NA 1365-63-000Recalls & reported problems

Summary

The FDA's MAUDE database contains 15 adverse event reports that list this exact device (DI 10603295034117), received between Oct 20, 2017 and Sep 16, 2024 — classified as 15 injuries.

The most frequently reported specific device problem is “Naturally Worn” (4 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 15 most recent of 15 reports, in the reporter's own words as published by the FDA.

• InjurySep 16, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION WAS RECEIVED STATING THAT THERE WAS NO SURGICAL DELAY REPORTED.

  Patient problems: Foreign Body Reaction

  MAUDE report 20226630 ↗
• InjuryJun 28, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  MEDICAL RECORDS RECEIVED AD 18 JUN 2024. ON (B)(6) 1997 PATIENT UNDERWENT A RIGHT TOTAL HIP ARTHROPLASTY (ALL IMPLANT USED WERE NON DEPUY PRODUCTS). ON (B)(6) 2008 PATIENT UNDERWENT A REVISION SURGERY ON RIGHT HIP. AFTER REVIEW OF MEDICAL RECORDS PATIENT WAS REVISED WAS DUE TO ASEPTIC LOOSENING WITH OSTEOLYSIS. OPERATIVE NOTES REPORTED THAT THE STEM WAS GROSSLY LOOSE. THE ACETABULUM WAS EXPOSED AND REVISED AS IT WAS IN SOMEWHAT NEUTRAL VERSION. THE PROXIMAL FEMUR WAS NOTED TO BE DEFORMED WITH THE STEM PROTRUDING ANTERIORLY TO THE PROXIMAL FEMUR, IT WAS THEN REASSEMBLED AROUND THE STEM. THERE WAS A CORTICAL DEFECT MEASURING APPROXIMATELY 3X1.5CM NEAR THE DISTAL MOST ASPECT OF THE OSTEOTOMY. A CORTICAL STRUT ALLOGRAFT WAS USED TO COVER THE AREA. (IMPLANT USED DURING REVISION WERE DEPUY AND NON DEPUY PRODUCTS). ON (B)(6) 2015 PATIENT ALLEGED OF DISCOMFORT AND ELEVATED COBALT LEVELS. MRI OBTAINED A COLLECTION OF FLUID ON RIGHT GREATER TROCHANTER CONCERNING A POSSIBILITY OF PSEUDOTUMOR. ON (B)(6) 2015 PATIENT UNDERWENT A ANOTHER REVISION SURGERY. AFTER REVIEW OF MEDICAL RECORDS PATIENT WAS REVISED WAS DUE TO ADVERSE REACTION TO METAL ON METAL RIGHT HIP AND LOOSENING OF MODULAR BODY. OPE

  Patient problems: Discomfort; Foreign Body Reaction; Metal Related Pathology; Swelling/ Edema

  MAUDE report 19634085 ↗
• InjuryMar 19, 2022Device Dislodged or Dislocated; Device Dislodged or Dislocated

  DOI: (B)(6) 2008: PATIENT RECEIVED A RIGHT TOTAL REVISION OF AN UNKNOWN PRIMARY THA TO TREAT A PERIPROSTHETIC FEMORAL FRACTURE, DISLOCATION, AND PAIN SECONDARY TO A FALL. THE PATIENT RECEIVED PINNACLE/SOLUTION MOM THA WITH TWO ACETABULAR DOME SCREWS AND THREE SYNTHES CABLES TO SECURE THE FEMORAL FRACTURE. THE PROCEDURE WAS COMPLETED WITHOUT COMPLICATIONS. DOR: (B)(6) 2010: PATIENT RECEIVED A RIGHT HIP REVISION TO TREAT RECURRENT DISLOCATIONS. UPON ENTERING THE JOINT, THE SURGEON IDENTIFIED SIGNIFICANT LATERAL AND POSTERIOR ACETABULAR WALL DEFICIENCIES. THE CUP WAS WELL-FIXED AND STABLE AND RETAINED. THE SURGEON NOTES THE CUP WAS IN 45 DEGREES OF ABDUCTION AND PERHAPS 10 DEGREES ANTEVERSION. THE DOME SCREWS WERE REMOVED AND REPLACED WITH LONGER COMPETITOR SCREWS TO ACCOMMODATE THE NEW LINER. THE DEPUY METAL LINER WAS REPLACED WITH A COMPETITOR CONSTRAINED LINER THAT WAS CEMENTED INTO PLACE WITH COMPETITOR CEMENT. THE HEAD WAS REPLACED WITH A DEPUY HEAD WITH A LONGER NECK. THE STEM WAS IN 10 DEGREES ANTEVERSION, WELL-FIXED, STABLE, AND RETAINED. THE PROCEDURE WAS COMPLETED WITHOUT COMPLICATIONS. DOI: (B)(6) 2008. DOR: (B)(6) 2010 (HEAD AND LINER) RIGHT HIP.

