NA 1365-12-500Recalls & reported problems

Summary

The FDA's MAUDE database contains 38 adverse event reports that list this exact device (DI 10603295033097), received between Jun 12, 2014 and Apr 14, 2026 — classified as 36 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (6 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 38 reports, in the reporter's own words as published by the FDA.

• InjuryApr 14, 2026Adverse Event Without Identified Device or Use Problem

  PORTED THAT THE LEFT FEMORAL ENDOPROSTHESIS DOME DISLOCATION. THE DOME AND LINER ARE REMOVED AND DAMAGED AND FRAGMENTED INTO MULTIPLE PARTS.

  Patient problems: Insufficient Information

  MAUDE report 24871176 ↗
• InjuryMar 10, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO INFECTION AND NEEDED HEAD SWAP. DOI: (B)(6) 2024. DOR: (B)(6) 2025. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 21560836 ↗
• InjuryJul 8, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT UNDERWENT REVISION DUE TO EPISODES OF DISCOMFORT AND SOME SENSATION OF SUBLUXATION. MOREOVER, INVESTIGATION CONFIRMED AN INFLAMMATORY PSEUDOTUMOR BY WAY OF ULTRASOUND. DOI: ON (B)(6) 2008, DOR: ON (B)(6) 2010, AFFECTED HIP: LEFT, THIS IS BILATERAL HIP ARTHROPLASTY.

  Patient problems: Discomfort; Hypersensitivity/Allergic reaction; Joint Laxity

  MAUDE report 19688039 ↗
• InjuryApr 18, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS PRESENTED WITH PAIN. SURGEON TOOK HER TO SURGERY FOR A REV RTH. SURGEON FOUND THE STEM AND ACETABULAR COMPONENTS WELL POSITIONED AND SOLIDLY FIXED. THE SURGEON THEN REMOVED THE FEMORAL HEAD AND ACETABULAR METAL INSERT. AFTER I&D THE REMAINING COMPONENTS WERE DETERMINED TO REMAIN. SURGEON INSERTED A POLY INSERT AND A TS CERAMIC HEAD. UNKNOWN SURGICAL DELAY. DOI: UNKNOWN. DOR: (B)(6) 2024. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Pain

  MAUDE report 19132535 ↗
• InjuryFeb 21, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT GOT INFECTED, REMOVED BIPOLAR HEAD AND 28 +5 HEAD. PUT NEW BIPOLAR HEAD AND HEAD BACK IN. DOI: (B)(6) 2023 DOR: UNKNOWN AFFECTED SIDE: LEFT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 18748744 ↗
• InjuryJan 25, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated

  PATIENT WAS REVISED DUE TO DISLOCATED HIP. SURGEON DID NOT FEEL THE CUP POSITION WAS OPTIMAL. EXPLANTED THE CUP AND PUT IN A NEW CUP HEAD AND LINER. THERE WAS NO SURGICAL DELAY. DOI: UNKNOWN. DOR: (B)(6) 2023. AFFECTED SIDE: LEFT HIP.

  Patient problems: Joint Dislocation

  MAUDE report 16240290 ↗
• MalfunctionSep 29, 2022Inaccurate Information; Inaccurate Information

  CUSTOMER IS CLAIMING A LABELLING ISSUE ON THE BARCODE WITH 2 DIFFERENT LOT OF THE SAME PRODUCT. "SEE PICTURE: THE FIRST PACKAGING HAS THE FIELD (20)12 IN THE BAR CODE. THE SECTION (B)(4) OF BOTH PACKAGES HAS A NON-STANDARD LENGTH (IN PREVIOUS VERSIONS OF THE LABEL THE FINAL PART WAS 3397 AND NOT 33097)"

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15503730 ↗
• MalfunctionSep 29, 2022Inaccurate Information; Inaccurate Information

