DJO SURGICAL 508-44-101Recalls & reported problems
Encore Medical, L.P. · 44MM RSP GLEN HD +8MM, · Class 2 · Implant
Data updated Oct 18, 2026 from official FDA records · Editorial policy
Quick summary
This is a DJO Surgical shoulder prosthesis, a metal-on-polymer cemented implant with a large glenosphere head used in shoulder replacement. The 55 reports mostly describe the shoulder joint coming apart or dislocating after surgery, with looseness of the joint, and many patients needing revision surgery to fix it. No deaths were reported, and all 55 reports describe injuries. 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
- 57
- Deaths reported
- 0
- Injuries reported
- 57
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 57 adverse event reports that list this exact device (DI 00888912024785), received between Jan 6, 2017 and Sep 25, 2026 — classified as 57 injuries.
The most frequently reported specific device problem is “Device Dislodged or Dislocated” (20 reports).
1 other recall cover devices cleared under the same FDA submission (K100741); they may or may not involve this specific model.
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 Problem27
- Device Dislodged or Dislocated20
- Appropriate Device Problem Term/Code Not Available10
- Unstable5
- Detachment of Device or Device Component1
- Insufficient Device Problem Information1
- Material Separation1
- Unintended System Motion1
Patient problems
- Joint Dislocation28
- Joint Laxity13
- No Code Available10
- Unspecified Infection6
- Insufficient Information5
- Failure of Implant2
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available1
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 25 most recent of 57 reports, in the reporter's own words as published by the FDA.
InjurySep 25, 2026Device Dislodged or Dislocated
Patient problems: Unspecified Infection
MAUDE report 50905479 ↗InjuryAug 5, 2026Device Dislodged or Dislocated
Revision surgery due to Infection / Dislocation.
Patient problems: Joint Laxity; Unspecified Infection
MAUDE report 50136694 ↗InjuryMar 24, 2026Unstable
InjuryMar 16, 2026Unstable
InjuryDec 17, 2025Unintended System Motion; Device Dislodged or Dislocated; Unintended System Motion; Device Dislodged or Dislocated
InjuryDec 9, 2025Unstable; Device Dislodged or Dislocated; Unstable; Device Dislodged or Dislocated
REVISION SURGERY DUE TO MULTIPLE DISLOCATIONS SINCE PRIMARY SURGERY. SHOULDER WAS STILL DISLOCATED AT TIME OF SURGERY LINER AND HEAD REMOVED SOFT TISSUE RELEASED TRIALLED - DIFFICULTY REDUCING FURTHER SOFT TISSUE RELEASE IMPLANTS REPLACED - DIFFICULTY REDUCING TENSION BAND REINFORCEMENT OF SOFT TISSUE WITH SUTURE AND SUTURE TAPE.
Patient problems: Joint Dislocation
MAUDE report 23758305 ↗InjuryJul 29, 2025Detachment of Device or Device Component; Adverse Event Without Identified Device or Use Problem; Detachment of Device or Device Component; Adverse Event Without Identified Device or Use Problem
InjuryJul 9, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryJun 3, 2025Unstable; Adverse Event Without Identified Device or Use Problem; Unstable; Adverse Event Without Identified Device or Use Problem
InjuryMay 6, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryJan 21, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjurySep 14, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjurySep 10, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjurySep 9, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryJun 6, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
REVISION SURGERY - DUE TO DISLOCATION AND INSTABILITY.
Patient problems: Joint Dislocation; Joint Laxity
MAUDE report 19480982 ↗InjuryJun 6, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
REVISION SURGERY - DUE TO DISLOCATION AND INSTABILITY.
Patient problems: Joint Dislocation; Joint Laxity
MAUDE report 19480980 ↗InjuryApr 18, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryApr 10, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryMar 13, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryMar 1, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryJan 16, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
REVISION SURGERY: PATIENT WAS CONVERTED TO CUSTOM 48MM SPHERE AND POLY. STEM, BASEPLATE, SCREWS WERE LEFT IN PATIENT. 66 YR OLD MALE.
Patient problems: Insufficient Information
MAUDE report 18522861 ↗InjuryOct 20, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
REVISION SURGERY - DUE TO DISLOCATION AND INSTABILITY.
Patient problems: Joint Dislocation; Joint Laxity
MAUDE report 17981436 ↗InjuryAug 18, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
REVISION SURGERY - DUE TO LOOSENING AND DISLOCATION.
Patient problems: Joint Dislocation; Joint Laxity
MAUDE report 17578671 ↗InjuryJul 18, 2023Unstable; Unstable
REVISION SURGERY - DUE INFECTION.
Patient problems: Joint Laxity; Unspecified Infection
MAUDE report 17347249 ↗InjuryJul 12, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
Recalls under the same FDA submission
These recalls involve devices cleared under K100741. One submission often covers many models, so check the product and lot details in each record.
- Z-1458-2026 · Jan 15, 2026 · Open, ClassifiedBrand Name: Reverse Shoulder Prosthesis (RSP) Product Name: RSP HUMERAL SOCKET INSERT, 32MM +4MM, STANDARD HXe-plus Model/Catalog Number: 509-00-432
Other PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED devices
- DJO SURGICAL 508-32-204Encore Medical, L.P. · PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED1 recall544 reports
- Comprehensive Reverse Shoulder 010000589Biomet Orthopedics, LLC · PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED1 recall142 reports
- DELTA XTEND 130738203Depuy (Ireland) · PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED175 reports
- DJO SURGICAL 509-00-432Encore Medical, L.P. · Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented1 recall117 reports
- Alliance® SBGL3007Zimmer, Inc. · PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED162 reports
- DELTA XTEND 130760138Depuy (Ireland) · PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED146 reports
- DELTA XTEND 130790030Depuy (Ireland) · PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED132 reports
- DJO SURGICAL 509-00-436Encore Medical, L.P. · Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented124 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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