DJO SURGICAL 506-03-118Recalls & reported problems
Encore Medical, L.P. · SCREW, LOCKING BONE, RSP, 5X18 · Class 2 · Implant
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 3
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00888912024549), received between Nov 8, 2019 and Dec 6, 2024 — classified as 3 injuries.
The most frequently reported specific device problem is “Mechanical Problem” (1 report).
4 other recalls cover devices cleared under the same FDA submission (K041066); 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 Problem1
- Appropriate Device Problem Term/Code Not Available1
- Mechanical Problem1
Patient problems
- Failure of Implant1
- Pain1
- Unspecified Infection1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
InjuryDec 6, 2024Mechanical Problem; Mechanical Problem
REVISION SURGERY DUE TO THE BROKEN SCREW IN THE BASEPLATE AND BROKEN SCREW WAS LEFT IN PATIENT.
Patient problems: Failure of Implant
MAUDE report 20872785 ↗InjuryOct 1, 2021Adverse Event Without Identified Device or Use Problem
REVISION SURGERY - DUE TO INFECTION. EVERYTHING FROM ORIGINAL SURGERY WAS REMOVED MINUS THE BASE PLATE THAT STAYED IN.
Patient problems: Unspecified Infection
MAUDE report 12561838 ↗InjuryNov 8, 2019Appropriate Device Problem Term/Code Not Available
SECOND REVISION SURGERY - PATIENT HAD PAIN. SUPERIOR SCREW WAS HITTING A NERVE, SO IT NEEDED TO BE REMOVED.
Patient problems: Pain
MAUDE report 9295961 ↗
Recalls under the same FDA submission
These recalls involve devices cleared under K041066. One submission often covers many models, so check the product and lot details in each record.
- Z-0098-2024 · Aug 22, 2023 · Open, ClassifiedREVERSE PROSTHESIS SHOULDER SYSTEM, SCREW, LOCKING BONE, RSP, 5mmX30mm long, REF: 506-03-130
- Z-0184-2008 · Aug 8, 2007 · TerminatedEncore Reverse Shoulder Prosthesis (RSP) System, Standard Size 36 RSP Humeral Socket Insert; Catalog #: 508-00-036; Sterile; Manufactured by Encore, Medical, L.P., Austin, TX 7875
- Z-0185-2008 · Aug 8, 2007 · TerminatedEncore Reverse Shoulder Prosthesis (RSP) System, Standard Size 40 RSP Humeral Socket Insert; Catalog #: 508-00-040; Sterile; Manufactured by Encore, Medical, L.P., Austin, TX 7875
- Z-1566-05 · Jul 28, 2005 · TerminatedEncore Reverse Shoulder Prosthesis (RSP), manufactured and distributed by Encore Medical, L.P. 9800 Metric Blvd., Austin, Texas 78758
Other shoulder prosthesis, reverse configuration devices
- DJO SURGICAL 508-36-101Encore Medical, L.P. · shoulder prosthesis, reverse configuration508 reports
- DJO SURGICAL 508-32-101Encore Medical, L.P. · shoulder prosthesis, reverse configuration433 reports
- DJO SURGICAL 508-32-103Encore Medical, L.P. · shoulder prosthesis, reverse configuration421 reports
- DJO SURGICAL 509-00-036Encore Medical, L.P. · shoulder prosthesis, reverse configuration1 recall259 reports
- DJO SURGICAL 508-32-104Encore Medical, L.P. · shoulder prosthesis, reverse configuration1 recall203 reports
- DJO SURGICAL 509-00-032Encore Medical, L.P. · shoulder prosthesis, reverse configuration233 reports
- DELTA XTEND 130760000Depuy (Ireland) · shoulder prosthesis, reverse configuration223 reports
- DJO SURGICAL 508-00-032Encore Medical, L.P. · shoulder prosthesis, reverse configuration122 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