PINNACLE 1219-28-148Recalls & reported problems

Summary

The FDA's MAUDE database contains 16 adverse event reports that list this exact device (DI 10603295013457), received between Dec 28, 2017 and Oct 3, 2024 — classified as 15 injuries, 1 malfunction.

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 16 most recent of 16 reports, in the reporter's own words as published by the FDA.

• InjuryOct 3, 2024Fracture; Device Dislodged or Dislocated; Fracture; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THERE HAVE BEEN EPISODES OF BREAKAGE AND/OR LOOSENING OF THE MARATHON +4 10 POLYETHYLENE INSERT IN SMALL PINNACLE CUP SIZES (44 TO 50) WITH 28 OR 32MM HEADS, THAT REQUIRED REVISION SURGERY.

  Patient problems: Insufficient Information

  MAUDE report 20362118 ↗
• InjurySep 11, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  MARATHON INSERT LOOSENING, PAIN AND SQUEAKING. THIS IS THE SECOND REVISION OF THE LINER, THE FIRST REVISION WAS 1 YEAR BEFORE (10 MONTHS AFTER THE FIRST IMPLANTATION).

  Patient problems: Pain

  MAUDE report 20189055 ↗
• InjurySep 6, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  MARATHON INSERT LOOSENING, PAIN AND SQUEAKING. THIS IS THE SECOND REVISION OF THE LINER, THE FIRST REVISION WAS 1 YEAR BEFORE (10 MONTHS AFTER THE FIST IMPLANTATION).

  Patient problems: Pain

  MAUDE report 20158727 ↗
• InjuryJan 11, 2024Device Dislodged or Dislocated; Naturally Worn; Device Dislodged or Dislocated; Naturally Worn

  ADDITIONAL INFORMATION RECEIVED: A. WAS/WERE THERE ANY ADVERSE CONSEQUENCE/S THAT AFFECTED THE PATIENT BECAUSE OF THE REPORTED EVENT? YES, PATIENT NEED A 2ND SURGERY TO CHANGE THE INLAY.

  Patient problems: Insufficient Information

  MAUDE report 18492258 ↗
• InjuryNov 22, 2023Naturally Worn; Naturally Worn

  1ST INTERVENTION TO REMOVE THE INSERT DUE TO WEAR WHICH TOOK PLACE ON (B)(6) 2019 2ND OPERATION TO REMOVE THE INSERT AGAIN DUE TO WEAR, WHICH TOOK PLACE ON (B)(6) 2022 THIS COMPLAINT COVERS THE FIRST REVISION SURGERY. SECOND REVISION IS CAPTURED UNDER (B)(4).

  Patient problems: Pain

  MAUDE report 18192648 ↗
• InjuryJul 30, 2021Naturally Worn; Naturally Worn

  ON (B)(6) 2021, THE PATIENT UNDERWENT A BILATERAL HIP REVISION. RIGHT SIDE: THE DEPUY FEMORAL HEAD AND ACETABULAR LINER WERE REVISED. THE PATIENT WAS EXPERIENCING PAIN. THERE WAS EVIDENCE OF POLY WEAR INVOLVING THE ACETABULAR LINER, DELAMINATION OF THE POLY LINER, AND FOREIGN BODY SYNOVITIS. THE HEAD AND LINER WERE REVISED WITH DEPUY PRODUCTS. THERE WERE NO INDICATED INTRA-OPERATIVE COMPLICATIONS.

  Patient problems: Insufficient Information; Pain; Synovitis

  MAUDE report 12253428 ↗
• MalfunctionFeb 25, 2021Device Dislodged or Dislocated; Naturally Worn; Device Dislodged or Dislocated; Naturally Worn

  EXAMINATION OF THE PROVIDED X-RAY IMAGES FINDS SUFFICIENT EVIDENCE TO CONFIRM A DISASSOCIATION EVENT.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Loss of Range of Motion

  MAUDE report 11378948 ↗
• InjuryDec 5, 2018Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT A REVISION OF CONSTRAINED LINER DUE TO DISLOCATION.

  Patient problems: Joint Dislocation; No Code Available

  MAUDE report 8132582 ↗
• InjurySep 10, 2018Device Dislodged or Dislocated; Device Dislodged or Dislocated

  THE PATIENT WAS REVISED TO ADDRESS DISLOCATION. DOI: UNKNOWN; DOR: (B)(6) 2018; LEFT HIP.

