PINNACLE GRIPTION 1217-30-062Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 10603295010036), received between Oct 5, 2018 and Jan 3, 2024 — classified as 9 injuries.

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

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

  IT WAS REPORTED THAT PATIENT WAS INFECTED. WASH OUT WAS DONE. DOI: UNKNOWN. DOR: (B)(3) 2023. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 18435118 ↗
• InjuryMar 15, 2022Use of Device Problem; Use of Device Problem

  MEDICAL RECORD RECEIVED. PATIENT WAS REVISED TO ADDRESS FEMORAL COMPONENT MALPOSITION AND MULTIPLE DISLOCATIONS. THERE WAS GROSSLY MALPOSITIONED ACETABULAR COMPONENT THAT HAS BECOME WELL FIXATED TO BONE WITH SUPERIOR ACETABULAR WALL LOSS AND POSTEROLATERAL WALL INSUFFICIENCY. DOI: (B)(6) 2010 - DOR: (B)(6) 2010 ( LEFT HIP).

  Patient problems: Unspecified Tissue Injury

  MAUDE report 13770011 ↗
• InjuryDec 10, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED TO ADDRESS PAIN. DOI: UNKNOWN. DOR: (B)(6) 2021. LEFT HIP.

  Patient problems: Pain

  MAUDE report 12977643 ↗
• InjuryApr 28, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION RECEIVED. IT WAS INDICATED THAT THE PATIENT HAS HAD INFECTION EVENTS AFTER REVISION ( (B)(6) 2016, (B)(6) 2016) WHICH WAS TREATED WITH IV ANTIBIOTICS. NO REVISION SURGERY WAS REPORTED. DOI: (B)(6) 2009 (STEM) DOI: (B)(6) 2016 DOR: NONE REPORTED LEFT HIP.

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

  MAUDE report 11738766 ↗
• InjuryJul 15, 2020Adverse Event Without Identified Device or Use Problem; No Apparent Adverse Event; Adverse Event Without Identified Device or Use Problem; No Apparent Adverse Event

  AFTER REVIEW OF MEDICAL RECORDS, VISIT NOTES REPORTED THAT PATIENT HAD DIFFICULTY IN WALKING.

  Patient problems: Abscess; Ambulation or Postural Difficulties; Anxiety; Calcium Deposits/Calcification; Discomfort; Edema; Fibrosis; Inflammation; No Code Available; Pain; Unspecified Infection; Weakness

  MAUDE report 10276114 ↗
• InjuryNov 14, 2019Loss of Osseointegration; Osseointegration Problem; Loss of Osseointegration; Osseointegration Problem

  PATIENT WAS REVISED TO ADDRESS LOOSENING OF THE CUP AT BONE TO IMPLANT INTERFACE. ORIGINAL IMPLANT DATE UNKNOWN. DOI: UNKNOWN. DOR: (B)(6) 2019. LEFT HIP.

  Patient problems: Inadequate Osseointegration; No Code Available

  MAUDE report 9323519 ↗
• InjuryMay 10, 2019Loss of Osseointegration; Osseointegration Problem; Loss of Osseointegration; Osseointegration Problem

  LITIGATION ALLEGES THAT THE PATIENT SUFFERS FROM PAIN, DISCOMFORT, INFLAMMATION, AND LARGE AMOUNTS OF TOXIC COBALT CHROMIUM METAL ION PARTICLES TO BE RELEASED INTO THE BLOOD, TISSUE, AND BONE. UPDATE REC¿D 1/28/2014 ¿ PFS AND MEDICAL RECORDS RECEIVED. PART/LOT WAS PROVIDED. ORIGINAL LITIGATION MENTIONED ISSUES FROM METAL ON METAL; HOWEVER, THE STICKER SHEET INDICATES THAT THE PATIENT WAS ACTUALLY IMPLANTED WITH POLY. UPDATE AD 25 JUN 2018: (B)(4) HAS BEEN RE-OPENED UNDER (B)(4) DUE TO THE RECEIPT OF PPF AND MEDICAL RECORDS. IN ADDITION TO WHAT WERE PREVIOUSLY ALLEGED, PPF ALLEGES CUP LOOSENING.

  Patient problems: Inadequate Osseointegration; No Code Available

  MAUDE report 8599274 ↗
• InjuryApr 24, 2019Loss of Osseointegration; Loss of Osseointegration

  CLAIM AND MEDICAL RECORDS RECEIVED. AFTER REVIEW OF CLAIM AND MEDICAL RECORDS, IT WAS STATED THAT THE PATIENT WAS REVISED TO ADDRESS PAIN AND ASEPTIC LOOSENING OF CUP COMPONENT. STIFFNESS, LIMPING, CLICKING, POPPING, WEAKNESS AND NUMBNESS WERE ALSO NOTED. OPERATIVE NOTES REPORTED SLIGHTLY BROWN TENTED AND TRANSLUCENT FLUID, THE TISSUE IS STAINED DARK GRAY CONSISTENT OF METALLOSIS, TWO SUPERIOR CYSTS WERE CURETTED AND THERE WAS NO ACETABULAR BONY INGROWTH NOTED. WHEN REMOVING THE ACETABULAR SHELL, THREE SCREWS BROKE BUT ONLY ONE WAS FULLY EXTRACTED AND THE TWO SCREWS WERE RECESSED SINCE THEY WERE EMBEDDED INTO THE SCLEROTIC BONE. MRI REPORTED TROCHANTERIC BURSITIS. X-RAY REPORTED ASEPTIC LOOSENING OF ACETABULAR COMPONENT AND HAS METAL WEAR DEBRIS REACTION. DOI: (B)(6) 2010; DOR: (B)(6) 2018; LEFT HIP.

  Patient problems: Cyst(s); Hypoesthesia; Inadequate Osseointegration; Limited Mobility Of The Implanted Joint; No Code Available; Pain; Tissue Damage; Weakness

  MAUDE report 8544302 ↗
• InjuryOct 5, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  INTRA-OPERATIVE NON-DISPLACED FRACTURE OF POSTERIOR WALL OF ACETABULUM DURING 2ND STAGE OF REVISION NO COMPONENTS REMOVED AT THIS TIME. DOI: (B)(6) 2018 (LEFT HIP).

  Patient problems: Bone Fracture(s)

  MAUDE report 7937830 ↗