PINNACLE POROCOAT 1217-20-060Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10603295009665), received between Jan 24, 2014 and Jan 6, 2023 — classified as 4 injuries.

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

• InjuryJan 6, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2021 PHYSICAL THERAPY NOTES STATING THE LEFT HIP DEMONSTRATES AN EFFUSION AND THE PATIENT HAS RECENTLY FALLEN. PHYSICAL THERAPY NOTES ON (B)(6) 2021 STATE THE LEFT HIP IS VERY SWOLLEN, RED, AND HARD. THE PATIENT ALSO STATES HE MAY HAVE HAD A LOW GRADE FEVER. THE TREATMENT WAS NOT COMPLETED DUE TO CONCERNS OVER INFECTION. NOTES DETAIL A PHYSICAL THERAPY EVALUATION PERFORMED ON (B)(6) 2021. THE NOTES STATE THE LEFT HIP IS BRUISED WITH A SIGNIFICANT EFFUSION. THIS PC WAS CREATED TO CAPTURE THE HARM REPORTED POST LEFT HIP REVISION ON (B)(6) 2021.

  Patient problems: Erythema; Fall; Fever; Swelling/ Edema; Unspecified Infection

  MAUDE report 16111843 ↗
• InjuryJan 3, 2018Osseointegration Problem; Osseointegration Problem

  (B)(4). LITIGATION ALLEGES THAT PATIENT EXPERIENCED HIP PAIN, CAUSING DIFFICULTY AMBULATING AND SLEEPING. ADDITIONALLY, IT IS ALLEGED THAT IMPLANT IS RELEASING METAL IONS INTO PATIENT'S BODY. DOI: UNKNOWN - DOR: NONE REPORTED (RIGHT SIDE). (B)(6). UPDATE DEC 05, 2017: PFS AND MEDICAL RECORDS RECEIVED. IN ADDITION TO WHAT WERE PREVIOUSLY ALLEGED, PFS ALLEGES INJURY AND LIMITED MOBILITY. AFTER THE REVIEW OF MEDICAL RECORDS FOR MDR REPORTABILITY, IT WAS STATED THAT THE PATIENT WAS REVISED TO ADDRESS FEMORAL AND ACETABULAR COMPONENT LOOSENING. REVISION NOTES REPORTED GROSSLY LOOSE FEMORAL COMPONENT. CLINICAL NOTES REPORTED OF LEG LENGTH DISCREPANCY, OSTEONECROSIS, ANTALGIC GAIT, DECREASED RANGE OF MOTION, BURSITIS AND TENDERNESS. LABORATORY RESULT FOR METAL IONS IS BELOW 7PPB. ADDED STEM, CUP AND CEMENT PRODUCT INFORMATION. THIS COMPLAINT WAS UPDATED ON: DECEMBER 22, 2017. DOI: (B)(6) 2007; DOR: (B)(6) 2014; RIGHT HIP.

  Patient problems: Inadequate Osseointegration; Loss of Range of Motion; Pain

  MAUDE report 7159887 ↗
• InjuryOct 20, 2017Insufficient Device Problem Information; Insufficient Device Problem Information

  COMPLAINT DESCRIPTION: SEP 22, 2017: PFS AND MEDICAL RECORDS RECEIVED. AFTER REVIEW OF THE MEDICAL RECORDS FOR THE MDR REPORTABILITY, IT WAS STATED THAT AFTER PATIENT'S 1ST REVISION (B)(6) 2008), PATIENT HAD EXPERIENCED PAIN AND TROCHANTERIC BURSITIS. THERE IS NO 2ND REVISION REPORTED AT THIS TIME. UPDATE (B)(6) 2017 REVIEWED RECORDS FOR REPORTABILITY. IDENTIFIED THAT DURING REVISION SURGERY (B)(6) 2008, SURGEON EXPLANTED S-ROM STEM (LEAVING THE S-ROM SLEEVE) AND REPLACED IT WITH ANOTHER STEM. THERE IS NO RECORD OF THIS NEW STEM ON THE IMPLANT RECORD FOR (B)(6) 2008, BUT IT IS CLEARLY NOTED IN THE OR REVISION OPERATIVE NOTE. ADDED AN UNKNOWN S-ROM STEM FOR ALLEGED PAIN. COMPLAINT UPDATED ON: OCT 20, 2017 / / INVESTIGATION METHOD: / / INVESTIGATION SUMMARY:

  Patient problems: Inflammation; Irritation; Pain; Tissue Damage

  MAUDE report 6965782 ↗
• InjuryJan 24, 2014Loss of Osseointegration; Osseointegration Problem

  LITIGATION ALLEGES PAIN AND DIFFICULTY AMBULATING. UPDATE REC¿D (B)(6) 2013 ¿ 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. REVISION OPERATIVE NOTES INDICATE SIGNIFICANT BONE LOSS ON ACETABULAR BONE AND CUP MIGRATION LOOSENING WITH DISLOCATED FEMORAL HEAD. THE CUP AND SCREWS HAVE NOW BEEN REPORTED. THERE IS NO NEW ADDITIONAL INFORMATION THAT WOULD AFFECT THE EXISTING MDR DECISION. RECORDS HAVE BEEN ATTACHED FOR FURTHER REVIEW. THE COMPLAINT WAS UPDATED ON: (B)(6) 2013.

  Patient problems: No Code Available

  MAUDE report 3591236 ↗