PINNACLE 1219-36-460Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 10603295014744), received between Jul 11, 2017 and Jul 15, 2022 — classified as 11 injuries.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (7 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 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• InjuryJul 15, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO DISLOCATED LEFT HIP. NO SURGICAL DELAY. DOI: UNKNOWN. DOR: (B)(6) 2022. AFFECTED SIDE: LEFT.

  Patient problems: Joint Dislocation

  MAUDE report 15027770 ↗
• InjuryApr 26, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD INFECTED HIP; REMOVED ALL COMPONENTS; PERFORMED I&D AND RE-IMPLANTED NEW COMPONENTS. DOI: (B)(6) 2021; DOR: (B)(6) 2021; AFFECTED SIDE: RIGHT HIP.

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

  MAUDE report 11726939 ↗
• InjuryMar 4, 2021Device Dislodged or Dislocated; Device Dislodged or Dislocated

  ON (B)(6) 2018, THE PATIENT UNDERWENT A RIGHT HIP REVISION DUE TO FOUR PREVIOUS DISLOCATIONS. THE DEPUY HEAD IS REMOVED AND REPLACED WITH A COMPETITOR HEAD AND ADAPTER ONTO THE CORAIL STEM. THE FEMORAL STEM, ACETABULAR LINER, ACETABULAR CUP, AND HOLE ELIMINATOR WERE RETAINED. THE SURGEON NOTED REMOVAL OF SCAR TISSUE. THERE WERE NO INDICATED INTRA-OPERATIVE COMPLICATIONS.

  Patient problems: Adhesion(s); Joint Dislocation

  MAUDE report 11411517 ↗
• InjuryFeb 4, 2021Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE REASON FOR REVISION ARE INFECTION AND POSTERIOR DISLOCATION. REASON FOR DISLOCATION UNDETERMINED. NO OTHER INFORMATION AVAILABLE. DOI: (B)(6) 2017, DOR: (B)(6) 2021, RIGHT HIP.

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

  MAUDE report 11281070 ↗
• InjuryOct 13, 2020Device Dislodged or Dislocated; Device Dislodged or Dislocated

  THE PATIENT WAS REVISED TO ADDRESS PAINFUL HIP AND DISLOCATED. NO OTHER INFO AVAILABLE. DOI: (B)(6) 2013, DOR: (B)(6) 2020, LEFT HIP.

  Patient problems: Joint Dislocation; No Code Available; Pain

  MAUDE report 10670413 ↗
• InjuryFeb 27, 2020Device Dislodged or Dislocated; Device Dislodged or Dislocated

  AFTER REVIEW OF MEDICAL RECORDS, THE PATIENT WAS REVISED TO ADDRESS RECURRENT INSTABILITY AND RECURRENT DISLOCATIONS. OPERATIVE FINDINGS INCLUDE CLEAR FLUID FROM THE JOINT WHICH WAS EXPECTED FROM A PATIENT WITH RECURRENT DISLOCATION, SCAR TISSUE, DISRUPTED POSTERIOR CAPSULAR REPAIR, EVIDENCE OF METALLOSIS AND SOME DISCOLORATION OF THE COMPETITOR FEMORAL HEAD FROM THE RECURRENT DISLOCATIONS AND REDUCTIONS. DOI: (B)(6) 2009. DOR: (B)(6) 2010. (RIGHT HIP).

  Patient problems: Adhesion(s); Edema; Foreign Body Reaction; Joint Dislocation; No Code Available; Tissue Damage

  MAUDE report 9763806 ↗
• InjuryNov 26, 2019Naturally Worn; Naturally Worn

  MEDICAL RECORDS RECEIVED. REVISION OPERATIVE NOTES 09/25/2019 INDICATE THE PATIENT RECEIVED A RIGHT TOTAL HIP REVISION DUE TO PAIN, INSTABILITY AND POLY LINER WEAR. SYNOVITIS WAS NOTED WITHIN THE JOINT. THE SURGERY WAS COMPLETED WITHOUT INDICATION OF COMPLICATION BY THE SURGEON.

