PINNACLE 1219-28-146Recalls & reported problems
Depuy Orthopaedics, Inc. · PINNACLE HIP SOLUTIONS MARATHON POLYETHYLENE ACETABULAR LINER +4 10 DEGREE 28mm ID 46mm OD · Class 2 · Implant
All models of PINNACLE (182)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
Quick summary
This DePuy Pinnacle hip liner is the plastic socket insert used in total hip replacement surgery. The 45 reports mostly describe the liner working loose or dislocating within the hip, wearing out early, or cracking and breaking, sometimes releasing metal debris into surrounding tissue; a few patients reported squeaking or noise from the hip. Forty-one injuries and no deaths were reported, with no recalls naming this device.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 45
- Deaths reported
- 0
- Injuries reported
- 41
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 45 adverse event reports that list this exact device (DI 10603295013440), received between Dec 14, 2017 and Nov 26, 2025 — classified as 41 injuries, 4 malfunctions.
The most frequently reported specific device problem is “Device Dislodged or Dislocated” (25 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 16, 2026.
Reports received per month
Most reported problems
Device problems
- Device Dislodged or Dislocated25
- Naturally Worn14
- Fracture13
- Noise, Audible6
- Adverse Event Without Identified Device or Use Problem2
- Detachment of Device or Device Component2
- Disassembly1
- Material Separation1
Patient problems
- Insufficient Information16
- Joint Dislocation12
- No Code Available12
- Foreign Body Reaction5
- Pain5
- Not Applicable4
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available3
- Joint Laxity2
Recent adverse event reports
The 25 most recent of 45 reports, in the reporter's own words as published by the FDA.
InjuryNov 26, 2025Naturally Worn; Noise, Audible; Naturally Worn; Noise, Audible
ADDITIONAL INFORMATION RECEIVED: AFTER INVESTIGATION, THE PATIENT UNDERWENT TOTAL HIP REPLACEMENT SURGERY IN THE HOSPITAL DUE TO FEMORAL NECK FRACTURE ON (B)(6) 2024. (B)(6) WAS IMPLANTED DURING THE SURGERY. THE HOSPITAL REPORTED THAT THE SURGERY WENT SMOOTHLY, THE POSTOPERATIVE REHABILITATION OF THE PATIENT WAS UNKNOWN, AND THE PATIENT OFTEN HAD SQUATTING ACTION IN DAILY LIFE. ONE YEAR AFTER THE SURGERY, IT WAS FOUND THAT THE PATIENT'S LINER SHOWED SEVERE WEAR, AND THERE WAS A CLICKING SOUND DURING MOVEMENT, ACCOMPANIED BY PAIN. THE DOCTOR PERFORMED A SECOND SURGERY TO REMOVE THE IMPLANT IN ADVANCE. DURING THIS PERIOD, THE BACTERIAL CULTURE RESULT WAS NEGATIVE THE SPECIFIC SAMPLES AND EXAMINATION ITEMS WERE UNKNOWN. THE PATIENT WAS IN STABLE CONDITION NOW, AND NO SUBSEQUENT ADVERSE EVENT REPORT WAS RECEIVED.
Patient problems: Pain
MAUDE report 23657620 ↗MalfunctionJul 2, 2025Noise, Audible; Noise, Audible
IT WAS REPORTED THAT PATIENT HAD A PRIMARY RIGHT THR DONE IN (B)(6) 2023. PATIENT PRESENTED WITH A "SQUEAKING" HIP. PATIENT WAS REVISED FROM A 46 100 SERIES SHELL AND 28/46 MARATHON +4 10 DEG LINER TO 48 MULTIHOLE SHELL AND 32/48 ALTREX +4 10 LINER. THE CERAMIC HEAD WAS CHANGED FROM 28 +8.5 TO 32 +9 DELTA TS HEAD. THERE WAS NO SURGICAL DELAY.
Patient problems: Insufficient Information
MAUDE report 22384086 ↗InjuryMar 17, 2025Naturally Worn; Naturally Worn
ADDITIONAL INFORMATION WAS RECEIVED AND STATED THAT THE REASON OF THE EXPLANT WAS WHENEVER A PE INLAY IS REVISED THE HEAD NEEDS TO BE EXCHANGED AS WELL.
Patient problems: Insufficient Information
MAUDE report 21617507 ↗InjuryFeb 11, 2025Fracture; Fracture
IT WAS REPORTED THAT THERE WAS PREMATURE WEAR AND CRITICAL FAILURE OF POLYETHYLENE ON INCONSISTENT TIMESCALES, LEADING TO DAMAGE OF THE METAL ACETABULAR COMPONENT AND WIDESPREAD METALLOSIS.
