PINNACLE 1219-32-258Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 10603295014218), received between Jun 28, 2018 and Sep 20, 2023 — classified as 6 injuries.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (1 report).

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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• InjurySep 20, 2023Naturally Worn; Naturally Worn

  LATERAL PAIN AT 12 MONTHS, CORTISONE INJECTION GIVE TO BURSA BY GP, PARTICLES NOTICED ON SCAN AND REVISION SURGERY WAS SCHEDULED. REVISION SURGERY DONE YESTERDAY, HEAD AND LINER EXCHANGED. SOME SOGGY RICE LOOKING MODULES IN THE LAYERS CLOSE TO THE JOINT WERE FOUND AND WERE WASHED OUT. SAMPLE SENT TO THE LAB FOR ANALYSIS. SOME WEAR AND YELLOWING NOTICED ON LINER. DOI: (B)(6) 2022, DOE: (B)(6) 2023, AFFECTED SIDE.

  Patient problems: Pain

  MAUDE report 17782205 ↗
• InjuryJul 17, 2020Fracture; Device Dislodged or Dislocated; Fracture; Device Dislodged or Dislocated

  BOOKING RECEIVED FROM HOSPITAL FOR REVISION OF HEAD AND LINER ON 30/06/2020 - CORAIL PINNACLE THA. LINER APPEARED LOOSE ON XRAY, ORIGINAL SURGERY PERFORMED 2013. REVISION SURGERY WAS PERFORMED ON (B)(6) 2020. PATIENT STATUS/ OUTCOME / CONSEQUENCES: UNKNOWN, WAS OTHER MEDICAL INTERVENTION (E.G. X-RAYS, ADDITIONAL PROCEDURES, PRESCRIPTIONS, OTC, REVISION) REQUIRED: UNKNOWN, IS THE PATIENT PART OF A CLINICAL STUDY --> UNKNOWN, (B)(4). DEVICE PROPERTY OF NONE, DEVICE IN POSSESSION OF NONE, (B)(4). DEVICE PROPERTY OF NONE, DEVICE IN POSSESSION OF NONE BY CHECKING THIS BOX I CERTIFY THAT ALL INFORMATION THAT ARE KNOWN/AVAILABLE HAS BEEN DISCLOSED. IF ANY NEW INFORMATION WILL BE MADE AVAILABLE, THE ADDITIONAL INFORMATION WILL BE SUBMITTED THROUGH CST. TRUE.

  Patient problems: No Code Available

  MAUDE report 10289102 ↗
• InjuryJun 1, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  INFECTED HIP, ORIGINALLY DONE ON THE (B)(6) 2020. MASSIVE SEROMA FOUND WHEN RE ENTERING THE HIP, PATIENT WASHED OUT AND THE LINER AND HEAD WHERE REMOVED AND REPLACED WITH NEW IMPLANTS. DOI: (B)(6) 2020. DOR: (B)(6) 2020; RIGHT HIP.

  Patient problems: No Code Available; Seroma; Unspecified Infection

  MAUDE report 10105912 ↗
• InjuryOct 25, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  LEFT REVISION TOTAL HIP REPLACEMENT: (B)(6) 2019. PRIMARY IMPLANT DATE: (B)(6) 2019. THE PATIENT PRESENTED WITH AN INFECTION. HEAD AND LINER WERE REMOVED AND REPLACED. CUP AND STEM WERE WELL FIXED.

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 9240144 ↗
• InjuryFeb 6, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PINNACLE LITIGATION RECORDS RECEIVED. LITIGATION ALLEGES THAT THE PATIENT EXPERIENCED INJURY, PAIN, SUFFERING, SWELLING, TISSUE DAMAGE, LACK OF MOBILITY, METALLOSIS, PSEUDOTUMORS, EMOTIONAL DISTRESS AND BONE EROSION. DOI: (B)(6) 2003, DOR: NOT INDICATED, (UNKNOWN HIP).

  Patient problems: Injury; Limited Mobility Of The Implanted Joint; No Code Available; Pain; Pocket Erosion; Swelling; Tissue Damage

  MAUDE report 8310199 ↗
• InjuryJun 28, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  PPF AND STICKER SHEETS RECEIVED. PPF HAS NO ALLEGATIONS REPORTED. DOI: (B)(6) 2004; DOR: NOT REPORTED; (RIGHT HIP).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7646001 ↗