PINNACLE 1219-28-156Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10603295013495), received between May 21, 2020 and Oct 13, 2020 — classified as 3 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 18, 2026.

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryOct 13, 2020Naturally Worn; Naturally Worn

  THE PATIENT WAS REVISED DUE TO POLYETHYLENE WEAR. LEG LENGTH WAS SHORT. BOTH THE HEAD AND LINER WERE EXCHANGED. HEAD WAS INCREASED FROM A 28 +3 TO A 36+9. LINER CHANGED FROM 56 X 28 WITH +4 10 DEGREE TO 56 X 36 +4 10 DEGREE. DOI: UNKNOWN, DOR: (B)(6) 2020, AFFECTED SIDE: LEFT HIP.

  Patient problems: No Code Available

  MAUDE report 10671549 ↗
• InjuryOct 1, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE SURGEON DID A LEFT HIP REVISION ON (B)(6) 2020, AT ST. PETERS DUE TO INSTABILITY. THE PATIENT HAD ORIGINAL SURGERY AROUND 20 YEARS AGO AT ST. PETERS. THE PATIENT HAD A PINNACLE 56 CUP WITH A PFC 3M STEM AND A 28MM +5 PFC HEAD, +4 10 DEG 28ID LINER. THE 28 PFC HEAD PLUS 5 WAS REMOVED-AND THE LINER WAS REMOVED AND REPLACED WITH DEPUY PARTS. NO FURTHER INFO IS KNOWN OR AVAILABLE AT THIS TIME. TO ANSWER THE QUESTION BELOW-NOTHING WAS BROKEN IN SURGERY AND THEREFORE NO INSTRUMENTATION WAS REMOVED FROM THE PATIENT. DOI: 20 YEARS AGO, DOR: (B)(6) 2020, LEFT HIP.

  Patient problems: No Code Available

  MAUDE report 10615316 ↗
• InjuryMay 21, 2020Device Dislodged or Dislocated; Device Dislodged or Dislocated

  THE PATIENT WAS REVISED DUE TO DISLOCATING HIS HIP ON MULTIPLE OCCASIONS. THE SURGEON REVISED THE ACETABULAR COMPONENTS TO IMPROVE STABILITY. THE PINNACLE CUP WAS EXPLANTED AND A ZIMMER BIOMET CUP WAS IMPLANTED. THE S ROM STEM WAS LEFT IMPLANTED BUT THE HEAD WAS REVISED TO A 28MM +9 METAL S ROM COMPONENT. DOI ; UNKNOWN. DOR : (B)(6) 2020. LEFT HIP.

  Patient problems: Joint Dislocation; No Code Available

  MAUDE report 10080731 ↗