PINNACLE 1219-28-048Recalls & reported problems
Depuy Orthopaedics, Inc. · PINNACLE HIP SOLUTIONS MARATHON POLYETHYLENE ACETABULAR LINER NEUTRAL 28mm ID 48mm OD · Class 2 · Implant
All models of PINNACLE (182)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 21
- Deaths reported
- 0
- Injuries reported
- 21
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 21 adverse event reports that list this exact device (DI 10603295013280), received between Jun 28, 2017 and Oct 30, 2025 — classified as 21 injuries.
The most frequently reported specific device problem is “Device Dislodged or Dislocated” (13 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 Dislocated13
- Naturally Worn7
- Disassembly6
- Adverse Event Without Identified Device or Use Problem2
- Fracture2
- Noise, Audible1
- Separation Problem1
Patient problems
- Joint Dislocation7
- Insufficient Information4
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available3
- Joint Laxity3
- Pain3
- No Code Available2
- No Information2
- No Consequences Or Impact To Patient1
Recent adverse event reports
The 21 most recent of 21 reports, in the reporter's own words as published by the FDA.
InjuryOct 30, 2025Naturally Worn; Naturally Worn
IT WAS REPORTED THAT THERE WAS PINNACLA INLAY WITH MASSIVE WEAR DUE TO MALPOSITION OF THE TRI-LOCK STEM. IT POSSIBLE TO IDENTIFY THE HEAD.
Patient problems: Insufficient Information
MAUDE report 23423787 ↗InjuryJan 15, 2025Naturally Worn; Naturally Worn
THE PATIENT WAS REVISED AND UNDERWENT HEAD AND LINER EXCHANGE. THE SURGICAL DELAY WAS UNKNOWN. DOI: (B)(6) 2005. DOR: (B)(6) 2024. AFFECTED SIDE: RIGHT HIP.
Patient problems: Joint Laxity
MAUDE report 21159301 ↗InjuryMar 27, 2023Device Dislodged or Dislocated; Naturally Worn; Device Dislodged or Dislocated; Naturally Worn
IT WAS REPORTED THAT THE PATIENT HAD LEFT HIP REVISION DUE TO ACETABULAR LINER DISASSOCIATION AND WEAR. LOOSENING OF LINER WAS REPORTED AT A NON-CEMENTED INTERFACE. CEMENT MANUFACTURER WAS UNKNOWN. NO SURGICAL DELAY. DOI: (B)(6) 2003, DOR: (B)(6) 2023, AFFECTED SIDE: LEFT HIP.
Patient problems: Insufficient Information
MAUDE report 16618121 ↗InjuryNov 14, 2022Device Dislodged or Dislocated; Device Dislodged or Dislocated
IT WAS REPORTED THAT PATIENT WITH A RECURRENTLY DISLOCATING THR. THE SCREENSHOT RECEIVED FROM MR (B)(6) SHOWS THE NJR RECORD OF THE IMPLANT DETAILS. NO PATIENT NOTES ARE AVAILABLE AT THIS STAGE. INDEX SURGERY WAS PERFORMED IN (B)(6) ON (B)(6) 2021 USING A PINNACLE CUP 1217-11-048 AND LINER 1219-28-048; THE STEM AND HEAD WERE PROVIDED BY STRYKER. THE LINER WAS EXCHANGED TO THE LIPPED VARIANT 1219-28-248 ON (B)(6) 2022 DUE TO RECURRENT DISLOCATION. THE CONSTRUCT HAS CONTINUED TO DISLOCATE AND THE PATIENT HAS BEEN REFERRED TO MR (B)(6). MR (B)(6) WISHES US TO PROVIDE A CUSTOM MADE DEVICE TO ADDRESS THE PATIENT¿S CHALLENGES.
Patient problems: Joint Dislocation; Joint Laxity
MAUDE report 15788292 ↗InjuryApr 25, 2022Device Dislodged or Dislocated; Device Dislodged or Dislocated
REVISION COMPLETED DUE TO DISSOCIATION OF THE LINER. PATIENT COMPLAINED OF PAIN IN DISCOMFORT IN THE HIP. XRAYS SHOWED WHAT LOOKED TO BE EVIDENCE OF A DISSOCIATED LINER. ON APRIL 7TH THE SURGEON THEN PERFORMED SURGERY TO CONFIRM THAT THE LINER WAS IN FACT DISSOCIATED. THE SURGEON REMOVED THE ARTICUL/EZE FEMORAL HEAD FROM THE PATIENT.
Patient problems: Pain
MAUDE report 14195644 ↗InjuryMar 30, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
THE PATIENT WAS REVISED DUE TO UNKNOWN REASON. DOI: UNKNOWN; DOR: (B)(6) 2022; AFFECTED SIDE: UNKNOWN.
Patient problems: Insufficient Information
MAUDE report 13950600 ↗InjuryJan 28, 2022Naturally Worn; Naturally Worn
REVISION COMPLETED DUE TO POLY WEAR.
