PINNACLE 1217-12-052Recalls & reported problems

Summary

The FDA's MAUDE database contains 19 adverse event reports that list this exact device (DI 10603295009160), received between Jul 11, 2017 and May 10, 2024 — classified as 17 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (5 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 19 most recent of 19 reports, in the reporter's own words as published by the FDA.

• InjuryMay 10, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION RECEIVED: WAS THERE ANY SURGICAL DELAY? NO, REVISION WENT AHEAD AS PLANNED. WHAT WAS THE ALLEGATION AGAINST THE CUP? NO.

  Patient problems: Loss of Range of Motion

  MAUDE report 19286421 ↗
• MalfunctionOct 18, 2023Difficult to Insert; Difficult to Insert

  IT WAS REPORTED THAT WHEN THE SURGEON WAS INSERTING HOLE ELIMINATOR INTO THE CUPS APEX HOLE, HE STATED THE HOLE ELIMINATOR DID NOT STOP RESULTING IN IT GOING STRAIGHT THROUGH. SURGEON WAS ABLE TO BACK OUT HOLE ELIMINATOR JUST ENOUGH TO LEAVE FLUSH WITH CUP AND DECIDED TO LEAVE IMPLANTED. THERE WAS NO SURGICAL DELAYS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17956833 ↗
• InjuryJan 31, 2023Naturally Worn; Naturally Worn

  THE DOCTOR REPORTS THE INCIDENCE OF A PATIENT OPERATED 6 MONTHS AGO OF PTM WITH PINNACLE CUP, WHICH WAS DEFORMED WHEN REMOVED IN A SECOND SURGERY. THE PATIENT IS REINTERVENED WITH A REVISION CUP. DOI: (B)(6) 2022. DOR: (B)(6) 2022.

  Patient problems: Insufficient Information

  MAUDE report 16271063 ↗
• MalfunctionNov 17, 2021Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT THE SURGEON DECIDED TO IMPLANT A SIZE 52 ACETABULAR CUP AFTER HAVING DRILLED 52 AND DONE HIS TEST BUT THIS SIZE 52 CUP DID NOT HOLD.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12828581 ↗
• InjuryMar 25, 2021Device Dislodged or Dislocated; Device Dislodged or Dislocated

  REVISION OF PINNACLE INSERT. INSERT WAS DISLOCATED FROM SHELL WITH OBVIOUS WEAR. LIKELY CAUSE IMPINGEMENT.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Muscular Rigidity; Pain

  MAUDE report 11568266 ↗
• InjuryMar 3, 2020Difficult to Remove; Difficult to Remove

  SURGEON REVISING CORAIL PINNACLE FOR DISLOCATION. INSITU WAS A CERAMIC LINER WHICH WOULD NOT DISASSOCIATE FROM THE PINNACLE SECTOR CUP.

  Patient problems: No Code Available; Not Applicable

  MAUDE report 9779341 ↗
• InjuryFeb 5, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PINNACLE CLAIM SUBMISSION FORM AND MEDICAL RECORDS RECEIVED. AFTER REVIEW OF MEDICAL RECORDS, IT WAS STATED THAT THE PATIENT WAS REVISED TO ADDRESS PROSTHETIC JOINT INFECTION, POSSIBLY CHRONIC. IT WAS STATED THAT THE SPECIMEN OF LEFT HIP SYNOVIUM YIELDED OVER 100 WBCS PER HIGH-POWER FIELD CONFIRMING DIAGNOSIS OF INFECTION. PROSTALAC COMPONENTS WERE IMPLANTED. DOI: (B)(6) 2010; DOR: (B)(6) 2015; LEFT HIP.

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 9671112 ↗
• InjuryAug 14, 2019Malposition of Device; Malposition of Device

  REVISED FOR INSTABILITY; INCORRECT ACETABULAR VERSION. THE CUP WAS PLACED IN APPROXIMATELY 0 DEGREES OF ANTEVERSION AS OPPOSED TO 20-25 DEGREES WHICH WOULD BE THE MOST CORRECT PLACEMENT.

