DJO SURGICAL 931-36-754Recalls & reported problems
Encore Medical, L.P. · LINER/NON-HOODED-NEU, MP8, HXe-plus, 36mm · Class 2 · Implant
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 22
- Deaths reported
- 0
- Injuries reported
- 22
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 22 adverse event reports that list this exact device (DI 00888912099622), received between Mar 10, 2017 and Jun 10, 2026 — classified as 22 injuries.
The most frequently reported specific device problem is “Unstable” (4 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 Problem7
- Appropriate Device Problem Term/Code Not Available7
- Unstable4
- Insufficient Device Problem Information2
- Microbial Contamination of Device2
- Contamination1
- Inadequacy of Device Shape and/or Size1
Patient problems
- Unspecified Infection14
- No Code Available3
- Joint Laxity2
- No Known Impact Or Consequence To Patient2
- Bacterial Infection1
- Implant Pain1
- Insufficient Information1
- Joint Dislocation1
Recent adverse event reports
The 22 most recent of 22 reports, in the reporter's own words as published by the FDA.
InjuryJun 10, 2026Unstable
InjuryJan 14, 2026Adverse Event Without Identified Device or Use Problem
REVISION SURGERY - DUE TO INFECTION, POLY SWAP.
Patient problems: Unspecified Infection
MAUDE report 24077021 ↗InjuryJul 5, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryMar 1, 2024Unstable; Adverse Event Without Identified Device or Use Problem; Unstable; Adverse Event Without Identified Device or Use Problem
InjuryJan 11, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
REVISION SURGERY - PATIENT WAS EXPERIENCING HIP PAIN.
Patient problems: Implant Pain
MAUDE report 16142645 ↗InjuryNov 30, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryApr 15, 2021Unstable
REVISION SURGERY - DUE TO POST-OPERATION HIP INSTABILITY.
Patient problems: Insufficient Information
MAUDE report 11671066 ↗InjurySep 2, 2020Appropriate Device Problem Term/Code Not Available
REVISION SURGERY - THE SURGEON PERFORMED A WASHOUT, A NEW LINER AND DELTA OPTION HEAD WERE IMPLANTED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 10482762 ↗InjuryAug 19, 2020Unstable; Appropriate Device Problem Term/Code Not Available
SECOND REVISION SURGERY - HIP WAS UNSTABLE.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 10426246 ↗InjuryJun 30, 2020Appropriate Device Problem Term/Code Not Available
SECOND REVISION SURGERY - THE PATIENT DEVELOPED AN INFECTION.
Patient problems: Unspecified Infection
MAUDE report 10212131 ↗InjuryMay 26, 2020Microbial Contamination of Device
SECOND REVISION SURGERY - DUE TO INFECTION, REMOVED ALL ITEMS.
Patient problems: No Code Available; Unspecified Infection
MAUDE report 10087670 ↗InjuryMar 26, 2020Adverse Event Without Identified Device or Use Problem
InjuryMar 3, 2020Appropriate Device Problem Term/Code Not Available
InjuryFeb 5, 2020Microbial Contamination of Device
REVISION SURGERY: DUE TO INFECTION. NEEDED TO WASH OUT.
Patient problems: Unspecified Infection
MAUDE report 9670976 ↗InjuryOct 23, 2019Appropriate Device Problem Term/Code Not Available
REVISION SURGERY - PATIENT SHOWED SIGNS OF AN INFECTION. SURGEON PERFORMED AN IRRIGATION AND DRAINAGE WITH A HEAD EXCHANGE AND POLY SWAP.
Patient problems: Unspecified Infection
MAUDE report 9226106 ↗InjuryAug 1, 2019Appropriate Device Problem Term/Code Not Available
REVISION SURGERY - DUE TO AN INFECTED HIP AND GROWING STAFF CULTURE.
Patient problems: Bacterial Infection; Unspecified Infection
MAUDE report 8851484 ↗InjuryJul 30, 2019Appropriate Device Problem Term/Code Not Available
InjuryJan 16, 2019Insufficient Device Problem Information
REVISION SURGERY - DUE TO AN INFECTION.
Patient problems: Unspecified Infection
MAUDE report 8254780 ↗InjuryMar 6, 2018Contamination
REVISION SURGERY - DUE TO THE PATIENT HAVING AN INFECTION.
Patient problems: No Code Available; Unspecified Infection
MAUDE report 7318698 ↗InjuryJul 20, 2017Inadequacy of Device Shape and/or Size
REVISION SURGERY: DUE TO THE INCORRECT POLY LINER HAVING BEEN IMPACTED INTO THE ACETABULAR SHELL AND HAVING TO BE REMOVED AND REPLACED WITH THE CORRECT LINER.
Patient problems: No Code Available
MAUDE report 6730695 ↗InjuryApr 10, 2017Insufficient Device Problem Information
REVISION SURGERY - DUE TO THE PATIENT HAVING AN INFECTION; THE SURGEON PERFORMED A POLY SWAP AND HEAD EXCHANGE.
Patient problems: Unspecified Infection
MAUDE report 6478416 ↗InjuryMar 10, 2017Adverse Event Without Identified Device or Use Problem
REVISION SURGERY - DUE TO AN INFECTION.
Patient problems: Unspecified Infection
MAUDE report 6397033 ↗
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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