENT WITH COMPONENT MIGRATION CONSISTENT WITH LOOSENING OF THE FEMORAL COMPONENT. EVENT IS NOT SERIOUS AND IS CONSIDERED MILD. EVENT IS RELATED TO DEVICE AND NOT RELATED TO PROCEDURE. DOI: (B)(6) 2013. DOE: (B)(6) 2017; (LEFT HIP). CLINICAL ADVERSE EVENT RECEIVED FOR FEMORAL COMPONENT LOOSENING. EVENT IS SERIOUS AND IS CONSIDERED SEVERE. EVENT IS RELATED TO DEVICE AND NOT RELATED TO PROCEDURE. DOI: (B)(6) 2013; DOE: (B)(6) 2014; DOR: (B)(6) 2014; (LEFT HIP).

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

  MAUDE report 7590887 ↗
• MalfunctionOct 27, 2017Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  CLINICAL DER STATES THAT THE PATIENT EXPERIENCED AN ADVERSE EVENT OF LEG LENGTH DISCREPANCY. THE EVENT DOES NOT MEET THE DEFINITION OF SERIOUS AND IS CONSIDERED MILD. THE EVENT IS RELATED TO DEVICE AND PROCEDURE. EVENT IS CURRENTLY NOT BEING TREATED. UPDATE OCTOBER 11, 2017: THE PATIENT'S MEDICAL RECORDS WERE RECEIVED. MEDICAL RECORDS WERE REVIEWED FOR MDR REPORTABILITY. ACCORDING TO THE MEDICAL RECORDS, DESPITE EXTENSIVE ATTEMPTS TO SINK THE FEMORAL PROSTHESIS MORE DEEPLY, THE FEMORAL COMPONENT SEATED APPROXIMATELY 5MM PROXIMAL TO THE TARGETED DEPTH. THE IMPLANT WAS FOUND TO BE STABLE AND IT WAS DETERMINED THAT THE OPERATIVE LEG WOULD BE LENGTHENED APPROXIMATELY 3-5MM.

  Patient problems: No Code Available

  MAUDE report 6984299 ↗