  Patient problems: No Code Available

  MAUDE report 8892781 ↗
• InjuryMay 1, 2019Unintended Movement; Migration; Unintended Movement; Migration

  ACCORDING TO THE SURGEON'S NOTES, THE INITIAL TOTAL HIP REPLACEMENT OF THE LEFT HIP WAS DONE ON (B)(6) 2011. PATIENT HAS SINCE THEN SUSTAINED SEVERAL FALLS, AND IN RECENT TIME THE PATIENT HAS EXPERIENCED SYMPTOMS OF PAIN AND DISCOMFORT. ON X-RAYS, THE ACETABULAR CUP APPEARS TO HAVE MOVED. BOTH CUP AND LINER REMOVED DURING THE REVISION TODAY. IF OTHER, DESCRIBE: REVISION OF THE INITIAL TOTAL HIP REPLACEMENT. DID THE PATIENT EXPERIENCE A POST-OP DEVICE MALFUNCTION? NO. DID THE PATIENT EXPERIENCE AN ADVERSE EVENT SUCH AS INFECTION, NON-UNION, ALLERGIC REACTION, OSTEOPOROSIS, OVERLOADING, PAIN, DEGENERATIVE DISEASES, BLEEDING OR OOZING? YES. DID THE PATIENT REQUIRE REVISION SURGERY OR HARDWARE REMOVAL? YES. REASON FOR REVISION SURGERY: PAIN. PATIENT STATUS/ OUTCOME / CONSEQUENCES: YES.

  Patient problems: Discomfort; Fall; No Code Available; Pain; Tissue Damage

  MAUDE report 8568874 ↗
• InjuryJan 29, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PPF ALLEGES INFECTION AFTER 1ST REVISION.

  Patient problems: Unspecified Infection

  MAUDE report 8284506 ↗
• InjurySep 28, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  TOTAL HIP REPLACEMENT: (B)(6) HOSPITAL. PRIMARY (B)(6) 2016. PATIENT UNDER WENT AT TOTAL HIP REPLACEMENT IN (B)(6) 2016, 6 MONTHS LATER, HE HAS UNEXPLAINED PAIN IN THE JOINT, THE SURGEON FIRST THOUGHT IT WAS INFECTED AND TREATED THE PATIENT AS PER AN INFECTION. HE HAD FLUID COLLECTION, WITH HIGH METAL IONS REPORTED. THE SURGEON THEN THOUGHT IT COULD BE METALLOSIS. A STAGE ONE REVISION FOR INFECTION/METALLOSIS WAS PERFORMED. THE SURGEON WOULD LIKE THE PROSTHESIS INVESTIGATED TO HELP WITH THE REASONING AS TO WHAT COULD EVENT MAY HAVE CAUSED THIS ISSUE. HE WOULD ALSO LIKE THE PROSTHESIS SENT BACK TO HIM, AFTER DEPUY SYNTHES HAS CONCLUDED THEIR INVESTIGATIONS, TO SEND TO DR WALSH FOR FURTHER ANALYSIS.

  Patient problems: Not Applicable; Pain; Tissue Damage; Unspecified Infection

  MAUDE report 7918105 ↗
• InjurySep 24, 2018Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PATIENT'S LINER DISASSOCIATED FROM THE ACETABULAR SHELL.

  Patient problems: No Code Available

  MAUDE report 7903719 ↗
• InjurySep 12, 2018Loss of Osseointegration; Loss of Osseointegration

  PATIENT REPORT: THE PATIENT DIRECTLY CALLED US TO HAVE THE HEAVY METALS COMPOSITION FOR HER HIP PROTHESIS BECAUSE HER SURGEON SUSPECTS ALLERGIA, AND HE WILL SOON PERFORM AN ABLATION OF THE MATERIAL. DOI : UNKNOWN, UNKNOWN HIP.

