PINNACLE ALTRX 1221-36-058Recalls & reported problems
Depuy Orthopaedics, Inc. · PINNACLE HIP SOLUTIONS ALTRX POLYETHYLENE ACETABULAR LINER NEUTRAL 36mm ID 58mm OD · Class 2 · Implant
All models of PINNACLE ALTRX (98)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
Quick summary
This DePuy Pinnacle hip liner has 201 adverse event reports, including 1 death and 193 injuries. Many reports describe the liner dislodging, hip dislocation or infection, with many patients needing revision surgery. Reports dropped to 8 in the last 12 months from 22 in the 12 months before. There are no recalls that 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
- 201
- Deaths reported
- 1
- Injuries reported
- 193
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 201 adverse event reports that list this exact device (DI 10603295016359), received between Aug 3, 2017 and Aug 6, 2026 — classified as 1 death, 193 injuries, 7 malfunctions.
The most frequently reported specific device problem is “Device Dislodged or Dislocated” (72 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 Problem109
- Device Dislodged or Dislocated72
- Insufficient Device Problem Information10
- Appropriate Device Problem Term/Code Not Available5
- Fracture5
- Difficult to Insert4
- Naturally Worn3
- Disassembly2
Patient problems
- Unspecified Infection70
- Joint Dislocation57
- No Code Available45
- Pain22
- Joint Laxity12
- Insufficient Information11
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available10
- Not Applicable10
Recent adverse event reports
The 25 most recent of 201 reports, in the reporter's own words as published by the FDA.
InjuryAug 6, 2026Device Dislodged or Dislocated
It was reported that Patient was dislocating after initial surgery. Revision surgery required.DOI: (b)(6) 2025,DOR: (b)(6) 2026,Affected Side: Right Hip.
Patient problems: Joint Dislocation
MAUDE report 50154606 ↗InjuryApr 14, 2026Device Dislodged or Dislocated
IT WAS REPORTED THAT THE PATIENT WAS IN A SNOWMOBILE ACCIDENT AND HAD DISLODGED THE LINER. THE LINER AND HEAD WERE EXCHANGED. THE ORIGINAL DOS WAS (B)(6) 2024. AFFECTED SIDE- LEFT HIP.
Patient problems: Insufficient Information
MAUDE report 24873454 ↗InjuryApr 1, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT PATIENT UNDERWENT A TOTAL HIP SURGERY ON (B)(6) 2026, DEVELOPED AN INFECTION. DR WENT IN AND DID A HEAD AND LINER SWAP. DOI: (B)(6) 2026. DOR: (B)(6) 2026. AFFECTED SIDE: UNKNOWN.
Patient problems: Unspecified Infection
MAUDE report 24756721 ↗InjuryMar 30, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE PATIENT UNDERWENT HIP REPLACEMENT ON (B)(6) 2023. HIP BECAME PAINFUL. CUP WAS REVISED TO A LARGER SIZE 60 FROM A 58. SURGERY WENT WITHOUT INCIDENT. DOI: (B)(6) 2023. DOR: (B)(6) 2026. AFFECTED SIDE: LEFT HIP.
Patient problems: Pain
MAUDE report 24717495 ↗InjuryFeb 2, 2026Adverse Event Without Identified Device or Use Problem
THE PATIENT WAS RETURNED TO OR FOR SUSPECTED INFECTION, LINER, HOLE ELIMINATOR AND CERAMIC HEAD WERE EXCHANGED. DOI: (B)(6) 2025, DOR: (B)(6) 2026, AFFECTED SIDE: UNKNOWN.
Patient problems: Unspecified Infection
MAUDE report 24240216 ↗InjuryJan 26, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT PSEUDOTUMOR, HEAD AND LINER WERE EXCHANGED TO CONSTRAINED AND TS HEADS. DOI: UNKNOWN. DOR: (B)(6) 2026. AFFECTED SIDE: UNKNOWN.
Patient problems: Hypersensitivity/Allergic reaction
MAUDE report 24178598 ↗InjuryDec 26, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
THE PATIENT WAS REVISED DUE TO INFECTED HIP. THE PATIENT HAD AN I&D WITH LINER AND HEAD BALL REPLACEMENT. DOI: (B)(6) 2025. DOR: (B)(6) 2025. AFFECTED SIDE: LEFT HIP.
