DJO SURGICAL 509-00-036Recalls & reported problems
Encore Medical, L.P. · RSP STANDARD HUMERAL SOCKET INSERT, 36MM, HXe-plus · Class 2 · Implant
Data updated Oct 18, 2026 from official FDA records · Editorial policy
1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.
Quick summary
This DJO RSP shoulder socket insert is a part of a reverse shoulder replacement. Its 252 reports often describe infection, dislocation and instability, and several led to repeat surgery. The reports include 252 injuries and no deaths. There is 1 open recall, started in January 2026, over incorrect labels on some implant parts.
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
- 259
- Deaths reported
- 0
- Injuries reported
- 259
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 259 adverse event reports that list this exact device (DI 00888912144544), received between Mar 22, 2016 and Sep 28, 2026 — classified as 259 injuries.
The most frequently reported specific device problem is “Device Dislodged or Dislocated” (41 reports).
1 FDA recall record name this device's identifier, 1 still open.
4 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
Recalls naming this device
- Jan 15, 2026Class IIOpen, Classified
Knee and Humeral socket implants contain incorrect labeling.
Z-1460-2026 · Root cause: Process control · Recall details · FDA record ↗
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem145
- Appropriate Device Problem Term/Code Not Available48
- Device Dislodged or Dislocated41
- Unstable30
- Loosening of Implant Not Related to Bone-Ingrowth4
- Insufficient Device Problem Information3
- Loose or Intermittent Connection2
- Break1
Patient problems
- Unspecified Infection121
- Joint Dislocation51
- Joint Laxity30
- No Code Available18
- Insufficient Information13
- Pain12
- Failure of Implant6
- Implant Pain6
Recent adverse event reports
The 25 most recent of 259 reports, in the reporter's own words as published by the FDA.
InjurySep 28, 2026Device Dislodged or Dislocated
Patient problems: Unspecified Infection
MAUDE report 50926531 ↗InjurySep 24, 2026Device Dislodged or Dislocated
Patient problems: Unspecified Infection
MAUDE report 50891991 ↗InjurySep 23, 2026Unstable
Patient problems: Joint Laxity
MAUDE report 50862966 ↗InjurySep 16, 2026Unstable
Patient problems: Joint Laxity
MAUDE report 50796557 ↗InjurySep 11, 2026Device Dislodged or Dislocated
Patient problems: Unspecified Infection
MAUDE report 50744259 ↗InjurySep 2, 2026No Apparent Adverse Event
Revision surgery - Due to poly swap.
Patient problems: Insufficient Information
MAUDE report 50554779 ↗InjurySep 1, 2026Device Dislodged or Dislocated
Patient problems: Joint Dislocation
MAUDE report 50554108 ↗InjuryJul 29, 2026Adverse Event Without Identified Device or Use Problem
InjuryJun 22, 2026Adverse Event Without Identified Device or Use Problem
InjuryJun 22, 2026Device Dislodged or Dislocated
InjuryJun 17, 2026Unstable
InjuryJun 17, 2026Adverse Event Without Identified Device or Use Problem
InjuryJun 3, 2026Unstable
PATIENT HAD A REVERSE ON (B)(6) 2026. PATIENT WAS UNSTABLE A FEW MONTHS AFTER SURGERY. SURGEON CHANGED COMPONENTS TO A LARGER GLENOSPHERE WITH A SPACER AND SEMI POLY. PATIENT WAS STABLE AFTER REVISION.
Patient problems: Joint Laxity
MAUDE report 25385852 ↗InjuryJun 1, 2026Device Dislodged or Dislocated
InjuryJun 1, 2026Unstable
InjuryJun 1, 2026Adverse Event Without Identified Device or Use Problem
InjuryMay 26, 2026Device Dislodged or Dislocated
InjuryMay 21, 2026Adverse Event Without Identified Device or Use Problem
InjuryMay 18, 2026Adverse Event Without Identified Device or Use Problem
REVISION SURGERY, INFECTION LED TO THE NEED FOR INSTRUMENTS TO BE PULLED AND JOINT WASHED OUT. REIMPLANTED NEW IMPLANTS.
Patient problems: Unspecified Infection
MAUDE report 25211557 ↗InjuryMay 18, 2026Device Dislodged or Dislocated
InjuryMay 18, 2026Adverse Event Without Identified Device or Use Problem
REVISION SURGERY, PATIENT PRESENTED APPROXIMATELY FOUR WEEKS POST OP FOR REVERSE TOTAL SHOULDER WITH SYMPTOMS OF EARLY POSSIBLE INFECTION. SURGEON OPTED TO REVISE AFTER IRRIGATION AND DEBRIDEMENT. GLENOSPHERE AND INSERT WERE REMOVED AND REPLACED.
Patient problems: Unspecified Infection
MAUDE report 25211554 ↗InjuryMay 15, 2026Adverse Event Without Identified Device or Use Problem
REVISION SURGERY DUE TO IRRIGATION AND DEBRIDMENT. POSSIBLE INFECTION, SWAPPED SPHERE AND LINER.
Patient problems: Unspecified Infection
MAUDE report 25194226 ↗InjuryApr 29, 2026Adverse Event Without Identified Device or Use Problem
InjuryApr 23, 2026Unstable
InjuryApr 23, 2026Unstable; Device Dislodged or Dislocated
REVISION SURGERY - DUE TO THE PATIENT WAS UNSTABLE AND DISLOCATING.
Patient problems: Joint Dislocation; Joint Laxity
MAUDE report 24974721 ↗
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-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 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
- DJO SURGICAL 509-01-436Encore Medical, L.P. · shoulder prosthesis, reverse configuration1 recall62 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 · each recall links to the FDA recall notice
- 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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