PINNACLE POROCOAT 1217-01-058Recalls & reported problems

Summary

The FDA's MAUDE database contains 40 adverse event reports that list this exact device (DI 10603295008583), received between Aug 1, 2017 and Dec 11, 2025 — classified as 37 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Loss of Osseointegration” (11 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 40 reports, in the reporter's own words as published by the FDA.

• InjuryDec 11, 2025Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT PATIENT'S DISLOCATION ORIGINAL WAS DONE 10 PLUS YEARS AGO. A POLY SWAP REVISION WAS DONE 2 YEARS AGO. THE PATIENT EXPERIENCED WEAR THROUGH THE ACETABULAR CUP AND LINER, NECESSITATING A REVISION PROCEDURE. DOI: UNKNOWN, DOR: (B)(6) 2025, AFFECTED SIDE: LEFT HIP.

  Patient problems: Insufficient Information

  MAUDE report 23783168 ↗
• InjurySep 18, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  PATIENT WAS REVISED DUE TO DISASSOCIATION OF LINER TO DM. ALL PARTS WERE RETRIEVED. THERE WAS NO CASE DELAY. DOI: UNKNOWN DOR: (B)(6) 2024 AFFECTED SIDE: RIGHT HIP.

  Patient problems: Insufficient Information

  MAUDE report 20248734 ↗
• InjurySep 16, 2024Osseointegration Problem; Osseointegration Problem

  IT WAS REPORTED THAT PATIENT WAS REVISED DUE TO LOOSENING AT THE BONE TO IMPLANT INTERFACE OF THE ACETABULAR CUP. DOI: (B)(6) 2005, DOR: UNKNOWN, AFFECTED SIDE : LEFT HIP..

  Patient problems: Inadequate Osseointegration

  MAUDE report 20226295 ↗
• InjuryMar 5, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  SUBJECT ID: (B)(6). STUDY NO: DOTS CLINICAL NOTIFICATION RECEIVED FOR REVISION DUE TO INFECTION. DATE OF IMPLANT: (B)(6) 2022 DATE OF REVISION: (B)(6) 2024 (LEFT HIP). TREATMENT: HEAD, LINER, AND CUP REVISED.

  Patient problems: Unspecified Infection

  MAUDE report 18837753 ↗
• MalfunctionJan 22, 2024Defective Device; Defective Device

  IT WAS REPORTED THAT THERE WAS MARRING ON INSIDE OF THE 58 CUP. UNKNOWN SURGICAL DELAY. DOE: (B)(6), 2024. AFFECTED SIDE: LEFT HIP.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18552409 ↗
• InjuryApr 1, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REVISION COMPLETED DUE TO PAIN. NO SURGICAL DELAY. DOI: UNKNOWN; DOR: (B)(6) 2022; AFFECTED SIDE: UNKNOWN HIP.

  Patient problems: Pain

  MAUDE report 13975341 ↗
• InjuryMar 10, 2022Device Dislodged or Dislocated; Noise, Audible; Device Dislodged or Dislocated; Noise, Audible

  SURGEON REPORTED TO BFARM: "HIP-TEP LEFT SIDE ON (B)(6) 2021 IN (B)(6). PATIENT NOW IS TRANSFERRED BY AMBULANCE FROM THE (B)(6) CLINIC IN (B)(6). PRESENTATION THERE BECAUSE OF SUBLUXATION PHENOMENA AT THE LEFT HIP JOINT. HE HAD NEVER BEEN FREE OF DISCOMFORT SINCE THE OPERATION. ALWAYS WHEN CLIMBING STAIRS AND DURING CERTAIN MOVEMENTS AND LOADS, HE HAD HEARD A CREAKING NOISE AND HAD SLIGHT PAIN. SO FAR, HE HAS HAD THE FEELING THAT THE HIP JOINT HAS JUMPED OUT SIX TIMES, BUT THEN LOCATED BACK IN ON ITS OWN. YESTERDAY RENEWED SUBLUXATION PHENOMENON WHEN BENDING, THIS TIME WITH SEVERE PAIN, AGAIN SNAPPING BACK BY ITSELF. HE NOW HAS A CONSIDERABLE FEELING OF INSTABILITY AND DOES NOT DARE TO MAKE CERTAIN MOVEMENTS. NO PAIN AT REST. NO TRAUMA. RADIOLOGICAL DISLOCATION OF THE PE. REVISION OF HEAD AND INLAY ON (B)(6) 2022 IN (B)(6)." DOI: (B)(6) 2021; DOR: (B)(6) 2022; LEFT HIP.

