TRI-LOCK GRIPTION 1012-04-010Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 10603295000723), received between Sep 1, 2017 and May 30, 2025 — classified as 10 injuries, 1 malfunction.

The most frequently reported specific device problem is “Migration” (3 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 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• InjuryMay 30, 2025Migration; Migration

  PATIENT HAD A FALL AND LEFT -STEM SUBSIDED. STEM AND HEAD BALL WERE EXTRACTED AND NEW STEM AND HEAD BALL WERE IMPLANTED. THERE WAS NO FURTHER PATIENT CONSEQUENCE.

  Patient problems: Fall; No Clinical Signs, Symptoms or Conditions

  MAUDE report 22117165 ↗
• InjuryNov 8, 2023Degraded; Osseointegration Problem; Degraded; Osseointegration Problem

  ADDITIONAL INFORMATION RECEIVED. AE WAS REPORTED TO NCA/BFARM BY USER: "HIP-TEP LEFT COC PAIRING BECAUSE OF COXARTHROSIS ON (B)(6) 2021 IN NEUSTADT. PERSISTENT PAIN AND RADIOLOGICAL LOOSENING OF THE STEM. PREOPERATIVE PUNCTURE STERILE. STEM CHANGE ON (B)(6) 2023. TAPER COMPLETELY MASSIVELY CORRODED / METALLOSIS."

  Patient problems: Foreign Body Reaction; Inadequate Osseointegration; Pain

  MAUDE report 18091591 ↗
• InjurySep 16, 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. THE SURGEON EXPLANTED AND REVISED WITH SUMMIT. DOI: UNKNOWN, DOR: (B)(6) 2021, AFFECTED SIDE: LEFT HIP.

  Patient problems: Inadequate Osseointegration

  MAUDE report 12480689 ↗
• InjurySep 8, 2021Osseointegration Problem; Migration; Osseointegration Problem; Migration

  COMPASS CASE (B)(4) REPORT: IT WAS REPORTED THAT THE STEM SUBSIDED. IMPLANT LOOSENING WAS ALSO NOTED OF THE TRILOCK COMPONENT-NONCEMENTED. THE SALE REP WAS CONTACTED BY THE SURGEON THAT SHE HAD A TRILOCK IMPLANTED SOME TIME AGO THAT HAD SUBSIDED IN ONE OF HER PATIENTS. SHE DID SAY THAT THE PATIENT MISSED THEIR POST-OP OFFICE VISIT. SHE SHOWED BACK UP WITH A PAINFUL HIP. SHE EXPLAINED THE STEM HAD SUBSIDED AND SHE WANTED TO REVISE IT TO A STRYKER AND HAVE LINERS AVAILABLE FOR EXCHANGE FOR THE PINNACLE CUP. THE PINNACLE LINER WAS EXCHANGED AND THE STEM AND HEAD WAS REVISED TO STRYKER. THE REF: (B)(4) LOT: 39030G PINNACLE ALTRX LINER 36MM/52MM WAS USED TO REPLACE THE OLD LINER. THE 52MM PINNACLE POROCOAT SHELL REF:(B)(4) LOT:C43763 WAS LEFT IN PATIENT. DOI: (B)(6) 2016; DOR: (B)(6) 2021; AFFECTED SIDE: RIGHT HIP.

  Patient problems: Inadequate Osseointegration; Pain

  MAUDE report 12438024 ↗
• InjuryApr 22, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED TO ADDRESS PERIPROSTHETIC FRACTURE. DOI: (B)(6) 2020; DOR: (B)(6) 2020; RIGHT HIP.

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

  MAUDE report 9985897 ↗
• MalfunctionJan 2, 2020Inadequacy of Device Shape and/or Size; Patient-Device Incompatibility; Inadequacy of Device Shape and/or Size; Patient-Device Incompatibility

  THE SURGEON PREPARED THE FEMUR FOR A RASP SIZE 1, AND WHEN HE TRIED TO GET THE IMPLANT IN, IT WAS NOT GOING ANYWHERE. THE IMPLANT SIZE 1 WAS TOO BIG FOR WHAT THE RASP SIZE 1. WE OPENED AN IMPLANT SIZE 0 AND IT WAS JUST PERFECT. SHIP TO ACCOUNT (B)(4). CUSTOMER REFERENCE/PO/SERVICE? (B)(4). WAS SURGERY DELAYED DUE TO THE REPORTED EVENT? YES. IF YES, NUMBER OF MINUTES: 5 MINUTES. WAS PROCEDURE SUCCESSFULLY COMPLETED? YES. WERE FRAGMENTS GENERATED? NO. IF YES, WERE THEY REMOVED EASILY WITHOUT ADDITIONAL INTERVENTION? UNKNOWN. PATIENT STATUS/ OUTCOME / CONSEQUENCES? NO. 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)(4). DEVICE PROPERTY OF? NONE. 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 WILL BE MADE AVAILABLE, THE ADDITIONAL INFORMATION WILL BE SUBMITTED THROUGH CST.? TRUE.

