BIOLOX DELTA 1365-32-310Recalls & reported problems

Summary

The FDA's MAUDE database contains 551 adverse event reports that list this exact device (DI 10603295033431), received between Jul 14, 2017 and Sep 29, 2026 — classified as 545 injuries, 6 malfunctions.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (263 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 25 most recent of 551 reports, in the reporter's own words as published by the FDA.

• InjurySep 29, 2026Device Dislodged or Dislocated

  It was reported that the patient was revised due to dislocation.Affected side: Left hip.

  Patient problems: Joint Dislocation

  MAUDE report 50931182 ↗
• InjurySep 24, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that the patient was revised due to instability.DOI: Unknown, DOR: (b)(6) 2026,Affected side: Unknown hip.

  Patient problems: Joint Laxity

  MAUDE report 50888522 ↗
• InjurySep 23, 2026Device Dislodged or Dislocated

  It was reported that Patient had lost a bunch of weight, muscle mass which created less tension on patient's hip. This was causing her to dislocate. The patient went from a 32+1 to a 32+9 and was very stable. Affected side-Left.

  Patient problems: Joint Dislocation

  MAUDE report 50867150 ↗
• InjurySep 8, 2026Device Dislodged or Dislocated

  It was reported the patient underwent a THA for left OA on (b)(6)2026. Post-operatively the patient experienced dislocation. The liner and head of the implanted device were replaced on (b)(6)2026.

  Patient problems: Joint Dislocation

  MAUDE report 50673198 ↗
• InjuryJul 27, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that patient underwent total hip arthroplasty (THA) on (b)(6) 2024. The then presented to the emergency department on (b)(6) 2026, complaining of severe pain in the left hip which had worsened significantly since the previous evening. Weight-bearing on the left leg was barely possible; the patient denied any preceding trauma. The patient had repeatedly noticed a "grinding" or "popping" sensation in the left hip while walking.An earlier consultation on (b)(6) 2026, due to increasing hip discomfort, had revealed no radiological or CT evidence of prosthesis loosening, periprosthetic fracture, or inlay dislocation. At that time, the femoral head appeared properly centered within the acetabular component. Current diagnostic imaging revealed an eccentric position of the prosthetic head within the acetabular component. CT findings raised suspicion of inlay dislocation or a material defect in the hip prosthesis. Additionally, an extensive periprosthetic fluid collection containing air pockets was noted. However, clinical and laboratory findings showed no evidence of an acute infection.Based on these findings, an indication for emergency surgical revision was established. Cu

  Patient problems: Discomfort; Pain; Swelling/ Edema

  MAUDE report 50045237 ↗
• InjuryJul 27, 2026Adverse Event Without Identified Device or Use Problem

  Patient was revised due to infection.DOI: ON (b)(6) 2022,DOR: ON (b)(6) 2026,Affected Side: Right Hip.

  Patient problems: Unspecified Infection

  MAUDE report 50009536 ↗
• InjuryJun 11, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT HAD SHORT LEG LENGTH DISCREPANCY AND SURGEON WANTED TO REMOVE HEAD/LINER TO GIVE PATIENT ADDITIONAL LEG LENGTH. AFFECTED SIDE: LEFT HIP.

  Patient problems: Physical Asymmetry

  MAUDE report 25472221 ↗
• InjuryJun 8, 2026Device Dislodged or Dislocated

  PATIENT WAS REVISED DUE TO DISLOCATION. SURGEON REPLACED HEAD AND LINER AND DEEMED HIP TO BE STABLE. THERE WERE NO DELAYS OR COMPLAINTS AND NO HARM TO THE PATIENT. DOI: (B)(6) 2026. DOR: (B)(6) 2026. AFFECTED SIDE: LEFT HIP.

  Patient problems: Joint Dislocation

  MAUDE report 25428642 ↗
• InjuryMay 12, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PAIN OCCURED 1217. DOI- (B)(6) 2020. DOR- (B)(6) 2026. AFFECTED SIDE-LEFT HIP.

  Patient problems: Pain

  MAUDE report 25148082 ↗
• InjuryApr 27, 2026Device Dislodged or Dislocated

  IT WAS REPORTED THAT PATIENT WAS REVISED DUE TO UNSTABLE HIP- DISLOCATION. DOI: UNKNOWN. DOR: (B)(6) 2026. AFFECTED SIDE: RIGHT.