  Patient problems: Discomfort; Joint Laxity; Loss of Range of Motion; Pain

  MAUDE report 13719703 ↗
• InjuryOct 12, 2021Difficult to Remove; Difficult to Remove

  THIS IS TO CAPTURE THE INTRAOPERATIVE COMPLICATION IN (B)(4). WE USED KINCISE TO TRY TO DISIMPACT THE METAL LINER FROM THE SHELL. THERE WAS A NEW TIP, WHICH DID NOT FIT WELL AROUND THE RIM OF THE CUP AND THIS WAS DIFFICULT TO USE AND THEY WERE UNABLE TO GET THE LINER DISIMPACTED FROM THE CUP DESPITE MANUAL ATTEMPTS AS WELL. THEREFORE, THE CUP WAS REVISED.

  Patient problems: Insufficient Information

  MAUDE report 12616422 ↗
• InjuryMay 20, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT HAS NOW BEEN REVISED TO ADDRESS A CONFIRMED INFECTION WITH EXPLANTATION OF ALL PRODUCTS. THIS INCLUDING THE USE OF AN OPENING FEMORAL OSTEOTOMY TO FACILITATE REMOVAL OF THE FEMORAL STEM. AN ANTIBIOTIC SPACER WAS RE-IMPLANTED TO ADDRESS THE INFECTION. ALL DEVICES ARE CONSIDERED REPORTABLE, GIVEN THAT IT IS NOT POSSIBLE TO RULE-OUT THEIR POSSIBLE CONTRIBUTION, GIVEN THAT THEY PRESENT A SAFE HARBOR FOR INFECTIOUS MICROORGANISMS TO TAKE HOLD.

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

  MAUDE report 11854916 ↗
• InjuryFeb 24, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  STUDY: (B)(6). CLINICAL ADVERSE EVENT RECEIVED FOR INTRAOPERATIVE BONE FRACTURE. EVENT IS SERIOUS. EVENT IS POSSIBLY RELATED TO DEVICE AND IS PROBABLY RELATED TO PROCEDURE. DATE OF IMPLANTATION: (B)(6) 2010, DATE OF EVENT (ONSET): (B)(6) 2010, (RIGHT HIP). TREATMENT: INTRAOPERATIVE ORIF. ADDITIONAL INFORMATION RECEIVED: ON (B)(6) 2010, THE PATIENT UNDERWENT A PRIMARY RIGHT HIP ARTHROPLASTY DUE TO AVASCULAR NECROSIS. DURING IMPACTION OF THE ACETABULAR CUP, A SMALL FRACTURE WAS NOTICED IN THE POSTERIOR WALL. THE ACETABULAR FRACTURE WAS CORRECTED INTRA-OPERATIVELY WITH A 5-HOLE SMALL FRAGMENT PELVIC RECONSTRUCTION PLATE ALONG WITH FOUR SCREWS.

  Patient problems: Bone Fracture(s)

  MAUDE report 11372429 ↗
• InjuryDec 22, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PINNACLE CLAIM SUBMISSION FORM AND MEDICAL RECORD RECEIVED. AFTER REVIEW OF MEDICAL RECORD, PATIENT WAS REVISED TO ADDRESS RIGHT HIP PROSTHETIC INFECTION, METALLOSIS, PSEUDOTUMOR. REVISION NOTE STATED THAT COPIOUS PURULENCE WAS NOTED IN ADDITION TO METALLOSIS DEBRIS. ALL COMPONENTS WERE REMOVED. THE ACETABULAR COMPONENT WAS REMOVED WITH MINIMAL BONE LOSS. DOI: (B)(6) 2008; DOR: (B)(6) 2020; (RIGHT HIP).

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Foreign Body Reaction; Hypersensitivity/Allergic reaction

  MAUDE report 11055104 ↗
• InjuryDec 17, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL ADVERSE EVENT RECEIVED FOR ADVERSE LOCAL TISSUE REACTION/ HIGH COBALT LEVEL 5.3 MCG/L. EVENT IS SERIOUS AND IS CONSIDERED SEVERE. EVENT IS DEFINITELY RELATED TO DEVICE AND IS DEFINITELY NOT RELATED TO PROCEDURE. DATE OF IMPLANTATION: (B)(6) 2005. DATE OF EVENT (ONSET): (B)(6) 2020; (LEFT HIP). TREATMENT: HIP REVISED ON (B)(6) 2020, OF HEAD AND LINER.

