Adapter Sleeve 6519-T-100Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 04546540608390), received between Jan 25, 2017 and Aug 22, 2022 — classified as 4 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (2 reports).

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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryAug 22, 2022Material Erosion; Device Appears to Trigger Rejection; Material Erosion; Device Appears to Trigger Rejection

  IT WAS REPORTED: "A CASE OF METALLOSIS ON A PATIENT WHOSE HIP PROSTHESIS WAS IMPLANTED. NICKEL ALLERGY."

  Patient problems: Foreign Body Reaction; Metal Related Pathology

  MAUDE report 15266959 ↗
• InjuryOct 28, 2019Material Separation; Device Dislodged or Dislocated; Material Separation; Device Dislodged or Dislocated

  UNIVERSAL V40 TAPER ADAPTER SLEEVE WAS SHOWN OFF OF THE TRUNNION IN THE POST OP X-RAY FOR A TOTAL HIP REPLACEMENT. UPDATE: THE HEAD DISENGAGED FROM THE SLEEVE. RIGHT HIP.

  Patient problems: Injury

  MAUDE report 9246546 ↗
• InjuryAug 8, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  UPDATED PER MEDICAL REVIEW: ¿AT HER OFFICE VISIT ON (B)(6) 2017 IT WAS NOTED SHE WAS "DOING WONDERFULLY ... STILL 12MM SHORT ON RIGHT ... BETTER THAN 25MM PRE-OP". ¿A (B)(6) 2018 MRI MARS OF THE HIP "WITHOUT CONTRAST FOR A DIAGNOSIS OF RIGHT HIP PAIN, COMPARISON: NONE AVAILABLE" DESCRIBES "TOTAL HIP ARTHROPLASTY IS PRESENT WITH ASSOCIATED ... ARTIFACT ... NO LARGE PERIPROSTHETIC SOFT TISSUE FLUID ... NO SIGNIFICANT JOINT EFFUSION ... HAMSTRING ORIGINS ARE INTACT ... NO FLUID IN GREATER TROCHANTERIC BURSA ...ILIOPSOAS INSERTION INTACT ... NO ILIOPSOAS BURSITIS." THE IMPRESSION IS ''NONSPECIFIC INTERMEDIATE SIGNAL INTENSITY AT THE INTERFACE BETWEEN THE NATIVE ACETABULUM AND ACETABULAR COMPONENT OF THE PROSTHESIS. ¿ON (B)(6) 2018 A PAIN EVALUATION SHEET FOR A DIAGNOSIS OF RIGHT HIP ILIOPSOAS BURSA INJECTION WITH A PAIN SCALE OF O TO 10 NOTES, "BEFORE INJECTION, 8; IMMEDIATELY AFTER, 3; ONE HOUR AFTER, 3; TWO HOURS AFTER, 4; FOUR HOURS AFTER, 5."

  Patient problems: Ambulation or Postural Difficulties; Pain

  MAUDE report 7763722 ↗
• InjuryJan 25, 2017Insufficient Device Problem Information; Insufficient Device Problem Information

  PATIENT HAD A TOTAL RIGHT HIP REPLACEMENT ON (B)(6) 2016. HE STATED THAT WHEN SITTING HE IS UNABLE TO LIFT HIS RIGHT LEG. HE CURRENTLY IS NOT EXPERIENCING ANY PAIN. HE IS CURRENTLY IN PHYSICAL THERAPY. UPDATE AS PER PATIENT ON (B)(6) 2016: PATIENT IS STILL EXPERIENCING PAIN, LIMPING AND CANNOT DRIVE, IS CURRENTLY IN PHYSICAL THERAPY.

  Patient problems: Ambulation or Postural Difficulties; Pain

  MAUDE report 6277717 ↗

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