NA 1365-13-500Recalls & reported problems

Summary

The FDA's MAUDE database contains 16 adverse event reports that list this exact device (DI 10603295033110), received between Nov 16, 2017 and Jul 3, 2024 — classified as 15 injuries, 1 malfunction.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (8 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 16, 2026.

Most reported problems

Recent adverse event reports

The 16 most recent of 16 reports, in the reporter's own words as published by the FDA.

• InjuryJul 3, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT UNDERWENT REVISION DUE TO CONSISTENT INFLAMMATORY PSEUDOTUMOR WITH ASSOCIATED MILD TO MODERATE ALVAL REACTION. ASSOCIATED SYNOVIAL TISSUE WITH MODERATE HEMOSIDERIN DEPOSITION WAS ALSO REPORTED. DOI: (B)(6) 2007. DOR: (B)(6) 2017. AFFECTED HIP: RIGHT. THIS IS BILATERAL HIP ARTHROPLASTY.

  Patient problems: Foreign Body Reaction; Hypersensitivity/Allergic reaction; Inflammation; Synovitis

  MAUDE report 19668087 ↗
• InjuryMay 5, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated

  ADDITIONAL INFORMATION RECEIVED. A. WAS THERE A SURGICAL DELAY? IF YES, WHAT IS THE DURATION OF THE DELAY? NO. B. CAN YOU PLEASE CLARIFY, WHY THE CUP WAS REVISED? WAS THERE AN INDICATION, THAT THE CUP WAS MALPOSITIONED THAT CONTRIBUTED TO DISLOCATION? YES, MALPOSITIONED.

  Patient problems: Joint Dislocation

  MAUDE report 16878661 ↗
• InjuryMar 22, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated

  PATIENT WAS REVISED DUE TO DISLOCATION. DOI: UNKNOWN. DOR: (B)(6) 2023. AFFECTED SIDE: UNKNOWN. THERE WAS NO SURGICAL DELAY.

  Patient problems: Joint Dislocation

  MAUDE report 16591389 ↗
• InjuryFeb 22, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT HAD A PINNACLE METAL LINER REMOVED BECAUSE OF SUSPECTED PSEUDO TUMOR. DOI: (B)(6) 2002. DOR: (B)(6) 2023. UNKNOWN SIDE.

  Patient problems: Hypersensitivity/Allergic reaction

  MAUDE report 16417694 ↗
• InjuryAug 24, 2022Device Dislodged or Dislocated; Device Dislodged or Dislocated

  PATIENT EXPERIENCED MULTIPLE DISLOCATIONS. DOI: UNKNOWN. DOR: (B)(6) 2022. AFFECTED SIDE: UNKNOWN.

  Patient problems: Joint Dislocation

  MAUDE report 15289783 ↗
• InjuryJul 28, 2022Device Dislodged or Dislocated; Device Dislodged or Dislocated

  PATIENT REVISED DUE TO DISLOCATING POSTERIORLY. THE SURGEON DECIDED TO REMOVE THE HEAD, LINER AND CUP TO CEMENT IN A BIMENTUM CUP FOR MORE STABILITY. UPON TRIALING HE DETERMINED HE NEED MORE LENGTH AND ELECTED TO GO WITH A 28 +15.5 HEAD. HE WAS NOTIFIED THAT THIS HEAD HAD A SKIRT AND SHOULDN¿T BE USED WITH THIS CONSTRUCT AND WANTED TO PROCEED IN USING IT. NO FURTHER PATIENT INFORMATION IS AVAILABLE AT THIS TIME. DOI: UNKNOWN. DOR: (B)(6) 2022. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Joint Dislocation; Joint Laxity

  MAUDE report 15121746 ↗
• InjuryApr 20, 2021Device Dislodged or Dislocated; Noise, Audible; Device Dislodged or Dislocated; Noise, Audible

  A. WAS THERE ANY SURGICAL DELAY? IF YES PLEASE INDICATE THE DURATION. B. DATE OF INITIAL SURGERY (B)(6) 2006. C. AFFECTED SIDE-LEFT. D. PLEASE CLARIFY WHAT SQUIZING MEANS. NOISE SOUND IN HIP (SQUEAKING).

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Foreign Body Reaction

  MAUDE report 11697368 ↗
• InjuryJul 20, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  LEFT TOTAL HIP REVISION. PATIENT REPORTING THIGH PAIN. REVISED STEM, FEMORAL HEAD, AND POLY LINER.