  Patient problems: Foreign Body Reaction; Inflammation

  MAUDE report 11027048 ↗
• InjuryDec 3, 2020Device Dislodged or Dislocated; Noise, Audible; Device Dislodged or Dislocated; Noise, Audible

  PATIENT IS DUE TO BE REVISED THIS WEEK BEGINNING (B)(6) 2020 CORAIL/PINNACLE THR (LEFT SIDE) IN (B)(6) 2012 3-4 WEEKS AGO (MID (B)(6) 2020) ¿ STOPPED TO PICK SOMETHING UP FROM FLOOR ¿ SUDDEN GROIN PAIN ¿ WHICH SETTLED QUICKLY NO ONGOING PAIN SINCE THEN. ONLY SQUEAKS WHEN WALKING AND USING STAIRS. AUDIBLE (CLASSIC) SQUEAK WHEN WALKING. PATIENT SHOWN HIS POST OP AND PREVIOUS FILMS AS COMPARED TO TODAY ¿ LINER DISSOCIATION NOTED AND EXPLAINED GIVEN A PAIR OF CRUTCHES.

  Patient problems: Ambulation or Postural Difficulties; Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Loss of Range of Motion; Muscular Rigidity; Pain

  MAUDE report 10942499 ↗
• MalfunctionAug 3, 2020Malposition of Device; Malposition of Device

  CLINICAL ADVERSE EVENT RECEIVED FOR IMPLANT FRACTURE - S-ROM STEM. EVENT IS SERIOUS AND IS CONSIDERED SEVERE. EVENT IS DEFINITELY RELATED TO DEVICE AND IS DEFINITELY NOT RELATED TO PROCEDURE. DATE OF IMPLANTATION: (B)(6) 2008. DATE OF EVENT (ONSET): (B)(6) 2020 (RIGHT HIP).

  Patient problems: No Code Available; Pain

  MAUDE report 10358032 ↗
• InjuryJul 7, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PINNACLE CLAIM SUBMISSION FORM ALLEGES ELEVATED METAL IONS AND INFECTION. AFTER REVIEW OF MEDICAL RECORDS PATIENT WAS REVISED TO ADDRESS INFECTED RIGHT TOTAL HIP REPLACEMENT. REVISION NOTES REPORTED A SEPTIC WITH INFECTED RIGHT HIP AND POSITIVE BLOOD CULTURES. THERE WAS MORE PURULENT MATERIAL. THE REMAINDER OF THE HIP DID SHOW A LOT OF HEMATOMA. 4 UNITS OF BLOOD GIVEN FOR THE INTRAOP BLOOD LOSS AS WELL AS THE PREOP ANEMIA. SURGICAL PATHOLOGY REPORTED OF ACUTE INFLAMMATION, DOI: (B)(6) 2008; DOR: (B)(6) 2019 (RIGHT HIP). 2ND STAGE REVISION WAS PERFORMED ON (B)(6) 2019 FOR THE REMOVAL OF CEMENT SPACER, CONVERSION TO TOTAL HIP REPLACEMENT.

  Patient problems: Anemia; Hematoma; Hemorrhage/Blood Loss/Bleeding; Inflammation; No Code Available; Unspecified Infection

  MAUDE report 10241967 ↗
• InjuryMay 21, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT CAME IN WITH AN INFECTED HIP. CULTURES REVEALED THAT THE PATIENT HAD TB AND STAPH. THE SURGEON DECIDED IT BEST TO REMOVE ALL IMPLANTS AND PUT IN AN ANTIBIOTIC SPACER. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME. DOI: UNKNOWN. DOR: (B)(6) 2020; UNKNOWN AFFECTED SIDE.

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 10077710 ↗
• InjuryMar 5, 2020Use of Device Problem; Malposition of Device; Use of Device Problem; Malposition of Device

  PCF AND MEDICAL RECORDS RECEIVED. AFTER REVIEW OF MEDICAL RECORDS IT WAS INDICATED THAT THE PATIENT HAS HAD CONTINUED PROBLEMS WITH GROIN PAIN. HIS ACETABULAR COMPONENT WAS HORIZONTAL IN A NEUTRAL VERSION AND IT WAS FELT THAT HE COULD BE HAVING IMPINGEMENT FROM A PSOAS TENDON. REVISION NOTE REPORTED THERE WAS A SIGNIFICANT AMOUNT OF HYPERTROPHIC TROCHANTERIC BURSAL TISSUE THAT WAS REMOVED. THE POAS TENDON WAS PALPATE AND SEE SOME INFLAMED ERYTHEMATOUS SYNOVIUM AROUND IT. THERE WAS NO SUSPICION OF INFECTION. THE SHELL WAS REMOVED WITH MINIMAL BONE LOSS. DOI: (B)(6) 2006. DOR: (B)(6) 2007, (LEFT HIP).

