PINNACLE 1218-28-650Recalls & reported problems
Depuy Orthopaedics, Inc. · PINNACLE HIP SOLUTIONS GVF POLYETHYLENE CONSTRAINED ACETABULAR LINER +4 NEUTRAL 28mm ID 50mm OD · Class 2 · Implant
All models of PINNACLE (182)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
Quick summary
This DePuy Pinnacle constrained hip liner is an implant used in hip replacement surgery. The 89 reports mostly describe the hip coming dislocated, along with infections and fractures, sometimes requiring follow-up surgery; there are no deaths, 78 injuries and 11 malfunctions. 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
- 89
- Deaths reported
- 0
- Injuries reported
- 78
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 89 adverse event reports that list this exact device (DI 10603295011514), received between Jun 21, 2017 and Sep 10, 2026 — classified as 78 injuries, 11 malfunctions.
The most frequently reported specific device problem is “Device Dislodged or Dislocated” (63 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
- Device Dislodged or Dislocated63
- Fracture15
- Difficult to Insert9
- Adverse Event Without Identified Device or Use Problem8
- Off-Label Use3
- Break2
- Disassembly2
- Naturally Worn2
Patient problems
- Joint Dislocation57
- No Code Available20
- Unspecified Infection8
- Joint Laxity7
- No Clinical Signs, Symptoms or Conditions6
- Not Applicable4
- Pain4
- Insufficient Information3
Recent adverse event reports
The 25 most recent of 89 reports, in the reporter's own words as published by the FDA.
InjurySep 10, 2026Device Dislodged or Dislocated
It was reported that patient had dislocation.DOI: (b)(6) 2026.DOR: (b)(6) 2026.Affected side: Left Hip.
Patient problems: Joint Dislocation
MAUDE report 50718007 ↗InjuryJul 27, 2026Difficult to Insert
It was reported the Constrained Liner had trouble seating into a Gription Multi-Hole Shell. The Liner sat slightly product anteriorly and could not be impacted further; the Liner was damaged while being removed, but was able to be removed. A second Constrained Liner was attempted and had the same issues.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50035429 ↗InjuryApr 13, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE PATIENT WAS REVISED DUE TO INFECTION. AFFECTED SIDE: LEFT HIP.
Patient problems: Unspecified Infection
MAUDE report 24859728 ↗InjuryMar 16, 2026Device Dislodged or Dislocated
IT WAS REPORTED THAT THE PATIENT HIP WAS DISLOCATED. DOI: (B)(6) 2022. DOR: (B)(6) 2026. AFFECTED SIDE: LEFT HIP.
Patient problems: Joint Dislocation
MAUDE report 24606161 ↗InjuryJan 30, 2026Device Dislodged or Dislocated
THE PATIENT HAD A DISLOCATION OF LEFT HIP. DOI: (B)(6) 2019. DOR: (B)(6) 2026. AFFECTED SIDE: LEFT HIP.
Patient problems: Joint Dislocation
MAUDE report 24221861 ↗InjuryJan 15, 2026Device Dislodged or Dislocated
IT WAS REPORTED THAT THE PATIENT EXPERIENCED A DISLOCATION AND SUBSEQUENTLY UNDERWENT A PROCEDURE INVOLVING THE PLACEMENT OF A NEW CONSTRAINED LINER AND HEADBALL. NO ADDITIONAL INFORMATION AVAILABLE. DOI: UNKNOWN. DOR: (B)(6) 2026. AFFECTED SIDE: UNKNOWN.
Patient problems: Joint Dislocation
MAUDE report 24081337 ↗InjuryDec 15, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated
IT WAS REPORTED THAT ORIGINAL CASE WAS DONE SEVEN YEARS AGO DUE TO INSTABILITY. PATIENT DISLOCATED PINNACLE CONSTRAINED LINER. DOCTOR STATED THAT THE CUP WAS NOT IN AN OPTIMAL POSITION AND WAS VERTICAL. THERE WAS VISIBLE IMPINGEMENT BETWEEN THE CUP AND TRUNION. NOTICEABLE METALLOSIS ON THE TISSUES. DOCTOR CUT OUT THE PINNACLE CUP AND REPLACED IT WITH A REDAPT CUP; REMOVED THE HEAD, CUP, LINER AND SCREWS. REPLACED WITH A +12 TO INSURE STABILITY. DOI: UNKNOWN. DOR: (B)(6) 2025. AFFECTED SIDE: RIGHT HIP.
