DJO SURGICAL 510-00-012Recalls & reported problems
Encore Medical, L.P. · RSP, Primary Humeral Monoblock, 12mm x 108 · Class 2 · Implant
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 17
- Deaths reported
- 0
- Injuries reported
- 17
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 17 adverse event reports that list this exact device (DI 00888912024839), received between Mar 24, 2016 and Mar 27, 2025 — classified as 17 injuries.
The most frequently reported specific device problem is “Loosening of Implant Not Related to Bone-Ingrowth” (4 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
- Adverse Event Without Identified Device or Use Problem5
- Loosening of Implant Not Related to Bone-Ingrowth4
- Loose or Intermittent Connection2
- Unstable2
- Appropriate Device Problem Term/Code Not Available1
- Break1
- Device Contamination With Biological Material1
- Device Dislodged or Dislocated1
Patient problems
- Joint Laxity5
- No Code Available3
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available2
- Failure of Implant2
- Bone Fracture(s)1
- Fall1
- Implant Pain1
- No Information1
Recent adverse event reports
The 17 most recent of 17 reports, in the reporter's own words as published by the FDA.
InjuryMar 27, 2025Unstable; Adverse Event Without Identified Device or Use Problem; Unstable; Adverse Event Without Identified Device or Use Problem
InjuryJul 12, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
REVISION SURGERY - DUE TO PAIN AND LOOSENING.
Patient problems: Implant Pain; Joint Laxity
MAUDE report 17312892 ↗InjuryApr 4, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryOct 31, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryJun 27, 2022Loosening of Implant Not Related to Bone-Ingrowth
REVISION SURGERY - DUE TO LOOSENING OF HUMERAL STEM.
Patient problems: Joint Laxity
MAUDE report 14837104 ↗InjurySep 15, 2021Unstable
REVISION SURGERY - PATIENT WAS UNSTABLE, REQUIRING A NEW STEM, INSERT & GLENOID HEAD.
Patient problems: Failure of Implant
MAUDE report 12475383 ↗InjuryJun 15, 2021Break
REVISION SURGERY - PATIENT BROKE THEIR HUMERUS. REMOVED AND EXCHANGED OUT THE STEM, HEAD AND INSERT. ADDED A SPACER.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 12005569 ↗InjuryApr 23, 2021Loosening of Implant Not Related to Bone-Ingrowth
REVISION SURGERY - PAINFUL SHOULDER. SUSPECTED LOOSE STEM. IMPINGEMENT ON ACROMION.
Patient problems: Pain
MAUDE report 11716482 ↗InjuryNov 20, 2020Adverse Event Without Identified Device or Use Problem
SECOND REVISION SURGERY - THE REASON IS UNKNOWN.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 10875576 ↗InjuryJul 6, 2020Loosening of Implant Not Related to Bone-Ingrowth
REVISION SURGERY - LOOSE STEM. STAGE WASH OUT TO REVERSE.
Patient problems: No Code Available
MAUDE report 10234330 ↗InjuryApr 15, 2020Appropriate Device Problem Term/Code Not Available; Loosening of Implant Not Related to Bone-Ingrowth
InjuryJan 10, 2018Device Operates Differently Than Expected
REVISION SURGERY - DUE TO THE PATIENT HAVING A PERIPROSTHETIC FRACTURE. THE STEM, SPACER, AND INSERT WERE REMOVED. THE DJO PARTS WERE WELL FIXED AND DID NOT FAIL. THE PATIENT REQUIRED A LONG STEM TO BYPASS THE FRACTURE SITE.
Patient problems: Bone Fracture(s)
MAUDE report 7178617 ↗InjuryMay 12, 2017Loose or Intermittent Connection
REVISION SURGERY - DUE TO THE HUMERAL STEM BEING LOOSE.
Patient problems: Failure of Implant
MAUDE report 6564687 ↗InjuryFeb 10, 2017Device Contamination With Biological Material
REVISION SURGERY - DUE TO THE PATIENT HAVING AN INFECTION; THE SURGEON REMOVED ALL OF THE IMPLANTS AND INSERTED AN ANTIBIOTIC SPACER.
Patient problems: Unspecified Infection
MAUDE report 6322480 ↗InjuryJan 13, 2017Fracture
REVISION SURGERY - A PERI-PROSTHETIC FRACTURE; REPORTED THAT THE PATIENT FELL.
Patient problems: Fall
MAUDE report 6249563 ↗InjuryJan 7, 2017Loose or Intermittent Connection
REVISION SURGERY - DUE TO THE STEM BECOMING LOOSE.
Patient problems: No Code Available
MAUDE report 6231846 ↗InjuryMar 24, 2016Device Dislodged or Dislocated
REVISION SURGERY - DUE TO THE PATIENT HAVING CONSTANT DISLOCATION PROBLEMS.
Patient problems: No Code Available
MAUDE report 5522023 ↗
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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