PINNACLE 1217-50-500Recalls & reported problems

Summary

The FDA's MAUDE database contains 33 adverse event reports that list this exact device (DI 10603295010418), received between Oct 5, 2017 and Aug 21, 2024 — classified as 32 injuries, 1 malfunction.

The most frequently reported specific device problem is “Loss of Osseointegration” (12 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 25 most recent of 33 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 21, 2024Difficult to Open or Remove Packaging Material; Difficult to Open or Remove Packaging Material

  IT WAS REPORTED THAT THE STERILE PACKAGE DID NOT OPEN UP PROPERLY AND THEREFORE COULD NOT BE SAFELY PASSED OFF TO THE SURGICAL FIELD. THE IMPLANT AND ITS BOX WERE KEPT AND WILL BE RETURNED.

  Patient problems: Insufficient Information

  MAUDE report 20020374 ↗
• InjuryApr 8, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO INFECTION. DOI: UNKNOWN. DOR: (B)(6) 2024. AFFECTED SIDE: LEFT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 19067603 ↗
• InjuryAug 4, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO HIP INFECTION. DURING THE FIRST STAGE OF THE TWO STAGE PROCEDURE, THE PATIENT'S PRIMARY IMPLANTS WERE REMOVED AND REPLACED BY A PROSTALAC ANTIBIOTIC SPACER. ONCE THE INFECTION HAS CLEARED, THE PATIENT WILL UNDERGO THE SECOND STAGE OF THE TWO STAGE PROCEDURE. DURING THIS STAGE, THE PROSTALAC SPACER WILL BE REMOVED AND REVISION COMPONENTS WILL BE IMPLANTED. DOI: (B)(6) 2021, DOR: (B)(6) 2023, AFFECTED SIDE: LEFT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 17457970 ↗
• InjuryJul 6, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2023, THE PATIENT HAD A REVISION LEFT HIP WITH REMOVAL OF ACETABULAR CUP, SCREWS X5, AND PLACEMENT OF COMPETITOR CUP AND SCREWS X4, ALONG WITH DEPUY FEMORAL HEAD. PRIOR TO SURGERY, THE PATIENT WAS EXPERIENCING INSTABILITY. DURING THE PROCEDURE, THE SURGEON OBSERVED WEAKNESS OF THE GLUTEUS MAXIMUS MUSCLE. THE DUAL MOBILITY HEAD WAS REVISED, ALONG WITH THE LINER. DOI: (B)(6) 2022; DOR: (B)(6) 2023; LEFT HIP.

  Patient problems: Fall; Fatigue; Joint Laxity; Pain

  MAUDE report 17266414 ↗
• InjuryMar 6, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT HIP WAS EXPLANTED FOR INFECTION. TEMPORARY SPACER WAS PUT IN. DOI: UNKNOWN. DOR: (B)(6) 2023. AFFECTED SIDE: UNKNOWN.

  Patient problems: Unspecified Infection

  MAUDE report 16488408 ↗
• InjuryOct 18, 2021Osseointegration Problem; Migration; Osseointegration Problem; Migration

  THE PATIENT WAS REVISED TO ADDRESS MIGRATION AND LOOSENING OF THE CUP AT THE BONE TO IMPLANT INTERFACE. CANCER PATIENT. CONVERTED TO TRI-FLANGE. PROXIMAL FEMUR AND SEGMENT REMOVED TO RE-ESTABLISH LEG LENGTH. DOI: (B)(6) 2018, DOR: (B)(6) 2021 AFFECTED SIDE: LEFT HIP.

  Patient problems: Inadequate Osseointegration

  MAUDE report 12646631 ↗
• InjuryOct 6, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  MEDICAL RECORDS RECEIVED. AFTER REVIEW OF THE MEDICAL RECORDS THE PATIENT WAS REVISED TO ADDRESS INFECTION, OSTEOMYELITIS AND PAIN. OPERATIVE NOTE REPORTED 20 ML SEROUS FLUID AND FIBROUS TISSUES. DOI: (B)(6) 2013. DOR: (B)(6) 2014; RIGHT HIP (2ND REVISION).