Patient problems: Unspecified Infection
MAUDE report 23898306 ↗InjuryNov 13, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE SURGEON STATED THAT PATIENT WAS IMPINGING ON THE POLY. IT WAS CHANGED TO DUAL MOBILITY. DOI: (B)(6) 2021. DOR: (B)(6) 2025. AFFECTED SIDE: RIGHT HIP.
Patient problems: Joint Laxity
MAUDE report 23549259 ↗InjuryOct 31, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated
PATIENT WAS REVISED DUE TO FALL AND KNOCKED THE HEAD AND LINER OUT OF PLACE. DOI: (B)(6) 2024. DOR: (B)(6) 2025. AFFECTED SIDE: RIGHT HIP.
Patient problems: Fall; Joint Dislocation
MAUDE report 23439676 ↗InjurySep 17, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
PATIENT WAS REVISED DUE TO INFECTION OF STAGE 1 OF 2. DOI: (B)(6) 2024, DOR: (B)(6) 2025, AFFECTED SIDE: UNKNOWN HIP.
Patient problems: Unspecified Infection
MAUDE report 23077074 ↗InjuryAug 5, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE PATIENT IS THREE WEEKS POST OP AND DEVELOPED AN INFECTION. PATIENT WAS BROUGHT BACK TO THE OR FOR AN I&D WITH HEAD AND POLY EXCHANGE. DOI: (B)(6) 2025. DOR: (B)(6) 2025. AFFECTED SIDE: LEFT HIP.
Patient problems: Unspecified Infection
MAUDE report 22715358 ↗InjuryJul 18, 2025Fracture; Illegible Information; Fracture; Illegible Information
IT WAS REPORTED THAT THE PATIENT WAS REVISED DUE TO INFECTION. AFFECTED SIDE: UNKNOWN.
Patient problems: Unspecified Infection
MAUDE report 22542376 ↗InjuryJun 12, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated
IT WAS REPORTED THAT AFTER THEIR ORIGINAL SURGERY, THE STEM HAD SUBSIDED, AND THE PATIENT STARTED TO DISLOCATE WHICH IS WHY THE HIP WAS REVISED. THE SURGEON REMOVED THE ACTIS STEM AND WENT UP IN STEM SIZE, AFTER THE NEUTRAL LINER WAS REMOVED AND REPLACED WITH DUAL MOBILITY FOR STABILITY. AFFECTED AREA: UNK HIP.
Patient problems: Joint Dislocation
MAUDE report 22194334 ↗InjuryMay 12, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
PATIENT REVISED DUE TO INFECTED HIP. HEAD AND LINER EXCHANGE. SECOND HEAD AND LINER EXCHANGE. DOI: (B)(6), 2025. DOR: (B)(6), 2025. AFFECTED SIDE: LEFT KNEE.
Patient problems: Unspecified Infection
MAUDE report 22004333 ↗InjuryMay 9, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated
IT WAS REPORTED THAT PATIENT UNDERWENT REVISION DUE TO DISASSOCIATION OF THE LINER AND CUP. DEPUY CUP, HOLE, ELIMINATOR, HEAD, AND LINER REVISED. COMPETITOR PRODUCTS PLACED WITHIN THE ACETABULUM WITH A NEW DEPUY FEMORAL HEAD AND EXISTING FEMORAL STEM. DOI: (B)(6) 2023 (CUP AND STEM), DOI: (B)(6) 2023 (HEAD AND LINER), DOR: (B)(6) 2024, AFFECTED SIDE: LEFT HIP. THIS IS A LINK PC OF (B)(4).
Patient problems: Insufficient Information
MAUDE report 21997889 ↗InjuryMay 9, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT ON (B)(6) 2023, PATIENT WAS ADMITTED FOR TREATMENT OF A PULMONARY EMBOLISM 17 DAYS AFTER A REVISION HIP SURGERY (TO TREAT IMPLANT LINER-CUP DISASSOCIATION). DOE: (B)(6) 2023. AFFECTED SIDE: LEFT HIP. THIS IS A LINK (B)(4).