  Patient problems: No Code Available; Pain; Synovitis

  MAUDE report 9375975 ↗
• InjuryNov 14, 2018Device Dislodged or Dislocated; Device Dislodged or Dislocated

  PPF AND STICKER SHEETS RECEIVED. PPF ALLEGES DISLOCATION.

  Patient problems: Discomfort; Joint Dislocation; No Code Available; Pain

  MAUDE report 8070599 ↗
• InjuryApr 18, 2018Device Dislodged or Dislocated; Device Dislodged or Dislocated

  INITIAL PROCEDURE, (B)(6) 2009 : TOTAL LEFT HIP REPLACEMENT. REVISION, (B)(6) 2010: CONVERSION FROM METAL TO POLYETHYLENE IMPLANT. IT WAS REPORTED BY LEGAL THAT THE PATIENT EXPERIENCED TWO LEFT HIP DISLOCATION. ON (B)(6) 2017 A CLOSED REDUCTION WAS PERFORMED ON THE PATIENT, THE PHYSICIAN NOTED SOME CAPSULE CONTRACTURE LIMITING EXTERNAL ROTATION. IT WAS NOTED THAT ON (B)(6) 2011 THE PATIENT DID NOT HAVE ANY RECURRENCE OF DISLOCATION OR PAIN. DEVICES INVOLVED: 1217-22-060 ACETABULAR CUP, SZ 60, LOT EH5EG1000. THE 1219-36-460 PINNACLE MARATHON, LOT B64BL1000. THE 1365-53-000 METAL FEMORAL HEAD, LOT 2717713. THE 1217-20-500 CANCELLOUS BONE SCREW, 428157. THE 1217-20-500 CANCELLOUS BONE SCREW, 421818. RELATED COMPLAINT (B)(4).

  Patient problems: Joint Dislocation

  MAUDE report 7439412 ↗
• InjuryNov 18, 2017Insufficient Device Problem Information; Insufficient Device Problem Information

  PATIENT HAD COMPLAINED OF PAIN AND WAS CONVINCED BY PHYSIO THAT THE SCREWS WERE RUBBING ON PSOAS MUSCLE SO REQUESTED REMOVAL OF THE CUP SCREWS. PATIENT ALSO HAD ABDUCTOR ISSUES SO A CONSTRAINED LINER WAS USED.

  Patient problems: Pain

  MAUDE report 7043971 ↗
• InjuryJul 11, 2017Device Dislodged or Dislocated; Device Dislodged or Dislocated

  DESCRIPTION OF THE ADVERSE EVENT SURGICAL SITE DISLOCATION - INITIAL. UPDATE RECEIVED 12/6/2016. CLINICAL REPORT WAS RECEIVED STATING THAT THE PATIENT HAS HAD A POSTERIOR DISLOCATION. THE DISLOCATION WAS TREATED WITH CLOSED REDUCTION. COMPLAINT WAS UPDATED ON 12/15/2016. UPDATE REC'D 01/31/2017 - THE PATIENT'S MEDICAL RECORDS WERE RECEIVED. MEDICAL RECORDS WERE REVIEWED FOR MDR REPORTABILITY. THERE IS NO NEW INFORMATION THAT WOULD CHANGE THE EXISTING MDR DECISION. THE COMPLAINT WAS UPDATED ON: 02/08/2017. UPDATE 01MAY2017- CLINICAL DER RECEIVED THAT THE PATIENT WAS REVISED TO ADDRESS DISLOCATION OF RIGHT HIP. THIS COMPLAINT WAS CREATED ON 29JUN2017. UPDATE 5-1-2017: REVISION OF RIGHT TOTAL HIP ON (B)(6)2017 FOR DISLOCATION. DEPUY HEAD AND LINER WERE REVISED. HEAD AND LINER ARE NOW REPORTABLE. UPDATED 7-5-2017.

  Patient problems: Joint Dislocation

  MAUDE report 6700204 ↗