DJO SURGICAL 510-00-010Recalls & reported problems
Encore Medical, L.P. · RSP, Primary Humeral Monoblock, 10mm x 108 · Class 2 · Implant
Data updated Oct 18, 2026 from official FDA records · Editorial policy
Quick summary
This DJO Surgical RSP shoulder implant is used to replace part of the shoulder joint. The 26 reports that name its identifier describe loosening, instability and fractures that led to revision surgery, with no deaths and 26 injuries. 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
- 26
- Deaths reported
- 0
- Injuries reported
- 26
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 26 adverse event reports that list this exact device (DI 00888912024822), received between Oct 5, 2015 and May 16, 2025 — classified as 26 injuries.
The most frequently reported specific device problem is “Loose or Intermittent Connection” (6 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 Problem10
- Loose or Intermittent Connection6
- Fracture4
- Insufficient Device Problem Information3
- Appropriate Device Problem Term/Code Not Available1
- Contamination1
- Device Dislodged or Dislocated1
- Device Slipped1
Patient problems
- No Code Available8
- Joint Laxity6
- No Known Impact Or Consequence To Patient4
- Unspecified Infection4
- Bone Fracture(s)3
- Failure of Implant3
- Fall2
- Implant Pain1
Recent adverse event reports
The 25 most recent of 26 reports, in the reporter's own words as published by the FDA.
InjuryMay 16, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryMar 17, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
REVISION SURGERY - DUE TO LOOSENING AND INSTABILITY.
Patient problems: Joint Laxity
MAUDE report 21627631 ↗InjuryJan 9, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
REVISION SURGERY - DUE TO FRACTURE AND INSTABILITY.
Patient problems: Bone Fracture(s); Joint Laxity
MAUDE report 21120831 ↗InjuryFeb 27, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryMay 26, 2023Unstable; Adverse Event Without Identified Device or Use Problem; Unstable; Adverse Event Without Identified Device or Use Problem
InjuryMay 8, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
REVISION SURGERY - DUE TO LOOSENING AND PAIN.
Patient problems: Implant Pain; Joint Laxity
MAUDE report 16892201 ↗InjuryApr 11, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryApr 12, 2022Appropriate Device Problem Term/Code Not Available
REVISION SURGERY - PATIENT HAD PAIN AND FUNCTION PROBLEMS. SURGERY REQUIRED DUE TO STEM LOOSENING AND FRACTURES OBSERVED VIA X-RAY. GLENOID APPEARS FINE. AFTER ASSESSMENT BY SURGEON OSTEOLYSIS AND FRACTURES AS A RESULT, POSSIBLE INFECTION TOO.
Patient problems: Bone Fracture(s); Pain
MAUDE report 14085942 ↗InjuryOct 13, 2020Fracture
REVISION SURGERY - FRACTURE BELOW TIP OF STEM LEADING TO NEED TO REVISE.
Patient problems: No Code Available
MAUDE report 10671326 ↗InjuryJul 22, 2020Loosening of Implant Not Related to Bone-Ingrowth
InjuryJul 15, 2020Fracture; Loose or Intermittent Connection
REVISION SURGERY - STEM BECAME LOOSE DUE TO A FRACTURE.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 10276651 ↗InjuryFeb 25, 2020Adverse Event Without Identified Device or Use Problem
InjuryApr 11, 2019Loose or Intermittent Connection
REVISION SURGERY - DUE TO THE STEM BEING LOOSE.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8504667 ↗InjuryAug 15, 2018Loose or Intermittent Connection
REVISION SURGERY - DUE TO A LOOSE HUMERAL STEM.
Patient problems: Failure of Implant
MAUDE report 7786546 ↗InjuryMay 1, 2018Fracture
REVISION SURGERY - DUE TO THE PATIENT FALLING AND FRACTURING THEIR HUMERUS AT THE PORTION OF THE STEM. THE SURGEON REVISED IT WITH A NEW STEM AND CHANGED THE GLENOSPHERE SIZE FOR GREATER STABILITY.
Patient problems: Fall
MAUDE report 7477259 ↗InjuryMar 13, 2018Device Dislodged or Dislocated
REVISION SURGERY - DUE TO THE PATIENT CONTINUALLY DISLOCATING. THE SURGEON PERFORMED A REVISION SURGERY WHERE HE WENT UP ONE SIZE ON THE STEM TO RESET THE VERSION AND REPLACED THE SOCKET INSERT TO A 36 MILLIMETER +4.
Patient problems: Joint Dislocation; No Code Available
MAUDE report 7334447 ↗InjuryDec 12, 2017Contamination; Loose or Intermittent Connection
REVISION SURGERY - DUE TO THE PATIENT HAVING AN ACUTE INFECTION. THE STEM WAS LOOSE.
Patient problems: Failure of Implant; No Code Available; Unspecified Infection
MAUDE report 7109132 ↗InjuryOct 12, 2017Device Slipped
REVISION SURGERY - DUE TO THE MONOBLOCK STEM BEING LOOSE.
Patient problems: No Code Available
MAUDE report 6943938 ↗InjuryOct 5, 2017Adverse Event Without Identified Device or Use Problem
REVISION SURGERY - DUE TO THE PATIENT'S HUMERUS BREAKING; STATUS POST FALL.
Patient problems: Bone Fracture(s); Fall
MAUDE report 6919089 ↗InjurySep 29, 2017Loose or Intermittent Connection
THIRD REVISION SURGERY - DUE TO THE STEM BEING LOSE IN THE PATIENT. IT SEEMED THAT THE CEMENT DID NOT HOLD.
Patient problems: Failure of Implant; No Code Available
MAUDE report 6905701 ↗InjuryJun 15, 2017Fracture
REVISION SURGERY: DUE TO THE PATIENT FALLING AND FRACTURING.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 6644983 ↗InjuryMar 13, 2017Loose or Intermittent Connection
REVISION SURGERY - DUE TO AN INFECTION CAUSING LOOSENING OF THE HUMERAL COMPONENT.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 6401073 ↗InjuryNov 18, 2016Insufficient Device Problem Information
REVISION SURGERY - THE PATIENT HAD A REVERSE TOTAL SHOULDER DONE ON (B)(6) 2016 AND DEVELOPED AN INFECTION. THIS SURGERY WAS THE REMOVAL OF THE HARDWARE; STAGE ONE IN A TWO STAGE REVISION.
Patient problems: Unspecified Infection
MAUDE report 6113390 ↗InjuryNov 17, 2016Adverse Event Without Identified Device or Use Problem
REVISION SURGERY - DUE TO THE PATENT HAVING AN INFECTION.
Patient problems: Unspecified Infection
MAUDE report 6110254 ↗InjuryOct 14, 2016Insufficient Device Problem Information
REVISION SURGERY - DUE TO AN INFECTION. THE SURGEON PERFORMED A SINGLE STAGE REVISION; EXCHANGED THE STEM, LINER AND HEAD.
Patient problems: Unspecified Infection
MAUDE report 6030375 ↗
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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