Patient problems: Pulmonary Embolism
MAUDE report 21996261 ↗InjuryMay 2, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT ON (B)(6) 2024, THE THA WAS INFECTED. I&D OCCURRED ON (B)(6) 2024 BUT FAILED. THE FEMUR WAS LOOSE. DURING THE HIP EXPLANT PROCEDURE ON APRIL 10, 2025, THE WATSON FEMORAL SLAP HAMMER WAS BENT TRYING TO REMOVE THE STEM. THIS REPORT CAPTURES THE INFECTION. RELATED COMPLAINT (B)(4) CAPTURED THE I&D FAILURE. RELATED COMPLAINT (B)(4) CAPTURES THE REVISION PROCEDURE. DOI: (B)(6) 2024, DOR: (B)(6) 2025, AFFECTED SIDE: UNKNOWN.
Patient problems: Unspecified Infection
MAUDE report 21949869 ↗InjuryMay 2, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT ON (B)(6) 2024, THE THA WAS INFECTED. I&D OCCURRED ON (B)(6) 2024 BUT FAILED. THE FEMUR WAS LOOSE. DURING THE HIP EXPLANT PROCEDURE ON (B)(6) 2025, THE WATSON FEMORAL SLAP HAMMER WAS BENT TRYING TO REMOVE THE STEM. THIS REPORT CAPTURES THE I&D FAILURE. RELATED COMPLAINT (B)(4) CAPTURED THE INFECTION. RELATED COMPLAINT (B)(4) CAPTURES THE REVISION PROCEDURE.
Patient problems: Unspecified Infection
MAUDE report 21949534 ↗InjuryMay 1, 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, LINER AND HEAD EXCHANGE. DOI: (B)(6) 2025. DOR: (B)(6) 2025. AFFECTED SIDE: RIGHT HIP.
Patient problems: Unspecified Infection
MAUDE report 21942547 ↗InjuryMar 11, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated
PATIENT WAS REVISED DUE TO DISLOCATION AND WENT TO CONSTRAINED LINER. SURGERY WENT GOOD. DOI: ON (B)(6) 2016, DOR: ON (B)(6) 2025, AFFECTED SIDE: UNKNOWN HIP.
Patient problems: Joint Dislocation
MAUDE report 21573064 ↗MalfunctionJan 23, 2025Difficult to Remove; Difficult to Remove
ADDITIONAL INFORMATION WAS RECEIVED AND STATED THAT THE DEVICE DID NOT SIT DOWN FULLY AND THE SURGEON DESTROYED IT WHILE TRYING TO REPOSITION IT.
Patient problems: Insufficient Information
MAUDE report 21219443 ↗InjuryJan 15, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE PATIENT DEVELOPED INFECTION APPROXIMATELY TWO MONTHS POSTOP. THEY REMOVED ALL COMPONENTS AND IMPLANTED CEMENT SPACERS. DOI: UNKNOWN. AFFECTED SIDE: LEFT HIP.
Patient problems: Unspecified Infection
MAUDE report 21160045 ↗InjuryJan 10, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE PATIENT RETURNED TO SURGERY FOR A JOINT SPACE INFECTION. THE HIP WAS IRRIGATED AND DEBRIDED. THE HEAD, LINER AND SCREW WERE REMOVED. A NEW HEAD AND LINER WAS PLACED. THE SCREW WAS NOT REPLACED. THERE WERE NO DELAYS. THE HIP IS INFECTED. DOI: (B)(6) 2024, DOR: (B)(6) 2024, AFFECTED SIDE: RIGHT HIP.
Patient problems: Unspecified Infection
MAUDE report 21126858 ↗InjuryJan 9, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
THE PATIENT HEAD AND LINER WERE REVISED FOR INFECTION. ALL PIECES REMOVED. IMPLANTED AT HOSPITAL APPROX. 4 WEEKS AGO. NO DELAY. NO BROKEN IMPLANTS OR INSTRUMENTS. NO IMPLANT FAILURE. NO OTHER INFORMATION. DOI: UNKNOWN. DOR: (B)(6) 2024. AFFECTED SIDE: LEFT HIP.
Patient problems: Unspecified Infection
MAUDE report 21112031 ↗InjuryJan 8, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THERE WAS DAIR WASHOUT FOR INFECTION IN A PATIENT. THE OT NURSE MENTIONED THAT THE PATIENT HAD THEIR LINER, FEMORAL HEAD AND STEM SWAPPED OUT AS PART OF THE DAIR.
Patient problems: Unspecified Infection
MAUDE report 21103412 ↗
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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