  Patient problems: Hemorrhage/Blood Loss/Bleeding; No Code Available; Pain; Unspecified Infection

  MAUDE report 10636319 ↗
• InjuryAug 24, 2020Fracture; Loss of Osseointegration; Fracture; Loss of Osseointegration

  PATIENT WAS REVISED TO ADDRESS LOOSENING OF THE CUP AND SUBSEQUENT SCREW BREAKAGE. DOI: (B)(6) 2018, DOR: (B)(6) 2020, LEFT HIP.

  Patient problems: Inadequate Osseointegration; No Code Available

  MAUDE report 10442904 ↗
• InjuryJul 6, 2020Loss of Osseointegration; Loss of Osseointegration

  IT WAS REPORTED THAT THE PATIENT WAS INFECTED. ORIGINAL DATE OF SURGERY (B)(6) 2017. REVISED ON (B)(6) 2018. DOI: (B)(6) 2018, DOR: (B)(6) 2020, RIGHT SIDE.

  Patient problems: Inadequate Osseointegration; No Code Available; Unspecified Infection

  MAUDE report 10233539 ↗
• InjuryJun 17, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD THEIR HIP OPERATED ON AT BEAUMONT ROYAL OAK BY DR (B)(6) ON (B)(6) 2019. THIS WAS ALSO A REVISION CASE, BUT I AM NOT SURE OF WHEN THE ORIGINAL PROCEDURE DATE. IT WAS NOT IN THE OPERATIVE NOTES. REVISION WAS BEING DONE BY DR (B)(6) DUE TO PATIENT INSTABILITY. DR (B)(6) BELIEVED THE ACETABULAR COMPONENT WAS NOT POSITIONED PROPERLY AND NEEDED TO BE ADJUSTED. ALL OF THE IMPLANTS WERE REMOVED FROM THE ACETABULAR SIDE OF THE PATIENT, AND REPLACED WITH ZIMMER COMPONENTS. DR (B)(6) FELT THAT THE FEMORAL STEM WAS WELL FIXED AND OPTED TO LEAVE IT. ONCE THE ZIMMER CUP WAS INSERTED, A TRIAL REDUCTION WAS PERFORMED WITH OUR 40MM HEAD TRIAL. A 40MM +12 WAS FOUND TO BE SATISFACTORY AND IMPLANTED. CLOSING PROCESS BEGAN. TO CAPTURE THE OTHER TWO BONE SCREWS FROM (B)(4). DOI: (B)(6) 2019, DOR: (B)(4) 2020, AFFECTED SIDE: RIGHT HIP.

  Patient problems: No Code Available

  MAUDE report 10160972 ↗
• InjuryJun 17, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD THEIR HIP OPERATED ON AT (B)(6) BY DR (B)(6) ON (B)(6) 2019. THIS WAS ALSO A REVISION CASE, BUT I AM NOT SURE OF WHEN THE ORIGINAL PROCEDURE DATE. IT WAS NOT IN THE OPERATIVE NOTES. REVISION WAS BEING DONE BY DR (B)(6) DUE TO PATIENT INSTABILITY. DR (B)(6) BELIEVED THE ACETABULAR COMPONENT WAS NOT POSITIONED PROPERLY AND NEEDED TO BE ADJUSTED. ALL OF THE IMPLANTS WERE REMOVED FROM THE ACETABULAR SIDE OF THE PATIENT, AND REPLACED WITH ZIMMER COMPONENTS. DR M. FELT THAT THE FEMORAL STEM WAS WELL FIXED AND OPTED TO LEAVE IT. ONCE THE ZIMMER CUP WAS INSERTED, A TRIAL REDUCTION WAS PERFORMED WITH OUR 40MM HEAD TRIAL. A 40MM +12 WAS FOUND TO BE SATISFACTORY AND IMPLANTED. CLOSING PROCESS BEGAN. TO CAPTURE THE OTHER TWO BONE SCREWS FROM (B)(4). DOI: (B)(6) 2019; DOR: (B)(6) 2020; AFFECTED SIDE: RIGHT HIP.

