BIOLOX DELTA 1365-36-340Recalls & reported problems

Summary

The FDA's MAUDE database contains 70 adverse event reports that list this exact device (DI 10603295033646), received between Aug 28, 2017 and Sep 23, 2026 — classified as 68 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (25 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 70 reports, in the reporter's own words as published by the FDA.

• InjurySep 23, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that the I&D poly swap & head exchange. No issues or problems or delays during this case.DOI: on (b)(6) 2026,DOR: on (b)(6) 2026,Affected side: Right Hip.

  Patient problems: Insufficient Information

  MAUDE report 50872169 ↗
• InjuryAug 28, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that patient had prostalac spacer for infection, right hip. Removal of all implants from original surgery date of (b)(6) 2026. Affected side- Right Hip.

  Patient problems: Unspecified Infection

  MAUDE report 50497242 ↗
• InjuryJun 23, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT WAS REVISED DUE TO INFECTION. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 25595195 ↗
• InjuryMar 13, 2026Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO INFECTION. HEAD BALL AND POLY WERE EXCHANGED. DOI: UNKNOWN, DOR: (B)(6) 2026, AFFECTED SIDE: UNKNOWN HIP.

  Patient problems: Unspecified Infection

  MAUDE report 24592597 ↗
• InjuryFeb 25, 2026Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PATIENT WAS REVISED DUE TO REOCCURRING DISLOCATIONS. NO DAMAGE REPORTED TO IMPLANTS. PATIENT DISLOCATED AND REQUIRED REVISION TO STABILIZE.

  Patient problems: Joint Dislocation

  MAUDE report 24447433 ↗
• InjuryJan 28, 2026Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PATIENT KEPT DISLOCATING. IT WAS BELIEVED BY THE SURGEON THAT THE INITIAL SURGEON PUT THE STEM TOO LOW WHEN PREPPING AND IMPLANTING. SURGEON REVISED STEM AND LINER AND INCREASED THE HEIGHT OF THE STEM PLACEMENT. DOI: (B)(6) 2025. DOR: (B)(6) 2026. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Joint Dislocation

  MAUDE report 24202187 ↗
• InjuryJun 26, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  THE PATIENT WAS REVISED DUE TO DISLOCATION; A LONGER HEAD WAS IMPLANTED. THE LINER WAS NOT REPLACED. DOI: (B)(6) 2025. DOR: (B)(6) 2025. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Joint Dislocation

  MAUDE report 22338902 ↗
• InjuryJun 9, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PATIENT STOOD UP FOR FIRST TIME IN PACU AND EXPERIENCED A POP AND PAIN. UPON GETTING AN XRAY, IT WAS FOUND THAT THE HEAD BALL HAD DISLODGED FROM THE NECK TRUNION OF THE STEM. THE HEAD WAS RETAINED IN THE CUP, BUT THE STEM DISLOCATED FROM THE HEAD AND OUT OF PLACE. THE PATIENT UNDERWENT REVISION SURGERY DUE TO DISLOCATION.

  Patient problems: Insufficient Information

  MAUDE report 22166332 ↗
• InjuryApr 21, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS REVISED DUE TO HAVING PAIN AND INFECTION. STEM, POLY, HEAD WERE TAKEN OUT. IT IS UNKNOWN IF THERE WAS A SURGICAL DELAY. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Pain; Unspecified Infection

  MAUDE report 21872073 ↗
• InjuryFeb 5, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PATIENT'S RIGHT HIP WAS REVISED DUE TO DISLOCATION. PATIENT'S PRIMARY FEMORAL HEAD AND LINER WERE REPLACED BY PINNACLE DUAL MOBILITY COMPONENTS TO STABILIZE PATIENT HIP. THERE WAS NO SURGICAL DELAY. DOI: UNKNOWN. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Joint Dislocation

  MAUDE report 21314958 ↗
• InjuryJan 7, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD SUBCUTANEOUS INFECTION. HEAD, LINER, STEM WERE REMOVED. THERE WAS NO DELAY IN CASE. DOI: (B)(6) 2024. DOR: (B)(6) 2024. AFFECTED SIDE: UNKNOWN.

  Patient problems: Unspecified Infection

  MAUDE report 21091521 ↗
• InjuryJan 3, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THE PATIENT EXPERIENCED A PAINFUL POSSIBLE INFECTION. THE PATIENT UNDERWENT A REVISION FOR WASH OUT AND EXCHANGE OF THE HEAD AND LINER.

  Patient problems: Pain; Unspecified Infection

  MAUDE report 21068550 ↗
• MalfunctionDec 4, 2024Fracture; Fracture

  IT WAS REPORTED THAT THE DOCTOR HIT THE CERAMIC HIP HEAD WITH THE HEAD PUSHER AND MALLET, AND HE COULD NOT GET IT TO SIT ON THE STEM CORRECTLY AND THEN NOTICED THERE WAS A CRACK IN IT. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Insufficient Information

  MAUDE report 20842899 ↗
• InjuryNov 22, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD REVISION SURGERY AND THE REASON WAS SEROMA. SURGICAL DELAY WAS UNKNOWN. DOI: (B)(6) 2024. DOR: (B)(6) 2024. AFFECTED SIDE: LEFT HIP.

