ASPHERE 1365-53-100Recalls & reported problems

Summary

The FDA's MAUDE database contains 18 adverse event reports that list this exact device (DI 10603295033967), received between Oct 22, 2017 and May 11, 2023 — classified as 18 injuries.

The most frequently reported specific device problem is “Naturally Worn” (3 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 18 most recent of 18 reports, in the reporter's own words as published by the FDA.

• InjuryMay 11, 2023Naturally Worn; Naturally Worn

  LITIGATION RECORDS AD (B)(6) 2023 ALLEGES PATIENT SUFFERED OF HEAVY METAL POISONING FROM THE TOXIC HEAVY METALS RELEASED BY THE PINNACLE HIP REPLACEMENT, RESULTING IN INJURY DECREASED LONGEVITY, INCLUDING BUT NOT LIMITED TO SIGNIFICANT PAIN, BONE DESTRUCTION, METAL WEAR, AND TOXIC HEAVY METAL POISONING, MOREOVER, INCURRED MEDICAL EXPENSES AND EXPECTS TO EXPERIENCE EMOTIONAL DISTRESS. DOI: 2008 DOR: (B)(6) 2022 AFFECTED SIDE: RIGHT HIP.

  Patient problems: Bone Notching; Distress; Loss of Range of Motion; Metal Related Pathology; Pain; Unspecified Tissue Injury

  MAUDE report 16909950 ↗
• InjuryFeb 1, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO PAIN . METAL LINER AND HEAD REMOVED AND REPLACED WITH TS BIOLOX AND ALTRX. DOI: (B)(6), 2009 DOR: (B)(6), 2023 AFFECTED SIDE: LEFT HIP. THERE WAS NO SURGICAL DELAY.

  Patient problems: Pain

  MAUDE report 16276863 ↗
• InjuryJan 6, 2021Adverse 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 RECORD, PATIENT WAS REVISED TO ADDRESS METALLOSIS. REVISION NOTES STATED THAT A RUSH OF FLUID WAS SEEN WHICH WAS BROWN AND CONSISTENT WITH METAL REACTION FLUID. THE HEAD WAS DISIMPACTED FROM THE TRUNNION AND THERE WAS SHOWN TO BE CORROSION ON THE TRUNNION ITSELF. LINER WAS REMOVED. PATIENT EXPERIENCED PAIN AND DISCOMFORT. DOI: (B)(6) 2010. DOR: (B)(6) 2020; (RIGHT HIP).

  Patient problems: Discomfort; Foreign Body Reaction; Pain

  MAUDE report 11122938 ↗
• InjuryApr 1, 2020Naturally Worn; Naturally Worn

  PCF AND MEDICAL RECORDS RECEIVED. AFTER REVIEW OF MEDICAL RECORDS PATIENT WAS REVISED TO ADDRESSED METAL ON METAL REACTION OF RIGHT HIP ARTHROPLASTY WITH OSTEOLYSIS. OPERATIVE NOTES INDICATED PAIN, SCARRING, METAL DEBRIS, BONE EROSION, OSTEOLYSIS SEEN IN THE TROCHANTER AND ELEVATED CHROMIUM AND COBALT LEVELS. DOI: (B)(6) 2011. DOR: (B)(6) 2020, RIGHT HIP.

  Patient problems: Adhesion(s); Erosion; Hypersensitivity/Allergic reaction; No Code Available; Osteolysis; Pain; Test Result

