Adapter Sleeve 6519-T-025Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 04546540608383), received between May 9, 2019 and Nov 27, 2019 — classified as 2 injuries.

The most frequently reported specific device problem is “Noise, Audible” (1 report).

2 other recalls cover devices cleared under the same FDA submission (K070885, K173499, K243784); they may or may not involve this specific model.

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 18, 2026.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryNov 27, 2019Unstable; Unstable

  DR. (B)(6) RIGHT HIP HEAD/SLEEVE DUE TO PATIENT INSTABILITY. HE REVISED FROM A 40 -2.5 TO A +4. ORIGINAL SURGERY WAS (B)(6) 2019 BY (B)(6). UPDATE (B)(6) 2019 WG: REP PROVIDED USAGE SHEETS FROM PRIMARY AND REVISION PROCEDURES AND REPORTED THAT NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON. REP ALSO CONFIRMED HE WAS THE ACTING MPS FOR THE PRIMARY PROCEDURE, AND THAT THE LOG AND SESSION FILES ARE NOT AVAILABLE FROM THE JULY PROCEDURE.

  Patient problems: Injury

  MAUDE report 9385512 ↗
• InjuryMay 9, 2019Noise, Audible; Noise, Audible

  IT WAS REPORTED THAT TOTAL HIP PROSTHESIS SURGERY OCCURRED. SURGEON DIDN'T SEE ANY STABILIZATION ISSUE WHILE SURGERY. AFTER 2 DAYS, SURGEON OBSERVES A NOISE FROM PATIENT HIP JOINT AND INDICATED THAT IT IS DUE TO FEMORAL HEAD AND TAPER ADAPTER SLEEVE. THE PATIENT HAD A REVISION ON (B)(6) 2019". UPDATE: "PATIENT DID NOT SUFFER ANY FALLS OR TRAUMA. REVISED DUE TO SOUND FROM FEMORAL HEAD AND ADAPTER SLEEVE. LEFT SIDE. NO DELAY.".

  Patient problems: Injury

  MAUDE report 8594755 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K070885, K173499, K243784. One submission often covers many models, so check the product and lot details in each record.

• Z-0314-2022 · Oct 15, 2021 · Open, Classified
  28MM -4 LFIT V40 HEAD, Catalog Number 6260-9-122
• Z-0313-2022 · Oct 15, 2021 · Open, Classified
  28MM -4 LFIT V40 HEAD, Catalog Number 6260-9-028