  Patient problems: No Code Available

  MAUDE report 10160944 ↗
• InjuryJun 16, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD THEIR HIP OPERATED ON AT (B)(6) ON (B)(6) 2019. THIS WAS ALSO A REVISION CASE, BUT I AM NOT SURE OF WHEN THE ORIGINAL PROCEDURE DATE. IT WAS NOT IN THE OPERATIVE NOTES. REVISION WAS BEING DONE BY DR M. DUE TO PATIENT INSTABILITY. DR (B)(6) BELIEVED THE ACETABULAR COMPONENT WAS NOT POSITIONED PROPERLY AND NEEDED TO BE ADJUSTED. ALL OF THE IMPLANTS WERE REMOVED FROM THE ACETABULAR SIDE OF THE PATIENT, AND REPLACED WITH ZIMMER COMPONENTS. DR (B)(6) FELT THAT THE FEMORAL STEM WAS WELL FIXED AND OPTED TO LEAVE IT. ONCE THE ZIMMER CUP WAS INSERTED, A TRIAL REDUCTION WAS PERFORMED WITH OUR 40 MM HEAD TRIAL. A 40 MM +12 WAS FOUND TO BE SATISFACTORY AND IMPLANTED. CLOSING PROCESS BEGAN. DOI: (B)(6) 2019, DOR: (B)(6) 2020, AFFECTED SIDE: RIGHT HIP.

  Patient problems: No Code Available

  MAUDE report 10159580 ↗
• InjuryJun 3, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS INFECTED. ORIGINAL DATE OF SURGERY (B)(6) 2017. REVISED ON (B)(6) 2018. DOI: (B)(6) 2017. DOR: (B)(6) 2018. RIGHT SIDE.

  Patient problems: No Code Available

  MAUDE report 10115293 ↗
• InjuryMar 20, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS UNSTABLE. TRIFLANGE IMPLANTED. DOI: (B)(6) 2018; DOR: (B)(6) 2020; AFFECTED SITE: LEFT HIP.

  Patient problems: No Code Available

  MAUDE report 9860234 ↗
• InjuryFeb 14, 2020Loss of Osseointegration; Loss of Osseointegration

  AFTER REVIEW OF MEDICAL RECORDS, THE PATIENT WAS REVISED FOR LEFT ACETABULAR FAILURE. OPERATIVE NOTES REPORTED THAT THERE WERE SEROSANGUINEOUS TYPE FLUID WAS ENCOUNTERED AND THAT THE CUP WAS GROSSLY LOOSE. DOI: (B)(6) 2010; DOR: (B)(6) 2011; LEFT HIP.

  Patient problems: Inadequate Osseointegration; No Code Available

  MAUDE report 9711097 ↗
• InjuryJan 10, 2020Loss of Osseointegration; Osseointegration Problem; Loss of Osseointegration; Osseointegration Problem

  IT WAS REPORTED THAT THERE WAS LOOSENING OF THE CUP AT THE BONE TO IMPLANT INTERFACE. CUP REVISION WAS PERFORMED. DOI: (B)(6) 2019. DOR: (B)(6) 2019, LEFT HIP.

  Patient problems: Inadequate Osseointegration; No Code Available

  MAUDE report 9575175 ↗
• InjuryJan 2, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD THEIR IMPLANTS REMOVED DUE TO INFECTION. THE IMPLANTS WERE WELL FIXED AND DIFFICULT TO REMOVE. THE PATIENT THEN HAD A PROSTALAC SPACER PLACED. THERE WAS SOME SCARRING ON THE CERAMIC HEAD PROBABLY DUE TO THE HEAD RIDING UP ON THE RIM OF THE SHELL. THE PATIENT HAD DISLOCATED MANY TIMES AND HAD A DARK DISCOLORATION TO THEIR TISSUE. DOI: UNKNOWN; DOR: (B)(6) 2019, (LEFT HIP).