Patient problems: Foreign Body Reaction; Metal Related Pathology
MAUDE report 21354547 ↗InjuryJan 31, 2025Naturally Worn; Naturally Worn
IT WAS REPORTED THAT THE PATIENT UNDERWENT REVISION SURGERY DUE TO PREMATURE WEAR OF POLYETHYLENE.
Patient problems: Insufficient Information
MAUDE report 21282540 ↗InjuryDec 5, 2024Fracture; Device Dislodged or Dislocated; Fracture; Device Dislodged or Dislocated
IT WAS REPORTED THAT ON (B)(6) 2023, THE PATIENT RECEIVED A POLYETHYLENE IMPLANT. THE PATIENT UNDERWENT REVISION SURGERY ON (B)(6) 2024. A REPLACEMENT OF THE PROSTHESIS HAD TO BE PERFORMED BECAUSE THE COMPONENT WAS IN POOR CONDITION, WHICH RESULTED IN METALOSIS AND DISLOCATION OF THE PROSTHESIS, WITHOUT ANY PRIOR CAUSE (SUCH AS A FALL OR INFECTION).
Patient problems: Foreign Body Reaction
MAUDE report 20853803 ↗InjuryOct 7, 2024Fracture; Fracture
IT WAS REPORTED THAT PATIENT EXPERIENCED POSTOPERATIVE POLYETHYLENE BREAKAGE.
Patient problems: Insufficient Information
MAUDE report 20391009 ↗MalfunctionOct 7, 2024Fracture; Fracture
IT WAS REPORTED THAT ON FEBRUARY 16, 2024, A POLYETHYLENE LINER BROKE.
Patient problems: Insufficient Information
MAUDE report 20390663 ↗MalfunctionOct 7, 2024Fracture; Fracture
IT WAS REPORTED THAT PATIENT EXPERIENCED POSTOPERATIVE POLYETHYLENE BREAKAGE. PATIENT WAS ORIGINALLY TREATED ON (B)(6) 2022.
Patient problems: Insufficient Information
MAUDE report 20388558 ↗InjurySep 9, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated
ADDITIONAL INFORMATION RECEIVED STATES THAT: A. WAS THERE ANY SURGICAL DELAY RELATED TO THE EVENT? THERE WAS NOT ANY SURGICAL DELAY RELATED TO THE EVENT. B. WHAT WAS THE LOOSENING INTERFACE? WAS THERE ANY CEMENT USED? THE POLYETHYLENE WAS UNLOCKED OR LOOSE FROM THE ACETABULAR CUP PINNACLE. C. WHAT WAS THE ALLEGATION AGAINST THE CUP? THE ALLEGATION IS NOT AGAINST THE CUP.
Patient problems: Insufficient Information
MAUDE report 20168942 ↗InjuryJun 7, 2024Naturally Worn; Naturally Worn
IT WAS REPORTED THAT PATIENT WAS REVISED DUE TO PREMATURE WEAR OF POLYETHYLENE. PATIENT ADMITTED TO MAKE POLYETHYLENE REPLACEMENT ON 04/16/2023
Patient problems: Insufficient Information
MAUDE report 19489465 ↗InjuryFeb 28, 2024Fracture; Device Dislodged or Dislocated; Fracture; Device Dislodged or Dislocated
PATIENT HAD SURGERY 1 YEAR AGO AND HAD TO BE RE-INTERVENED BECAUSE THE POLYETHYLENE INSERT SPLIT. THE PINNACLE CUP AND POLYETHYLENE INSERT WERE REMOVED.
Patient problems: Insufficient Information
MAUDE report 18799855 ↗InjuryFeb 23, 2024Fracture; Fracture
WAS THERE ANY ADVERSE CONSEQUENCE TO THE PATIENT RELEVANT TO THIS EVENT? IF YES, PLEASE KINDLY PROVIDE DETAILS. PATIENT HAVING ISSUES AND CAME FOR THE REVISION OF COMPONENT.
Patient problems: Insufficient Information
MAUDE report 18769044 ↗InjuryFeb 16, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated
ADDITIONAL CASE IN REGARDS TO (B)(4) TO CAPTURE THE PREVIOUS REVISION. THE PATIENT RETURNED FOR PINNACLE CUP SIZE INCREASE AND PUT IN A CONSTRAINED LINER.
