DJO SURGICAL 508-01-036Recalls & reported problems
Encore Medical, L.P. · SOCKET, INSERT 36MM SEMI RSP HUMERAL · Class 2 · Implant
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 17
- Deaths reported
- 0
- Injuries reported
- 17
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 17 adverse event reports that list this exact device (DI 00888912024709), received between Sep 11, 2015 and Jun 11, 2026 — classified as 17 injuries.
The most frequently reported specific device problem is “Device Dislodged or Dislocated” (3 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 Dislocated3
- Unstable3
- Insufficient Device Problem Information2
- Loose or Intermittent Connection1
- Use of Device Problem1
Patient problems
- Unspecified Infection9
- No Code Available4
- Joint Dislocation2
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available1
- Failure of Implant1
- Insufficient Information1
- Loss of Range of Motion1
Recent adverse event reports
The 17 most recent of 17 reports, in the reporter's own words as published by the FDA.
InjuryJun 11, 2026Unstable
InjuryNov 15, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryOct 14, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryAug 9, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryApr 19, 2022Appropriate Device Problem Term/Code Not Available
REVISION SURGERY - DUE TO AN INFECTION.
Patient problems: Unspecified Infection
MAUDE report 14142802 ↗InjuryFeb 11, 2022Unstable
REVISION SURGERY: DUE TO INSTABILITY.
Patient problems: Insufficient Information
MAUDE report 13514938 ↗InjurySep 14, 2021Adverse Event Without Identified Device or Use Problem
REVISION SURGERY - PATIENT HAD TORN SUBSCAPULARIS DUE TO BE HYPER EXTENDED DURING PHYSICAL THERAPY.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 12469428 ↗InjuryJul 27, 2020Appropriate Device Problem Term/Code Not Available
REVISION SURGERY - DUE TO INFECTION, WASH OUT AND POLY SWAP.
Patient problems: Unspecified Infection
MAUDE report 10326032 ↗InjuryJun 9, 2020Unstable
InjuryJan 8, 2020Appropriate Device Problem Term/Code Not Available
InjurySep 26, 2019Appropriate Device Problem Term/Code Not Available
REVISION SURGERY - THE SURGEON JUST REPLACED THE LINER. PATIENT HAD SOME SOFT TISSUE THAT WAS IMPEDING THE RANGE OF MOTION OF THE PATIENT, SO THEY CLEARED THAT UP AND REPLACED THE LINER. PATIENT IS DOING GREAT AND THERE WAS NO PROBLEM WITH THE DJO IMPLANTS.
Patient problems: Loss of Range of Motion
MAUDE report 9124147 ↗InjuryJul 5, 2019Loose or Intermittent Connection
REVISION SURGERY - LOOSENING & INFECTION.
Patient problems: Failure of Implant; Unspecified Infection
MAUDE report 8765285 ↗InjuryJul 20, 2018Use of Device Problem; Device Dislodged or Dislocated
REVISION SURGERY - DUE TO A DISLOCATION. THE PATIENT PUSHED HIMSELF UP AND DISLOCATED HIS SHOULDER.
Patient problems: Joint Dislocation; No Code Available
MAUDE report 7707754 ↗InjuryJan 4, 2018Insufficient Device Problem Information
SECOND REVISION SURGERY - DUE TO THE PATIENT BEING INFECTED. ALL HARDWARE WAS REMOVED. A NEW STEM WAS OPENED BUT WENT IN AND OUT. PATIENT CURRENTLY HAS NO DJO IMPLANTS IN THE SHOULDER.
Patient problems: Unspecified Infection
MAUDE report 7164379 ↗InjuryJan 20, 2016Insufficient Device Problem Information
REVISION SURGERY - DUE TO THE PATIENT HAVING AN INFECTION; AND NEEDING A POLY AND GLENOSPHERE SWAP.
Patient problems: Unspecified Infection
MAUDE report 5381620 ↗InjurySep 11, 2015Device Dislodged or Dislocated
REVISION SURGERY - DUE TO THE PATIENT'S SHOULDER DISLOCATING.
Patient problems: No Code Available
MAUDE report 5071637 ↗InjurySep 11, 2015Device Dislodged or Dislocated
REVISION SURGERY - DUE TO THE PATIENT'S SHOULDER DISLOCATING.
Patient problems: No Code Available
MAUDE report 5071117 ↗
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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