  Patient problems: Joint Dislocation; Unspecified Tissue Injury

  MAUDE report 13823995 ↗
• InjuryJan 30, 2020Adverse Event Without Identified Device or Use Problem; No Apparent Adverse Event; Adverse Event Without Identified Device or Use Problem; No Apparent Adverse Event

  UNF AND MEDICAL RECORDS RECEIVED. THERE WERE NO NEW ALLEGATION REPORTED FROM UNF. AFTER REVIEW OF MEDICAL RECORDS, PATIENT WAS REVISED TO ADDRESS PAINFUL LEFT TOTAL HIP REPLACEMENT WITH METALLOSIS, AND HIGH COBALT AND CHROMIUM LEVELS. REVISION NOTE REPORTED DISCOMFORT, INCREASE COBALT AND CHROMIUM LEVELS, AND ACETABULAR CUP SHOWED DISCOLORATION AND ACETABULAR COMPONENT WAS SIGNIFICANTLY CORRODED, AND IT WAS MENTION THAT THERE WERE NO METALLOSIS NOTED, AND NO SIGNS OF LYSIS AROUND STEM. DOI: (B)(6) 2009; DOR: (B)(6) 2019 (LEFT HIP) FIRST REVISION. PATIENT IS BILATERAL, PLEASE SEE (B)(4) FOR THE RIGHT HIP.

  Patient problems: Discomfort; No Code Available; Pain; Test Result

  MAUDE report 9647470 ↗
• InjuryNov 5, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE DOCTOR STATED THAT HE WANTED TO SWAP OUT HEAD AND METAL LINER TO A CERAMIC HEAD AND POLYETHYLENE LINER. DOCTOR STATED THAT THE PATIENT WAS EXPERIENCING HIP PAIN. NO OF OTHER INFORMATION WAS PROVIDED TO ME FROM THE DOCTOR OR THE HOSPITAL. THERE WAS NO OP NOTE FROM THE ORIGINAL SURGERY. THIS IS ALL THE INFORMATION GIVEN. ORIGINAL IMPLANT DATE UNKNOWN. DOI: UNKNOWN. DOR: (B)(6) 2019. RIGHT HIP.

  Patient problems: No Code Available; Pain

  MAUDE report 9278492 ↗
• InjuryMar 21, 2019Naturally Worn; Adverse Event Without Identified Device or Use Problem; Naturally Worn; Adverse Event Without Identified Device or Use Problem

  AFTER REVIEW OF MEDICAL RECORD, PATIENT WAS REVISED TO ADDRESS FAILED RIGHT TOTAL HIP ARTHROPLASTY SECONDARY TO BEARING WEAR. REVISION NOTES STATED THAT THE HIP CAPSULE ANTERIORLY WAS THICKENED AND THERE WAS SYNOVIAL FLUID BENEATH. MOST OF THE ANTERIOR CAPSULE WAS SEVERELY DISEASED, VERY INFLAMED, AND THICKENED WITH HYPERTROPHIC SYNOVIUM. SYNOVECTOMY WAS PERFORMED DUE TO THE SEVERITY OF SOFT TISSUE DAMAGE. THE HEAD AND LINER WERE REMOVED. THERE WAS CORROSION AT THE TRUNNION. CLINICAL VISITS PRIOR TO THE REVISION STATED THAT PATIENT HAD A LARGE PSEUDOTUMOR WITH METAL SYNOVITIS. OPERATIVE FINDINGS STATED THAT THE HETEROTOPIC BONE WAS REMOVED. THE METAL SYNOVITIS HAD ERODED. THERE WAS NECROTIC SOFT TISSUE. THE LEG WAS LENGTHENED SLIGHTLY DUE TO LOSS OF SOFT TISSUE. BLEEDING WAS MINIMAL. DOI: (B)(6) 2009 - DOR: (B)(6) 2019 (RIGHT HIP).

  Patient problems: Edema; Erosion; Extraskeletal ossification; Foreign Body Reaction; Hemorrhage/Blood Loss/Bleeding; Hypersensitivity/Allergic reaction; Inflammation; Necrosis; No Code Available; Synovitis; Tissue Damage

  MAUDE report 8439418 ↗
• InjuryFeb 1, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PPF ALLEGES INFECTION. DOI: (B)(6) 2008 - DOR: (B)(6) 2013 (LEFT HIP) (STEM). DOI: (B)(6) 2011 - DOR: (B)(6) 2013 (LEFT HIP).

  Patient problems: Pain; Unspecified Infection

  MAUDE report 8296179 ↗
• InjuryDec 3, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT'S METAL ON METAL CONSTRUCT WAS REVISED DUE TO PAIN.

