DJO SURGICAL 508-00-044Recalls & reported problems
Encore Medical, L.P. · SOCKET, INSERT, 44MM, STD · Class 2 · Implant
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 4
- Deaths reported
- 0
- Injuries reported
- 4
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00888912024662), received between Dec 14, 2017 and Oct 19, 2025 — classified as 4 injuries.
The most frequently reported specific device problem is “Device Dislodged or Dislocated” (2 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 Dislocated2
- Appropriate Device Problem Term/Code Not Available1
- Loosening of Implant Not Related to Bone-Ingrowth1
- Naturally Worn1
- Unstable1
Patient problems
- Erosion1
- Joint Dislocation1
- No Code Available1
- No Known Impact Or Consequence To Patient1
- Unspecified Infection1
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
InjuryOct 19, 2025Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth
IT WAS REPORTED THAT THE PATIENT COMPLAINT OF FEELEING LOOSE. POLY ERODED.
Patient problems: Erosion; Joint Dislocation
MAUDE report 23333908 ↗InjuryFeb 14, 2020Appropriate Device Problem Term/Code Not Available
SECOND REVISION SURGERY - PATIENT HAD AN INFECTION. SURGEON REMOVED ALL PREVIOUS IMPLANTS AND REPLACED WITH NEW ONES.
Patient problems: Unspecified Infection
MAUDE report 9711386 ↗InjuryDec 4, 2018Device Dislodged or Dislocated; Naturally Worn
REVISION SURGERY - DUE TO A DISLOCATION DUE TO POLY WEAR ON INSERT COMPONENT. THE SURGEON REVISED WITH A SPACER, E+ POLY INSERT, AND 44 MILLIMETER HEAD.
Patient problems: No Code Available
MAUDE report 8129815 ↗InjuryDec 14, 2017Unstable; Device Dislodged or Dislocated
FOURTH REVISION SURGERY - DUE TO THE PATIENT HAVING DISLOCATED THE REVERSE TOTAL SHOULDER AND WAS UNSTABLE. THE SURGEON REPOSITIONED THE ALTIVATE REVERSE STEM AND IMPLANTED A +4 44 STANDARD HUMERAL LINER. HE USED COBALT BONE CEMENT TO IMPLANT THE STEM.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7118820 ↗
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.
How reports and recalls are matched · Editorial policy · Report an error on this page