DJO SURGICAL 508-01-436Recalls & reported problems
Encore Medical, L.P. · RSP HUM SOCKET INSERT, 36MM +4MM, SEMI · Class 2 · Implant
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 10
- Deaths reported
- 0
- Injuries reported
- 10
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 00888912144292), received between Sep 16, 2015 and Apr 14, 2024 — classified as 10 injuries.
The most frequently reported specific device problem is “Device Dislodged or Dislocated” (2 reports).
5 other recalls cover devices cleared under the same FDA submission (K051075); 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 Problem4
- Appropriate Device Problem Term/Code Not Available4
- Device Dislodged or Dislocated2
- Material Integrity Problem1
Patient problems
- Unspecified Infection3
- Insufficient Information2
- Joint Dislocation2
- Pain2
- No Clinical Signs, Symptoms or Conditions1
- No Code Available1
- Scar Tissue1
- Sepsis1
Recent adverse event reports
The 10 most recent of 10 reports, in the reporter's own words as published by the FDA.
InjuryApr 14, 2024Material Integrity Problem; Adverse Event Without Identified Device or Use Problem; Material Integrity Problem; Adverse Event Without Identified Device or Use Problem
COMPLAINT - DUE TO AN EXPIRED IMPLANT WAS IMPLANTED INTO A PATIENT.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 19103054 ↗InjuryApr 2, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryFeb 27, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
REVISION SURGERY - DUE TO PATIENT WAS LAX IN THEIR JOINT SO WE STACKED A SPACER AND NEW POLY TO TIGHTEN THEM UP. 67 YR OLD MALE.
Patient problems: Insufficient Information
MAUDE report 18794350 ↗InjuryFeb 24, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryJul 18, 2022Appropriate Device Problem Term/Code Not Available
REVISION SURGERY - PATIENT WAS HAVING ANTERIOR SHOULDER PAIN. SURGEON WENT IN AND CLEANED UP THE SCAR TISSUE AND DID SOFT TISSUE RELEASES. NEW, BUT IDENTICAL COMPONENTS WERE PUT BACK IN.
Patient problems: Pain; Scar Tissue
MAUDE report 15048406 ↗InjuryApr 11, 2022Appropriate Device Problem Term/Code Not Available
REVISION SURGERY: PATIENT WAS SEPTIC AND HAD INFECTION, EVERYTHING HAD BEEN REMOVED.
Patient problems: Sepsis; Unspecified Infection
MAUDE report 14074325 ↗InjuryFeb 17, 2022Appropriate Device Problem Term/Code Not Available
InjuryApr 5, 2016Appropriate Device Problem Term/Code Not Available
REVISION SURGERY - THE PATIENT HAD FRACTURED HIS HUMERUS AND THE SURGEON IMPLANTED A REVERSE SHOULDER. SEVERAL WEEKS AFTER THE SURGERY THE PATIENT UNKNOWINGLY DISLOCATED HIS SHOULDER. THE SURGEON DECIDED TO REVISE THE REVERSE SHOULDER WITH A HEMI. THE SURGEON BELIEVES THERE WAS NOTHING WRONG WITH THE PRODUCT, BUT MAY BE ISSUES WITH PATIENT COMPLIANCE OR HE SHOULD HAVE PUT IN A 44MM VS. A 36MM GLENOID HEAD.
Patient problems: Joint Dislocation
MAUDE report 5548525 ↗InjuryMar 9, 2016Device Dislodged or Dislocated
SECOND REVISION SURGERY - DUE TO EXCESS BONE LEFT IN THE PATIENT; IT WAS CAUSING IMPINGEMENT/DISLOCATION; NO COMPONENT FAILURE PRESENT.
Patient problems: No Code Available
MAUDE report 5489738 ↗InjurySep 16, 2015Device Dislodged or Dislocated
SECOND REVISION SURGERY - DUE TO DISLOCATION. THE ORIGINAL DTICKET COULD NOT BE RETRIEVED. (B)(4).
Patient problems: Joint Dislocation
MAUDE report 5080800 ↗
Recalls under the same FDA submission
These recalls involve devices cleared under K051075. One submission often covers many models, so check the product and lot details in each record.
- Z-1460-2026 · Jan 15, 2026 · Open, ClassifiedBrand Name: Reverse Shoulder Prosthesis (RSP) Product Name: RSP STANDARD HUMERAL SOCKET INSERT, 36MM, HXe-plus Model/Catalog Number: 509-00-036
- Z-0625-2024 · Oct 5, 2023 · CompletedReverse Shoulder System e+, REF 509-01-032, RSP Humeral Socket Insert, Sz. 32mm, Semi-Constrained, Sterile H2o2, CE 2797
- Z-0282-2024 · Sep 25, 2023 · Open, ClassifiedRSP Humeral Socket Insert Size 36mm Semi-Constrained +4 mm, REF: 509-01-436, orthopedic shoulder implant component.
- Z-2606-2023 · Aug 4, 2023 · Open, ClassifiedDJO Surgical: Reverse Shoulder System (RSP) Semi Humeral Socket Insert, 32mm, REF: 508-01-032; Baseplate, Glenoid HA-Coat, RSP, 6.5mm X 30mm, REF: 508-32-104; Reverse Shoulder Syst
- Z-2739-2011 · Apr 18, 2011 · TerminatedReverse Shoulder Prosthesis System RSP Humeral Socket Shell DJO 9800 Metric Blvd. Austin, TX 78758 STERILE R Model numbers: 508-00-000 and 508-00-008. The Reverse Shoulder Prost
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.
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