ASPHERE 1365-50-100Recalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 10603295033905), received between Sep 15, 2017 and Apr 1, 2020 — classified as 13 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (2 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 13 most recent of 13 reports, in the reporter's own words as published by the FDA.

• InjuryApr 1, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PINNACLE CLAIM SUBMISSION FORM AND MEDICAL RECORD RECEIVED. AFTER REVIEW OF MEDICAL RECORDS, PATIENT ALLEGES PAIN. CORONAL LARGE FIELD OF VIEW IMAGES DEMONSTRATE METALLIC ARTIFACT AT THE LEVEL OF THE RIGHT HIP, CONSISTENT HIP PROSTHESIS. DOI: (B)(6) 2011. DOR: NONE REPORTED, (RIGHT HIP).

  Patient problems: No Code Available; Pain

  MAUDE report 9911275 ↗
• InjuryJan 23, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED TO ADDRESS ELEVATED ION LEVELS AND PAIN AS REPORTED BY THE SURGEON. DOI: UNKNOWN; DOR: (B)(6) 2020; (LEFT HIP).

  Patient problems: No Code Available; Pain; Test Result

  MAUDE report 9623368 ↗
• InjuryJan 14, 2020Naturally Worn; Naturally Worn

  PINNACLE LITIGATION RECORDS RECEIVED ALLEGING PAIN, SUFFERING, INJURIES PERMANENT IN NATURE, ELEVATED HIGH CHROMIUM AND COBALT LEVELS IN HER BLOOD, SEVERE PAIN IN THE LOWER BACK, LEFT HIP, THIGH AND GROIN ARE CAUSING HER TO LIMP, LIMITATIONS, ACETABULAR CUP DETACHMENT, DISCONNECTION, CREATION OF METALLIC DEBRIS, AND/OR LOOSENING, EMOTIONAL DISTRESS, LOST ENJOYMENT OF LIFE, LOST EARNINGS, LOST EARNING CAPACITY, MENTAL SUFFERING, PERMANENT IMPAIRMENT AND SCARRING. DOI: (B)(6) 2010; DOR: SCHEDULED ON (B)(6) 2020 (LEFT HIP).

  Patient problems: Adhesion(s); Limited Mobility Of The Implanted Joint; No Code Available; Pain; Test Result

  MAUDE report 9586232 ↗
• InjuryDec 5, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED TO ADDRESS PAINFUL HIP. DOI: (B)(6) 2010; DOR: (B)(6) 2019; RIGHT HIP.

  Patient problems: Pain

  MAUDE report 9418243 ↗
• InjuryMar 6, 2019Naturally Worn; Naturally Worn

  UPDATED PATIENT HARM.

  Patient problems: Foreign Body Reaction; Test Result; Tissue Damage

  MAUDE report 8396064 ↗
• InjuryFeb 5, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PINNACLE PPF HAS NO NEW ALLEGATION AFTER FIRST REVISION.

  Patient problems: No Code Available

  MAUDE report 8304354 ↗
• InjuryJan 24, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  LITIGATION ALLEGED SEVERE PAIN INTERFERED WITH PATIENT'S DAILY ACTIVITIES, DISCOMFORT, HIGH LEVELS OF COBALT AND CHROMIUM, EMOTIONAL DISTRESS, AND DISFIGUREMENT.

  Patient problems: Deformity/ Disfigurement; Discomfort; No Code Available; Pain; Test Result

  MAUDE report 8273840 ↗
• InjuryJan 15, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PPF AND STICKER SHEETS RECEIVED. PPF ALLEGES INFECTION AFTER FIRST REVISION.

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 8250666 ↗
• InjuryNov 14, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  LITIGATION ALLEGES ELEVATED METAL IONS.

  Patient problems: Test Result

  MAUDE report 8070817 ↗
• InjuryMay 8, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  PPF, PFS AND MEDICAL RECORDS RECEIVED. PFS ALLEGES PHYSICAL INJURIES, PAIN, HIVES, AND CANNOT LIE ON RIGHT SIDE. AFTER REVIEW OF MEDICAL RECORDS FOR MDR REPORTABILITY, THERE IS NO REVISION REPORTED. LAB RESULTS SHOWS BELOW 7PPB. PLAINTIFF PROFILE FORM PROVIDED THE PRODUCT AND LOT NUMBER OF THE HEAD AND LINER. DOI: (B)(6) 2009; DOR: UNKNOWN; RIGHT HIP (PINNACLE).

  Patient problems: Injury; Limited Mobility Of The Implanted Joint; Pain; Skin Irritation

  MAUDE report 7493864 ↗
• InjuryFeb 19, 2018Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  DER STATED THAT THE SURGEON REPLACED THE METAL HEAD AND METAL INSERT BECAUSE OF HIGH CHROMIUM LEVELS AND METALLOSIS. THEN PUT IN A POLYETHYLENE INSERT AND A CERAMIC HEAD. DOI: (B)(6) 2010; (B)96) 2018; RIGHT HIP.

  Patient problems: Foreign Body Reaction; Tissue Damage

  MAUDE report 7280054 ↗
• InjuryDec 6, 2017Insufficient Device Problem Information; Insufficient Device Problem Information

  THE PATIENT WAS REVISED TO ADDRESS DISCOMFORT.

  Patient problems: Discomfort

  MAUDE report 7086435 ↗
• InjurySep 15, 2017Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  DER STATES THAT REVISION OF METAL ON METAL IMPLANT. HORIZONTAL CUP REVISED TO A MORE FAVORABLE POSITION. UPDATE: 21AUG2017: THE PATIENT WAS REVISED DUE TO ELEVATED ION LEVELS.

  Patient problems: No Information

  MAUDE report 6868180 ↗