  Patient problems: Seroma

  MAUDE report 20759362 ↗
• InjurySep 25, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT HAD HEAD AND LINER REMOVAL. NO DELAY IN SURGERY. DOI- UNKNOWN. DOR- (B)(6) 2024. AFFECTED SIDE- RIGHT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 20302859 ↗
• InjuryJun 3, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO POSSIBLE INFECTION. THE PATIENT HAD IRRIGATION AND DEBRIDEMENT (I&D) WITH HEAD AND LINER EXCHANGE. IT WAS UNKNOWN, IF THERE WAS A SURGICAL DELAY. DOI- (B)(6) 2024, DOR- (B)(6) 2024, AFFECTED SIDE- RIGHT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 19451719 ↗
• MalfunctionMay 2, 2024Difficult to Insert; Difficult to Insert

  IT WAS REPORTED THAT THE HEAD DID NOT PROPERLY ENGAGED TO THE STEM NECK. A NEW IMPLANTED WAS INSERTED.

  Patient problems: Insufficient Information

  MAUDE report 19228351 ↗
• InjuryMar 12, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD HIS HIP REPLACED ON (B)(6) 2024 BY THE SURGEON WHERE HE HAD A SUMMIT PINNACLE CONSTRUCT IMPLANTED. THE PATIENT BEGAN TO EXPERIENCE SOME WOUND DRAINAGE A WEEK AFTER SURGERY. THE DECISION WAS MADE TO BRING THE PATIENT IN FOR A IRRIGATION AND DEBRIDEMENT (I&D) PROCEDURE. THE ACETABULAR CUP LINER AND HIP BALL WERE EXPLANTED AND REPLACED WITH A NEW HEAD AND LINER. THE STEM AND THE CUP WERE LEFT IN SITU. THERE WAS NO CAUSE OF INFECTION TO REPORT, AND NO SURGICAL DELAY OR ADVERSE EVENTS TO REPORT. DOI: (B)(6) 2024. DOR: (B)(6) 2024. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Fluid Discharge

  MAUDE report 18885133 ↗
• InjuryJan 4, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT LINER AND HEAD WERE REMOVED AND REPLACED FOR IRRIGATION AND DEBRIDEMENT. SURGICAL DELAY UNKNOWN. US-FDA MDR REPORTABILITY DETERMINATION: HEAD AND LINER WERE REVISED TO PERFORM AN I&D WASHOUT. ALTHOUGH CLEAR ALLEGATIONS WERE NOT PROVIDED, IT IS REASONABLE TO CONCLUDE THAT THE HIP WAS REVISED TO ADDRESS A SERIOUS INJURY, WHETHER FOR INFECTION OR FOR A HEMATOMA, OR SOME SUCH TISSUE RELATED EVENT. DOI: (B)(6) 2023; DOR: (B)(6) 2023; AFFECTED SIDE: LEFT HIP.

  Patient problems: Insufficient Information

  MAUDE report 18442530 ↗
• InjuryOct 10, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE POLY LINER AND HEAD WERE EXCHANGED DUE TO INFECTION. DOI: (B)(6) 2023 DOR: (B)(6) 2023 AFFECTED SIDE: UNKNOWN HIP SIDE.

  Patient problems: Unspecified Infection

  MAUDE report 17904064 ↗
• InjurySep 28, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE CERAMIC HEAD LOOSENED FROM TRUNION OF ACTIS STEM AFTER CLOSURE OF THE WOUND. THE PATIENTS WOUND WAS OPENED UP AGAIN AND THE CERAMIC HEAD WAS REMOVED. A METAL HEAD WAS THEN IMPLANTED IN ITS PLACE. DOI: SEPTEMBER 18, 2023. DOR: (B)(6) 2023. AFFECTED SIDE: RIGHT HIP.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17833096 ↗
• InjuryMay 30, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated

  THE PATIENT STATED THAT SINCE FILING THE VOLUNTARY REPORT, SHE IS RECOVERING WELL AND HER PAIN HAS SIGNIFICANTLY DECREASED. SHE CLARIFIED THAT THE FIRST SURGERY WAS A CLOSED REDUCTION AND THAT THE HEAD AND LINER WERE REPLACED DURING THE REVISION. SHE HAS NO FURTHER QUESTIONS OR CONCERNS AT THIS TIME.

  Patient problems: Ambulation or Postural Difficulties; Joint Dislocation; Numbness; Pain

  MAUDE report 17022261 ↗
• InjuryMay 23, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO WASHOUT WITH I&D; NO WAY TO CONFIRM INFECTION. THERE ARE NO BROKEN PIECES. DOI: (B)(6) 2023. DOR: (B)(6) 2023. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 16984084 ↗
• InjuryMay 3, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated

  PATIENT WAS REVISED DUE TO DISLOCATION HAPPENED PREVIOUSLY AND THE SURGEON ELECTED TO CONVERT TO DUAL MOBILITY. THERE WAS NO LOOSENING WAS REPORTED. DOI: (B)(6) 2020. DOR: (B)(6) 2023. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Joint Dislocation

  MAUDE report 16860072 ↗
• InjuryApr 12, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT WAS EXPERIENCING LEG DROP FROM LONG LEG LENGTH. A BIGGER STEM WAS IMPLANTED ALONG WITH A SHORTER HEAD. DOI- (B)(6) 2023. DOR- (B)(6) 2023. AFFECTED SIDE- UNKNOWN HIP.

  Patient problems: Nerve Damage; Physical Asymmetry

  MAUDE report 16723810 ↗