NA 498.806SRecalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 10886982236975), received between Jan 19, 2018 and Jun 17, 2020 — classified as 6 injuries.

The most frequently reported specific device problem is “Improper or Incorrect Procedure or Method” (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 17, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED ON (B)(6) 2020 THAT ON AN UNKNOWN DATE A PATIENT PRESENTED TO THE SURGEON FOR FOLLOW UP AFTER TOTAL HIP SURGERY WITH TI TROCHANTERIC REATTACHMENT DEVICE W/CABLES/STANDARD-STER. THE PATIENT EXPERIENCED DELAYED HEALING AND WAS DIAGNOSED WITH METALLOSIS AND OSTEOLYSIS IN THE HIP. THERE IS NO FURTHER INFORMATION AVAILABLE. CONCOMITANT DEVICE REPORTED: UNK - CERCLAGE POSITIONING PIN (PART# UNKNOWN; LOT# UNKNOWN; QUANTITY: UNKNOWN). THIS COMPLAINT INVOLVES ONE (1) DEVICE. THIS REPORT IS FOR ONE (1) TI TROCHANTERIC REATTACHMENT DEVICE W/CABLES/STANDARD-STER. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: Injury; No Code Available

  MAUDE report 10164056 ↗
• InjuryJun 10, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS REPORT CAPTURES THE FIRST PATIENT WHILE RELATED COMPLAINT (B)(4) CAPTURES THE SECOND PATIENT WHO ALSO HAS METALLOSIS AND OSTEOLYSIS.

  Patient problems: No Code Available

  MAUDE report 10138774 ↗
• InjuryFeb 10, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED TO RTI SURGICAL ON (B)(6) 2020 THAT THERE WAS A PATIENT WHO UNDERWENT A REVISION ON AN UNKNOWN DATE DUE TO 2 STAGE INFECTION RELATED TO A PREVIOUS HIP SURGERY. IT IS UNKNOWN WHEN INDEX SURGERY WAS PERFORMED.

  Patient problems: Post Operative Wound Infection

  MAUDE report 9689372 ↗
• InjuryNov 13, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE CAUSE FOR REVISION WAS 2 STAGE INFECTION.

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 9316806 ↗
• InjuryJan 11, 2019Improper or Incorrect Procedure or Method; Adverse Event Without Identified Device or Use Problem; Improper or Incorrect Procedure or Method; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE, THE SURGEON HAD DIFFICULTY WITH A TROCHANTERIC REATTACHMENT DEVICE. THE SURGEON WAS UNSURE HOW TO USE THE TROCHANTERIC ATTACHMENT DEVICE AND TRIED TO USE IT ON HIS OWN UNSUCCESSFULLY. THE DEVICE WAS REMOVED FROM THE PATIENT. THE PROCEDURE AND PATIENT OUTCOME IS UNKNOWN. PATIENT WAS SCHEDULED FOR A FOLLOW UP SURGERY ON ANOTHER DATE. THIS REPORT IS FOR A TITANIUM (TI) TROCHANTERIC REATTACHMENT DEVICE WITH CABLES. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Code Available

  MAUDE report 8240779 ↗
• InjuryJan 19, 2018Loose or Intermittent Connection; Loose or Intermittent Connection

  IT WAS REPORTED THAT A PATIENT UNDERWENT REVISION SURGERY ON (B)(6) 2017 DUE TO NON-UNION AND LOOSENING OF ONE (1) TROCHANTERIC REATTACHMENT DEVICE. THE REATTACHMENT DEVICE WAS ONE UNIT AND INCLUDED A PLATE AND UNKNOWN QUANTITY OF CABLES. THE INITIAL SURGERY TO IMPLANT THE TROCHANTERIC REATTACHMENT DEVICE WITH CABLES TOOK PLACE ON AN UNKNOWN DATE AND THE DEVICE BECAME LOOSE ON AN UNKNOWN DATE POST-OPERATIVELY. THE DEVICE WAS EXPLANTED INTACT ON (B)(6) 2017. NO COMPLICATIONS DURING THE REVISION SURGERY WERE NOTED. NO SURGICAL DELAY WAS NOTED. PROCEDURE WAS COMPLETED SUCCESSFULLY. IT IS UNKNOWN WHAT THE PATIENT WAS REVISED TO. PATIENT WAS LISTED STABLE THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: Failure of Implant; Nonunion/Delayed-union Bone Fracture

  MAUDE report 7205559 ↗