  Patient problems: Hypersensitivity/Allergic reaction; Not Applicable

  MAUDE report 7871437 ↗
• InjuryJun 18, 2018Use of Device Problem; Loss of Osseointegration; Osseointegration Problem; Use of Device Problem; Loss of Osseointegration; Osseointegration Problem

  PINNACLE LITIGATION RECORDS RECEIVED. LITIGATION ALLEGES PROGRESSIVELY WORSE PAIN, LACK OF MOBILITY, EMOTIONAL DISTRESS, METALLOSIS AND ELEVATED METAL LEVELS OF COBALT AND CHROMIUM. REVISION NOTE REPORTED, ON THE FEMORAL SIDE THERE WAS A SIGNIFICANT DEGREE OF BONE LOSS. THERE WAS A LARGE BLACK STAINED ON MASS ON THE LATERAL ASPECT OF THE GREATER TROCHANTER, THIS WAS FILLED WITH METAL DEBRIS. THERE WAS A PATHOLOGIC FRACTURE AT THE BASE OF THE GREATER TROCHANTER. THE ACETABULAR COMPONENT WAS GROSSLY LOOSE AND THERE WAS PRONOUNCED METAL STAINING OF THE REMAINING NATIVE ACETABULUM AND SURROUNDING SOFT TISSUES. THERE WAS ALMOST COMPLETE LOSS OF THE ANTERIOR COLUMN AND SEVERE THINNING OF THE POSTERIOR COLUMN. RADIOGRAPH SHOWS SOME OSTEOLYSIS WITH AN AREA OF LUCENCY AT THE ACETABULAR MEDIAL WALL. LABORATORY RESULTS FOR BLOOD METAL ION LEVEL SHOWS ABOVE 7 PPB. DOI: (B)(6) 2008 : DOR: (B)(6) 2017 (LEFT HIP).

  Patient problems: Discomfort; Distress; Fatigue; Foreign Body Reaction; Inadequate Osseointegration; Injury; Limited Mobility Of The Implanted Joint; Not Applicable; Osteolysis; Pain; Tissue Damage

  MAUDE report 7609251 ↗
• InjuryFeb 6, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  REVISION DUE TO MASS IN RIGHT GROIN. REPORTED - SEVERE PAIN, GRINDING & PATIENT STRUGGLES TO STRAIGHT LEG RAISE. WALKING DISTANCE 100YARDS. OXFORD SCORE 12/48. DOI: (B)(6) 2005; DOR: (B)(6) 2012; RIGHT HIP. UPDATE (B)(6) 2018. PINNACLE SPREADSHEET RECEIVE. ADDED PATIENT DETAILS, AFFECTED SIDE, ADDED PRODUCT RECORD FOR THE ACETABULAR CUP AND CORAIL. CORRECTED DOI.

  Patient problems: Cyst(s); Loss of Range of Motion; Pain

  MAUDE report 7243523 ↗
• InjuryJan 31, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  PERSISTENT HIP PAIN. (B)(6) 2006; (B)(6) 2012; RIGHT HIP.

  Patient problems: Pain

  MAUDE report 7230417 ↗
• InjuryJan 31, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  THE PATIENT HAS INCREASING PAIN IN RIGHT HIP FROM MID-2009; TWO ASPIRATIONS OF FLUID. DOI: (B)(6) 2007; DOR: (B)(6) 2010; RIGHT HIP.

  Patient problems: Pain

  MAUDE report 7230295 ↗
• InjuryDec 12, 2017Insufficient Device Problem Information; Insufficient Device Problem Information

  THE PATIENT WAS REVISED TO ADDRESS RIGHT HIP/BUTTOCK PAIN ON WALKING AND PRESUMED INFECTION.

  Patient problems: Pain; Unspecified Infection

  MAUDE report 7109975 ↗
• InjuryJul 11, 2017Insufficient Device Problem Information; Insufficient Device Problem Information

  THE PATIENT WAS REVISED TO ADDRESS POLYETHYLENE WEAR AND PAIN.

  Patient problems: Pain

  MAUDE report 6701421 ↗