  Patient problems: No Code Available; Pain

  MAUDE report 8125539 ↗
• InjuryDec 3, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED TO ADDRESS STEM LOOSENING. UPDATE IN ADDITION TO WHAT WERE PREVIOUSLY ALLEGED, PPF ALLEGES ELEVATED METAL IONS. DOI: (B)(6) 2009 - DOR: (B)(6) 2011; (RIGHT HIP).

  Patient problems: No Code Available; Test Result

  MAUDE report 8124302 ↗
• InjuryNov 14, 2018Insufficient Device Problem Information; Noise, Audible; Insufficient Device Problem Information; Noise, Audible

  PPF AND STICKER SHEETS RECEIVED. PPF ALLEGES ABDUCTOR MUSCLE REPAIR.

  Patient problems: Ambulation or Postural Difficulties; Cramp(s); No Code Available; Pain; Tissue Damage

  MAUDE report 8070078 ↗
• InjuryOct 25, 2018Naturally Worn; Naturally Worn

  THE PATIENT WAS REVISED TO ADDRESS INSTABILITY. LITIGATION ALLEGED FRICTION AND WEAR BETWEEN THE METAL HEAD AND LINER CAUSED THE RELEASE OF TOXIC METAL IONS AND PARTICLES INTO THE PATIENT'S BODY RESULTING TO INJURY ASSOCIATED WITH METALLOSIS, PAIN, DISCOMFORT, SORENESS, NEGATIVELY AFFECTING THE ABILITY TO PERFORM ACTIVITIES OF DAILY LIVING, AND EMOTIONAL DISTRESS. DOI: (B)(6) 2009; DOR: (B)(6) 2018; LEFT HIP.

  Patient problems: Discomfort; Foreign Body Reaction; Hypersensitivity/Allergic reaction; Injury; Limited Mobility Of The Implanted Joint; No Code Available; Pain; Test Result; Tissue Damage

  MAUDE report 8006366 ↗
• InjuryOct 24, 2018Naturally Worn; Naturally Worn

  THE PATIENT WAS REVISED TO ADDRESS INSTABILITY.

  Patient problems: Discomfort; Foreign Body Reaction; Hypersensitivity/Allergic reaction; Injury; Limited Mobility Of The Implanted Joint; No Code Available; Pain; Test Result; Tissue Damage

  MAUDE report 7998764 ↗
• InjurySep 24, 2018Device Dislodged or Dislocated; Device Dislodged or Dislocated

  PPF AND MEDICAL RECORDS RECEIVED. PPF ALLEGES DISLOCATION WITH OPEN AND CLOSED REDUCTION AND LOOSENING OF THE CUP AFTER THE FIRST REVISION. AFTER REVIEW OF MEDICAL RECORDS FOR THE MDR REPORTABILITY, THE OPERATIVE NOTES DURING THE SECOND AND THIRD REVISION DOES NOT SUPPORT THE PPF ALLEGATION AFTER THE FIRST REVISION. HEAD, LINER, AND CUP WERE REPORTED TO THE IMPACTED PRODUCT DUE TO DISLOCATION AND LOOSENING OF THE CUP. DOI: (B)(6) 2009 - DOR: NONE REPORTED; (LEFT HIP). (B)(4), (LEFT HIP) FIRST REVISION. (B)(4), (LEFT HIP) SECOND REVISION. (B)(4), (LEFT HIP) THIRD REVISION.

  Patient problems: Joint Dislocation

  MAUDE report 7901454 ↗
• InjuryJun 1, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  DER STATES THAT THE PATIENT HAD AN MOM CONSTRUCT. PATIENT DEVELOPED HIP PAIN APPROXIMATELY 6 MONTHS AGO. SURGEON REVISED THE HEAD AND LINER. IT WAS ALSO REPORTED THAT COBALT LEVEL- 7.3, CHROMIUM LEVEL- 3.9. DOI-2008; DOR: (B)(6) 2018; RIGHT HIP.

  Patient problems: No Code Available; Not Applicable; Pain

  MAUDE report 7560171 ↗
• InjuryOct 20, 2017Device Dislodged or Dislocated; Naturally Worn; Device Dislodged or Dislocated; Naturally Worn

  COMPLAINT DESCRIPTION: DER STATES THAT THE PATIENT IS 8 YEARS POST-OP IS DISLOCATED FOR THE SECOND TIME. REVISED TO A POLY CONSTRAINED LINER AND HEAD SWAP. IT WAS ALSO STATED THAT CORROSION OF THE THE TRUNION WAS NOTED AT THE TIME OF REVISION. / / INVESTIGATION METHOD: / / INVESTIGATION SUMMARY:

  Patient problems: Foreign Body Reaction; Host-Tissue Reaction; Hypersensitivity/Allergic reaction; Joint Dislocation

  MAUDE report 6965406 ↗