Biolox 6519-1-036Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 04546540608437), received between Aug 9, 2018 and Apr 24, 2025 — classified as 6 injuries.

The most frequently reported specific device problem is “Degraded” (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 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.

• InjuryApr 24, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT REQUIRES A SECOND REVISION SURGERY DUE TO ONGOING DISCOMFORT EXPERIENCED WITH A STRYKER CERAMIC FEMORAL HEAD & SOCKET. THE SECOND REVISION IS SCHEDULED FOR (B)(6) 2025. THE PATIENT'S INITIAL IMPLANT SURGERY WAS IN (B)(6) 2019 AND THE FIRST REVISION WAS PERFORMED IN (B)(6) 2024. IT WAS FURTHER REPORTED THAT DURING THE FIRST REVISION, THE SURGEON REPLACED THE ACCOLADE HEAD WITH A STRYKER CERAMIC FEMORAL HEAD AND A NEW SOCKET. THE ORIGINAL STEM FROM 2019 WAS NOT REPLACED.

  Patient problems: Discomfort; Pain

  MAUDE report 21898643 ↗
• InjuryJul 26, 2024Unstable; Unstable

  AS REPORTED: "PATIENT IS STATUS POST REVISION RTHA DUE TO PATIENT FALLING AND THE INSERT BECAME DISLODGED. PATIENT WITH COMPETITOR CUP/INSERT AND STRYKER STEM/FEMORAL HEAD. COMPONENTS REMOVED TODAY INCLUDED INSERT AND HEAD." REP CONFIRMED THAT NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.

  Patient problems: Joint Dislocation

  MAUDE report 19836773 ↗
• InjuryJun 27, 2022Degraded; Degraded

  IT WAS REPORTED THAT THE PATIENT'S RIGHT HIP WAS REVISED. AS REPORTED: "CHRONIC DISLOCATION AND TRUNNIONOSIS." CONFIRMED DISLOCATION WAS OF THE HEAD FROM THE LINER. THE STEM HAD PREVIOUSLY BEEN REPORTED FOR TRUNNIONOSIS AND HAD BEEN LEFT IN-SITU. A HEAD, 10° LINER, AND SLEEVE WERE REVISED TO ANOTHER HEAD, CONSTRAINED INSERT, AND SLEEVE (THE STEM WAS AGAIN RETAINED).

  Patient problems: Joint Dislocation

  MAUDE report 14826750 ↗
• InjuryApr 20, 2021Material Erosion; Material Erosion

  A REVISION SURGERY TOOK PLACE DUE TO TRUNNIONOSIS.

  Patient problems: Ambulation or Postural Difficulties; Insufficient Information

  MAUDE report 11692894 ↗
• 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 APRIL 3RD".

  Patient problems: Injury

  MAUDE report 8594752 ↗
• InjuryAug 9, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  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 7768758 ↗

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