TRI-LOCK GRIPTION 1012-04-090Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10603295000808), received between May 10, 2018 and Oct 16, 2019 — classified as 4 injuries.

The most frequently reported specific device problem is “Fracture” (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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryOct 16, 2019Loss of Osseointegration; Osseointegration Problem; Loss of Osseointegration; Osseointegration Problem

  PINNACLE CLAIM SUBMISSION FORM AND MEDICAL RECORDS RECEIVED. AFTER REVIEW OF MEDICAL RECORDS, THE PATIENT WAS REVISED TO ADDRESS ASEPTIC LOOSENING AND LACK OF INGROWTH ONTO THE FEMORAL STEM. INTRAOPERATIVELY, THE STEM WAS NOTED TO BE GROSSLY LOOSE. THERE WAS BONE OVERGROWTH ON THE SHOULDER OF THE STEM. DOI: (B)(6) 2008; DOR: (B)(6) 2016; (LEFT HIP).

  Patient problems: Inadequate Osseointegration; No Code Available

  MAUDE report 9199020 ↗
• InjuryDec 14, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED TO ADDRESS PAINFUL HIP.

  Patient problems: No Code Available; Pain

  MAUDE report 8163884 ↗
• InjuryNov 5, 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 (RIGHT HIP).

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

  MAUDE report 8037282 ↗
• InjuryMay 10, 2018Fracture; Fracture

  TRI-LOCK BPS FEMORAL STEM 12/14 TAPER SIZE 9 STD 113MM. CODE 1012-04-090 LOT 360212 Q-TY- 1 (RIGHT IMPLANT). DATE OF IMPLANTATION -(B)(6) 2013. DATE OF EVENT (B)(6) 2018. ALERT DATE - (B)(6) 2018 BUT HOSPITAL DIDN'T PROVIDE EVENT DETAILS LONG TIME. WE RECEIVED INFORMATION IN APRIL,16. WHILE MOVING UP THE STAIRS, THE PATIENT'S IMPLANT BROKE THE NECK OF THE ENDOPROSTHESIS IN THE RIGHT LEG IS BROKEN (THE FEMORAL STEM) ADVERSE EVENT, PATIENT WAS HOSPITALIZED AND CARRIED OUT A REVISION IN (B)(6) 2018. NOW PATIENT'S CONDITION IS GOOD. PRODUCT IS AVAILABLE FOR RETURN TO LAB. DOI: (B)(6) 2013; DOR: (B)(6) 2018; RIGHT HIP.

  Patient problems: No Known Impact Or Consequence To Patient; Not Applicable

  MAUDE report 7502089 ↗