PINNACLE POROCOAT 1217-01-054Recalls & reported problems

Summary

The FDA's MAUDE database contains 82 adverse event reports that list this exact device (DI 10603295008569), received between Dec 12, 2013 and Oct 28, 2024 — classified as 71 injuries, 11 malfunctions.

The most frequently reported specific device problem is “Osseointegration Problem” (10 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 82 reports, in the reporter's own words as published by the FDA.

• InjuryOct 28, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

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

  Patient problems: Unspecified Infection

  MAUDE report 20544460 ↗
• InjuryMay 3, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  COMPLETE REVISION OF THA FOLLOWING PAIN.

  Patient problems: Pain

  MAUDE report 19237812 ↗
• InjuryMar 19, 2024Osseointegration Problem; Osseointegration Problem

  AFTER THE REVIEW OF MEDICAL RECORDS, OPERATIVE NOTES REPORTED PAIN. X-RAY SHOWED OBVIOUS SUBSIDENCE OF THE IMPLANT, IMPLANT LOOSENING AND INFECTION MAY ALREADY BE PRESENT. THE SURGEON WAS ABLE TO EXTERNALLY ROTATE SOME OF THE SLEEVE SCAR TISSUE. CLINIC VISITS REPORTED DISCOMFORT AND MOVEMENT IMPAIRMENT. DOI: (B)(6) 2007; DOR: (B)(6) 2022; RIGHT HIP.

  Patient problems: Adhesion(s); Bone Fracture(s); Discomfort; Inadequate Osseointegration; Loss of Range of Motion; Pain; Scar Tissue; Unspecified Infection

  MAUDE report 18933617 ↗
• InjuryOct 25, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT IS HAVING A REVISION SURGERY FOR SUSPECTED PSEUDOTUMOR RELATED TO METAL ON METAL IMPLANTS. PATIENT STATUS/ OUTCOME / CONSEQUENCES: YES, PATIENT CONSEQUENCE DESCRIPTION/WAS THERE A CLINICAL OUTCOME EXPERIENCED BY THE PATIENT (INFECTION, INFLAMMATION, ETC.)? PSEUDO TUMOUR, WAS OTHER MEDICAL INTERVENTION (E.G. X-RAYS, ADDITIONAL PROCEDURES, PRESCRIPTIONS, OTC, REVISION) REQUIRED: YES, IF YES, DESCRIBE: REVISION SURGERY REQUIRED , IS THE PATIENT PART OF A CLINICAL STUDY: UNKNOWN, (B)(4). DEVICE PROPERTY OF: NONE, DEVICE IN POSSESSION OF: NONE, (B)(4). DEVICE PROPERTY OF: NONE, DEVICE IN POSSESSION OF: NONE, (B)(4). DEVICE PROPERTY OF: NONE, DEVICE IN POSSESSION OF: NONE, (B)(4). DEVICE PROPERTY OF: NONE, DEVICE IN POSSESSION OF: NONE, (B)(4). 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: Hypersensitivity/Allergic reaction

  MAUDE report 18004618 ↗
• MalfunctionAug 8, 2023Tear, Rip or Hole in Device Packaging; Device Contaminated During Manufacture or Shipping; Tear, Rip or Hole in Device Packaging; Device Contaminated During Manufacture or Shipping

  IT WAS REPORTED THAT THERE WERE HOLES IN PACKAGING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17481696 ↗
• InjuryApr 17, 2023Device Dislodged or Dislocated; Naturally Worn; Noise, Audible; Device Dislodged or Dislocated; Naturally Worn; Noise, Audible

  PRIMARY SURGERY DETAILS. HOSPITAL: (B)(6). DATE: (B)(6) 2022. PATIENT: 57 YR OLD FEMALE. IMPLANTS AVAILABLE FOR RETURN: NO - HOSPITAL HAVE SENT AWAY FOR INDEPENDENT ANALYSIS. REVISION SURGERY DETAILS. HOSPITAL: (B)(6). DATE: (B)(6) 2023. REASON FOR REVISION: POLY LINER HAD FLIPPED OUT OF CUP (SEE IMAGE OF PRE-REVISION SURGERY X RAY ATTACHED). PATIENT PRESENTED TO CLINIC WITH SQUEAKING. DURING REVISION SURGERY THERE WAS LOCALISED METALLURGY WHERE THE HEAD HAD RUBBED AGAINST PINNACLE CUP.

