DJO SURGICAL 510-00-008Recalls & reported problems
Encore Medical, L.P. · RSP, Primary Humeral Monoblock, 8mm x 108 · Class 2 · Implant
Data updated Oct 18, 2026 from official FDA records · Editorial policy
Quick summary
This Encore Medical shoulder implant, a primary humeral monoblock used in shoulder replacement, appears in 29 adverse event reports, all describing injuries and no deaths. Most reports describe the stem loosening or breaking free of the cement, and bone fractures around the implant, often requiring revision surgery. 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
- 28
- Deaths reported
- 0
- Injuries reported
- 28
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 28 adverse event reports that list this exact device (DI 00888912024815), received between Sep 2, 2015 and Mar 4, 2025 — classified as 28 injuries.
The most frequently reported specific device problem is “Device Dislodged or Dislocated” (3 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 Problem11
- Appropriate Device Problem Term/Code Not Available8
- Device Dislodged or Dislocated3
- Fracture3
- Loose or Intermittent Connection3
- Break1
- Insufficient Device Problem Information1
- Loosening of Implant Not Related to Bone-Ingrowth1
Patient problems
- Bone Fracture(s)8
- Unspecified Infection5
- Joint Laxity4
- Fall3
- No Known Impact Or Consequence To Patient3
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available2
- No Code Available2
- Failure of Implant1
Recent adverse event reports
The 25 most recent of 28 reports, in the reporter's own words as published by the FDA.
InjuryMar 4, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryJun 8, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryApr 6, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryFeb 16, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjurySep 26, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryAug 4, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjurySep 28, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryNov 17, 2021Break; Loose or Intermittent Connection; Appropriate Device Problem Term/Code Not Available
REVISION SURGERY - DUE TO THE PATIENT FALL, STEM WAS LOOSE AND BASEPLATE BROKE.
Patient problems: Fall
MAUDE report 12832398 ↗InjuryAug 18, 2021Fracture
REVISION SURGERY - PATIENT FELL AND HAD PERI-PROSTHETIC FRACTURE.
Patient problems: Fall
MAUDE report 12338611 ↗InjuryApr 29, 2021Device Dislodged or Dislocated
THIRD REVISION SURGERY - DUE TO RECURRENT DISLOCATION.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 11744759 ↗InjuryMar 30, 2021Therapeutic or Diagnostic Output Failure; Loosening of Implant Not Related to Bone-Ingrowth
REVISION SURGERY - PATIENT HAD A DJO MONOBLOCK IMPLANTED. PATIENT HAD A LOOSE HUMERAL IMPLANT THAT WAS CEMENTED. SURGEON REMOVED THE OLD IMPLANT AND IMPLANTED A LONGER MONOBLOCK. PATIENT IS DOING FINE AND THE REVISION WAS NOT RELATED TO THE PRODUCT. THE REVISION WAS FROM A LOOSE STEM DUE TO CEMENT FAILURE.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 11590558 ↗InjuryNov 4, 2020Appropriate Device Problem Term/Code Not Available
SECOND REVISION SURGERY - DUE TO INFECTION.
Patient problems: Unspecified Infection
MAUDE report 10784317 ↗InjurySep 1, 2020Malposition of Device; Appropriate Device Problem Term/Code Not Available
REVISION SURGERY - DUE TO THE HUMERAL STEM WAS NEVER POSITIONED CORRECTLY IN CANAL OF HUMERUS. STEM WAS PLACED OUTSIDE OF CANAL AND WAS NOT DETECTED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 10479776 ↗InjuryApr 16, 2020Appropriate Device Problem Term/Code Not Available
REVISION SURGERY - THE PATIENT FELL AND HAD DISTAL FRACTURE.
Patient problems: Bone Fracture(s); Fall
MAUDE report 9968390 ↗InjuryOct 21, 2019Fracture; Appropriate Device Problem Term/Code Not Available
REVISION SURGERY - DUE TO PERIPROSTHETIC FRACTURE OF HUMERUS.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 9213772 ↗InjuryJul 18, 2019Appropriate Device Problem Term/Code Not Available
InjuryApr 18, 2019Appropriate Device Problem Term/Code Not Available
REVISION SURGERY - DUE TO THE ORIGINAL STEM SITTING SLIGHTLY PROUD AND IMPINGING. THE SURGEON REMOVED THE 8 MONOBLOCK AND DOWNSIZED TO A 6 SMALL SHELL.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8527454 ↗InjuryOct 4, 2018Device Dislodged or Dislocated
SECOND REVISION SURGERY - DUE TO A DISLOCATION.
Patient problems: Failure of Implant
MAUDE report 7935064 ↗InjuryMar 20, 2018Adverse Event Without Identified Device or Use Problem
REVISION SURGERY - DUE TO THE PATIENT HAVING A FRACTURE.
Patient problems: Bone Fracture(s)
MAUDE report 7355396 ↗InjuryJan 24, 2018Appropriate Device Problem Term/Code Not Available
REVISION SURGERY - DUE TO THE PATIENT SUFFERING A FRACTURE AND NEEDING A LONG STEM REVERSE.
Patient problems: Bone Fracture(s)
MAUDE report 7216729 ↗InjuryJan 4, 2018Device Dislodged or Dislocated
REVISION SURGERY - THE PATIENT KEPT DISLOCATING, SO THE SURGEON DID A REVISION.
Patient problems: Joint Dislocation; No Code Available
MAUDE report 7165891 ↗InjuryAug 31, 2017Loose or Intermittent Connection
REVISION SURGERY - DUE TO THE PATIENT'S MONOBLOCK STEM BEING LOOSE AND THE PATIENT FRACTURING HER HUMERUS. THE SURGEON TOOK THE REVERSE SHOULDER OUT AND IMPLANTED IN A LONG TURON STEM AND HUMERAL HEAD.
Patient problems: Bone Fracture(s)
MAUDE report 6835145 ↗InjuryJan 6, 2017Adverse Event Without Identified Device or Use Problem
REVISION SURGERY - DUE TO THE PATIENT HAVING A HUMERAL FRACTURE.
Patient problems: Bone Fracture(s)
MAUDE report 6230578 ↗InjuryDec 13, 2016Adverse Event Without Identified Device or Use Problem
REVISION SURGERY - DUE TO A SUPERFICIAL INFECTION; THE HUMERAL STEM, LINER AND GLENOSPHERE WERE REMOVED. THE SURGEON WASHED OUT THE WOUND AND REINSTALLED NEW COMPONENTS.
Patient problems: Unspecified Infection
MAUDE report 6171429 ↗InjurySep 22, 2016Fracture; Unstable
REVISION SURGERY - DUE TO THE PATIENT BEING REVISED FOR A FRACTURE WITH THE MONOBLOCK STEM. THE PATIENT HAD MILD PAIN AND INSTABILITY ISSUES WHEN SHE CAME INTO THE CLINIC. THE SURGEON SUSPECTED A LOW OR MILD INFECTION; HE REVISED THE PATIENT WITH A LONG ALTIVATE 220 STEM.
Patient problems: Pain; Unspecified Infection
MAUDE report 5971757 ↗
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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