DJO SURGICAL 508-00-436Recalls & reported problems
Encore Medical, L.P. · RSP HUM SOCKET INSERT, 36MM +4MM, STANDARD · Class 2 · Implant
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 23
- Deaths reported
- 0
- Injuries reported
- 23
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 23 adverse event reports that list this exact device (DI 00888912024686), received between Apr 5, 2016 and Sep 28, 2026 — classified as 23 injuries.
The most frequently reported specific device problem is “Device Dislodged or Dislocated” (2 reports).
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
Most reported problems
Device problems
- Appropriate Device Problem Term/Code Not Available8
- Adverse Event Without Identified Device or Use Problem6
- Device Dislodged or Dislocated2
- Insufficient Device Problem Information2
- Unstable2
- Device Slipped1
- Fracture1
- Material Disintegration1
Patient problems
- Unspecified Infection11
- No Known Impact Or Consequence To Patient4
- Joint Dislocation3
- Pain2
- Fall1
- Joint Laxity1
- Medical device site infection1
- No Code Available1
Recent adverse event reports
The 23 most recent of 23 reports, in the reporter's own words as published by the FDA.
InjurySep 28, 2026Unstable
Patient problems: Joint Laxity
MAUDE report 50926078 ↗InjuryMay 8, 2024No Apparent Adverse Event; No Apparent Adverse Event
InjuryApr 21, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryNov 23, 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 15853770 ↗InjuryMar 24, 2022Appropriate Device Problem Term/Code Not Available
InjuryFeb 18, 2021Adverse Event Without Identified Device or Use Problem
SECOND REVISION SURGERY - PATIENT HAD PAIN. SURGEON WENT IN TO POP LINER OUT AND EXCHANGE WITH SPACER AND NEW LINER.
Patient problems: Pain
MAUDE report 11342720 ↗InjuryOct 1, 2020Adverse Event Without Identified Device or Use Problem
InjuryJul 15, 2020Appropriate Device Problem Term/Code Not Available
InjuryJul 14, 2020Unstable
InjuryMar 20, 2020Appropriate Device Problem Term/Code Not Available
REVISION SURGERY - PATIENT PRESENTED TO SURGEON WITH PAIN IN THE LEFT SHOULDER. UPON FURTHER TESTS AND WORK-UPS, IT WAS PROBABILITY THE PATIENT'S LEFT SHOULDER WAS INFECTED. THEN SURGEON EXTRACTED THE ABOVE NOTATED IMPLANTS IN A SURGICAL PROCEDURE AT THE UNIVERSITY OF COLORADO HOSPITAL.
Patient problems: Pain; Unspecified Infection
MAUDE report 9860733 ↗InjuryMar 5, 2020Device Dislodged or Dislocated; Appropriate Device Problem Term/Code Not Available
REVISION SURGERY - DISLOCATION. APPARENTLY WAS CAUSED BY AN INCORRECT POST-OPERATIVE PATIENT'S MANAGEMENT.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 9794002 ↗InjuryJan 7, 2020Appropriate Device Problem Term/Code Not Available
InjuryJul 9, 2019Appropriate Device Problem Term/Code Not Available
REVISION SURGERY - UNSTABLE SHOULDER.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8773862 ↗InjuryApr 23, 2019Adverse Event Without Identified Device or Use Problem
REVISION SURGERY - DUE TO AN INFECTION.
Patient problems: Unspecified Infection
MAUDE report 8541583 ↗InjuryFeb 27, 2019Device Dislodged or Dislocated
REVISION SURGERY; DUE TO THE PATIENT HAVING DISLOCATED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8376167 ↗InjuryMar 29, 2018Insufficient Device Problem Information
InjuryJan 26, 2018Insufficient Device Problem Information
REVISION SURGERY - DUE TO THE PATIENT HAVING AN INFECTION. THE SURGEON PERFORMED A LINER EXCHANGE IN CONJUNCTION WITH THE WASHOUT.
Patient problems: Unspecified Infection
MAUDE report 7222329 ↗InjuryDec 4, 2017Material Disintegration
REVISION SURGERY - DUE TO GLENOSPHERE DISASSOCIATION.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7080610 ↗InjuryJul 6, 2017Adverse Event Without Identified Device or Use Problem
REVISION SURGERY - DUE TO THE PATIENT HAVING AN INFECTION.
Patient problems: Unspecified Infection
MAUDE report 6691821 ↗InjuryJan 5, 2017Fracture
REVISION SURGERY - DUE TO THE PATIENT FALLING AND FRACTURING THE HUMERUS BELOW THE STEM.
Patient problems: Fall
MAUDE report 6227364 ↗InjuryOct 7, 2016Appropriate Device Problem Term/Code Not Available
REVISION SURGERY - DUE TO THE WASHOUT AND REPLACEMENT OF THE LINER INSERT FOR A POSSIBLE INFECTION.
Patient problems: Unspecified Infection
MAUDE report 6011618 ↗InjuryOct 1, 2016Device Slipped
REVISION SURGERY - DUE TO DISLOCATION AND THE STEM BEING LOOSE.
Patient problems: Joint Dislocation
MAUDE report 5992734 ↗InjuryApr 5, 2016Appropriate Device Problem Term/Code Not Available
REVISION SURGERY - DUE TO DISLOCATION; SUSPECTED PATIENT NON-COMPLIANCE.
Patient problems: Joint Dislocation
MAUDE report 5547758 ↗
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
- 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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