ARTICUL/EZE 1365-14-000Recalls & reported problems

Summary

The FDA's MAUDE database contains 40 adverse event reports that list this exact device (DI 10603295033127), received between Sep 7, 2017 and Apr 29, 2025 — classified as 39 injuries, 1 malfunction.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (13 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 40 reports, in the reporter's own words as published by the FDA.

• InjuryApr 29, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE HEAD AND LINER WERE REVISED DUE TO LUXATION.

  Patient problems: Joint Dislocation

  MAUDE report 21927068 ↗
• InjuryApr 2, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT PATIENT UNDERWENT REVISION SURGERY DUE TO POOR CUP POSITION LEADING TO DISLOCATION. SURGEON IMPLANTED A NEW CUP, LINER, AND HEAD. THERE WAS NO SURGICAL DELAY. DOI: (B)(6) 2020 DOR: (B)(6) 2025 AFFECTED AREA: LEFT HIP.

  Patient problems: Joint Dislocation

  MAUDE report 21755024 ↗
• InjuryMar 19, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT WAS UNSTABLE DUE TO DEMENTIA/POST OP PROTOCOL. DOI: UNKNOWN; DOR: (B)(6) 2025; AFFECTED SIDE: UNKNOWN.

  Patient problems: Joint Laxity

  MAUDE report 21641712 ↗
• InjuryOct 22, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION RECEIVED STATES THAT THERE WAS NO PATIENT CONSEQUENCE AND NO SURGICAL DELAY REPORTED. THE REASON FOR WASHOUT AND REVISION WAS BECAUSE THE PATIENT'S INCISION WAS RED, IRRITATED AND DRAINING.

  Patient problems: Erythema; Fluid Discharge; Skin Inflammation/ Irritation

  MAUDE report 20506197 ↗
• InjuryOct 15, 2024Adverse 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 PELVIC FRACTURE AND INFECTION. THERE WAS AN ACETABULAR CUP LOOSENING AT NON-CEMENTED INTERFACE. DOI: (B)(6) 2024. DOR: (B)(6) 2024. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 20451392 ↗
• InjuryJun 20, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT SURGEON CHANGED THE HEAD SIZE FOR THE HEAD BALL FROM +12 TO A +5. DOI: ON (B)(6) 2024, DOR: ON (B)(6) 2024, AFFECTED SIDE: LEFT HIP.

  Patient problems: Insufficient Information

  MAUDE report 19574420 ↗
• InjuryApr 12, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT WAS REVISED DUE TO INFECTION RESISTANT TO ANTIBIOTICS. HEAD REMOVED AND REPLACED WITH NEW ANTIBIOTICS. DOI: (B)(6) 2024. DOR: (B)(6) 2024. AFFECTED SIDE: UNKNOWN.

  Patient problems: Unspecified Infection

  MAUDE report 19098669 ↗
• InjuryDec 7, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PATIENT HAD ECCENTRIC WEAR OF POLY AND WORE THROUGH THE POLY OVER TIME. A CUP REVISION WAS DONE AND THE HEAD WAS SWAPPED. DOI :(B)(6) 2002, DOR: (B)(6) 2023, AFFECTED SIDE : RIGHT HIP.

  Patient problems: Joint Dislocation

  MAUDE report 18284452 ↗
• InjuryNov 8, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT HAD PAIN. BIPOLAR WAS CONVERTED TO TOTAL. IT WAS UNKNOWN ABOUT SURGICAL DELAY. DOI: (B)(6) 2021. DOR: (B)(6) 2023. AFFECTED SIDE: RIGHT.

  Patient problems: Pain

  MAUDE report 18097191 ↗
• InjuryMay 31, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT PATIENT HAD A COUPLE DISLOCATIONS OVER THE LAST HANDFUL OF YEARS. CUP WAS SLIGHTLY INCLINED AND A LITTLE TOO MUCH ANTEVERSION. DOI: UNKNOWN, DOR: (B)(6)2023, AFFECTED SIDE: RIGHT HIP.

  Patient problems: Joint Dislocation

  MAUDE report 17030364 ↗
• InjuryMar 3, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO HIP PAIN, SURGEON CHANGED HEAD AND INSERT. DOI- UNKNOWN, DOR- (B)(6) 2023, AFFECTED SIDE- UNKNOWN.

