PINNACLE 1217-11-052Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 10603295009061), received between Aug 15, 2017 and Nov 7, 2022 — classified as 7 injuries, 1 malfunction.

The most frequently reported specific device problem is “Disassembly” (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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• InjuryNov 7, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PINNACLE CUP REVISION DUE TO INSTABILITY. G7 DUAL MOBILITY PUT IN PLACE. PATIENT STATUS/ OUTCOME / CONSEQUENCES. WAS OTHER MEDICAL INTERVENTION (E.G. X-RAYS, ADDITIONAL PROCEDURES, PRESCRIPTIONS, OTC, REVISION) REQUIRED: UNKNOWN. IS THE PATIENT PART OF A CLINICAL STUDY? UNKNOWN, IP-01563673. DEVICE PROPERTY OF? NONE. DEVICE IN POSSESSION OF? NONE, IP-01563674. 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: Joint Laxity

  MAUDE report 15742739 ↗
• MalfunctionNov 29, 2021Difficult to Insert; Difficult to Insert

  IT WAS REPORTED THAT THE SURGEON WAS IMPLANTING THE HOLE ELIMINATOR AND RATHER THAN THE HOLE ELIMINATOR STOPPING WHEN ALL THE WAY DOWN, IT WENT ALL THE WAY THROUGH THE CUP. THE SURGEON WAS NOT HAPPY. HE DECIDED THE CUP WAS WELL FIXED AND COULD BE MORE PROBLEMATIC TO REMOVE THE CUP TO RETRIEVE THE HOLE ELIMINATOR THAN TO LEAVE IT THE WAY IT WAS. HE DECIDED TO PUT THE LINER INTO THE CUP AND MOVE ON. IT WAS ALSO INDICATED THAT THERE WAS A SURGICAL DELAY OF 3 MINUTES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12882543 ↗
• InjuryMar 23, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAVING INCREASING PAIN & INSTABILITY. CUP REVISION W HEAD EXCHANGE PERFORMED. DOI: (B)(6) 2009; DOR: (B)(6) 2021: RIGHT HIP.

  Patient problems: Joint Laxity; Pain

  MAUDE report 11553364 ↗
• InjuryApr 3, 2020Loose or Intermittent Connection; Loss of Osseointegration; Adverse Event Without Identified Device or Use Problem; Loose or Intermittent Connection; Loss of Osseointegration; Adverse Event Without Identified Device or Use Problem

  AFTER REVIEW OF THE SURGERY REPORT, PATIENT WAS REVISED TO ADDRESS LOOSENING OF THE CUP WITH METALLOSIS. REVISION NOTES STATED THAT THERE WERE MASSIVELY SWOLLEN JOINT CAPSULE FOUND FROM WHICH A DARK FLUID DRAINED AND LUXATION OF THE HIP JOINT STRIKING OFF THE HEAD WAS NOTED.

  Patient problems: Foreign Body Reaction; Inadequate Osseointegration; Joint Disorder; Limited Mobility Of The Implanted Joint; No Code Available; Osteolysis; Pain; Swelling

  MAUDE report 9921932 ↗
• InjuryJul 27, 2018Detachment of Device or Device Component; Detachment of Device or Device Component

  EVENT OR PRODUCT PROBLEM OUTCOME LUXATION OF A PINNACLE LINER OUT OF THE PINNACLE SHELL. THE PATIENT HAD BENDED FORWARD, FELT SOMETHING GLIDING AND HEARD A KIND OF CRACK. THIS HAD HAPPENED BEFORE ONLY THIS TIME THERE WAS A LOT OF PAIN AND THE FEELING THAT SOMETHING WAS TERRIBLY WRONG. DESCRIBE THE 'DAMAGE' OR 'OTHER' OUTCOME REVISION SURGERY WAS NECESSARY, SURGEON REPLACED THE PINNACLE SYSTEM BY A SYSTEM OF THE DESCRIBE EVENT PATIENT FELL FROM HER BICYCLE ON HER RIGHT HIP AND FELT PAIN IN HER LEFT HIP. COMPETITOR- PATIENT INFORMATION: (B)(6), BIRTH DATE (B)(6); (B)(6), GENDER FEMALE ; (B)(6), WEIGHT (B)(6); (B)(6), HEIGHT 1.74 METER; DATE THE EVENT, IF DIFFERENT FROM DATE OF PROCEDURE/SURGERY: PRIMARY SURGERY: (B)(6) 2010; REVISION SURGERY:(B)(6) 2018.

  Patient problems: Pain

  MAUDE report 7726301 ↗
• InjuryMay 2, 2018Disassembly; Malposition of Device; Disassembly; Malposition of Device

  PROCEDURE/SURGERY NAME TOTAL HIP ARTHROPLASTY PROCEDURE/SURGERY DATE (B)(6) 2016 NORMAL THA PROCEDURE, NO COMPLICATIONS, (B)(6) 2018 NOTICED NO LINER IN SHELL ON XRAY, EARLIER XRAYS DIDN¿T SHOW THIS. IS THIS REPORT RELATED TO A: SINGLE USE DEVICE: ACETABULAR IMPLANT, INSERT IS PROBLEM DESCRIBE THE 'DAMAGE' OR 'OTHER' OUTCOME IMPLANT DAMAGE WITH NECESSITY FOR LARGE REVISION DATE THE EVENT, IF DIFFERENT FROM DATE OF PROCEDURE/SURGERY: (B)(6) 2018 (COMPLAIN DIRECT POST OP, INVESTIGATION NO RESULTS).

  Patient problems: No Consequences Or Impact To Patient; Not Applicable

  MAUDE report 7480678 ↗
• InjuryNov 7, 2017Insufficient Device Problem Information; Insufficient Device Problem Information

  ON (B)(6) 2017: EMAIL NOTIFICATION RECEIVED. THERE IS NO REPORT OF ADVERSE EVENT AT THIS TIME. UPDATE OCT 9, 2017: ADDITIONAL INFORMATION RECEIVED. PATIENT WAS REVISED TO ADDRESS ACHEY, FLUID COLLECTION IN HIP, HIGH METAL IONS AND VALGUS ALIGNMENT. PRODUCT CODES AND LOT NUMBERS UPDATED.

  Patient problems: Host-Tissue Reaction; Pain

  MAUDE report 7005531 ↗
• InjuryAug 15, 2017Disassembly; Disassembly

  THE PATIENT WAS REVISED TO ADDRESS DISASSOCIATION. UPDATE 7-25-2017: MEDICAL RECORDS HAVE BEEN REVIEWED. PRIMARY OPERATIVE NOTES (B)(6) 2008 INDICATE THE PATIENT RECEIVED A CORAIL CEMENTLESS METAL ON POLYETHYLENE LEFT TOTAL HIP ARTHROPLASTY DUE TO OSTEOARTHRITIS LEFT HIP. THE PROCEDURE WAS COMPLETED WITHOUT ANY COMPLICATION NOTED BY THE SURGEON. REPORTABILITY REMAINS UNCHANGED. UPDATED 8-14-2017.

  Patient problems: No Information

  MAUDE report 6793750 ↗