PINNACLE Hip Solutions 1218-56-049Recalls & reported problems
Depuy (Ireland) · PINNACLE Hip Solutions DUAL MOBILITY LINER PINNACLE Acetabular Shell BI-MENTUM PE Liner 56/49 56mm 49/28 · Class 2 · Implant
All models of PINNACLE Hip Solutions (10)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
Quick summary
This DePuy Pinnacle hip implant is a metal-and-polymer hip replacement with a dual mobility liner. The 35 adverse event reports mostly describe hip infections that led to removing and replacing the implant, along with joint dislocation, hip pain, and pelvic fracture. There are 32 injuries and no deaths. No recalls name 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
- 35
- Deaths reported
- 0
- Injuries reported
- 32
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 35 adverse event reports that list this exact device (DI 10603295520290), received between Feb 15, 2021 and Jun 17, 2026 — classified as 32 injuries, 3 malfunctions.
The most frequently reported specific device problem is “Device Dislodged or Dislocated” (9 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.
Reports received per month
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem23
- Device Dislodged or Dislocated9
- Off-Label Use2
- Difficult to Insert1
- Improper or Incorrect Procedure or Method1
- Naturally Worn1
Patient problems
- Unspecified Infection19
- Joint Dislocation6
- Pain3
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available2
- Discomfort2
- Insufficient Information2
- Joint Laxity1
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 25 most recent of 35 reports, in the reporter's own words as published by the FDA.
InjuryJun 17, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT PATIENT WAS REVISED DUE TO PAIN. DOI: (B)(6) 2026. DOR: (B)(6) 2026. AFFECTED SIDE: UNKNOWN HIP.
Patient problems: Pain
MAUDE report 25531768 ↗InjuryDec 23, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT PATIENT WAS SHOWING SIGNS OF INFECTION AND SURGEON WANTED TO DO A HEAD AND LINER EXCHANGE. DOI: (B)(6) 2025. DOR: (B)(6) 2025. AFFECTED SIDE: RIGHT HIP.
Patient problems: Unspecified Infection
MAUDE report 23876773 ↗InjuryDec 15, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE PATIENT WAS INFECTED. THE IMPLANTS WERE REMOVED AND PROSTALAC WAS INSERTED. AFFECTED SIDE: RIGHT HIP.
Patient problems: Unspecified Infection
MAUDE report 23804480 ↗InjurySep 12, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE PATIENT BECAME INFECTED, SO THE SURGEON WASHED THE IMPLANT OUT AND SWITCHED THE METAL AND POLY LINERS AND THE HEAD. AFFECTED SIDE: UNKNOWN.
Patient problems: Unspecified Infection
MAUDE report 23040257 ↗InjuryMay 26, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THE PATIENT ORIGINALLY HAD A HIP REPLACED IN (B)(6) 2024. THE PATIENT DEVELOPMENT AN INFECTION IN THE RIGHT HIP. ALL THE COMPONENTS WERE EXPLANTED AND REPLACED WITH A PROSTALAC STEM.
Patient problems: Unspecified Infection
MAUDE report 22084823 ↗InjuryMay 1, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE PATIENT UNDERWENT THE REVISION DUE TO INFECTION. PSEUDOMONAS INFECTION, LIKELY AS A RESULT OF THE CANNULA DONE BY NURSING STAFF IN ICU. ALL IMPLANTS WERE REMOVED.
Patient problems: Unspecified Infection
MAUDE report 21944010 ↗InjuryDec 4, 2024Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method
IT WAS REPORTED THAT THE PATIENT WAS REVISED DUE TO PAIN. DOI: (B)(6) 2024. DOR: (B)(6) 2024. AFFECTED SIDE: LEFT HIP.
Patient problems: Pain
MAUDE report 20843894 ↗InjuryOct 15, 2024Off-Label Use; Off-Label Use
IT WAS REPORTED THAT THE PATIENT WAS REVISED DUE TO PELVIC FRACTURE AND INFECTION. THERE WAS A ACETABULAR CUP LOOSENING AT NON-CEMENTED INTERFACE. DOI: (B)(6) 2024. DOR: (B)(6) 2024. AFFECTED SIDE: RIGHT HIP.
Patient problems: Unspecified Infection
MAUDE report 20451338 ↗InjuryAug 8, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE PATIENT WAS INFECTED. ALL IMPLANTS WERE REMOVED AND A TEMPORARY SPACER WAS PLACED. DOI: ON (B)(6) 2024. DOR: ON (B)(6) , 2024. AFFECTED SIDE: RIGHT HIP.
Patient problems: Unspecified Infection
MAUDE report 19944708 ↗InjuryJun 24, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated
PATIENT WAS REVISED DUE TO DISLOCATED HIP. IT WAS UNKNOWN, IF THERE WAS A SURGICAL DELAY. DOI- UNKNOWN. DOR- (B)(6) 2024. AFFECTED SIDE- UNKNOWN HIP.
Patient problems: Joint Dislocation
MAUDE report 19601047 ↗InjuryMay 20, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE PATIENT ACQUIRED AN INFECTION AFTER SURGERY. WASHED OUT JOINT. ALL POROUS IMPLANTS WERE WELL FIXED. REPLACED LINER AND HEAD WITH NEW IMPLANTS OF THE SAME SIZE AND LENGTH. DOI: (B)(6) 2024 DOR: (B)(6) 2024 AFFECTED SIDE : RIGHT HIP.
Patient problems: Unspecified Infection
MAUDE report 19352615 ↗InjuryApr 17, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
ADDITIONAL INFORMATION RECEIVED STATES THAT THERE WAS NO SURGICAL DELAY.
