PINNACLE 1217-11-058Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10603295009092), received between May 31, 2018 and Jun 28, 2019 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Device-Device Incompatibility” (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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 28, 2019Device-Device Incompatibility; Device-Device Incompatibility

  COMPLAINT DESCRIPTION FROM ETQ: 1217-11-058 X1 PINNACLE ACETABULAR SHELL 100 SERIES (LOT: 311131) WAS IMPLANTED AS PER SURGICAL TECHNIQUE. SUBSEQUENTLY, SURGEON ATTEMPTED TO SCREW IN (1246-03-000) APEX HOLE ELIMINATOR (LOT: D13033399) INTO ACETABULAR SHELL. HOWEVER, THE APEX HOLE ELIMINATOR COULD NOT SCREW INTO THREADS OF ACETABULAR SHELL. THEREFORE, A SECOND APEX HOLE ELIMINATOR (LOT: D13050493) WAS OPENED. THIS TOO COULD NOT BE IMPLANTED. THE SURGEON THEN SAID, ALTHOUGH HE HAD NEVER HAD THIS ISSUE IN HIS MULTIPLE PRIOR CASES, THE THREADS OF THE ACETABULAR SHELL MUST HAVE BEEN BURRED. THE SURGEON DECIDED TO NOT WORRY ABOUT USING A HOLE ELIMINATOR AND SUBSEQUENTLY IMPLANTED A SHELL LINER, AS PER SURGICAL TECHNIQUE. THE OPERATION WAS COMPLETED WITH NO FURTHER PROBLEMS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8746153 ↗
• InjuryMay 31, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  THE PATIENT WAS REVISED TO ADDRESS INFECTION. DOI: UNKNOWN; DOR: (B)(6) 2018; UNKNOWN SIDE.

  Patient problems: Not Applicable; Unspecified Infection

  MAUDE report 7556356 ↗