DJO SURGICAL 508-40-101Recalls & reported problems
Encore Medical, L.P. · GLENOID, HEAD W/RETAINING SCREW, RSP, 40MM, NEUTRAL · Class 2 · Implant
Quick summary
This DJO reverse shoulder glenoid component has 110 adverse event reports, with no deaths and 110 injuries. Many reports describe the shoulder joint dislocating or the implant part coming loose, many patients needed revision surgery, and some describe fractures. Reports fell to 6 in the last 12 months from 15 in the 12 months before. 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
- 111
- Deaths reported
- 0
- Injuries reported
- 111
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 111 adverse event reports that list this exact device (DI 00888912144490), received between Mar 3, 2016 and Sep 16, 2026 — classified as 111 injuries.
The most frequently reported specific device problem is “Device Dislodged or Dislocated” (32 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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem51
- Device Dislodged or Dislocated32
- Appropriate Device Problem Term/Code Not Available16
- Unstable14
- Fracture3
- Naturally Worn2
- Patient Device Interaction Problem2
- Contamination1
Patient problems
- Joint Dislocation46
- No Code Available19
- Joint Laxity12
- Insufficient Information10
- Failure of Implant9
- Unspecified Infection8
- No Known Impact Or Consequence To Patient5
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available3
Recent adverse event reports
The 25 most recent of 111 reports, in the reporter's own words as published by the FDA.
InjurySep 16, 2026Unstable
Patient problems: Joint Laxity
MAUDE report 50796563 ↗InjuryJul 7, 2026Adverse Event Without Identified Device or Use Problem
InjuryApr 22, 2026Patient Device Interaction Problem
REVISION SURGERY - DUE TO PAINFUL RIGHT SHOULDER, FAILED ARTHROPLASTY.
Patient problems: Implant Pain
MAUDE report 24961034 ↗InjuryMar 21, 2026Patient Device Interaction Problem
REVISION SURGERY - GLENOID HEAD CAME OFF.
Patient problems: Failure of Implant
MAUDE report 24657092 ↗InjuryFeb 6, 2026Fracture
REVISION SURGERY - DUE TO GLENOID FRACTURE.
Patient problems: Bone Fracture(s)
MAUDE report 24285048 ↗InjuryNov 26, 2025Device Dislodged or Dislocated; Adverse Event Without Identified Device or Use Problem; Device Dislodged or Dislocated; Adverse Event Without Identified Device or Use Problem
InjuryNov 10, 2025Unstable; Unstable
IT WAS REPORTED THAT PATIENT FELL AND REQUIRED REVISION SURGERY TO TREAT JOINT INSTABILITY.
Patient problems: Fall; Joint Dislocation; Joint Laxity
MAUDE report 23519022 ↗InjuryAug 25, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
REVISION SURGERY - DUE TO MALUNION IN ADDITION TO A NONUNION OF THEGREATER TUBEROSITY.
Patient problems: Insufficient Information
MAUDE report 22891778 ↗InjuryAug 21, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryJul 1, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryMay 28, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
REVISION SURGERY - DOCTOR INCREASED 40N TO 50 +4. PATIENT HAS 2B STEM IN , REASON UNKNOWN.
Patient problems: Insufficient Information
MAUDE report 22102178 ↗InjuryApr 28, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryMar 17, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
REVISION SURGERY - DUE TO INSTABILITY AND DISLOCATION.
Patient problems: Joint Dislocation; Joint Laxity
MAUDE report 21627622 ↗InjuryMar 4, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
REVISION SURGERY: DUE TO IMPLANT DISSOCIATION.
Patient problems: Joint Dislocation; Joint Laxity
MAUDE report 21521221 ↗InjuryFeb 7, 2025Mechanical Problem; Detachment of Device or Device Component; Mechanical Problem; Detachment of Device or Device Component
COMPLAINT - THE GLENOID SET SCREW BROKE OFF AT THE THREADING WHEN BEING IMPLANTED. SURGEON FELT THE TAPER OF THE GLENOPSPHERE WAS ENGAGED AND NOT IN JEOPARDY. SURGEON FELT REMOVING COMPONENTS TO REPLACE WOULD CAUSE MORE DAMAGE THAN LEAVING THE BROKEN SCREW.
Patient problems: Foreign Body In Patient; No Clinical Signs, Symptoms or Conditions
MAUDE report 21339781 ↗InjuryJan 29, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryJan 28, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
REVISION SURGERY: DUE TO INFECTION AND INSTABILITY.
Patient problems: Joint Laxity; Unspecified Infection
MAUDE report 21261096 ↗InjuryJan 20, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryJan 15, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
REVISION SURGERY - DUE TO THIS PATIENT HAS HAD A NUMBER OF SURGERIES, A 2-TIME APC REVISION WITH REVERSE. THIS TIME, THE POLY WAS DISASSOCIATED FROM THE STEM. THE SURGEON ATTRIBUTED THIS TO THE FORCES ON THE REVERSE STEM AND SPHERE. HE CHOSE TO ADD A SPACER, A BIGGER GLENOSPHERE, AND A SEMI-CONSTRAINED LINER TO HOPEFULLY PREVENT THIS IN THE FUTURE.
Patient problems: Joint Laxity
MAUDE report 21164336 ↗InjuryDec 10, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryDec 9, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
REVISION SURGERY: DUE TO UNKNOWN REVISION REASON.
Patient problems: Insufficient Information
MAUDE report 20888204 ↗InjuryNov 27, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryAug 22, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryAug 21, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
REVISION SURGERY - DUE TO PATIENT PRESENTED TO DR WITH PAIN, LOSS OF MOTION AND STRENGTH, FOLLOWING A REVISION REVERSE TOTAL SHOULDER. XRAYS CONFIRMED A DISASSOCIATION OF THE GLENOSPHERE FROM THE BASEPLATE. PATIENT AND DR AGREED A REVISION WAS MERITED. THE PROCEDURE CONFIRMED THE DISASSOCIATION AND A LOOSE HUMERAL STEM. EVERYTHING INVENTORIED ABOVE WAS REMOVED FROM THE PATIENT AND REPLACED BY IMPLANTS ON REVISION.
Patient problems: Joint Laxity
MAUDE report 20018530 ↗InjuryJul 17, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
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: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.