BI-MENTUM ALTRX 122128049Recalls & reported problems
Depuy (Ireland) · BI-MENTUM ALTRX LINER 49/28 · Class 2 · Implant
All models of BI-MENTUM ALTRX (10)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
Quick summary
This DePuy BI-MENTUM ALTRX hip liner is the plastic socket liner used in hip replacement surgery. The 35 reports describe hip joints coming dislocated or dislodged, along with infections, pain, and revision surgery to remove, swap, or replace the liner and femoral head. There were35 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
- 36
- Deaths reported
- 0
- Injuries reported
- 36
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 36 adverse event reports that list this exact device (DI 10603295525226), received between Dec 8, 2022 and Sep 1, 2026 — classified as 36 injuries.
The most frequently reported specific device problem is “Device Dislodged or Dislocated” (11 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 Dislocated11
- Off-Label Use4
- Improper or Incorrect Procedure or Method1
- Naturally Worn1
Patient problems
- Unspecified Infection18
- Joint Dislocation11
- Pain5
- Fall2
- Insufficient Information2
Recent adverse event reports
The 25 most recent of 36 reports, in the reporter's own words as published by the FDA.
InjurySep 1, 2026Adverse Event Without Identified Device or Use Problem
It was reported that due to infection, surgeon chose to replace head and liner.DOI: Unknown.DOR: (b)(6) 2026. Affected Side: Unknown Hip.
Patient problems: Unspecified Infection
MAUDE report 50547083 ↗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 25531864 ↗InjuryMay 27, 2026Adverse Event Without Identified Device or Use Problem
PATIENT WAS REVISED DUE TO INFECTION. HEAD AND LINER WERE SWAPPED. AFFECTED SIDE: LEFT KNEE.
Patient problems: Unspecified Infection
MAUDE report 25299670 ↗InjuryMay 11, 2026Device Dislodged or Dislocated
IT WAS REPORTED THAT THE PATIENT WAS REVISED DUE TO DISLOCATED SO COMPONENTS WERE REVISED TO A LONGER NECK OPTION. NO ADVERSE EVENTS REPORTED, NO ADDITIONAL INFORMATION AVAILABLE. AFFECTED SIDE: LEFT HIP.
Patient problems: Joint Dislocation
MAUDE report 25135234 ↗InjuryApr 17, 2026Device Dislodged or Dislocated
IT WAS REPORTED THAT DISLOCATION/FRACTURE DUE TO FALL. DOI: (B)(6) 2024. DOR: (B)(6) 2026. AFFECTED SIDE: RIGHT.
Patient problems: Fall; Joint Dislocation
MAUDE report 24914638 ↗InjuryApr 15, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE PATIENT UNDERWENT IRRIGATION AND DEBRIDEMENT DUE TO SUSPECTED INFECTION. SURGEON EXCHANGED HEAD/LINER WHILE IN CAPSULE. AFFECTED SIDE: UNKNOWN HIP.
Patient problems: Unspecified Infection
MAUDE report 24885051 ↗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 23876794 ↗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 23804379 ↗InjurySep 19, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
THE PATIENT HAD A REMOVAL SURGERY DUE TO INFECTION. DOI: (B)(6) 2025. DOR: (B)(6) 2025. AFFECTED SIDE: RIGHT HIP.
Patient problems: Unspecified Infection
MAUDE report 23098187 ↗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 23040224 ↗InjuryAug 13, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
PATIENT REVISED DUE TO PAIN. DOI: (B)(6) 2025. DOR: (B)(6) 2025. AFFECTED SIDE: RIGHT HIP.
Patient problems: Pain
MAUDE report 22793140 ↗InjuryJul 8, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT PATIENT WAS REVISED DUE TO PAIN. THERE WAS NO SURGICAL DELAY. AFFECTED SIDE: RIGHT HIP.