  Patient problems: Inflammation; Local Reaction; Necrosis; No Code Available; Pain

  MAUDE report 9792772 ↗
• InjurySep 20, 2019Loss of Osseointegration; Osseointegration Problem; Loss of Osseointegration; Osseointegration Problem

  LITIGATION ALLEGES THE PATIENT SUFFERS FROM PAIN, DISCOMFORT, AND ELEVATED METAL IONS LEVELS IN HIS BLOOD. IN ADDITION TO WHAT WAS PREVIOUSLY REPORTED, LITIGATION ALSO ALLEGES THE PATIENT SUFFERS FROM INFLAMMATION AND PPF ALLEGES LOOSENING OF THE CUP. DOI: (B)(6) 2003, DOR: (B)(6) 2013, (LEFT HIP).

  Patient problems: Discomfort; Inadequate Osseointegration; Inflammation; No Code Available; Pain; Test Result

  MAUDE report 9097782 ↗
• InjurySep 12, 2019Use of Device Problem; Malposition of Device; Use of Device Problem; Malposition of Device

  CLINICAL ADVERSE EVENT RECEIVED FOR RECURRENT DISLOCATIONS. EVENT IS SERIOUS AND IS CONSIDERED MODERATE. EVENT IS DEFINITELY RELATED TO DEVICE AND THERE IS A REMOTE POSSIBILITY THAT IT IS RELATED TO PROCEDURE. DOI: (B)(6) 2012; DOR: (B)(6) 2014, (INSTABILITY/DISLOCATION--HEAD, STEM, AND LINER REVISED); DOE: (B)(6) 2019, (RIGHT HIP).

  Patient problems: Joint Laxity; No Code Available; Pain

  MAUDE report 9006511 ↗
• InjuryApr 30, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PPF ALLEGES INFECTION. (RIGHT HIP).

  Patient problems: Unspecified Infection

  MAUDE report 8566051 ↗
• InjuryApr 26, 2019Loss of Osseointegration; Osseointegration Problem; Loss of Osseointegration; Osseointegration Problem

  LITIGATION ALLEGES CUP LOOSENING. DOI: (B)(6) 2005 - DOR: (B)(6) 2016, (LEFT HIP).

  Patient problems: Discomfort; Inadequate Osseointegration; Inflammation; No Code Available; Tissue Damage

  MAUDE report 8556098 ↗
• InjuryApr 24, 2019Osseointegration Problem; Osseointegration Problem

  PPF ALLEGES LOOSENING OF CUP, CLOSED DISLOCATION, INFECTION, METAL WEAR AND METALLOSIS. DOI: (B)(6) 2009 - DOR: (B)(6) 2011 (RIGHT HIP).

  Patient problems: Inadequate Osseointegration; Limited Mobility Of The Implanted Joint; Pain; Tissue Damage; Unspecified Infection

  MAUDE report 8543717 ↗
• InjuryMar 27, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PINNACLE LITIGATION RECEIVED. LITIGATION ALLEGED FRICTION AND WEAR BETWEEN THE METAL HEAD AND LINER CAUSED THE RELEASE OF TOXIC METAL IONS AND PARTICLES INTO THE PATIENT'S BODY. AS A RESULT PLAINTIFF BEGAN EXPERIENCING SEVERE PAIN, INJURY, LOSS OF MOBILITY, LOSS OF MOTION, DISCOMFORT AND INFLAMMATION. DOI: (B)(6) 2006; DOR: (B)(6) 2018; RIGHT HIP.

  Patient problems: Discomfort; Inflammation; Injury; Limited Mobility Of The Implanted Joint; No Code Available; Pain

  MAUDE report 8456916 ↗
• MalfunctionMar 11, 2019Loss of Osseointegration; Loss of Osseointegration

  PINNACLE PPF AND STICKER SHEETS RECEIVED. PPF ALLEGES LOOSENING OF CUP AFTER FIRST REVISION. DOI: (B)(6) 2012 - DOR: NONE REPORTED (RIGHT HIP).

  Patient problems: Inadequate Osseointegration

  MAUDE report 8408784 ↗
• InjuryFeb 5, 2019Loss of Osseointegration; Loss of Osseointegration

  IN ADDITION TO PAIN, PATIENT SUFFERS FROM METALLOSIS, LOOSENING, AND LACK OF MOBILITY. DOI: (B)(6) 2009, DOR: (B)(6) 2011, (LEFT HIP).

  Patient problems: Inadequate Osseointegration; Limited Mobility Of The Implanted Joint; Pain; Tissue Damage

  MAUDE report 8304234 ↗