  Patient problems: Insufficient Information

  MAUDE report 16752385 ↗
• MalfunctionJan 27, 2023Difficult to Insert; Difficult to Insert

  THE SURGEON IMPLANTED A 54ER PINNACLE CUP BUT THE CORRESPONDING INLAY DID NOT FIT. THEY OPEN A NEW INLAY AND IT COULD THEN BE INSERTED IN THE USUAL WAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16256964 ↗
• InjuryJan 19, 2023Adverse Event Without Identified Device or Use Problem; Migration; Adverse Event Without Identified Device or Use Problem; Migration

  CLINICAL NOTIFICATION RECEIVED FOR REVISION DUE TO INFECTION. DATE OF IMPLANT: (B)(6) 2006, DATE OF REVISION: (B)(6) 2022, (RIGHT HIP). TREATMENT: REVISION; HEAD, LINER AND SHELL WERE REVISED.

  Patient problems: Cyst(s); Foreign Body Reaction; Low Blood Pressure/ Hypotension; Necrosis; Sepsis; Swelling/ Edema; Unspecified Infection; Unspecified Tissue Injury

  MAUDE report 16205024 ↗
• InjuryJan 5, 2023Use of Device Problem; Use of Device Problem

  PATIENT WAS REVISED DUE TO INFECTION. PATIENT HAD BILATERAL TOTAL SROM HIPS. SHE WAS REVISED DUE TO INFECTION IN BOTH HIPS. LOT NUMBER ON THE CUP WAS DAMAGED DURING EXPLANT AND UNRETRIEVABLE. THE R SIDE WAS CONVERTED TO A REVISION PINNACLE CUP FOR BETTER POSITIONING THE L SIDE WAS REVISED WITH HEAD AND LINER EXCHANGE. NO SURGICAL DELAY. DOI: UNKNOWN. DOR: ON (B)(6) 2022. AFFECTED SIDE: RIGHT.

  Patient problems: Unspecified Infection

  MAUDE report 16101787 ↗
• InjuryApr 22, 2022Osseointegration Problem; Migration; Osseointegration Problem; Migration

  IT WAS REPORTED THAT THE CUP HAS SPUN DUE TO LOOSENING AT BONE TO IMPLANT INTERFACE. REVISING CUP AND ADDING SCREWS. THERE WAS NO SURGICAL DELAY. DOI: (B)(6) 2021; DOR: (B)(6) 2022; AFFECTED SIDE: RIGHT HIP.

  Patient problems: Inadequate Osseointegration; Unspecified Tissue Injury

  MAUDE report 14186386 ↗
• InjuryMar 20, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PINNACLE LITIGATION RECORD RECEIVED. LITIGATION ALLEGED PAIN, EMOTIONAL TRAUMA, AND DISTRESS. DOI: (B)(6) 2008; DOR: NOT PROVIDED; RIGHT HIP.

  Patient problems: Distress; Pain

  MAUDE report 13835486 ↗
• InjuryFeb 10, 2022Naturally Worn; Adverse Event Without Identified Device or Use Problem; Naturally Worn; Adverse Event Without Identified Device or Use Problem

  CLINICAL ADVERSE EVENT RECEIVED FOR DISLOCATION. EVENT IS SERIOUS AND IS CONSIDERED MODERATE. EVENT IS POSSIBLY RELATED TO DEVICE AND IS POSSIBLY RELATED TO PROCEDURE. DATE OF IMPLANTATION: (B)(6) 2016, DATE OF EVENT: (B)(6) 2022, (RIGHT HIP). TREATMENT: CLOSED REDUCTION/MANIPULATION.