  Patient problems: Joint Dislocation; Not Applicable

  MAUDE report 7859620 ↗
• InjuryAug 17, 2018Detachment of Device or Device Component; Detachment of Device or Device Component

  CUSTOMER REPORTED TO BFARM: PRIMARY IMPLANTATION OF A CEMENTLESS DEPUY HIP-TEP (PINNACLE CUP / CORAIL STEM) LEFT ON (B)(6) 2017. INITIALLY INCONSPICUOUS POST-OP COURSE. PATIENT INDICATED ONSET OF PAIN / MUSCULAR PROBLEM IN THE LEFT HIP SINCE END OF (B)(6) 2018. ADDITIONAL ON (B)(6) 2018 OCCURRENCE OF NOISE PHENOMENA IN THE AREA OF THE HIP TEP ON THE LEFT SIDE. A PREVIOUS RELEVANT TRAUMA / MOVEMENT MOMENT IS NEGATED BY THE PATIENT. THEREUPON VISIT AT THE ORTHOPEDIC PRACTITIONER ON (B)(6) 2018 AND ALSO ON (B)(6) 2018 AT OUR HOSPITAL. RADIOGRAPH SHOWED DECENTRALISATION OF HIP HEAD OF THE HIP PROSTHESIS WITHOUT EVIDENCE OF DISLOCATION. ON (B)(6) 2018 REVISION OF HIP-TEP LEFT. INTRAOPERATIVELY A DISLOCATION OF THE INLAY FROM THE PINNACLE-PRESSFIT CUP WAS OBVIOUS - AN EXPLANATORY CORRELATE FOR THIS WAS NOT EVIDENT. REVISION OF HIP-HEAD AND INLAY.

  Patient problems: Pain

  MAUDE report 7793012 ↗
• InjuryAug 13, 2018Naturally Worn; Naturally Worn

  THE PATIENT WAS REVISED TO ADDRESS POLY WEAR. DOI: (B)(6) 2008; (B)(6) 2018; RIGHT HIP.

  Patient problems: Pain

  MAUDE report 7778348 ↗
• InjuryJul 17, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  UPDATE AD (B)(6) 2018: REASON FOR REVISION PAIN AND OSTEOLYSIS.

  Patient problems: Osteolysis; Pain

  MAUDE report 7693369 ↗
• InjuryJun 28, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  PINNACLE REVISION PROCEDURE. UNKNOWN HIP. REASON FOR REVISION: UNKNOWN. DOI: (B)(6) 2009; DOR: (B)(6) 2015.

  Patient problems: Not Applicable

  MAUDE report 7645471 ↗
• InjuryJan 22, 2018Naturally Worn; Naturally Worn

  THE PATIENT WAS REVISED TO ADDRESS PAIN. SURGEON FOUND BUILD UP OF FLUID DUE TO POLY DEBRIS FROM LINER. DOI: 2002 ; DOR: (B)(6) 2017 ; UNKNOWN AFFECTED SIDE.

  Patient problems: Pain

  MAUDE report 7209123 ↗
• InjuryJan 9, 2018Disassembly; Disassembly

  COMPLAINT DESCRIPTION: THE PATIENT WAS REVISED TO ADDRESS DISASSOCIATION OF THE INLAY FROM THE PINNACLE CUP. IT WAS ALSO REPORTED THAT THE CUSTOMER WAS REPORTING A DYSPLASIA INLAY.

  Patient problems: No Consequences Or Impact To Patient; No Known Impact Or Consequence To Patient

  MAUDE report 7176107 ↗
• InjuryDec 28, 2017Disassembly; Material Separation; Adverse Event Without Identified Device or Use Problem; Disassembly; Material Separation; Adverse Event Without Identified Device or Use Problem

  SCF ALLEGES DISCOMFORT. PATIENT WAS REVISED DUE TO AN ATRAUMATIC DETACHMENT OF PINNACLE COATING. THIS WAS PREVIOUSLY CODED IN LEGACY RECORD WITH IMPLANT DISASSOCIATION CHANGE TO WEAR.

  Patient problems: Ambulation or Postural Difficulties; Discomfort; No Code Available; Pain

  MAUDE report 7151127 ↗