Patient problems: Foreign Body Reaction; Joint Dislocation; Joint Laxity
MAUDE report 23803863 ↗InjuryNov 10, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated
THE PATIENT FELL AND DISLOCATED. NEW CONSTRAINED LINER WAS USED. DOI: (B)(6) 2024. DOR: (B)(6) 2025. AFFECTED SIDE: UNKNOWN.
Patient problems: Fall; Joint Dislocation
MAUDE report 23512386 ↗InjurySep 8, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated
PATIENT WAS REVISED WITH LINER AND HEAD DUE TO DISLOCATION. LINER DISASSOCIATED FROM CUP. THERE WAS A CONSTRAINED ACETABULAR LINER AT UNKNOWN INTERFACE. DOI: UNKNOWN, DOR: (B)(6) 2025, AFFECTED SIDE: RIGHT HIP.
Patient problems: Joint Dislocation
MAUDE report 22995021 ↗InjuryJul 24, 2025Fracture; Fracture
IT WAS REPORTED THAT THE PATIENT UNDERWENT RIGHT HIP REVISION SURGERY TO REPLACE CONSTRAINED POLY LINER THAT HAD CRACKED DUE TO FEMORAL NECK IMPINGEMENT. FEMORAL HEAD 28MM +5 WAS REPLACED WITH SAME SIZE FEMORAL HEAD 28MM +5 CERAMIC. SAME SIZE PINNACLE CONSTRAINED LINER 50MM X 28MM NEUTRAL +4 THAT WAS REMOVED WAS ALSO REPLACED.
Patient problems: Joint Laxity
MAUDE report 22588887 ↗InjuryJul 18, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated
IT WAS REPORTED THAT THE PATIENT HAS A SUMMIT PRESSFIT STEM WITH A PINNACLE CONSTRAINED LINER. PATIENT DISLOCATED THE HEAD OUT OF THE CONSTRAINED LINER AND SURGEON REMOVED THE HEAD AND LINER, THEN REIMPLANTED A NEW CONSTRAINED LINER AND LONGER HEAD. AFFECTED SIDE: LEFT HIP.
Patient problems: Joint Dislocation
MAUDE report 22543975 ↗MalfunctionJul 14, 2025Fracture; Difficult to Insert; Fracture; Difficult to Insert
IT WAS REPORTED THAT DURING THE REDUCTION OF THE HIP, THE SURGEON BROKE ONE OF THE POLY SLITS. AS A RESULT, THE FEMORAL HEAD COULD NO LONGER LOCK INTO THE LINER. AFFECTED SIDE: RIGHT HIP.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22501063 ↗MalfunctionJul 11, 2025Fracture; Difficult to Insert; Fracture; Difficult to Insert
IT WAS REPORTED THAT THE LINER WAS IMPLANTED INTO PATIENT INTRAOPERATIVELY. DUE TO THE SIZE NOT FITTING APPROPRIATELY, THE SURGEON DECIDED TO EXPLANT THE LINER. WHILE EXPLANTING, THE LINER BROKE INSIDE THE PATIENT INTO SMALLER PIECES. ALL PIECES WERE REMOVED AS VISUALLY CONFIRMED BY SURGICAL TEAM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22481787 ↗InjuryJun 2, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE PATIENT WAS REVISED DUE TO INFECTION. NO FURTHER INFORMATION AVAILABLE. AFFECTED SIDE: RIGHT HIP.
