DJO SURGICAL 510-00-007Recalls & reported problems
Encore Medical, L.P. · RSP, Primary Humeral Monoblock, 7mm x 108 · Class 2 · Implant
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 7
- Deaths reported
- 0
- Injuries reported
- 7
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00888912024808), received between Apr 24, 2017 and Mar 24, 2026 — classified as 7 injuries.
The most frequently reported specific device problem is “Fracture” (1 report).
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 Available4
- Adverse Event Without Identified Device or Use Problem2
- Fracture1
- Loose or Intermittent Connection1
- Patient-Device Incompatibility1
Patient problems
- Insufficient Information3
- Unspecified Infection3
- Bone Fracture(s)1
- Pain1
Recent adverse event reports
The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.
InjuryMar 24, 2026Adverse Event Without Identified Device or Use Problem
FULL REMOVAL DUE TO INFECTION. 78 YR OLD FEMALE.
Patient problems: Unspecified Infection
MAUDE report 24678326 ↗InjuryJun 27, 2022Fracture; Appropriate Device Problem Term/Code Not Available
InjuryMay 20, 2022Loose or Intermittent Connection; Appropriate Device Problem Term/Code Not Available
REVISION SURGERY - DUE TO LOOSENING.
Patient problems: Insufficient Information
MAUDE report 14458807 ↗InjuryApr 18, 2022Appropriate Device Problem Term/Code Not Available
REVISION SURGERY - DUE TO UNKNOWN REASON.
Patient problems: Insufficient Information
MAUDE report 14137580 ↗InjuryAug 23, 2021Appropriate Device Problem Term/Code Not Available
REVISION SURGERY - DUE TO PATIENT HAD A MONOBLOCK STEM, NEUTRAL POLY INSERT, 32-4 GLENOSPHERE, BASEPLATE AND 4 5.0MM LOCKING BONE SCREWS. THIS PATIENT HAD A SEVERE FRACTURE OF THE GLENOID WITH SUSPECTED INFECTION. THE BASEPLATE, SCREWS, GLENOSPHERE, AND PLOY LINER WERE REMOVED. A RSP MONOBLOCK HEMI ADAPTER WAS IMPLANTED WITH A 46X24 TURON HEAD AFTER AN EXTENSIVE WASH OUT.
Patient problems: Bone Fracture(s); Unspecified Infection
MAUDE report 12356070 ↗InjuryMay 30, 2018Adverse Event Without Identified Device or Use Problem
REVISION SURGERY - DUE TO AN INFECTION.
Patient problems: Unspecified Infection
MAUDE report 7554280 ↗InjuryApr 24, 2017Patient-Device Incompatibility
REVISION SURGERY - THE SURGEON REMOVED THE RIGHT SHOULDER'S ORIGINAL SURGERY IMPLANTS DUE TO A PAINFUL PROSTHESIS AND TO RULEOUT AN INFECTION.
Patient problems: Pain
MAUDE report 6516566 ↗
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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