  CUSTOMER IS CLAIMING A LABELLING ISSUE ON THE BARCODE WITH 2 DIFFERENT LOT OF THE SAME PRODUCT. "SEE PICTURE: THE FIRST PACKAGING HAS THE FIELD (20)12 IN THE BAR CODE. THE SECTION (B)(4) OF BOTH PACKAGES HAS A NON-STANDARD LENGTH (IN PREVIOUS VERSIONS OF THE LABEL THE FINAL PART WAS 3397 AND NOT 33097)".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15503449 ↗
• InjuryJan 7, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED DUE TO INFECTION. IT HAD NOTHING WHATSOEVER TO DO WITH THE IMPLANTS. THE SURGEON ELECTED TO DO A SINGLE-STAGE REVISION, THAT INCLUDED A WASHOUT AND PARTIAL IMPLANT SWAP OUT. FEMORAL HEAD AND BIPOLAR SHELL WERE REPLACED WITH THE EXACT SAME SIZES FROM THE PRIMARY SURGERY. THERE IS NO OTHER PT INFO AVAILABLE BEYOND WHAT'S BEEN PROVIDED. DOI: (B)(6) 2020, DOR: (B)(6) 2020, AFFECTED SIDE: LEFT HIP.

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

  MAUDE report 11130979 ↗
• InjuryMay 14, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED TO ADDRESS PAINFUL HIP. DOI: UNKNOWN. DOR: (B)(6) 2020; RIGHT HIP.

  Patient problems: No Code Available; Pain

  MAUDE report 10057166 ↗
• InjuryMay 12, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD INFECTION. DOI: (B)(6) 2020; LEFT HIP.

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 10049051 ↗
• InjuryApr 29, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PRIMARY SURGERY WAS PERFORMED VIA THA (THE DATE WAS UNKNOWN). IT WAS REPORTED THAT THE REVISION SURGERY WAS PERFORMED ON (B)(6) 2020 BY REPLACING THE HEAD (P/N: (B)(4)), THE LINER (P/N: (B)(4)) AND THE CUP (KYOCERA¿S PRODUCT, P/N: (B)(4)) DUE TO ACETABULAR OSTEOLYSIS CAUSED BY MOM. THE SURGERY WAS COMPLETED, AND IT WAS UNKNOWN WHETHER THERE WAS A SURGICAL DELAY. THE CUSTOMER REQUESTS THE INVESTIGATION FOR THE WEAR CONDITIONS OF THE CONNECTION OF THE CUP AND THE LINER, THE LINER¿S SLIDING SURFACE, AND NECK-HEAD JUNCTION. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Code Available; Osteolysis

  MAUDE report 10012599 ↗
• InjuryApr 3, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  UNF AND MEDICAL RECORDS RECEIVED. AFTER A REVIEW OF THE MEDICAL RECORD, THE PATIENT WAS REVISED TO ADDRESS FAILED LEFT HIP REPLACEMENT SECONDARY TO METALLOSIS. REVISION OPERATIVE NOTES REPORTED THAT THE SYNOVIUM WAS STAINED WITH METALLOSIS. IT WAS CONFIRMED THAT THE PATIENT HAS COBALT POISONING DURING THE LEFT HIP REVISION. DOI: (B)(6) 2009. DOR: (B)(6) 2019. LEFT HIP.

  Patient problems: Foreign Body Reaction; No Code Available; Pain; Test Result

  MAUDE report 9921784 ↗
• InjuryApr 1, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  UNF AND MEDICAL RECORDS RECEIVED. AFTER A REVIEW OF THE MEDICAL RECORD, THE PATIENT WAS REVISED TO ADDRESS FAILED RIGHT TOTAL HIP REPLACEMENT SECONDARY TO METALLOSIS. REVISION OPERATIVE NOTES REPORTED THAT METALLOSIS WAS NOTED IN THE HIP CAPSULE. PATIENT CLINIC VISIT NOTE ON (B)(6) 2019, REPORTED A HIGH COBALT LEVEL. DOI: (B)(6) 2009; DOR: (B)(6) 2019; RIGHT HIP. PLEASE SEE (B)(4) FOR THE LEFT HIP REVISION.

  Patient problems: Foreign Body Reaction; No Code Available; Pain; Test Result

  MAUDE report 9912880 ↗
• InjuryFeb 11, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL NOTIFICATION RECEIVED FOR REVISION OF LEFT TOTAL HIP TO ADDRESS OSTEOLYSIS DATE OF IMPLANTATION: UNKNOWN; DATE OF REVISION #1: (B)(6) 2013; DATE OF REVISION #2: (B)(6) 2020; (LEFT HIP). TREATMENT: DEPUY FEMORAL HEAD WAS REVISED, ALONG WITH A COMPETITOR CUP AND LINER; DEPUY FEMORAL STEM RETAINED.

