DJO SURGICAL 509-00-040Recalls & reported problems
Encore Medical, L.P. · RSP STANDARD HUMERAL SOCKET INSERT, 40MM, HXe-plus · Class 2 · Implant
Data updated Oct 18, 2026 from official FDA records · Editorial policy
Quick summary
This DJO Surgical shoulder prosthesis component is used in reverse total shoulder replacement surgery. The 36 reports mostly describe infection at the surgical site and the shoulder joint dislocating or feeling unstable, with several patients needing revision surgery to remove or swap the implant;36 injuries and no deaths were reported. No recalls name this device.
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
- 37
- Deaths reported
- 0
- Injuries reported
- 37
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 37 adverse event reports that list this exact device (DI 00888912144551), received between Jan 25, 2017 and Sep 14, 2026 — classified as 37 injuries.
The most frequently reported specific device problem is “Unstable” (5 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 Problem23
- Appropriate Device Problem Term/Code Not Available5
- Unstable5
- Insufficient Device Problem Information2
- Device Dislodged or Dislocated1
- Fracture1
- Inadequacy of Device Shape and/or Size1
- No Apparent Adverse Event1
Patient problems
- Unspecified Infection16
- Joint Dislocation10
- Joint Laxity6
- Medical device site infection3
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available1
- Bacterial Infection1
- Bone Fracture(s)1
- Fall1
Recent adverse event reports
The 25 most recent of 37 reports, in the reporter's own words as published by the FDA.
InjurySep 14, 2026Unstable
Patient problems: Joint Laxity
MAUDE report 50765490 ↗InjuryJan 19, 2026Adverse Event Without Identified Device or Use Problem
InjuryDec 10, 2025Unstable; Unstable
PATIENT UNSTABLE SHOULDER. REMOVED 40 IMPLANTED 55.
Patient problems: Joint Laxity
MAUDE report 23774436 ↗InjuryDec 2, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryNov 6, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryOct 27, 2025Inadequacy of Device Shape and/or Size; Unstable; Inadequacy of Device Shape and/or Size; Unstable
THE PATIENT PRESENTED APPROXIMATELY FOUR (4) YEARS POSTOPERATIVELY FROM A REVERSE TOTAL SHOULDER ARTHROPLASTY WITH COMPLAINTS OF INSTABILITY. THE SURGEON ELECTED TO REVISE THE IMPLANT TO A LARGER GLENOSPHERE. DURING THE PROCEDURE, THE EXISTING GLENOSPHERE AND INSERT WERE REMOVED AND REPLACED.
Patient problems: Joint Dislocation
MAUDE report 23399419 ↗InjuryMay 30, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryMay 19, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryOct 8, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryJul 16, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryJul 3, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryMay 18, 2024No Apparent Adverse Event; No Apparent Adverse Event
InjuryJan 11, 2024Adverse 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
InjuryJul 26, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryJul 24, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryMay 25, 2023Unstable; Adverse Event Without Identified Device or Use Problem; Unstable; Adverse Event Without Identified Device or Use Problem
InjuryFeb 15, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
REVISION SURGERY - DUE TO DISCOMFORT AND POSSIBLE INFECTION.
Patient problems: Implant Pain; Unspecified Infection
MAUDE report 16382988 ↗InjuryDec 20, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
REVISION SURGERY - THE PATIENT'S JOINT WAS DISLOCATED AND UNSTABLE.
Patient problems: Joint Dislocation; Joint Laxity
MAUDE report 16015390 ↗InjuryDec 2, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
REVISION SURGERY - THE PATIENT DISLOCATED AND HAS A CHRONIC RISK OF DISLOCATION DUE TO A PRE-EXISTING CONDITION (CHARCOT).
Patient problems: Joint Dislocation
MAUDE report 15908432 ↗InjuryNov 17, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryNov 14, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
REVISION SURGERY - DUE TO AN INFECTION AND DISLOCATION.
Patient problems: Joint Dislocation; Medical device site infection
MAUDE report 15794422 ↗InjuryOct 28, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
REVISION SURGERY - BASEPLATE WAS NOT DJO, BECAME LOOSE SURGEON DECIDED TO CHANGE IT.
Patient problems: Joint Laxity
MAUDE report 15693570 ↗InjuryOct 24, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
REVISION SURGERY - DUE TO AN INFECTION.
Patient problems: Medical device site infection
MAUDE report 15663133 ↗InjurySep 6, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
REVISION SURGERY - DUE TO AN INFECTION AND INSTABILITY.
Patient problems: Joint Laxity; Medical device site infection
MAUDE report 15365152 ↗
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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