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 9540338 ↗
• InjuryOct 2, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  COMPLAINT DESCRIPTION: PATIENT WAS REVISED TO ADDRESS ACUTE INFECTION. UPDATE FEB 14, 2018: PINNACLE LITIGATION RECORDS RECEIVED. IN ADDITION TO WHAT WAS PREVIOUSLY ALLEGED, LITIGATION ALLEGES THAT CORROSION AND FRICTION WEAR HAD CAUSED METAL ION AND PARTICLES TO BE RELEASED INTO THE PATIENT¿S BLOOD AND TISSUES AND BONE SURROUNDING THE IMPLANT RESULTING TO INJURIES SUCH AS ADVERSE LOCAL TISSUE REACTION, PAIN, CRUNCHING OR POPPING NOISES IN THE HIPS, STANDING AND WALKING DIFFICULTIES, HIP FRACTURES OR DISLOCATIONS, FATIGUE, TISSUE INFLAMMATION, NECROSIS, METALLOSIS, LIMITED MOBILITY, AND TISSUE AND BONE DAMAGE. THE PATIENT IS ALSO SUFFERING FROM DISCOMFORT, EMOTIONAL DISTRESS AND OTHER INJURIES CAUSED BY THE FAILED HIP IMPLANT. ADDED STEM DUE TO REPORTED METAL ION TOXICITY, FRACTURES AND CORROSION. ADDED NEW ASSOCIATED CONTACT. DOI: (B)(6) 2008; DOR: (B)(6) 2016 ; RIGHT HIP THIS COMPLAINT WAS UPDATED ON: FEBRUARY 21, 2018. PATIENT IS BILATERAL, SEE (B)(4) FOR THE LEFT HIP.

  Patient problems: Cardiac Arrest; Discomfort; Foreign Body Reaction; Hypersensitivity/Allergic reaction; Inflammation; Injury; Necrosis; No Code Available; Osteolysis; Pain; Unspecified Infection

  MAUDE report 9146470 ↗
• InjurySep 27, 2019Loss of Osseointegration; Osseointegration Problem; Loss of Osseointegration; Osseointegration Problem

  LITIGATION ALLEGES PATIENT SUFFERS FROM PAIN, DISCOMFORT, INFLAMMATION, AND LARGE AMOUNTS OF TOXIC COBALT CHROMIUM METAL ION PARTICLES TO BE RELEASED INTO THE BLOOD, TISSUE, AND BONE. UPDATE (B)(6) 2015 PFS RECEIVED. AFTER REVIEW OF THE PFS FOR MDR REPORTABILITY, THERE IS NO NEW ADDITIONAL INFORMATION THAT WOULD AFFECT THE EXISTING INVESTIGATION. THE COMPLAINT WAS UPDATED ON: (B)(6) 2015. UPDATE REC'D (B)(6) 2016 - SALES REP REPORTED PATIENT HAD A PAINFUL HIP AND METALOSIS. REVISED HEAD AND LINER, CUP AND STEM WERE SOLID. PART AND LOT WERE UPDATED, STEM REMAINS UNKNOWN. COMPLAINT WAS UPDATED (B)(6) 2016. UPDATE AD (B)(6) 2018: (B)(4) HAS BEEN RE-OPENED UNDER (B)(4) DUE TO THE RECEIPT OF PPF AND STICKER SHEETS. IN ADDITION TO WHAT WERE PREVIOUSLY ALLEGED, PPF ALLEGES LOOSENING OF CUP. ADDED CUP AND SCREW DUE TO NEW ALLEGATION. ADDED REVISION HOSPITAL, REVISION SURGEON, AND EXPIRATION DATES OF HEAD AND LINER. UPDATED EVENT DATE, AND PRODUCT DETAILS OF UNKNOWN STEM. DOI: (B)(6) 2008 - DOR: (B)(6) 2016 (LEFT HIP). PATIENT IS BILATERAL. SEE (B)(4) FOR THE RIGHT HIP.

  Patient problems: Discomfort; Foreign Body Reaction; Inadequate Osseointegration; Inflammation; No Code Available; Pain

  MAUDE report 9129134 ↗
• InjuryAug 7, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE IMPLANTS WERE REMOVED FOR INFECTION, TEMPORARY IMPLANTS WERE PLACED. DOI: (B)(6) 2019, DOR: (B)(6) 2019, LEFT HIP.

