DURALOC 1245-80-056Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10603295019657), received between Oct 4, 2018 and Jul 28, 2022 — classified as 2 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Inadequacy of Device Shape and/or Size” (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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjuryJul 28, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT REVISED DUE TO DISLOCATING POSTERIORLY. THE SURGEON DECIDED TO REMOVE THE HEAD, LINER AND CUP TO CEMENT IN A BIMENTUM CUP FOR MORE STABILITY. UPON TRIALING HE DETERMINED HE NEED MORE LENGTH AND ELECTED TO GO WITH A 28 +15.5 HEAD. HE WAS NOTIFIED THAT THIS HEAD HAD A SKIRT AND SHOULDN¿T BE USED WITH THIS CONSTRUCT AND WANTED TO PROCEED IN USING IT. NO FURTHER PATIENT INFORMATION IS AVAILABLE AT THIS TIME. DOI: UNKNOWN. DOR: (B)(6) 2022. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Joint Laxity

  MAUDE report 15121772 ↗
• InjuryAug 26, 2021Use of Device Problem; Adverse Event Without Identified Device or Use Problem; Use of Device Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION RECEIVED INDICATED THAT THE CUP WAS REMOVED DUE TO MALPOSITION. THE HEAD HAD WORN THE POLY DOWN OVER TIME.

  Patient problems: Joint Laxity

  MAUDE report 12373640 ↗
• MalfunctionDec 19, 2019Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  SIZE ISSUE. IT WAS REPORTED THAT DURING THE TOTAL HIP REPLACEMENT OPERATION, USED 50MM TRIAL, IT WAS OK, BUT AFTER INSERT THE IMPLANT, IT WAS SMALLER THAN THE TRIAL AS THE PHOTOS AND VIDEO SHOW. ANOTHER DEVICE (52MM) WAS USED TO COMPLETE THE SURGERY. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. PLEASE REFER TO THE ATTACHED PHOTOS OF THE DEFECT PRODUCT. NO ADDITIONAL INFORMATION COULD BE PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9498404 ↗
• MalfunctionFeb 7, 2019Defective Device; Defective Device

  SIZE ISSUE. THE OUTER DIAMETER OF ACETABULAR CUP IS TOO SMALL TO IMPLANT. THERE IS A LITTLE BIT SMALLER THAN LABEL INDICATES AS THE PHOTO SHOWS. ANOTHER DEVICE (52MM) WAS USED TO COMPLETE THE SURGERY. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8315808 ↗
• MalfunctionOct 4, 2018Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  SIZE ISSUE. THE OUTER DIAMETER OF ACETABULAR CUP IS TOO SMALL TO IMPLANT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7934180 ↗