TRI-LOCK GRIPTION 1012-14-005Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 10603295001027), received between Aug 23, 2017 and Mar 10, 2026 — classified as 10 injuries, 1 malfunction.

The most frequently reported specific device problem is “Loss of Osseointegration” (2 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.

• InjuryMar 10, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS REVISED DUE TO GROIN PAIN. THERE WAS NO SURGICAL DELAY. AFFECTED SIDE: LEFT HIP.

  Patient problems: Pain

  MAUDE report 24559652 ↗
• InjuryJan 3, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ASR XL LITIGATION COMPLAINT RECEIVED AD 26 DEC 2023. PATIENT REVISION WAS DUE TO ALLEGED SEVERE PAIN AND DISCOMFORT, INCREASED METAL LEVELS IN BLOOD INCLUDING COBALT AND CHROMIUM; PERMANENT INJURIES, EMOTIONAL DISTRESS, DISABILITY, DISFIGUREMENT; ECONOMIC DAMAGES INCLUDING MEDICAL AND HOSPITAL EXPENSES FOR REVISION SURGERY FOLLOWED BY MONITORING, REHABILITATION AND PHARMACEUTICAL COSTS. DOI: (B)(6) 2008. DOR: (B)(6) 2023. RIGHT HIP.

  Patient problems: Deformity/ Disfigurement; Discomfort; Distress; Metal Related Pathology; Pain

  MAUDE report 18441267 ↗
• InjurySep 28, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO PAINFUL RIGHT HIP. DOI: (B)(6) 2016; DOR: (B)(6) 2023; AFFECTED SIDE: RIGHT HIP.

  Patient problems: Pain

  MAUDE report 17835836 ↗
• InjuryMar 30, 2022Osseointegration Problem; Migration; Osseointegration Problem; Migration

  PATIENTS WAS REVISED DUE TO LOOSENING. STEM SUBSIDED AND BECAME LOOSE, SO SURGEON REMOVED STEM AND HEAD AND REPLACED WITH AN ACTIS AND A NEW FEMORAL HEAD. DOI: (B)(6) 2018, DOR: (B)(6) 2022, AFFECTED SIDE: RIGHT HIP.

  Patient problems: Inadequate Osseointegration

  MAUDE report 13949771 ↗
• MalfunctionNov 19, 2021Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT THE SURGEON TRIED TO INSERT THE REAL OFFSET IN QUESTION, BUT THE OFFSET OF THE STEM WAS TIGHTLY ATTACHED, AND THE SURGEON COULDN¿T REDUCE IT. THEREFORE, THE SURGEON USED THE DIFFERENT OFFSET (TRI-LOCK BPS SZ 0 HI OFFSET) INSTEAD. THE SURGERY WAS COMPLETED SUCCESSFULLY WITHIN 30 MINUTES DELAY. NO FURTHER INFORMATION IS AVAILABLE. CAPA(B)(4) / LOCAL #(B)(4))HAS BEEN CREATED FOR THIS LATE REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12846482 ↗
• InjuryApr 15, 2020Migration; Migration

  IT WAS REPORTED THAT ON (B)(6) 2018, THE PRIMARY SURGERY WAS PERFORMED VIA THA WITH THE TRI-LOCK STEM AND DELTA CERAMIC HEAD IN QUESTION. IN (B)(6) 2020, THE PATIENT REPORTED PAIN AND THE SURGEON CONFIRMED BY X-RAY THAT THE STEM SINKING OCCURRED. ON (B)(6) 2020, THE PATIENT UNDERWENT REVISION SURGERY BY REPLACING THE STEM AND HEAD WITH S-ROM SYSTEM. THE REVISION SURGERY WAS COMPLETED SUCCESSFULLY. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Code Available; Pain

  MAUDE report 9965202 ↗
• InjuryJul 29, 2019Loss of Osseointegration; Loss of Osseointegration

  IT WAS REPORTED THAT PATIENT HAD MOM HIP PAIN, PSEUDO TUMOR AND LOOSENING OF THE CUP AND STEM. DOI: (B)(6) 2008, DOR: (B)(6) 2019, UNKNOWN AFFECTED SIDE.

  Patient problems: Foreign Body Reaction; Hypersensitivity/Allergic reaction; Inadequate Osseointegration; No Code Available; Pain

  MAUDE report 8836394 ↗
• InjuryFeb 12, 2019Loose or Intermittent Connection; Osseointegration Problem; Loose or Intermittent Connection; Osseointegration Problem

  LITIGATION ALLEGES LOOSENING OF STEM. DOI: (B)(6) 2010 - DOR: (B)(6) 2012 (LEFT HIP).

  Patient problems: Discomfort; Inadequate Osseointegration; No Code Available; Pain

  MAUDE report 8331450 ↗
• InjuryJul 18, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  PATIENT WAS REVISED TO ADDRESS PAINFUL HIP. DOI: (B)(6) 2017; DOR: (B)(6) 2018; RIGHT HIP.

  Patient problems: Not Applicable; Pain

  MAUDE report 7698156 ↗
• InjurySep 7, 2017Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  COMPLAINT DESCRIPTION: DER STATES THAT THE O HI TRILOCK STEM SAT AT ABOUT 5MM PROUD AS COMPARED TO THE O HI BROACH. IT WAS ALSO REPORTED THAT THE SURGEON SPECULATED THE GRIPTION ON THE IMPLANT THAT MAY HAVE BEEN THICK.

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

  MAUDE report 6849204 ↗
• InjuryAug 23, 2017Loss of Osseointegration; Appropriate Device Problem Term/Code Not Available; Loss of Osseointegration; Appropriate Device Problem Term/Code Not Available

  THE PATIENT WAS REVISED TO ADDRESS SUBSIDENCE AND LOOSENING OF THE FEMORAL STEM AT THE BONE TO IMPLANT INTERFACE.

  Patient problems: No Code Available

  MAUDE report 6813061 ↗