  Patient problems: Pain

  MAUDE report 16477200 ↗
• InjuryOct 1, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL NOTIFICATION RECEIVED FOR REVISION DUE TO INFECTION. DATE OF IMPLANTATION: (B)(6) 2013; DATE OF REVISION #1: (B)(6) 2013; DATE OF REVISION #2:(B)(6) 2015; DATE OF REVISION #3: (B)(6) 2021; DATE OF REVISION #4: (B)(6) 2021; DATE OF REVISION#5: (B)(6) 2022; (LEFT HIP).

  Patient problems: Swelling/ Edema; Unspecified Infection; Unspecified Tissue Injury

  MAUDE report 15524197 ↗
• InjuryMay 12, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO PAIN. DOI: UNKNOWN; DOR: (B)(6) 2022; AFFECTED SIDE: UNKNOWN HIP.

  Patient problems: Pain

  MAUDE report 14371750 ↗
• InjuryOct 14, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD A HEMIARTHROPLASTY ON (B)(6) 2021. THE SURGEON STATED THAT HE FELL A FEW DAYS AFTER AND DISLOCATED, THE PATIENT HAS PARKINSON¿S. THE SURGEON ELECTED TO REDUCE AND CHANGE THE BIPOLAR HEAD ON (B)(6) 2021. THE PATIENT WAS PLACED IN A BRACE TO STABILIZE THE LEG BUT THE SURGEON SAID HE WASN¿T WEARING IT CONSISTENTLY. THE SURGEON SAID HE FELL AGAIN AROUND THE END OF SEPTEMBER AND THAT HE BELIEVED THE PATIENT TO POSSIBLY BE INFECTED. THE SURGEON ELECTED TO REMOVE ALL THE IMPLANTS AND LEAVE THE PATIENT WITH A GIRDLE STONE AND TEY TO CLEAR THE INFECTION. DOI: (B)(6) 2021 (STEM), (B)(6) 2021 (BIPOLAR HEAD AND FEMORAL HEAD). DOR: (B)(6) 2021 AFFECTED SIDE: RIGHT HIP.

  Patient problems: Fall; Unspecified Infection

  MAUDE report 12636771 ↗
• InjurySep 28, 2021Device Dislodged or Dislocated; Adverse Event Without Identified Device or Use Problem; Device Dislodged or Dislocated; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION RECEIVED INDICATED THE FOLLOWING: A. CAN YOU PLEASE CONFIRM IF THE PRODUCTS REPLACED ON (B)(6) 2018 WERE DEPUY? IF YES, PLEASE PROVIDE PRODUCT AND LOT DETAILS OR COMPLAINT NUMBER IF PREVIOUSLY REPORTED. NO, THEY WERE DEVICES FROM THE TORNIER COMPANY. B. WAS THERE A SURGICAL DELAY BECAUSE OF THIS EVENT? IF YES, WHAT WAS THE DURATION OF THE DELAY? NO SURGICAL DELAY BUT NEED FOR REVISION SURGERY. C. PLEASE ADD TO THE FOLLOW-UP: WHAT WAS THE REASON FOR THE REMOVAL OF THE PROSTHESIS WITH FEMOROTOMY, ENLARGED SYNOVECTOMY AND PLACEMENT OF SPACER? FUNCTIONAL DETERIORATION SINCE MID-JULY WITH TOTAL FUNCTIONAL IMPOTENCE AND PAIN RESULTING IN A CT SCAN SHOWING LOOSENING OF THE ACETABULAR IMPLANT. D. WHAT DATE WAS THIS REVISION? (B)(6) 2021. E. WHY WAS A SPACER PLACED? AFTER LOOSENING OF THE PROSTHESIS, AWAITING REIMPLANTATION OF LEFT THP. F. HISTOLOGY/PATHOLOGY REPORT:- - PRIMARY AND/OR REVISION MICROBIOLOGY REPORTS, ARTHROSCOPY SAMPLES PRIOR TO REVISION, HISTOLOGY/PATHOLOGY REPORTS FROM REVISION. SEE DOCUMENT ATTACHED -OPERATING REPORT: RESULT: THE LEFT FEMORAL AND GLUTEAL SOFT TISSUE COLLECTIONS ARE NOTED. - THE GLUTEAL COLLECTION IS MEASURED AT 144X107MMX53MM, STABLE

  Patient problems: Foreign Body Reaction; Joint Dislocation; Osteolysis; Pain

  MAUDE report 12539521 ↗
• InjurySep 1, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT WAS REVISED DUE TO INFECTION. NO SURGICAL DELAY. DOI: (B)(6) 2021. DOR: (B)(6) 2021. UNKNOWN AFFECTED SIDE.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 12406999 ↗
• InjuryAug 11, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PPF AND MEDICAL RECORDS RECEIVED. PPF HAS NO ALLEGATION. AFTER REVIEW OF MEDICAL RECORDS, IT WAS INDICATED THAT THE PATIENT HAD A REVISION AND REASON WAS NOT PROVIDED. DOI: (B)(6) 2012, DOR: (B)(6) 2019, RIGHT HIP.