  MAUDE report 9912711 ↗
• InjuryMar 20, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AFTER REVIEW OF MEDICAL RECORDS PATIENT WAS REVISED TO ADDRESS METAL REACTION IN HIP CAUSING INCREASED FLUID VOLUME AROUND RIGHT TOTAL HIP REPLACEMENT. THE PATIENT HAD RECENT PAIN AND SWELLING. REVISION NOTES REPORTED THAT THE RESULT OF THIS RUPTURE OBVIOUSLY GAVE ACCESS OF THE FLUID FROM THE JOINT TO THE PERIPHERY AND MOST LIKELY RESULTED IN THE LARGE CYSTIC MASS THAT WE SAW ON THE MRI. ABOUT 60 ML FLUID BUT POSSIBLY EVEN MORE WAS ASPIRATE FROM THE HIP. THERE WAS QUITE A BIT OF CORROSION INSIDE THE TAPER OF THE METAL FEMORAL HEAD. DOI: (B)(6) 2010. DOR: (B)(6) 2016. (RIGHT HIP). PLEASE SEE (B)(4) FOR THE 2ND REVISION.

  Patient problems: Cyst(s); Edema; Foreign Body Reaction; No Code Available; Pain

  MAUDE report 9861987 ↗
• InjuryFeb 5, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PINNACLE CLAIM SUBMISSION FORM AND MEDICAL RECORDS RECEIVED. AFTER REVIEW OF MEDICAL RECORDS, IT WAS STATED THAT THE PATIENT WAS REVISED TO ADDRESS PROSTHETIC JOINT INFECTION, POSSIBLY CHRONIC. IT WAS STATED THAT THE SPECIMEN OF LEFT HIP SYNOVIUM YIELDED OVER 100 WBCS PER HIGH-POWER FIELD CONFIRMING DIAGNOSIS OF INFECTION. PROSTALAC COMPONENTS WERE IMPLANTED. DOI: (B)(6) 2010; DOR: (B)(6) 2015; LEFT HIP.

  Patient problems: No Code Available; Test Result; Unspecified Infection

  MAUDE report 9671117 ↗
• InjuryNov 22, 2019Device Dislodged or Dislocated; Device Dislodged or Dislocated

  PPF AND IMPLANT RECORDS RECEIVED. PPF ALLEGES DISLOCATION AFTER FIRST REVISION. DOI: (B)(6) 2013 - DOR: NONE REPORTED (LEFT HIP).

  Patient problems: Joint Dislocation

  MAUDE report 9362447 ↗
• InjuryOct 22, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PPF AND IMPLANT RECORDS RECEIVED. PPF HAS NO ALLEGATION, HOWEVER PPF HAS REPORTED OF REVISION. THE LINER AND HEAD WERE REPORTED TO THE IMPACTED PRODUCT. DOI: (B)(6) 2010; DOR: (B)(6) 2011; (RIGHT HIP) FIRST REVISION. PLEASE (B)(4) FOR THE RIGHT HIP SECOND REVISION.

  Patient problems: No Code Available

  MAUDE report 9218000 ↗
• InjuryOct 16, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PPF AND IMPLANT RECORDS RECEIVED. PPF ALLEGES LOOSENING OF CUP, FRACTURE (BONE) AND ELEVATED METAL IONS AFTER FIRST REVISION. UNKNOWN HIP IMPLANT HAS BEEN ADDED TO CAPTURED THE ALLEGATION OF A FRACTURE AS ITS UNKNOWN WHERE THE FRACTURE WAS. IF/WHEN MORE INFORMATION IS RECEIVED, THE PC WILL BE UPDATED AS NEEDED.  DOI: (B)(6) 2011; DOR: (B)(6) 2015; LEFT HIP. SEE (B)(4) RIGHT HIP. SEE (B)(4) LEFT HIP 1ST REVISION.

  Patient problems: No Code Available; Test Result

  MAUDE report 9199314 ↗
• InjuryFeb 8, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PPF ALLEGES INFECTION AFTER FIRST REVISION.

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 8323494 ↗
• InjuryDec 27, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AFTER REVIEW OF MEDICAL RECORDS PATIENT WAS REVISED TO ADDRESSED BILATERAL HIP MECHANICAL FAILURE OF TOTAL HIP ARTHROPLASTY WITH PSEUDOTUMOR FORMATION FROM METAL ON METAL. THERE WAS ALSO SOME CORROSION ON THE TRUNNION THAT WAS REMOVED USING A SPONGE IN SALINE. DOI: (B)(6) 2011, DOR: (B)(6) 2018 LEFT HIP.