  Patient problems: Not Applicable

  MAUDE report 9539442 ↗
• InjuryAug 20, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  LITIGATION ALLEGES THE PATIENT SUFFERS FROM PAIN, POPPING/JERKING, AND LIMITED MOBILITY. IN ADDITION TO WHAT WERE PREVIOUSLY ALLEGED, PPF ALLEGES ELEVATED METAL IONS. ADDED PATIENT HARM AND FACILITY NAME. ADDED STEM ON IP DUE TO THE ALLEGED ELEVATED METAL IONS. DOI: (B)(6) 2011, DOR: NONE REPORTED, (RIGHT HIP).

  Patient problems: Limited Mobility Of The Implanted Joint; Pain; Test Result

  MAUDE report 8910127 ↗
• InjuryJul 23, 2019Corroded; Degraded; Corroded; Degraded

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

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

  MAUDE report 8815629 ↗
• InjuryJun 14, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PINNACLE CLAIM SUBMISSION FORM AND MEDICAL RECORDS RECEIVED. PINNACLE CLAIM FORM HAS NO ALLEGATION PROVIDED. AFTER REVIEW OF MEDICAL RECORDS ON CERAMIC ON METAL, THE PATIENT WAS REVISED DUE TO METALLOSIS AND TRUNNIONOSIS WITH ELEVATED METAL IONS. INDICATIONS OF THE PROCEDURE STATED, THE PATIENT DEVELOPED SIGNS AND SYMPTOMS AND CLINICAL FINDINGS CONSISTENT WITH METALLOSIS. CLINICAL VISIT ON (B)(6) 2016 REPORTED PAIN, LIMITED RANGE OF MOTION, BURSITIS, WALKS WITH ANTALGIC GAIT, AND METALLOSIS. HOWEVER, RECENT LABORATORY RESULTS ON (B)(6) 2016 SHOWS CR ION LEVEL IS BELOW 7PPB. DOI: (B)(6) 2009 - DOR: (B)(6) 2017 (LEFT HIP).

  Patient problems: Foreign Body Reaction; Loss of Range of Motion; No Code Available; Pain; Tissue Damage

  MAUDE report 8701257 ↗
• InjuryMar 4, 2019Loose or Intermittent Connection; Loss of Osseointegration; Loose or Intermittent Connection; Loss of Osseointegration

  LITIGATION ALLEGES PSEUDOTUMOR, LOOSENING OF STEM, METAL WEAR, AND METALLOSIS. DOI: (B)(6) 2010; DOR: (B)(6) 2012; (RIGHT HIP).

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

  MAUDE report 8386778 ↗
• InjurySep 1, 2017Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  NEW ETQ RECORD CREATED IN ORDER TO UPDATE ETQ (LEGACY SYSTEM) COMPLAINT NUMBER (B)(4). REASON FOR ORIGINAL COMPLAINT ¿ LITIGATION ALLEGES THAT PATIENT EXPERIENCED PAIN AND SUFFERING, ADDITIONAL UNFORESEEN SURGERIES, AND METALLOSIS. PATIENT IS NOT SCHEDULED FOR AN EXPLANTATION, BUT IS REGULARLY BEING MONITORED FOR CHROMIUM/COBALT IONS AND HIP FRACTION. UPDATE: 5/21/12 - PLAINTIFF¿S PRELIMINARY DISCLOSURE FORM WAS RECEIVED, WHICH IDENTIFIED PART/LOT) INFORMATION. THE COMPLAINT AND ASSOCIATED MDRS WERE UPDATED. THERE WAS NO NEW INFORMATION THAT WOULD CHANGE THE OUTCOME OF THE INVESTIGATION. UPDATE REC'D 08/04/2014 - PLAINTIFF¿S PRELIMINARY DISCLOSURE FORM WAS RECEIVED, WHICH IDENTIFIED DOR INFORMATION. THE COMPLAINT AND ASSOCIATED MDRS WERE UPDATED. THERE WAS NO NEW INFORMATION THAT WOULD CHANGE THE OUTCOME OF THE INVESTIGATION. THE COMPLAINT WAS UPDATED ON: 08/06/2014 UPDATE REC'D 11/24/2014 - PLAINTIFF¿S PRELIMINARY DISCLOSURE FORM WAS RECEIVED, WHICH IDENTIFIED DOR INFORMATION FROM MEDICAL RECORDS. THE DOR WILL BE CORRECTED. THE COMPLAINT AND ASSOCIATED MDRS WERE UPDATED. THERE WAS NO NEW INFORMATION THAT WOULD CHANGE THE OUTCOME OF THE INVESTIGATION. THE COMPLAINT WAS UPDATED ON:

  Patient problems: Host-Tissue Reaction; Pain

  MAUDE report 6837558 ↗