Patient problems: Unspecified Infection
MAUDE report 22124237 ↗InjuryAug 20, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated
ADDITIONAL INFORMATION RECEIVED: A. CAN YOU PROVIDE THE PRODUCT CODE AND LOT NO OF UNK HIP LOCKING RING? THE LOCKING RING COMES PACKAGED WITH THE CONSTRAINED LINER. DOES NOT HAVE A SEPARATE CODE. B. WAS THE DAMAGE TO THE POLY LIP PRESENT UP RECEIPT, OR DID THE DAMAGE HAPPEN WHEN THE LOCKING RING DISASSOCIATED? NOT SURE WHAT YOU MEAN ¿PRESENT UP RECEIPT¿. THE DAMAGE MAY HAVE OCCURRED WHEN THE LOCKING RING DISASSOCIATED.
Patient problems: Insufficient Information
MAUDE report 20001127 ↗InjuryJul 15, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
PATIENT WAS SICK AND HAD ELEVATED NUMBERS SO SURGEON DECIDED TO TAKE HER BACK AND WASH HER OUT SWAPPING THE HEAD AND CONSTRAINED LINER. DOI: (B)(6) 2024. DOR: (B)(6) 2024. AFFECTED SIDE: RIGHT HIP.
Patient problems: Unspecified Infection
MAUDE report 19742029 ↗InjuryFeb 13, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated
ADDITIONAL INFORMATION WAS RECEIVED. STATING, THAT THERE WAS NO SURGICAL DELAY REPORTED.
Patient problems: Joint Dislocation
MAUDE report 18695381 ↗InjuryDec 6, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated
PATIENT WAS REVISED DUE TO CONSTRAINED LINER HAD DISLOCATED FROM THE CUP. SURGEON REMOVED THE OLD HEAD AND CONSTRAINED LINER AND REPLACED WITH A NEW ONE OF THE SAME SIZE. HE DID NOT NOTICE A PROBLEM WITH OUR CUP OR LINER BUT THOUGHT PATIENT HAD JUST LEVERED IT OUT. DOI: (B)(6) 2022 DOR: (B)(6) 2023 AFFECTED SIDE: RIGHT HIP
Patient problems: Insufficient Information
MAUDE report 18274310 ↗MalfunctionNov 28, 2023Difficult to Insert; Difficult to Insert
IT WAS REPORTED THAT THE CONSTRAINT LINER WOULD NOT FULLY SEAT. IT WAS GETTING HUNG UP ANTERIORLY. THE SURGEON HAD TO WASTE THE +4 AND USE A +4 10* WHICH ENDED UP SEATING FLUSH WITH THE CUP. UNKNOWN SURGICAL DELAY. DOE: NOV 15, 2023. AFFECTED SIDE: RIGHT HIP.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18215530 ↗InjuryNov 21, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated
IT WAS REPORTED THAT PATENT WAS REVISED DUE TO RIGHT HIP DISLOCATION. THERE WAS NO SURGICAL DELAY. DOI: UNKNOWN; DOR: (B)(6) 2023 AFFECTED SIDE: RIGHT HIP.
Patient problems: Joint Dislocation
MAUDE report 18185338 ↗InjuryNov 6, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated
PATIENT WAS REVISED DUE TO DISLOCATION. DOI: UNKNOWN; DOR: (B)(6) 2023; AFFECTED SIDE : LEFT HIP .
Patient problems: Joint Dislocation
MAUDE report 18074004 ↗InjuryOct 26, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated
IT WAS REPORTED THAT PATIENT HAS DISLOCATED MULTIPLE TIMES. CONSTRAINED LINER WAS REMOVED AND REPLACED WITH NEW CONSTRAINED LINER AND LONGER HEAD. THERE WAS NO SURGICAL DELAY. DOI- UNKNOWN. DOR- (B)(6) 2023. AFFECTED SIDE- LEFT HIP.