Patient problems: Insufficient Information
MAUDE report 13388173 ↗InjurySep 20, 2021Device Dislodged or Dislocated; Device Dislodged or Dislocated
ADDITIONAL INFORMATION RECEIVED INDICATED THAT THE AFFECTED SIDE INVOLVED IN THIS EVENT WAS THE LEFT HIP. THIS WAS A REVISION CASE. CUP STAYED IN.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 12497039 ↗InjuryMay 5, 2021Fracture; Device Dislodged or Dislocated; Naturally Worn; Fracture; Device Dislodged or Dislocated; Naturally Worn
PATIENT WAS SUFFERING FROM HIP PAIN IN HER REPLACED HIP. INITIAL SURGERY WAS DONE IN (B)(6) 2006. FEMORAL HEAD AND POLY SWAP WAS PERFORMED. DR. FOX BELIEVES THE LINER WAS POSSIBLY DISLODGED FROM THE CUP AT ONE POINT DUE TO A POSSIBLY DAMAGED ARD. THERE WAS NOTICEABLE POLYETHYLENE WEAR. ON THE EXPLANTED LINER. DOI: (B)(6) 2006, DOR: (B)(6) 2021, UNKNOWN HIP.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Pain
MAUDE report 11778452 ↗InjuryMar 10, 2021Device Dislodged or Dislocated; Noise, Audible; Device Dislodged or Dislocated; Noise, Audible
PATIENT WAS REVISED AGAIN BECAUSE OF ISSUES WITH THE PE INLAY. DOR UNKNOWN; ALL ACETABULAR COMPONENTS WERE REVISED. THE MOST RECENT REVISION SURGERY WAS PERFORMED ON (B)(6) 2021. THE OPERATIVE TIME WAS NOT PROLONGED. IN THIS PATIENT, REVISION SURGERY WAS REQUIRED DUE TO SUBLUXATION OF THE FEMORAL HEAD WITH DISLOCATION OF THE CUP INLAY THAT WAS PLACED DURING THE MOST RECENT REVISION, SQUEAKING SOUNDS, AND A SENSE OF INSTABILITY. THE REPEAT REVISION SURGERY WAS THE ADVERSE CONSEQUENCE OF THE COMPLICATION.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Joint Laxity
MAUDE report 11452861 ↗InjuryDec 20, 2019Fracture; Fracture
SALES REP REPORTED: "I RECEIVED A COMPLAINT ABOUT A HIP IMPLANT THAT BROKE". CODE AND LOT NUMBERS WERE NOT INFORMED. JUST THE OPCO: DEPUY JOINT.
Patient problems: No Code Available; Pain
MAUDE report 9506032 ↗InjuryDec 17, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE PATIENT COMPLAINTS OF A "FEELING OF INSTABILITY". HAD HER PRIMARY HIP REPLACED ABOUT 15 YEARS AGO. PATIENT HAD A LARGE AMOUNT OF HETEROTROPIC BONE AROUND CUP AND SURGEON CHANGED TO A 32 MM + 4 N LINER AND 32 CERAMIC +6 HEAD. ADVISED HIM THERE IS NOT A SLEEVE IN HEAD AND IS A PRIMARY THR HEAD. DOI: UNKNOWN. DOR: (B)(6) 2019. LEFT HIP.
Patient problems: No Code Available
MAUDE report 9482404 ↗InjuryJul 17, 2018Naturally Worn; Separation Problem; Naturally Worn; Separation Problem
AFTER ABOUT FOUR YEARS IN VIVO THE INLAY SHOWED STRONG WEAR AND LUXATED FROM THE CUP.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7694481 ↗InjuryOct 27, 2017Naturally Worn; Naturally Worn
THE PATIENT WAS REVISED FOR ECCENTRIC POLY WEAR. IT WAS INDICATED THAT IT WAS REVISED TO NEW ALTRX POLY AND CERAMIC HEAD.
Patient problems: No Information
MAUDE report 6983520 ↗InjuryOct 13, 2017Disassembly; Device Dislodged or Dislocated; Disassembly; Device Dislodged or Dislocated
THE PATIENT WAS REVISED TO ADDRESS DISASSOCIATION.
Patient problems: Joint Dislocation
MAUDE report 6948911 ↗InjuryOct 13, 2017Disassembly; Device Dislodged or Dislocated; Disassembly; Device Dislodged or Dislocated
THE PATIENT WAS REVISED TO ADDRESS DISASSOCIATION.
Patient problems: Joint Dislocation
MAUDE report 6948890 ↗InjuryOct 13, 2017Disassembly; Device Dislodged or Dislocated; Disassembly; Device Dislodged or Dislocated
COMPLAINT DESCRIPTION: THE PATIENT WAS REVISED TO ADDRESS DISASSOCIATION.
Patient problems: Joint Dislocation
MAUDE report 6948867 ↗InjuryOct 13, 2017Disassembly; Device Dislodged or Dislocated; Disassembly; Device Dislodged or Dislocated
THE PATIENT WAS REVISED TO ADDRESS DISASSOCIATION.
Patient problems: Joint Dislocation
MAUDE report 6948819 ↗InjuryOct 13, 2017Disassembly; Device Dislodged or Dislocated; Disassembly; Device Dislodged or Dislocated
THE PATIENT WAS REVISED TO ADDRESS DISASSOCIATION.
Patient problems: Joint Dislocation
MAUDE report 6948792 ↗InjuryOct 13, 2017Disassembly; Device Dislodged or Dislocated; Disassembly; Device Dislodged or Dislocated
COMPLAINT DESCRIPTION: THE PATIENT WAS REVISED TO ADDRESS DISASSOCIATION.
Patient problems: Joint Dislocation; No Consequences Or Impact To Patient
MAUDE report 6948764 ↗InjuryJun 28, 2017Device Dislodged or Dislocated; Device Dislodged or Dislocated
IT WAS INDICATED THAT THE PATIENT DEVELOPED LATE CHRONIC DISLOCATION. SURGEON WENT BACK WITH A CONSTRAINED LINER.
Patient problems: No Information
MAUDE report 6674410 ↗
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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