Patient problems: Joint Dislocation; Unspecified Infection
MAUDE report 18721338 ↗InjuryFeb 7, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated
ADDITIONAL INFORMATION WAS RECEIVED: A. CAN YOU PLEASE PROVIDE THE AFFECTED SIDE? RIGHT HIP. B. WAS THE EXTEND OF THE SURGICAL DELAY? NO DELAY.
Patient problems: Joint Dislocation; Joint Laxity
MAUDE report 18658197 ↗InjuryFeb 3, 2024Fracture; Fracture
PATIENT WAS REVISED ON (B)(6)2022 FOR UNKNOWN REASON, AND LATER RE-REVISED ON (B)(6)2023, WHERE THE HEAD AND INSERT WERE REPLACED DUE TO METALLOSIS. NO SURGICAL DELAY REPORTED.
Patient problems: Foreign Body Reaction
MAUDE report 18637056 ↗InjurySep 11, 2023Fracture; Device Dislodged or Dislocated; Naturally Worn; Fracture; Device Dislodged or Dislocated; Naturally Worn
PATIENT WHO HAD UNDERGONE SURGERY A YEAR AGO SCHEDULED FOR TOTAL HIP REPLACEMENT REVISION. PATIENT DID NOT REPORT DISCOMFORT, HOWEVER, INCONGRUITY OBSERVED IN X-RAYS BETWEEN CUP AND INSERTS POSITIONED A YEAR AGO. INTRAOPERATIVELY, BLACK-LOOKING LIQUID (METALLOSIS) WAS OBSERVED. A SAMPLE WAS TAKEN AND THERE WAS A WASHING & REMOVAL OF SURROUNDING TISSUE AFFECTED BY METAL. IT WAS THEN OBSERVED THAT THE INSERT AND THE HEAD WERE AFFECTED. THE FIRST PRESENTS WITH WEAR AND A FRACTURE, ADDITIONALLY, IT WAS NOT IN ITS NORMAL OR INITIAL POSITION. THE SECOND WEAR WAS OBSERVED, DUE TO DIRECT CONTACT WITH THE ACETABULAR CUP. WE PROCEEDED TO REMOVE AFFECTED IMPLANTS AND SURROUNDING TISSUE EQUALLY AFFECTED BY METALLOSIS. ACETABULAR CUP WAS NOT AFFECTED, THEREFORE IT WAS NOT CHANGED. INTEGRITY OF THE SAME WAS REVIEWED FOR PLACEMENT OF A NEW INSERT AND WE PROCEEDED TO ITS IMPLANTATION WITHOUT NOVELTY, IT WAS DECIDED TO PLACE A CERAMIC HEAD. PATIENT REQUIRES A NEW INTERVENTION DUE TO RADIOLOGICAL FINDINGS IDENTIFIED IN POSTOPERATIVE CONTROL..
Patient problems: Foreign Body Reaction
MAUDE report 17726287 ↗InjuryFeb 4, 2023Fracture; Naturally Worn; Noise, Audible; Fracture; Naturally Worn; Noise, Audible
HCP HAD DONE TOTAL HIP REPLACEMENT SURGERY OF THE PATIENT IN (B)(6) 2021 IN WHICH HE USED PINNACLE MARATHON POLY LINER. EVENTUALLY PATIENT CAME IN (B)(6) 2022 WITH THE COMPLAINT OF NOISE AND PAIN ON MOVEMENT. HCP DID ADDITIONAL X-RAYS AND FOUND REQUIREMENT OF REVISION. SO HE REVISED IT LAST WEEK AND FOUND THE PINNACLE LINER WAS BROKEN SO HE REPLACED IT WITH ANOTHER LINER AND FEMORAL HEAD. SO HCP HAS COMPLAINT THAT THE PRODUCT COULD WEAR OFF BY THE TIME BUT IT SHOULD NOT BROKEN OFF DURING IT'S CYCLE. DID THE PATIENT EXPERIENCE AN ADVERSE EVENT SUCH AS INFECTION, NON-UNION, ALLERGIC REACTION, OSTEOPOROSIS, OVERLOADING, PAIN, DEGENERATIVE DISEASES, BLEEDING OR OOZING? YES, DID THE PATIENT REQUIRE REVISION SURGERY OR HARDWARE REMOVAL? YES, FACILITY NAME OF ORIGINAL IMPLANT : (B)(6) HOSPITAL, WAS DEVICE EXPLANTED? TRUE, HARDWARE/EXPLANT REMOVAL DUE TO: BREAKING OF ORIGINAL IMPLANT, DID PATIENT REQUIRE REVISION SURGERY? TRUE, IF YES, DATE OF REVISION SURGERY. (B)(6) 2023, REASON FOR REVISION SURGERY. PAIN, NOISE AND ROM RESTRICTION, PATIENT STATUS/ OUTCOME / CONSEQUENCES: YES, PATIENT CONSEQUENCE DESCRIPTION/WAS THERE A CLINICAL OUTCOME EXPERIENCED BY THE PATIENT (INFECTION, INFLAMMATION
Patient problems: Loss of Range of Motion; Pain
MAUDE report 16301904 ↗InjuryOct 27, 2022Fracture; Device Dislodged or Dislocated; Fracture; Device Dislodged or Dislocated