  Patient problems: Ambulation or Postural Difficulties; Fall; Joint Laxity; Pain

  MAUDE report 13505573 ↗
• InjuryFeb 9, 2022Use of Device Problem; Use of Device Problem

  PINNACLE HIP CUP REVISION BECAUSE OF LUXATION. DOI: UNK. DOR: UNK. UNKNOWN HIP.

  Patient problems: Insufficient Information

  MAUDE report 13498528 ↗
• InjuryFeb 7, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  HIP PATIENT CONTACTED A FRIEND WHO IS J&J EMPLOYEE: HIP PATIENT RECEIVED HIP-TEP LEFT SIDE IN (B)(6) 2021. HE IS NOW SUFFERING FROM A LEG LENGTH DISCREPANCY. THE LEFT LEG IS 1.4 TO 3.0 CM SHORTER THAN THE RIGHT ONE. IN ADDITION, THE HIP HEAD DISLOCATED FROM THE CUP. A TREATMENT WAS DONE NON-INVASIVE. ANY MOVEMENT IS ONLY POSSIBLE WIT HELP OF CRUTCHES. DOI: (B)(6) 2021, LEFT HIP.

  Patient problems: Loss of Range of Motion; Physical Asymmetry

  MAUDE report 13472435 ↗
• InjuryNov 2, 2021Difficult to Remove; Difficult to Remove

  CLINICAL NOTIFICATION RECEIVED FOR REVISION OF RIGHT TOTAL HIP TO ADDRESS DISLOCATION. PRIMARY OPERATIVE NOTES (B)(6) 2010 INDICATE THE PATIENT RECEIVED A RIGHT TOTAL HIP REPLACEMENT DUE TO END STAGE OSTEOARTHRITIS. THE SURGERY WAS COMPLETED WITHOUT INDICATION OF COMPLICATION BY THE SURGEON. OFFICE NOTES (B)(6) 2021 INDICATE THE PATIENT IS EXPERIENCING PAIN, SWELLING, STIFFNESS AND EPISODES OF SUBLUXATION IN HER RIGHT HIP. REVISION OPERATIVE NOTES (B)(6) 2021 INDICATE THE PATIENT RECEIVED A RIGHT TOTAL HIP REVISION DUE TO ADVERSE REACTION TO METAL DEBRIS, PAIN, OSTEOLYSIS AND AVASCULAR FACIA SOFT TISSUE. INTRA-OP FINDINGS INCLUDE BONE LOSS, AND FRACTURE OF THE TIP OF THE TROCHANTER. IT WAS NOTED THAT THE METAL LINER WAS COLD-WELDED TO THE ACETABULAR SHELL AND UNABLE TO BE REMOVED ¿ THEREFORE, THE ENTIRE CUP WAS REMOVED. THE STEM WAS WELL FIXED AND RETAINED. THE SURGERY WAS COMPLETED WITHOUT INDICATION OF COMPLICATION BY THE SURGEON. THERE IS NO MENTION OF A HIP DISLOCATION BEYOND THE EPISODES OF SUBLUXATION NOTED IN OFFICE NOTES. DATE OF IMPLANTATION: (B)(6) 2010; DATE OF REVISION: (B)(6) 2021; (RIGHT HIP). TREATMENT: REVISION OF CUP, HOLE ELIMINATOR, LINER, AND HEAD.

  Patient problems: Inflammation; Joint Laxity; Muscular Rigidity; Osteolysis; Pain; Swelling/ Edema; Unspecified Tissue Injury

  MAUDE report 12737641 ↗
• InjurySep 24, 2021Osseointegration Problem; Osseointegration Problem

  REVISION DUE TO CUP DISLOCATION. PATIENT EXPERIENCED PAIN.