  Patient problems: No Code Available; Pain

  MAUDE report 10296074 ↗
• InjuryJun 24, 2020Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PATIENT'S HIP SUBLUXED MANY TIMES OVER THE PAST COUPLE OF YEARS, BUT LAST WEEK IT FINALLY DISLOCATED COMPLETELY. THEY WERE ABLE TO REDUCE HIM BUT HE DECIDED TO HAVE IT REVISED. NO CORROSION ON THE NECK TAPER AND HEAD JOINT. EVERYTHING WAS WELL FIXED. I DO NOT HAVE THE EXACT DATE THEY WERE ORIGINALLY IMPLANTED IN 2003. DOI: 2003. DOR: (B)(6) 2020; RIGHT SIDE.

  Patient problems: Joint Dislocation; No Code Available

  MAUDE report 10191091 ↗
• InjuryNov 18, 2019Naturally Worn; Adverse Event Without Identified Device or Use Problem; Naturally Worn; Adverse Event Without Identified Device or Use Problem

  AFTER A REVIEW OF THE MEDICAL RECORDS, THE PATIENT WAS REVISED TO ADDRESS THE LEFT PROXIMAL FRACTURE ON THE FEMUR, OSTEOLYSIS, METAL ION TOXICITY, PSEUDOTUMOR, AND MINIMAL TAPER WEAR ON THE FEMORAL STEM. REVISION NOTE INDICATED THAT THERE WAS A LARGE AMOUNT OF RESOLVING HEMARTHROSIS FLUID THAT WAS FOUND AFTER T-CAPSULOTOMY WAS PERFORMED. THE HEAD HAS MINIMAL TAPER WEAR AND SMALL LOCALIZED OSTEOLYTIC ON THE CUP.

  Patient problems: Foreign Body Reaction; Hypersensitivity/Allergic reaction; No Code Available; Osteolysis; Test Result

  MAUDE report 9336861 ↗
• MalfunctionAug 16, 2019Device Dislodged or Dislocated; Device Dislodged or Dislocated

  PPF AND STICKER SHEETS RECEIVED. PPF ALLEGES DISLOCATION AND ELEVATED METAL IONS AFTER THE FIRST REVISION. THE STEM WAS REPORTED IN THE LEFT HIP FIRST REVISION UNDER (B)(4). DOI: (B)(6) 2007. DOR: NONE REPORTED, (LEFT HIP). (B)(4), (LEFT HIP), FIRST REVISION. (B)(4), (RIGHT HIP).

  Patient problems: Joint Dislocation; Joint Disorder; Test Result

  MAUDE report 8903088 ↗
• InjuryDec 18, 2018Material Disintegration; Material Disintegration

  LITIGATION ALLEGES PAIN,DISCOMFORT AND INFLAMMATION. AFTER SURGERY, FRICTION AND WEAR BETWEEN THE COBALT-CHROMIUM METAL IONS AND PARTICLES TO BE RELEASED INTO PATIENT'S BLOOD AND TISSUE AND BONE SURROUNDING THE IMPLANT. PATIENT EXPERIENCES A POPPING AND SNAPPING SENSATION IN HER HIP-JOINT WHEN WALKING OR MOVING TO AND FROM A SITTING POSITION.

  Patient problems: Discomfort; Inflammation; Pain; Test Result

  MAUDE report 8174062 ↗
• InjuryOct 3, 2018Loose or Intermittent Connection; Loose or Intermittent Connection

  FOUND FRAGMENT LOOSE INSIDE THE CAVITY.

  Patient problems: Joint Dislocation

  MAUDE report 7931283 ↗
• InjurySep 13, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  PATIENT WAS REVISED TO ADDRESS METALLOSIS AND LOOSENING OF STEM AT BONE TO IMPLANT INTERFACE. DOI: UNKNOWN; DOR: (B)(6) 2018; RIGHT HIP.

  Patient problems: Not Applicable; Tissue Damage

  MAUDE report 7872480 ↗
• InjuryFeb 14, 2018Device Dislodged or Dislocated; Device Dislodged or Dislocated

  THE PATIENT WAS REVISED TO ADDRESS HIP DISLOCATION. DATE OF ORIGINAL IMPLANTATION NOT DAY SPECIFIC. (B)(6) 2013 IN NOTES. DOI: (B)(6) 2013; DOR: (B)(6) 2018; RIGHT HIP.

  Patient problems: Joint Dislocation

  MAUDE report 7269451 ↗
• InjuryNov 16, 2017Insufficient Device Problem Information; Insufficient Device Problem Information

  PATIENT WAS REVISED TO ADDRESS INFECTION.

  Patient problems: Unspecified Infection

  MAUDE report 7039955 ↗