InjuryJun 9, 2022Device Dislodged or Dislocated; Naturally Worn; Device Dislodged or Dislocated; Naturally Worn
DUE TO MECHANICAL COMPLICATIONS, THE PATIENT HAS UNDERGONE A NEW SURGICAL REVISION. REASON: DISASSEMBLY BETWEEN COTYL AND PE INSERT. DATE: (B)(6) 2022. REVISION WITH REPLACEMENT OF THE HEAD AND INSERT. THE INSERT WAS MOVABLE AND WORN IN THE POST-UPPER PORTION. CAN YOU PLEASE CONFIRM THE PRIMARY SURGERY DATE OR THE ORIGINAL IMPLANTATION DATE? INITIAL IMPLANT WAS ON (B)(6) 2020. FIRST REVISION ON (B)(6) 2020. SECOND REVISION ON (B)(6) 2022. THIRD REVISION ON (B)(6) 2022.
Patient problems: Insufficient Information
MAUDE report 14647731 ↗MalfunctionJun 1, 2022Device Dislodged or Dislocated; Device Dislodged or Dislocated
IT WAS REPORTED THAT AFTER A X-RAY, IT WAS DETECTED A DISLOCATION OF THE PE INSERT AFTER 13 DAYS FROM THE REVISION SURGERY OF THE (B)(6) 2022.
Patient problems: Insufficient Information
MAUDE report 14566629 ↗InjuryMar 8, 2022Naturally Worn; Naturally Worn
SURGEON REPORTED REVISION WAS COMPLETED DUE TO POLY WEAR 2 YEARS AFTER ORIGINAL SURGERY. DOI: (B)(6) 2019, DOR: (B)(6) 2021, RIGHT HIP.
Patient problems: Insufficient Information
MAUDE report 13688785 ↗InjuryFeb 25, 2022Device Dislodged or Dislocated; Device Dislodged or Dislocated
REVISION COMPLETED DUE TO ACETABULAR CUP AND LINER NOT FITTING PROPERLY. TWO SEPARATE REVISIONS WERE COMPLETED TO ADDRESS THE ISSUE. DOI: (B)(6) 2018. DOR: (B)(6) 2021. DOR: (B)(6) 2022.
Patient problems: Insufficient Information
MAUDE report 13600708 ↗InjuryJun 8, 2021Device Dislodged or Dislocated; Naturally Worn; Device Dislodged or Dislocated; Naturally Worn
ADDITIONAL INFORMATION RECEIVED INDICATED THAT THERE WAS NO SURGICAL DELAY AND THE AFFECTED SIDE WAS THE RIGHT HIP.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Insufficient Information
MAUDE report 11959106 ↗InjuryJun 2, 2021Device Dislodged or Dislocated; Naturally Worn; Device Dislodged or Dislocated; Naturally Worn
ADDITIONAL INFORMATION RECEIVED INDICATED THAT THE AFFECTED SIDE WAS THE RIGHT HIP.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Insufficient Information; Joint Laxity
MAUDE report 11920583 ↗
Other PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED devices
- PINNACLE 1217-25-500Depuy Orthopaedics, Inc. · PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED735 reports
- NA 1365-52-000Depuy (Ireland) · PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED683 reports
- APEX 1246-03-000Depuy (Ireland) · PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED3 deaths613 reports
- PINNACLE 1217-20-500Depuy Orthopaedics, Inc. · PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED2 deaths590 reports
- PINNACLE 1217-30-500Depuy Orthopaedics, Inc. · PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED1 death484 reports
- NA 1365-53-000Depuy (Ireland) · PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED404 reports
- PINNACLE ALTRX 1221-36-054Depuy Orthopaedics, Inc. · PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED388 reports
- PINNACLE ALTRX 1221-32-050Depuy Orthopaedics, Inc. · PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED386 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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