  Patient problems: Inadequate Osseointegration; Pain

  MAUDE report 12528274 ↗
• MalfunctionJun 28, 2021Difficult to Insert; Difficult to Insert

  THE APEX HOLE ELIMINATOR WENT THROUGH THE PINNACLE CUP. OCCURRED DURING SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12080219 ↗
• MalfunctionJun 22, 2021Difficult to Insert; Difficult to Insert

  ADDITIONAL INFORMATION RECEIVED INDICATED THAT THE AFFECTED SIDE WAS THE RIGHT SIDE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12040733 ↗
• InjuryMay 25, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION WAS RECEIVED INDICATED THAT THE PRIMARY OPERATIVE NOTE WAS REVIEWED FROM (B)(6) 2004. THERE WERE NO INDICATED INTRA-OPERATIVE COMPLICATIONS. THERE WAS NO SURGICAL DELAY AND THE RIGHT SIDE WAS THE AFFECTED SIDE INVOLVED IN THIS EVENT.

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

  MAUDE report 11877336 ↗
• MalfunctionMay 7, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REVISION SURGERY CAUSE OF PINNACLE MARATHON. INITIAL SURGERY WAS ON (B)(6) 2016.

  Patient problems: Insufficient Information

  MAUDE report 11791803 ↗
• InjuryApr 7, 2021Use of Device Problem; Use of Device Problem

  CHANGE OF PINNACLE CUP. CERAMIC/CERAMIC REASON IS NOT CORRECT PLACEMENT IN YEAR 2011. NO WEAR.

  Patient problems: Insufficient Information

  MAUDE report 11631869 ↗
• MalfunctionMar 16, 2021Difficult to Insert; Difficult to Insert

  PHYSICIAN REPORTED THAT MARATHON DIDN`T MATCH TO PINNACLE 100 SERIES. TO PROCEDURE COMPLETED PHYSICIAN USED ANOTHER ONE SET. THE SALES REP INDICATED THE SURGEON TRIED A SECOND INSERT WHICH ALSO DID NOT FIT. NO CONSEQUENCES FOR THE PATIENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11494529 ↗
• InjuryMar 8, 2021Device Dislodged or Dislocated; Noise, Audible; Device Dislodged or Dislocated; Noise, Audible

  ON (B)(6) 2021, THE PATIENT DISLOCATED WITH "LUXATION OF THE HEAD IN THE CUP WITH INLAY DISLOCATION." METALLOSIS WAS FOUND AS WELL AS A TILTED INLAY FOR UNKNOWN REASON.

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

  MAUDE report 11436581 ↗
• InjuryDec 29, 2020Difficult to Remove; Difficult to Remove

  THIS IS A REVISION OF THE CORAIL AND PINNACLE HIP. THIS WAS REVISED DUE TO THE CORAIL STEM'S SUBSIDENCE, AND THE CERAMIC LINED WAS CHIPPING OFF. PATIENT EXPERIENCING PAIN.

  Patient problems: Pain

  MAUDE report 11087721 ↗
• InjuryDec 5, 2020Migration; Migration

  IT WAS REPORTED AS REVISING A PINNACLE METAL ON METAL LINER. CONCERN OF PSEUDOTUMOR. A 54X36 METAL ULTAMET LINER AND 36 8.5MM HEAD WERE REMOVED. WHILE ATTEMPTING TO REMOVE THE LINER THE SHELL WAS DISLODGED. THE SHELL DID NOT APPEAR TO BE LOOSE ON THE X-RAY. A 54 PINNACLE GRIPTION CUP WAS IMPLANTED WITH A 54X36 +4 10 DEGREE LINER AND A 36 +8.5 TS BIOLOGICS HEAD. DOI: (B)(6) 2005. DOR: (B)(6) 2020. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Hypersensitivity/Allergic reaction

  MAUDE report 10950630 ↗