  Patient problems: Insufficient Information

  MAUDE report 12308943 ↗
• InjuryMar 10, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS REVISED USING DUAL MOBILITY FOR STABILITY. ORIGINAL IMPLANT DATE UNKNOWN. DOI: UNKNOWN - DOR: (B)(6) 2021 (LEFT HIP).

  Patient problems: Joint Laxity

  MAUDE report 11453114 ↗
• InjuryMar 8, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS REVISED TO A DUAL MOBILITY FOR STABILITY. ORIGINAL IMPLANT DATE: UNKNOWN. DOI: UNKNOWN. DOR: (B)(6) 2021; LEFT HIP.

  Patient problems: Joint Laxity

  MAUDE report 11436070 ↗
• InjuryDec 10, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED DUE TO INSTABILITY. DOI: (B)(6) 2020, DOR: (B)(6) 2020, AFFECTED SIDE: LEFT HIP.

  Patient problems: Joint Laxity

  MAUDE report 10983502 ↗
• MalfunctionNov 13, 2020Difficult to Insert; Difficult to Insert

  A. BAD INSTRUMENTS » : WHICH INSTRUMENTS WERE USED ? REFERENCE AND OF NUMBER ? BIMENTUM PRESS SYSTEM OF NUMBER? DS50012 / RA90430072 BI MENTUM LINER HEADPRESS DS50017 / RA90130305 BI MENTUM ANGLED WRENCH B. WILL THE LINER AND THE INSTRUMENTS BE SENT BACK ? YES C. BATCH OF THE BIMENTUM PE LINER INCRIMINATED? YES IT DOES NOT ANSWER TO THE QUESTION. PLEASE GIVE US THE BATCH NUMBER ARTICUL/EZE BALL 28 +12 BLK 1365140000 / LOT: D1411953B BI MENTUM PFR PE LINER 55/28 DS10005528 / LOT: 1807181A D. HOW WAS THE SURGICAL PROCEDURE COMPLETED ? CANCELLATION ? WE TRIED IT AGAIN WITH NEW IMPLANTS, IT WORKED IN SECOND TIME TRYING. REFERENCES OF NEW IMPLANTS ARTICUL/EZE BALL 28 +12 BLK 1365140000 BI MENTUM PFR PE LINER 55/28 DS10005528 E. USE OF OTHER INSTRUMENTS ? WHICH REFERENCES ? NO NO F. USE OF OTHER IMPLANTS ? WHICH REFERENCES ? NO NOT CONSISTENT WITH THE ANSWER ABOVE. NO

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10838001 ↗
• InjuryJun 12, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED DUE TO PAIN. ORIGINAL IMPLANT DATE UNKNOWN. DOI: UNKNOWN. DOR: (B)(6) 2020; LEFT HIP.

  Patient problems: No Code Available; Pain

  MAUDE report 10148710 ↗
• InjuryMar 26, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  3RD LEFT HIP REVISION. ORIGINAL SURG: (B)(6) 2019. 1ST REV SURG: (B)(6) 2020 (B)(4). 2ND REV SURG; (B)(6)2020 (B)(4). REMOVED HEAD AND STEM DUE TO INFECTION.

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 9884902 ↗
• InjuryJan 15, 2020Device Dislodged or Dislocated; Device Dislodged or Dislocated

  ACETABULAR REVISION TO INCLUDE REMOVAL OF CUP, LINER AND HEAD DUE TO CRONIC DISLOCATIONS.

  Patient problems: Joint Dislocation; No Code Available

  MAUDE report 9593037 ↗
• InjuryDec 26, 2019Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE HIP BALL WAS DISLOCATED FROM CONSTRAINED LINER. LINER WAS DEEMED TO BE DAMAGED FROM SKIRT ON HIP BALL CAUSED POLY FIN BREAKAGE. BALL WAS NO LONGER CONSTRAINED BY LOCKING MECHANISM. DOI: (B)(6) 2018; DOR: (B)(6) 2019; LEFT HIP.

  Patient problems: Joint Dislocation; No Code Available

  MAUDE report 9521498 ↗