Patient problems: Joint Dislocation
MAUDE report 18011475 ↗MalfunctionOct 24, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated
IT WAS REPORTED THAT A PATIENT PRESENTED WITH A PINN LNR CON +4 NEUT 28IDX50OD WHERE THE LOCKING RING HAD DISENGAGED. PATIENT HYPERMOBILE. PATIENT FELT MOVEMENT TWO WEEKS PRIOR. ON INSPECTION LOCKING RING WAS LOOSE AND DISENGAGED FROM POLY AND RIM OF POLY WHERE THE LOCKING RING SITS WAS DAMAGED. SURGEON STATED THIS COULD BE BECAUSE SHE IS HYPERMOBILE, BUT NOT SURE WHY THE RING HAD DISENGAGED UNLESS IT WASN'T SEATED PROPERLY IN THE FIRST INSTANCE. HIP HAD NOT DISLOCATED. HE IS HAS NOT ASKED FOR A REPORT AND IMPLANT WAS DISCARDED AT HOSPITALS PROTOCOL. DID THE PATIENT EXPERIENCE AN ADVERSE EVENT SUCH AS INFECTION, NON-UNION, ALLERGIC REACTION, OSTEOPOROSIS, OVERLOADING, PAIN, DEGENERATIVE DISEASES, BLEEDING OR OOZING?: NO, DID THE PATIENT REQUIRE REVISION SURGERY OR HARDWARE REMOVAL?: YES, FACILITY NAME OF ORIGINAL IMPLANT:[HOSPITAL], WAS DEVICE EXPLANTED?: TRUE, HARDWARE/EXPLANT REMOVAL DUE TO: LOCKING RING ON CONSTRAINED LINER HAD DISENGAGED., DID PATIENT REQUIRE REVISION SURGERY?: TRUE, IF YES, DATE OF REVISION SURGERY: [DATE], REASON FOR REVISION SURGERY: LOCKING RING ON CONSTRAINED LINER HAD DISENGAGED. CHANGED LINER TO NEW LINER., PATIENT STATUS/ OUTCOME / CONSEQUENCES: YES, PA
Patient problems: Joint Laxity
MAUDE report 17998203 ↗InjuryAug 8, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated
PATIENT WAS REVISED DUE TO HIP DISLOCATION. DOI: UNKNOWN. DOR: (B)(6) 2023. AFFECTED SIDE: RIGHT HIP.
Patient problems: Joint Dislocation
MAUDE report 17479453 ↗InjuryJun 6, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated
PATIENT'S HIP REVISION DUE TO RECURRENT DISLOCATION OF PINNACLE CONSTRAINED LINER. SURGEON ELECTED TO GIRDLESTONE PATIENT. PINNACLE CONSTRAINED LINER AND LOCKING RING AS WELL AS SROM STEM AND HEAD WERE REMOVED. A 50X32 PINNACLE LINER WAS IMPLANTED. THE SROM SLEEVE REMAINED IN PLACE. IT WAS UNKNOWN ABOUT SURGICAL DELAY. DOI: (B)(6) 2023. DOR: (B)(6) 2023. AFFECTED SIDE: LEFT HIP.
Patient problems: Joint Dislocation
MAUDE report 17070111 ↗
Other Prosthesis, hip, constrained, cemented or uncemented, metal/polymer devices
- Novation 134-36-45Exactech, Inc. · Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer2 recalls0 reports
- Trident 690-00-28FHowmedica Osteonics Corp. · Prosthesis, hip, constrained, cemented or uncemented, metal/polymer1 recall37 reports
- Trident 690-00-22EHowmedica Osteonics Corp. · Prosthesis, hip, constrained, cemented or uncemented, metal/polymer1 recall36 reports
- PINNACLE 1218-32-652Depuy Orthopaedics, Inc. · Prosthesis, hip, constrained, cemented or uncemented, metal/polymer75 reports
- Trident 690-00-22DHowmedica Osteonics Corp. · Prosthesis, hip, constrained, cemented or uncemented, metal/polymer1 recall22 reports
- PINNACLE 1218-32-654Depuy Orthopaedics, Inc. · Prosthesis, hip, constrained, cemented or uncemented, metal/polymer70 reports
- Trident 69-2850Howmedica Osteonics Corp. · Prosthesis, hip, constrained, cemented or uncemented, metal/polymer1 recall11 reports
- Trident 690-00-28GHowmedica Osteonics Corp. · Prosthesis, hip, constrained, cemented or uncemented, metal/polymer1 recall11 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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