DJO SURGICAL 509-00-440Recalls & reported problems
Encore Medical, L.P. · RSP HUMERAL SOCKET INSERT, 40MM +4MM, STANDARD 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.
- Adverse event reports
- 17
- Deaths reported
- 0
- Injuries reported
- 17
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 17 adverse event reports that list this exact device (DI 00888912144599), received between Mar 13, 2019 and Sep 15, 2026 — classified as 17 injuries.
The most frequently reported specific device problem is “Unstable” (8 reports).
1 FDA recall record name this device's identifier, 1 still open.
1 other recall cover devices cleared under the same FDA submission (K100741); 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
- Aug 7, 2020Class IIOpen, Classified
Product may be mislabeled with the size etched onto products differing from the size information shown on patient sticker labels. Risks associated with this issue may include the Surgeon implanting the incorrect size; significant physical impairment, discomfort and/or disruption of treatment of underlying condition; and the patient experiencing dislocation resulting in revision surgery.
Z-3022-2020 · Root cause: Other · Recall details · FDA record ↗
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem9
- Unstable8
- Appropriate Device Problem Term/Code Not Available4
- No Apparent Adverse Event1
Patient problems
- Joint Laxity8
- Unspecified Infection6
- Discharge1
- Medical device site infection1
- Pain1
Recent adverse event reports
The 17 most recent of 17 reports, in the reporter's own words as published by the FDA.
InjurySep 15, 2026Unstable
InjuryMay 26, 2026Unstable
InjuryFeb 10, 2026Unstable
InjuryJun 20, 2025Unstable; Adverse Event Without Identified Device or Use Problem; Unstable; Adverse Event Without Identified Device or Use Problem
InjuryJun 20, 2025Unstable; Adverse Event Without Identified Device or Use Problem; Unstable; Adverse Event Without Identified Device or Use Problem
InjuryOct 10, 2024Unstable; Adverse Event Without Identified Device or Use Problem; Unstable; Adverse Event Without Identified Device or Use Problem
InjuryApr 24, 2024No Apparent Adverse Event; No Apparent Adverse Event
InjuryMar 1, 2024Unstable; Adverse Event Without Identified Device or Use Problem; Unstable; Adverse Event Without Identified Device or Use Problem
InjuryNov 30, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
REVISION SURGERY - PATIENT WAS UNSTABLE AND THE SURGEON CHOSE TO UPSIZE THE POLY AND USE A SPACER.
Patient problems: Joint Laxity
MAUDE report 18237177 ↗InjuryJun 12, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryNov 29, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
REVISION SURGERY - PATIENT HAD SUSPECTED MILD INFECTION. A WASHOUT WAS DONE AND POLY AND GLENOSPHERE WERE EXCHANGED.
Patient problems: Medical device site infection
MAUDE report 15880046 ↗InjurySep 9, 2021Appropriate Device Problem Term/Code Not Available
InjuryJun 2, 2021Unstable; Appropriate Device Problem Term/Code Not Available
REVISION SURGERY - PATIENT WAS UNSTABLE AND HAD PAIN. NEEDED A NEW GLENOSPHERE AND POLY.
Patient problems: Pain
MAUDE report 11919112 ↗InjuryMay 6, 2020Adverse Event Without Identified Device or Use Problem
REVISION SURGERY - DUE TO PATIENT HAD INFECTION. REMOVED ALL ORIGINAL IMPLANTS. PLACED ANTIBIOTIC SPACERS FOR THE TIME BEING.
Patient problems: Unspecified Infection
MAUDE report 10030779 ↗InjuryNov 2, 2019Appropriate Device Problem Term/Code Not Available
REVISION SURGERY - PATIENT CONTINUED TO HAVE DRAINAGE FROM SURGERY SITE FOR DAYS FOLLOWING SURGERY. SURGEON DECIDED TO BRING THE PATIENT BACK IN AND DO A WASH OUT WITH A HEAD AND LINER SWAP.
Patient problems: Discharge
MAUDE report 9269880 ↗InjuryAug 1, 2019Appropriate Device Problem Term/Code Not Available
REVISION SURGERY - PATIENT PRESENTED WITH SYMPTOMS OF POSSIBLE INFECTION OF RIGHT REVERSE TOTAL SHOULDER 31/2 YEARS POST OPERATION. SURGEON OPTED TO REVISE WITH REMOVAL AND REPLACEMENT OF ALL COMPONENTS EXCEPT BASEPLATE AND SCREWS.
Patient problems: Unspecified Infection
MAUDE report 8852902 ↗InjuryMar 13, 2019Adverse Event Without Identified Device or Use Problem
REVISION SURGERY - DUE TO THE PATIENT BECOMING INFECTED. ALL IMPLANTS WERE REMOVED AND A CEMENT SPACER WAS PLACED UNTIL INFECTION WAS RESOLVED. THE PATIENT WAS REIMPLANTED AS INTENDED.
Patient problems: Unspecified Infection
MAUDE report 8418181 ↗
Recalls under the same FDA submission
These recalls involve devices cleared under K100741. One submission often covers many models, so check the product and lot details in each record.
- Z-1458-2026 · Jan 15, 2026 · Open, ClassifiedBrand Name: Reverse Shoulder Prosthesis (RSP) Product Name: RSP HUMERAL SOCKET INSERT, 32MM +4MM, STANDARD HXe-plus Model/Catalog Number: 509-00-432
Other Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented devices
- DJO SURGICAL 508-32-204Encore Medical, L.P. · PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED1 recall544 reports
- Comprehensive Reverse Shoulder 010000589Biomet Orthopedics, LLC · PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED1 recall142 reports
- DELTA XTEND 130738203Depuy (Ireland) · PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED175 reports
- DJO SURGICAL 509-00-432Encore Medical, L.P. · Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented1 recall117 reports
- Alliance® SBGL3007Zimmer, Inc. · PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED162 reports
- DELTA XTEND 130760138Depuy (Ireland) · PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED146 reports
- DELTA XTEND 130790030Depuy (Ireland) · PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED132 reports
- DJO SURGICAL 509-00-436Encore Medical, L.P. · Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented124 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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