  Patient problems: Joint Dislocation; Joint Laxity

  MAUDE report 25001679 ↗
• MalfunctionApr 15, 2026Tear, Rip or Hole in Device Packaging; Device Contaminated During Manufacture or Shipping

  IT WAS REPORTED THE FEMORAL HEAD IMPLANT PACKAGING WAS FAULTY, AND SURGEON WAS UNABLE TO RETRIEVE HEAD FROM PACKAGING. NO SURGICAL DELAY. SURGEON OPENED A NEW FEMORAL HEAD . PROCEDURE WAS COMPLETED SUCCESSFULLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24888463 ↗
• InjuryApr 15, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2025, THE PATIENT UNDERWENT THA FOR FEMORAL NECK FRACTURES. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH NO SURGICAL DELAY. ON (B)(6) 2026, THE SURGEON DETERMINED THAT THERE WAS A POSTOPERATIVE INFECTION, AND DEBRIDEMENT WAS PERFORMED ON THE SAME DAY. THE LINER AND HEAD WERE REPLACED AS THE SLIDING SURFACE AND THE INFECTION SITE WAS THOROUGHLY CLEANSED. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. NO FURTHER INFORMATION IS AVAILABLE. IMPLANT DATE: (B)(6) 2025. EXPLANT DATE: (B)(6) 2026 (ONLY THE LINER AND HEAD WERE REPLACED).

  Patient problems: Unspecified Infection

  MAUDE report 24885807 ↗
• InjuryApr 14, 2026Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PATIENT DISLOCATED DURING THE NIGHT IN BED AND ELECTED TO CHANGE THE VERSION ON THE CUP AND PUT IN AN ELEVATED RIM LINER. DOI: (B)(6) 2026, DOR: (B)(6) 2026, AFFECTED SIDE: UNKNOWN.

  Patient problems: Joint Dislocation

  MAUDE report 24875538 ↗
• InjuryApr 7, 2026Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PATIENT HAD HIP DONE ORIGINALLY ON (B)(6) 2020. PATIENT SUFFERED A DISLOCATION. DR. FELT THE PATIENTS CUP POSITION MAY BE THE CAUSE FOR DISLOCATION. THEY OPTED TO REVISE THE CUP TO A COMPETITOR ACETABULAR COMPONENT. TRIAL REDUCTION WAS PERFORMED WITH A NEW FEMORAL HEAD TRIAL AND THE HIP WAS FOUND TO BE STABLE. NEW TS CERAMIC FEMORAL HEAD WAS OPENED AND IMPLANTED. STABILITY OF THE HIP WAS CONFIRMED AND THE CLOSING PROCESS BEGAN. NO DELAYS OR ADVERSE EVENTS TOOK PLACE. ACTIVITY LEVEL - YES. DOI: (B)(6) 2020. DOR: UNKNOWN. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Joint Dislocation

  MAUDE report 24805176 ↗
• InjuryApr 7, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS REVISED DUE TO PAIN. DOI: ON (B)(6) 2024, DOR: ON (B)(6) 2026, AFFECTED SIDE: UNKNOWN.

  Patient problems: Pain

  MAUDE report 24800545 ↗
• InjuryApr 6, 2026Device Dislodged or Dislocated

  IT WAS REPORTED THAT ON JANUARY 19, 2026, THE PATIENT UNDERWENT THA. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH NO SURGICAL DELAY. ON (B)(6) 2026, THE PATIENT SUFFERED HIP DISLOCATION. THE DISLOCATION WAS SUCCESSFULLY REDUCED MANUALLY. SINCE THERE WERE NO PROBLEMS WITH THE PLACEMENT OF THE IMPLANTS, THE SURGEON DECIDED TO MONITOR THE SITUATION FOR A WHILE. ACCORDING TO THE SURGEON, THE PATIENT FELL SHORTLY AFTER THE THA SURGERY AND SUFFERED GREATER TROCHANTERIC FRACTURES. THE FRACTURES WERE TREATED WITH CABLES. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Fall; Joint Dislocation; Joint Laxity

  MAUDE report 24793968 ↗
• InjuryMar 17, 2026Naturally Worn

  IT WAS REPORTED THAT DELTA CER HEAD 12/14 32MM +1 AND PINN MAR +4 10D 32IDX48OD WERE INVOLVED IN A REPORTED EVENT. THE EVENT CONCERNED PREMATURE WEAR OF POLYETHYLENE AND CERAMIC MATERIALS, LEADING TO TWO REVISION SURGERIES FOR REPLACEMENT OF THE INSERT AND HEAD. THE PATIENT REQUIRED CORRECTIVE INVASIVE PROCEDURES, AND THE IMPACTED IMPLANTS WERE EXPLANTED.