Patient problems: Pain
MAUDE report 22435670 ↗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 22084827 ↗InjuryMay 6, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated
PATIENT WAS REVISED DUE TO DISLOCATION OF LEFT HIP, REMOVAL OF DUAL MOBILITY IMPLANTS AND REPLACED WITH A CONSTRAINED LINER. DOI: (B)(6) 2024 DOR: (B)(6) 2025 AFFECTED SIDE: LEFT HIP.
Patient problems: Joint Dislocation
MAUDE report 21971069 ↗InjuryFeb 19, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated
ADDITIONAL INFORMATION RECEIVED STATES THAT THERE WAS NO ALLEGATION AGAINST THE STEM OR HEAD.
Patient problems: Joint Dislocation
MAUDE report 21415157 ↗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 20843949 ↗InjuryNov 21, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated
IT WAS REPORTED THAT THERE WAS PATIENT DISLOCATION OF HEAD FROM POLY. DOI: UNKNOWN. DOR: UNKNOWN. AFFECTED SIDE : LEFT HIP.
Patient problems: Joint Dislocation
MAUDE report 20749138 ↗InjuryOct 24, 2024Off-Label Use; Device Dislodged or Dislocated; Off-Label Use; Device Dislodged or Dislocated
IT WAS REPORTED THAT PATIENT WAS DISLOCATED. PATIENT WAS REVISED TO CONSTRAINED LINER FROM DM. LUMBAR FUSION. THERE WAS NO DELAY. ALL PIECES WERE REMOVED. THERE WAS NO IMPLANT FAILURE AND NO LOOSENING. DOI: UNKNOWN. DOR: (B)(6) 2024. AFFECTED SIDE: RIGHT HIP.
Patient problems: Joint Dislocation
MAUDE report 20524396 ↗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 20451554 ↗InjurySep 16, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT PATIENT WAS REVISED DUE TO PAIN. DOI: UNKNOWN. DOR: (B)(6) 2024. AFFECTED SIDE: UNKNOWN.
Patient problems: Pain
MAUDE report 20226623 ↗InjuryAug 12, 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:(B)(6) 2024. DOR:(B)(6) 2024. AFFECTED SIDE: RIGHT HIP.
Patient problems: Unspecified Infection
MAUDE report 19959396 ↗InjuryJun 25, 2024Off-Label Use; Device Dislodged or Dislocated; Off-Label Use; 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 19604259 ↗InjuryJun 21, 2024Adverse 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. PARTS WERE EXCHANGED. THERE WAS NO DELAY AND NO BROKEN INSTRUMENTS. DOI: (B)(6) 2024 DOR: (B)(6) 2024. AFFECTED SIDE: LEFT HIP.
Patient problems: Unspecified Infection
MAUDE report 19586879 ↗InjuryJun 6, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE PATIENT HAS INFECTED HIP AFTER CONVERSION FROM HEMI TO TOTAL. REMOVED DUAL MOBILITY METAL LINER AND POLY HEAD. WASHED OUT THE JOINT AND RE-IMPLANTED THE SAME SIZE IMPLANTS. HIP WAS VERY STABLE DOI: (B)(6) 2024. DOR: (B)(6) 2024. AFFECTED SIDE : RIGHT HIP.
Patient problems: Unspecified Infection
MAUDE report 19477436 ↗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 19352518 ↗
Other Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented devices
- BIOLOX DELTA 1365-32-310Depuy Orthopaedics, Inc. · Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented551 reports
- PINNACLE ALTRX 1221-36-052Depuy Orthopaedics, Inc. · Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented481 reports
- BIOLOX DELTA 1365-32-320Depuy Orthopaedics, Inc. · Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented1 death314 reports
- BIOLOX DELTA 1365-36-720Depuy Orthopaedics, Inc. · Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented1 death189 reports
- DJO SURGICAL 400-03-362Encore Medical, L.P. · Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented187 reports
- Anthology 71365705Smith & Nephew, Inc. · Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented176 reports
- BIOLOX DELTA 1365-40-710Depuy Orthopaedics, Inc. · Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented170 reports
- PINNACLE GRIPTION 1217-32-054Depuy Orthopaedics, Inc. · Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented169 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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