  Patient problems: No Code Available; Osteolysis

  MAUDE report 9693652 ↗
• InjuryNov 12, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE MOM HEAD AND INSERT WERE REMOVED AND REPLACED WITH ALTRX AND TS CERAMIC. DOI: (B)(6) 2001. DOR: (B)(6) 2019; RIGHT HIP.

  Patient problems: No Code Available; Test Result

  MAUDE report 9310994 ↗
• InjuryJul 25, 2019Device Dislodged or Dislocated; Device Dislodged or Dislocated

  PPF AND IMPLANT RECORD RECEIVED. IMPLANT RECORDS REPORTED THAT THE PATIENT UNDERWENT CLOSED REDUCTION CONVERTED TO OPEN. DOI: (B)(6) 2016; DOR: (B)(6) 2017, (RIGHT HIP) FOURTH REVISION.

  Patient problems: Joint Dislocation; No Code Available

  MAUDE report 8826081 ↗
• InjuryJul 3, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE HEAD AND LINER WERE EXCHANGED FOR ULTAMET MOM. CHROMIUM LEVEL-14.3, COBALT LEVEL-10. DOI: (B)(6) 2001, DOR: (B)(6) 2019, LEFT HIP.

  Patient problems: No Code Available; Test Result

  MAUDE report 8759445 ↗
• InjuryJul 1, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AFTER REVIEW OF MEDICAL RECORDS, THE PATIENT WAS REVISED TO ADDRESS PAIN, INSTABILITY, SENSATIONS OF SUBLUXATION AND FEELING LIKE THE HIP WAS GOING OUT. OPERATIVE NOTES CONFIRM SUBLUXATION OF THE HIP AS THEY WERE MOVING IT THROUGH RANGE OF MOTION TESTS. DOI: (B)(6) 2002; DOR: (B)(6) 2005; (LEFT HIP).

  Patient problems: No Code Available; Pain

  MAUDE report 8749754 ↗
• InjuryApr 23, 2019Naturally Worn; Naturally Worn

  PPF AND STICKER SHEETS RECEIVED. PPF ALLEGES METAL WEAR, METALLOSIS AND ELEVATED METAL IONS. DOI: (B)(6) 2004; DOR: (B)(6) 2014; (RIGHT HIP). PLEASE SEE (B)(4) FOR LEFT HIP.

  Patient problems: No Code Available; Test Result; Tissue Damage

  MAUDE report 8539469 ↗
• InjuryMar 11, 2019Naturally Worn; Naturally Worn

  PINNACLE PPF AND STICKER SHEETS RECEIVED. PPF ALLEGES METAL WEAR/METALLOSIS. DOI: (B)(6) 2004; DOR: (B)(6) 2017; (RIGHT HIP).

  Patient problems: No Code Available; Tissue Damage

  MAUDE report 8407728 ↗
• InjuryMar 7, 2019Device Dislodged or Dislocated; Device Dislodged or Dislocated

  LITIGATION ALLEGES DISLOCATION WITH CLOSED REDUCTION AND INFECTION. DOI: (B)(6) 2006- DOR: (B)(6) 2007 (RIGHT HIP).

  Patient problems: Joint Dislocation; No Code Available; Unspecified Infection

  MAUDE report 8398766 ↗
• InjuryJan 23, 2019Material Disintegration; Material Disintegration

  PPF AND MEDICAL RECORDS RECEIVED. PPF ALLEGES PSEUDOTUMOR, CONSTRAINED LINER, METAL WEAR, METALLOSIS AND ELEVATED METAL IONS. AFTER REVIEW OF MEDICAL RECORDS, NO REVISION NOTES PROVIDED.

  Patient problems: No Code Available; Test Result; Tissue Damage

  MAUDE report 8270821 ↗
• InjuryDec 14, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ALLEGED LOOSENING OF CUP AND STEM, FRACTURE(BONE) AND INFECTION.

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 8164569 ↗
• InjuryNov 16, 2018Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  PATIENT WAS REVISED DUE TO PAIN.

  Patient problems: Pain

  MAUDE report 8080988 ↗