Patient problems: Joint Laxity
MAUDE report 19126049 ↗InjuryMar 15, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
PATIENT GOT AN INFECTION POST SURGERY. THERE WAS NO ADDED TIME TO THE SURGERY. NO INSTRUMENTS WERE BROKEN DURING THE SURGERY. DOI: (B)(6) 2024. DOR: (B)(6) 2024. AFFECTED SIDE: RIGHT HIP.
Patient problems: Unspecified Infection
MAUDE report 18913659 ↗InjuryMar 5, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
THE PATIENT UNDERWENT REVISION AS THE LINERS WERE REPLACED DUE TO SUSPECTED INFECTION. SURGICAL DELAY WAS UNKNOWN. DOI: UNKNOWN; DOR: (B)(6) 2024; AFFECTED SIDE: RIGHT HIP.
Patient problems: Unspecified Infection
MAUDE report 18838471 ↗InjuryFeb 27, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
ADDITIONAL INFORMATION WAS RECEIVED: A. WAS THERE ANY SURGICAL DELAY RELATED TO THE EVENT? NO DELAY.
Patient problems: Unspecified Infection
MAUDE report 18790266 ↗InjuryJan 19, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated
PATIENT WAS REVISED DUE TO DISLOCATION OF HIP. ITEMS WERE EXPLANTED. DOI: (B)(6).2023. DOR: JAN 15, 2024. AFFECTED SIDE: UNKNOWN HIP.
Patient problems: Joint Dislocation
MAUDE report 18543286 ↗InjuryDec 6, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
PATIENT WAS REVISED DUE TO INFECTION. SURGICAL DELAY UNKNOWN. (B)(6). AFFECTED SIDE: RIGHT HIP
Patient problems: Unspecified Infection
MAUDE report 18275746 ↗InjuryAug 23, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
PATIENT WAS REVISED DUE TO EARLY INFECTION. HEAD LINER EXCHANGED. DOI- (B)(6) 2023. DOR- (B)(6), 2023. AFFECTED SIDE- RIGHT HIP.
Patient problems: Unspecified Infection
MAUDE report 17603525 ↗InjuryAug 22, 2023Device Dislodged or Dislocated; Naturally Worn; Device Dislodged or Dislocated; Naturally Worn
PATIENT WAS REVISED DUE TO DISCOMFORT IN HIP. SURGERY REVEALED FLUID WITH POSSIBLE METAL DEBRIS IN CUP. LOOSENING OF PINNACLE DM LINER WAS ALSO REPORTED. THERE WAS NO SURGICAL DELAY. DOI: UNKNOWN, DOR: (B)(6) 2023, AFFECTED SIDE: UNKNOWN.
Patient problems: Discomfort; Swelling/ Edema
MAUDE report 17595584 ↗InjuryJun 26, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated
IT WAS REPORTED THAT THE PRIMARY TOTAL HIP REPLACEMENT DISLOCATED.
Patient problems: Joint Dislocation
MAUDE report 17197771 ↗InjuryApr 18, 2023Off-Label Use; Device Dislodged or Dislocated; Off-Label Use; Device Dislodged or Dislocated
DISLOCATED PDM LINER REPLACED WITH CONSTRAINED LINER. DOI: (B)(6) 2023. DOR: (B)(6) 2023. UNKNOWN SIDE.
Patient problems: Joint Dislocation
MAUDE report 16760911 ↗InjuryNov 7, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
REVISION COMPLETED DUE TO PAIN/DISCOMFORT. SURGEON REMOVED THE DUAL MOBILITY LINER AND STEM TO SHORTEN THE OFFSET OF THE LIMB. DOI- (B)(6) 2022. DOR- (B)(6) 2022. AFFECTED SIDE- LEFT HIP.
Patient problems: Discomfort; Pain; Physical Asymmetry
MAUDE report 15747157 ↗MalfunctionJun 23, 2022Device Dislodged or Dislocated; Device Dislodged or Dislocated
IT WAS REPORTED SURGEON IMPLANTED 56 PINNACLE CUP, AND 56 PINNACLE DUAL MOBILITY LINER. SURGEON SEATED THE LINER AND CHECKED POSITION WITH PINNACLE SCREW DEPTH GAUGE. POST OPERATIVE X-RAY WAS TAKEN, AFTER SURGEON REVIEW, IT WAS NOTICED ON X-RAY THE PINNACLE DUAL MOBILITY LINER MAY HAVE BEEN MALPOSITIONED. SURGEON HAD NOT SEEN PT IN OFFICE AT THE TIME OF REVIEW, AND PATIENT HAD NOT REPORTED ANY KNOWN ISSUES. THERE WAS NO LOOSENING AND NO SURGICAL DELAY.
Patient problems: Insufficient Information
MAUDE report 14787088 ↗InjuryMay 25, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE INFECTED HIP WAS WASHED OUT AND DEBRIDED. HEAD AND LINER WERE EXCHANGED FOR NEW COMPONENTS. THERE WERE NO DEFICIENCIES NOTED WITH COMPONENTS. EXPLANTED COMPONENTS ARE NOT AVAILABLE FOR RETURN. LOT NUMBERS WERE NOT LEGIBLE ON CERAMIC HEAD AND BIMENTUM HEAD. NO SURGICAL DELAY. DOI: UNKNOWN. DOR: (B)(6) 2021. AFFECTED SIDE: UNKNOWN.
Patient problems: Unspecified Infection
MAUDE report 14498849 ↗InjuryApr 26, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
PATIENT WAS REVISED DUE TO INFECTION. RESECTION ARTHROPLASTY AND GIRDLE STONE. DOI: (B)(6) 2022; DOR: (B)(6) 2022; AFFECTED SIDE: LEFT HIP.
Patient problems: Unspecified Infection
MAUDE report 14213219 ↗
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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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