BIOLOX DELTA 1365-36-250Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 10603295033608), received between Nov 19, 2018 and Nov 11, 2024 — classified as 5 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (4 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 18, 2026.

Most reported problems

Recent adverse event reports

The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• InjuryNov 11, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT PATIENT WAS STILL UNSTABLE AND WAS DISLOCATING. SURGEON STATED THAT IT IS DUE TO AN OLD GRATER TORCH FRACTURE AND SOFT TISSUE INSTABILITY. SURGEON DECIDED TO REVISE IT TO A CONSTRAINED OPTION. THERE WAS NO SURGICAL DELAY. DOI: UNKNOWN; DOR: UNKNOWN; AFFECTED SIDE: RIGHT SIDE.

  Patient problems: Joint Dislocation; Joint Laxity

  MAUDE report 20653453 ↗
• MalfunctionFeb 22, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  MEDICAL RECORDS RECEIVED. AFTER REVIEW OF MEDICAL RECORDS AFTER CLINIC VISIT XRAY SHOWS SROM IMPLANT WITH PROBABLE LOOSENING REPORTED AFTER FIRST REVISION. CLINIC VISITS REPORTED OF PAIN, DIFFICULTY OF WALKING AND REQUIRED TO USE OF A CRUCTH TO WALK. THERE IS A STABLE SMALL AMOUNT OF LUCENCY ADJACENT TO THE FEMORAL COMPONENT. X-RAYS SHOW S-ROM PROSTHESIS WITH LUCENCY AROUND PROXIMAL SLEEVE. DOE: (B)(6) 2019. PLEASE SEE (B)(4) FOR 1ST REVISION.

  Patient problems: Ambulation or Postural Difficulties; Pain

  MAUDE report 16416169 ↗
• InjuryJan 17, 2022Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PATIENT WAS IMPLANTED WITH AN SROM STEM AND HIP BALL BUT HAD A COMPETITOR ACETABULAR COMPONENT. THE ORIGINAL IMPLANT DATE IS UNKNOWN. THE PATIENT'S HIP DISLOCATED, AND WHEN SURGEON WENT TO REDUCE THE HIP UNDER THE C-ARM, HE NOTICED THAT THE PATIENTS ACETABULAR COMPONENT HAD BECOME LOOSE. SURGEON REALIZED THAT THE PATIENTS ACETABULUM WAS BEYOND REPAIR WITHOUT IMPLANTING A TRI-FLANGE CONSTRUCT, SO HE OPTED TO REMOVE ALL IMPLANTS EXCEPT FOR THE SROM SLEEVE. HE WANTS TO BE ABLE TO TOSS AN SROM STEM BACK IN ONCE THE TRI-FLANGE COMPONENT IS READY. DOI: UNKNOWN, DOR: (B)(6) 2022, AFFECTED SIDE: LEFT HIP.

  Patient problems: Joint Dislocation

  MAUDE report 13265938 ↗
• MalfunctionJun 9, 2021Fracture; Off-Label Use; Fracture; Off-Label Use

  IT WAS REPORTED THAT THE SURGEON TRIALED SROM HEAD AND ASKED FOR A CERAMIC +12 36 MM IMPLANT. AND IT WAS MENTION THAT IT WAS OFF LABEL TO PUT A CERAMIC HEAD ON A PREVIOUSLY USED TAPER. UPON IMPACTION OF REAL CERAMIC HEAD, THE HEAD SPLIT IN TWO PIECES. SURGEON SAID THIS WAS DUE TO A USED TAPER. ALL PIECES OF CERAMIC HEAD WERE SUCCESSFULLY REMOVED AND SURGEON IMPACTED METAL SROM +12 36 MM HEAD ONTO TRUNNION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11967292 ↗
• InjuryDec 18, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PFS AND MEDICAL RECORDS RECEIVED. PFS ALLEGES LESS FLEXIBILITY, PAIN, TIGHTNESS IN THE LEFT LEG WHICH LIMITS ABILITY TO STAND AFTER FIRST REVISION. AFTER REVIEW OF EMDICAL RECORDS, THERE IS NO REVISION REPORTED. DOI: (B)(6) 2014; DOR: NOT REPORTED (LEFT HIP).

  Patient problems: Limited Mobility Of The Implanted Joint; Pain

  MAUDE report 9491194 ↗
• InjuryApr 18, 2019Device Dislodged or Dislocated; Device Dislodged or Dislocated

  PPF ALLEGES ELEVATED METAL IONS AND DISLOCATION WITH CLOSED REDUCTION AFTER FIRST REVISION (LEFT HIP).

  Patient problems: Joint Dislocation

  MAUDE report 8528960 ↗
• InjuryNov 19, 2018Device Dislodged or Dislocated; Device Dislodged or Dislocated

  LITIGATION ALLEGES DISLOCATION. DOI: (B)(6) 2017. DOR: (B)(6) 2017.

  Patient problems: Joint Dislocation; Joint Disorder; No Code Available

  MAUDE report 8084303 ↗