DURALOC 1245-80-049Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 10603295019589), received between Oct 26, 2017 and Jun 23, 2021 — classified as 4 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Loose or Intermittent Connection” (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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• InjuryJun 23, 2021Adverse Event Without Identified Device or Use Problem; Appropriate Device Problem Term/Code Not Available; Adverse Event Without Identified Device or Use Problem; Appropriate Device Problem Term/Code Not Available

  ON (B)(6) 2020, THE PATIENT PRESENTED FOR A MINIMALLY INVASIVE DIAGNOSTIC HIP TAP PROCEDURE TO RULE-OUT INFECTION OF THE RIGHT HIP. THE PATIENT PRESENTED WITH "POLYETHYLENE WEAR OF ENCLOSED TOTAL HIP ENDOPROSTHESIS ON THE RIGHT WITH OSTEOLYSIS IN GRUEN ZONES 1 AND 7, AS WELL AS CHARNLEY ZONE 1", AND HAD BEEN SCHEDULED FOR REVISION SURGERY TO ADDRESS THE POLYETHYLENE WEAR AND OSTEOLYSIS AFFECTING THE FEMUR AND THE ACETABULUM. THE PROCEDURE WAS COMPLETED USING RADIOGRAPHIC IMAGING WITHOUT COMPLICATIONS. THE PATIENT HAD SIGNIFICANTLY INCREASING COMPLAINTS IN THE RIGHT FEMORAL JOINT FOR ABOUT 3 MONTHS. NO TRIGGERING TRAUMA WAS IDENTIFIED. MOBILITY AND WEIGHT BEARING HAVE BEEN SIGNIFICANTLY REDUCED. CLINICALLY, NO SIGN OF INFECTION. ON RIGHT, THE PATIENT PRESENTED WITH PRONOUNCED LIMPING GAIT PATTERN. MOBILITY IN THE RIGHT FEMORAL JOINT WAS EXTENSION/FLEXION 0/0/70°, OUTER ROTATION/INNER ROTATION 10/0/0°, ABDUCTION/ADDUCTION 10/0/0°. MOBILITY WAS REPORTEDLY LIMITED DUE TO PAIN. PAIN ON PRESSURE AT GROIN, TROCHANTER MUSCLE FREE. DIFFERENCE IN LEG LENGTH ON THE RIGHT WAS -2 CM COMPARED TO LEFT. X-RAY RESULT OF THE RIGHT FEMORAL JOINT ON 2 LEVELS DATED (B)(6) 2020 SHOWED A TOTAL HIP ENDOPR

  Patient problems: Ambulation or Postural Difficulties; Loss of Range of Motion; Osteolysis; Pain; Physical Asymmetry

  MAUDE report 12051963 ↗
• InjuryOct 6, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO EXPERIENCING PAIN. L HIP REVISION. DOI: (B)(6) 2009, DOR: (B)(6) 2020.

  Patient problems: No Code Available; Pain

  MAUDE report 10637512 ↗
• InjuryJun 12, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED DUE TO PAIN. ORIGINAL IMPLANT DATE UNKNOWN. DOI: UNKNOWN. DOR: (B)(6) 2020; LEFT HIP.

  Patient problems: No Code Available; Pain

  MAUDE report 10148737 ↗
• MalfunctionAug 9, 2018Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  THERE WAS A SURGICAL DELAY OF 30 MINUTES.

  Patient problems: No Code Available

  MAUDE report 7766857 ↗
• InjuryMay 11, 2018Loose or Intermittent Connection; Loose or Intermittent Connection

  DER STATED THAT PRIMARY THA WAS DONE IN 2003 (EXACT DATE UNKNOWN). HEAD-ON AUTOMOBILE COLLISION IN (B)(6) 2017 LED TO CHRONIC DISLOCATION OF IMPLANT, REQUIRING ACETABULAR REVISION. CUP, LINER, AND HEAD WERE REVISED. CUP WAS LOOSE AT THE BONE TO IMPLANT INTERFACE. DOI: 2003; DOR (B)(6) 2018; RIGHT HIP. NO SURGICAL DELAY.

  Patient problems: Inadequate Osseointegration; Not Applicable

  MAUDE report 7507500 ↗
• MalfunctionOct 26, 2017Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT THE DEVICE WAS FOUND LESS THAN 52MM AFTER TESTED AND COULD NOT USE. THE DEVICE'S STANDARD SIZE IS 52MM.

  Patient problems: No Information

  MAUDE report 6979290 ↗