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 8871237 ↗
• InjuryJul 22, 2019Fracture; Loss of Osseointegration; Osseointegration Problem; Fracture; Loss of Osseointegration; Osseointegration Problem

  PATIENT WAS REVISED TO ADDRESS ACETABULAR CUP LOOSENING. LITIGATION ALLEGES THE PATIENT SUFFERS FROM "METAL STAINING THROUGHOUT THE JOINT" AND "A FAIR AMOUNT OF METALLOSIS." IN ADDITION TO WHAT WERE PREVIOUSLY ALLEGED, PPF ALLEGES METAL WEAR. DOI: (B)(6) 2009; DOR: (B)(6) 2015; (RIGHT HIP).

  Patient problems: Foreign Body Reaction; Inadequate Osseointegration; Loss of Range of Motion; No Code Available; Pain

  MAUDE report 8811804 ↗
• InjuryApr 12, 2019Break; Break

  PATIENT WAS REVISED TO ADDRESS LOOSENING OF THE CUP AT BONE TO IMPLANT INTERFACE WITH BROKEN SCREWS RESULTING IN FLUID COLLECTION AND PAIN.

  Patient problems: No Code Available; Pain

  MAUDE report 8510463 ↗
• InjuryMar 20, 2019Fracture; Loss of Osseointegration; Fracture; Loss of Osseointegration

  PFS ALLEGES PAIN, INSTABILITY, AND RECURRENT ABSCESSES, AND USING CANE FOR MOBILITY. AFTER REVIEW OF MEDICAL RECORDS, PATIENT WAS REVISED TO ADDRESS ASEPTIC LOOSENING. GROSS PATHOLOGY REPORTED OF A LARGE VOLUME SYNOVIAL FLUID WITH CONSISTENT SYNOVITIS, METALLOSIS, METALLIC DEBRIS, BROKEN RIM FIT SCREW ONLY ONE OF FOUR SCREW , GROSS LOOSENING OF CUP. OPERATIVE REPORT CUP HAD A VERTICAL ALTITUDE WITH GROSS ANTEVERSION AND HAD MIGRATED. LOOSENING CONFIRMED. ONE BROKEN SCREW WERE READILY IDENTIFIED AS BROKEN INVOLVING THE LIPPED PORTION OF THE CUP AND DEMONSTRATED WITH GROSS METALLOSIS AND GRAY STAINED. DOI: (B)(6) 2012; DOR: (B)(6) 2014; (RIGHT HIP).

  Patient problems: Inadequate Osseointegration; Limited Mobility Of The Implanted Joint; No Code Available; Pain; Tissue Damage

  MAUDE report 8435656 ↗
• InjuryMar 13, 2019Loss of Osseointegration; Loss of Osseointegration

  THE PATIENT WAS REVISED TO ADDRESS LOOSENING/PROTRUSION OF ACETABULAR COMPONENT AT BONE TO IMPLANT INTERFACE. DOI: (B)(6) 2016; DOR: (B)(6) 2019; RIGHT HIP.

  Patient problems: Inadequate Osseointegration; No Code Available

  MAUDE report 8417302 ↗
• InjuryJan 17, 2019Loss of Osseointegration; Osseointegration Problem; Loss of Osseointegration; Osseointegration Problem

  LITIGATION ALLEGES THAT PATIENT HAS EXPERIENCED SEVERE PAIN AND DISCOMFORT, STIFFNESS IN THE HIPS, AND DIFFICULTY WALKING. PPF ALLEGES STROKE/HEART ATTACK, PULMONARY EMBOLISM, LOOSENING OF CUP, LOOSENING OF STEM AND METAL WEAR/METALLOSIS. DOI: (B)(6) 2002; DOR: (B)(6) 2007; (LEFT HIP).

  Patient problems: Cardiac Arrest; Discomfort; Inadequate Osseointegration; Infarction, Cerebral; No Code Available; Pain; Pulmonary Embolism; Tissue Damage

  MAUDE report 8256779 ↗