  Patient problems: Hypersensitivity/Allergic reaction; No Code Available; Tissue Damage

  MAUDE report 8200050 ↗
• InjuryDec 26, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AFTER REVIEW OF MEDICAL RECORDS PATIENT WAS REVISED TO ADDRESSED BILATERAL HIP MECHANICAL FAILURE OF TOTAL HIP ARTHROPLASTY WITH PSEUDOTUMOR FORMATION FROM METAL ON METAL. THERE WAS SOME CORROSION BETWEEN THE HEAD AND TRUNNION. THIS WAS CLEANED USING A SPONGE AND IRRIGATION.

  Patient problems: No Code Available; Tissue Damage

  MAUDE report 8197700 ↗
• InjurySep 18, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE PATIENT HAD A PAINFUL METAL ON METAL HIP. DOI: (B)(6) 2010; DOR: (B)(6) 2018; RIGHT HIP.

  Patient problems: Not Applicable; Pain

  MAUDE report 7886508 ↗
• InjuryMay 18, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  PPF AND STICKER SHEET RECEIVED. PINNACLE PLAINTIFF PROFILE FORM ALLEGES PSEUDOTUMOR AND INFECTION. DOI: (B)(6) 2011; DOR: NOT REPORTED; RIGHT HIP.

  Patient problems: Tissue Damage; Unspecified Infection

  MAUDE report 7525884 ↗
• InjuryMar 23, 2018Material Disintegration; Naturally Worn; Material Disintegration; Naturally Worn

  ALLEGES PAIN, DISCOMFORT, MOBILITY ISSUES, PSYCHOLOGICAL AND EMOTIONAL TRAUMA, ELEVATED METAL IONS, AND MRI REVEALED PERITROCHANTERIC FLUID COLLECTION. AFTER REVIEW OF MEDICAL RECORDS FOR MDR REPORTABILITY, IT WAS REPORTED THAT THE PATIENT WAS REVISED TO ADDRESS CHRONIC PAIN DISABILITY DUE TO THE FAILED HIP ARTHROPLASTY. ADMISSION NOTES REPORTED GRINDING OF METAL IMPLANTS RELEASED METAL IONS INTO THE PATIENT'S BLOOD. NO LAB RESULTS WERE PROVIDED. DOI: (B)(6) 2009; DOR: (B)(6) 2017; LEFT HIP.

  Patient problems: Discomfort; Distress; Host-Tissue Reaction; Limited Mobility Of The Implanted Joint; No Code Available; Not Applicable; Pain

  MAUDE report 7366223 ↗
• InjuryJan 22, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED TO ADDRESS PAINFUL RIGHT HIP WITH MOM PINNACLE LINER. REMOVE MOM LINER AND REPLACED WITH AHRX LINER AND TS HEAD. DOI: (B)(6) 2010; DOR: (B)(6) 2017; RIGHT HIP.

  Patient problems: Pain

  MAUDE report 7208964 ↗
• InjuryDec 28, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DER STATED THAT THE PATIENT HAD A SWELLING IN THE HIP AREA AND METALLOSIS. NO ABNORMAL SIGNS OF WEAR ON EXPLANTS. DOI: (B)(6) 2009; DOR: (B)(6) 2017 RIGHT HIP.

  Patient problems: Swelling; Tissue Damage

  MAUDE report 7150890 ↗
• InjuryOct 22, 2017Device Dislodged or Dislocated; Device Dislodged or Dislocated

  COMPLAINT DESCRIPTION: PATIENT WAS REVISED TO ADDRESS DISLOCATION.

  Patient problems: Joint Dislocation

  MAUDE report 6967724 ↗