  Patient problems: Insufficient Information

  MAUDE report 24615629 ↗
• InjuryMar 16, 2026Naturally Worn

  IT WAS REPORTED THAT THE PATIENT WAS REVISED AS THE PINNACLE LINER WAS FOUND TO BE DISLOCATED. THE PATIENT REPORTED HEARING A "POP" PRIOR TO PRESENTATION. UPON INSPECTION, THE LINER¿S ROTATIONAL TABS WERE NOTED TO BE WORN OFF. THE CERAMIC HEAD EXHIBITED BLACK DEBRIS. DOCTOR DOCUMENTED SIGNS OF OSTEOLYSIS AND MEDIAL CALCAR BONE LOSS. DOCTOR INSPECTED THE LOCKING MECHANISM AND WAS SATISFIED WITH ITS INTEGRITY, PROCEEDING WITH REPLACEMENT OF THE LINER. THE PATIENT REQUESTED TO KEEP THE IMPLANTS REMOVED. AFFECTED SIDE: UNKNOWN HIP.

  Patient problems: Bone Notching; Osteolysis

  MAUDE report 24605612 ↗
• InjuryMar 13, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS REVISED FOR RIGHT HIP INSTABILITY. THERE WAS NO SURGICAL DELAY. ACTIVITY LEVEL WAS YES. DOI: UNKNOWN, DOR: (B)(6) 2026, AFFECTED SIDE-RIGHT HIP.

  Patient problems: Joint Laxity

  MAUDE report 24598520 ↗
• InjuryMar 13, 2026Naturally Worn

  IT WAS REPORTED THAT PINN MAR +4 10D 32IDX48OD, DELTA CER HEAD 12/14 32MM +1, AND PINN SECTOR W/GRIPTION 48MM WERE INVOLVED IN A REPORTED EVENT. THE COMPLAINT DESCRIBED PREMATURE WEAR OF POLYETHYLENE AND IMPLANT BEARING MATERIALS, RESULTING IN TWO REVISION SURGERIES AND REPLACEMENT OF THE POLYETHYLENE INSERT AND FEMORAL HEAD. THE EVENT WAS ASSOCIATED WITH IMPLANT DISASSOCIATION BETWEEN THE CUP AND LINER, AND THE AFFECTED IMPLANTS WERE EXPLANTED AND PREPARED FOR RETURN.

  Patient problems: Insufficient Information

  MAUDE report 24589484 ↗
• InjuryMar 10, 2026Device Dislodged or Dislocated

  PATIENT WAS REVISED DUE TO DISLOCATION. DOI: (B)(6) 2019. DOR: (B)(6) 2026. AFFECTED SIDE: LEFT HIP.

  Patient problems: Joint Dislocation

  MAUDE report 24558972 ↗
• InjuryMar 9, 2026Device Dislodged or Dislocated

  IT WAS REPORTED THAT ON (B)(6) 2026 A TRIFLANGE WAS PLACED WITH A PROXIMAL FEMORAL REPLACEMENT. UPON SURGEON DISCRETION, THE PATIENT WAS LEFT 5 CM SHORT. TODAY WE CHANGED THE CONSTRAINED LINER AND ADDED 8 MM IN LENGTH DUE TO THE HEAD DISASSOCIATING FROM THE MORSE TAPER IN THE PROXIMAL FEMORAL REPLACEMENT. AFFECTED SIDE: LEFT HIP.

  Patient problems: Physical Asymmetry

  MAUDE report 24544272 ↗
• InjuryFeb 24, 2026Noise, Audible

  ADDITIONAL INFORMATION WAS RECEIVED STATING: PATIENT CALLED THIS WRITER BACK ON (B)(6) 2026. SHE STATES THAT SHE HAS NO HISTORY OF FALLS BUT HER HIP FELT UNSTABLE AND LIKE IT WAS GOING TO "POP." DURING THE REVISION THE LINER WAS JAGGED AND BROKEN OFF. THE FEMORAL HEAD WAS BLACK AND "SCRAPED UP." THE SURGEON STATED THE HEAD RUBBING ON THE CUP WAS THE CAUSE OF THE SQUEAKING. DOI: 2018. DOR: 2024. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Pain

  MAUDE report 24431139 ↗
• InjuryFeb 17, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT UNDERWENT WASH OUT DUE TO INFECTION. DOI: (B)(6) 2026. DOR: (B)(6) 2026. AFFECTED SIDE: LEFT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 24369722 ↗
• InjuryFeb 9, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT HEAD EXPLANTED DUE TO INFECTION. DOI: (B)(6) 2026. DOR: (B)(6) 2026. AFFECTED SIDE: UNKNOWN.

  Patient problems: Unspecified Infection

  MAUDE report 24299073 ↗