PINNACLE 1217-12-056Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 10603295009184), received between Nov 4, 2017 and Jul 11, 2023 — classified as 9 injuries.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (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. 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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• InjuryJul 11, 2023Use of Device Problem; Use of Device Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT PRIMARY RIGHT CORAIL/PINNACLE TKR. PATIENT SUBSEQUENTLY HAS EXPERIENCED DISLOCATION OF JOINT. SURGEON SUSPECTED THE CUP WAS IN SLIGHTLY MORE ANTEVERSION THAN INTENDED. PATIENT HAS A +4/10 DEGREE LINER IN-SITU, WHICH IN ITS CURRENT ORIENTATION WAS IMPINGING ON THE NECK OF THE FEMORAL STEM, LEADING TO DISLOCATION. PROCEDURE REVISION OF ACETABULAR LINER AND HEAD CHANGE. SURGEON REMOVED EXISTING LINER, REPLACED IT WITH ANOTHER +4/10 DEGREE LINER WITH THE ORIENTATION CHANGED. UPON REMOVING THE EXISTING LINER THE SURGEON NOTED AN OBVIOUS 'DENT' IN THE LINER WHERE THE NECK HAD BEEN IMPACTING IT. DOI: (B)(6)2022. DOE: (B)(6)2023. AFFECTED SIDE: UNKNOWN.

  Patient problems: Joint Laxity

  MAUDE report 17297298 ↗
• InjuryMar 13, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  MEDICAL RECORDS RECEIVED. IN ADDITION TO WHAT WAS PREVIOUSLY REPORTED. AFTER REVIEW THE PATIENT WAS REVISED TO ADDRESS DEPRESSION AND WEAKNESS, PATHOLOGY REPORT METALLIC PARTICULATE DEBRIS AND CORROSION. IMAGING REPORTED MILD NONSPECIFIC SYNOVIAL EXPANSION. THERE IS ATROPHY THE SHORT EXTERNAL ROTATOR MUSCLE BELLIES, TENDONS WHICH ARE SCARRED TO THE POSTERIOR PSEUDO CAPSULE. THE HIP ABDUCTORS ARE MILDLY TENDINOTIC WITH AREAS OF SLIGHT FRAYING. MILD- HYPERINTENSITY IS NOTED IN THE REGION OF THE TROCHANTERIC BURSA. SLIGHT ILIOPSOAS TENDINOSIS. TRACE FLUID IS NOTED DECOMPRESSING INTO THE PSOAS BURSA. THE RECTUS FEMORIS IS MILDLY TENDINOTIC PROXIMALLY. FEMORAL HEAD SHOWS CIRCULAR CORROSION. CLINICAL VISIT ON (B)(6) 2016 REPORTED HIP PAIN, BILATERAL HAMSTRING TENDINOPATHY WITH PARTIAL TEARING AT THE INSERTION WHERE THERE IS BURSITIS. MILD LEFT ILIOPSOAS BURSITIS, WEAKNESS JOINT SWELLING AND PAIN. SYNOVITIS CONSISTENT WITH MOM. BLACK CORROSION AT THE TRUNNION.

  Patient problems: Adhesion(s); Depression; Distress; Fatigue; Foreign Body Reaction; Hypersensitivity/Allergic reaction; Inflammation; Loss of Range of Motion; Muscle/Tendon Damage; Osteolysis; Pain; Scar Tissue; Swelling/ Edema; Synovitis; Unspecified Tissue Injury

  MAUDE report 16530100 ↗
• InjurySep 23, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  LITIGATION COMPLAINT RECEIVED AD 6 SEP 2022. PATIENT WAS REVISED WAS DUE TO METALLOSIS AND COBALT POISONING. DOI: (B)(6) 2009. DOR: (B)(6) 2021. RIGHT HIP.

  Patient problems: Foreign Body Reaction

  MAUDE report 15474128 ↗
• InjurySep 23, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  LITIGATION COMPLAINT RECEIVED AD 6 SEP 2022. PATIENT WAS REVISED WAS DUE TO METALLOSIS AND COBALT POISONING. DOI: (B)(6) 2011, DOR: (B)(6) 2020, LEFT HIP.

  Patient problems: Foreign Body Reaction

  MAUDE report 15470242 ↗
• InjuryFeb 1, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT UNDERWENT THA ON (B)(6) 2012 WHERE A SUMMIT STEM AND PINNACLE SHELL WERE UTILIZED. PATIENT COMPLAINED OF PROGRESSIVELY WORSENING GROIN PAIN AROUND THE ACETABULUM. DECISION WAS MADE TO REVISE THE ACETABULAR COMPONENT AS CT SCAN APPEAR TO INDICATE THAT THERE IS OSTEOLYSIS AND GRANULOMA BEHIND THE ACETABULAR COMPONENT. THE ACETABULAR COMPONENT WAS REVISED ALONG WITH THE HEAD OF THE FEMORAL COMPONENT. THE FEMORAL COMPONENT WAS LEFT IN SITU AS IT WAS WELL FIXED.

  Patient problems: Osteolysis; Pain

  MAUDE report 13418860 ↗
• InjuryOct 21, 2021Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE LINER DISSOCIATED FROM THE CUP. THE LINER WAS REMOVED DUE TO DISSOCIATION WITH THE CUP. LOCKING TABS ALONG THE ANTERIOR AND SUPERIOR PORTION OF THE LINER WERE SHEERED OFF. X-RAYS WERE USED TO FIRST IDENTIFY THE ISSUE WITH THE LINER. DOI: (B)(6) 2021. DOR: (B)(6) 2021. AFFECTED SIDE: LEFT HIP.

  Patient problems: Insufficient Information

  MAUDE report 12673889 ↗
• InjuryJul 6, 2021Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THERE WAS A REVISION CASE INVOLVING A PINNACLE LINER. THE REVISION CASE HAPPENED (B)(6) 2021 AND IT WAS PERFORM DUE TO THE PINNACLE LINER AND THE 3 PEGS WERE FLATTENED AND DISLODGED FROM THE ARDS IN THE PINNACLE CUP. THE LINER WAS DISCARDED INTO A SHARPS BIN AND IS NOT AVAILABLE TO BE SENT FOR TESTING. THE PRIMARY CASE WAS ON THE (B)(6) 2019. FOR THE REVISION, THE PINNACLE CUP WAS LEFT IN THE PATIENT AND THE LINER WAS CHANGED.

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

  MAUDE report 12121134 ↗
• InjuryMar 23, 2020Use of Device Problem; Loss of Osseointegration; Malposition of Device; Use of Device Problem; Loss of Osseointegration; Malposition of Device

  PINNACLE CLAIM SUBMISSION FORM AND MEDICAL RECORD RECEIVED. AFTER REVIEW OF MEDICAL RECORD , PATIENT WAS REVISED TO ADDRESS LOOSENED, MALPOSITIONED ACETABULAR COMPONENT. REVISION NOTES STATED THAT EXTRANEOUS BONE WAS REMOVED. CUP, LINER, HEAD AND SCREWS WERE REMOVED. DOI: (B)(6) 2008; DOR: (B)(6) 2008 (LEFT HIP). DOI: (B)(6) 2008 (CUP&SCREWS).

  Patient problems: Inadequate Osseointegration; No Code Available

  MAUDE report 9865885 ↗
• InjuryNov 4, 2017Insufficient Device Problem Information; Insufficient Device Problem Information

  PINNACLE REVISION; LEFT HIP; REASON FOR REVISION: PERSISTENT PAIN IN HIP, THIGH AND GROIN.

  Patient problems: Pain

  MAUDE report 7002116 ↗