DJO SURGICAL 509-00-044Recalls & reported problems
Encore Medical, L.P. · RSP STANDARD HUMERAL SOCKET INSERT, 44MM, HXe-plus · Class 2 · Implant
Data updated Oct 18, 2026 from official FDA records · Editorial policy
1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.
Quick summary
This is a shoulder prosthesis component from Encore Medical, a 44mm humeral socket insert used in shoulder replacement surgery. The 28 reports mostly describe repeat operations on the shoulder — many because of infection, along with dislocation and pain — with 28 injuries and no deaths. One open recall, started in August 2020, concerns products that may be labeled with a size different from the one etched on the part, which could lead a surgeon to implant the wrong size.
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
- 1
Summary
The FDA's MAUDE database contains 28 adverse event reports that list this exact device (DI 00888912144568), received between Jun 12, 2019 and Sep 25, 2026 — classified as 28 injuries.
The most frequently reported specific device problem is “Device Dislodged or Dislocated” (4 reports).
1 FDA recall record name this device's identifier, 1 still open.
1 other recall cover devices cleared under the same FDA submission (K141006); 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
Recalls naming this device
- Aug 7, 2020Class IIOpen, Classified
Product may be mislabeled with the size etched onto products differing from the size information shown on patient sticker labels. Risks associated with this issue may include the Surgeon implanting the incorrect size; significant physical impairment, discomfort and/or disruption of treatment of underlying condition; and the patient experiencing dislocation resulting in revision surgery.
Z-3021-2020 · Root cause: Other · Recall details · FDA record ↗
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem21
- Appropriate Device Problem Term/Code Not Available4
- Device Dislodged or Dislocated4
- Device Markings/Labelling Problem1
- Inadequacy of Device Shape and/or Size1
- Insufficient Device Problem Information1
Patient problems
- Unspecified Infection12
- Joint Dislocation6
- Implant Pain3
- Insufficient Information3
- Joint Laxity3
- Failure of Implant1
- Loss of Range of Motion1
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 25 most recent of 28 reports, in the reporter's own words as published by the FDA.
InjurySep 25, 2026Adverse Event Without Identified Device or Use Problem
Patient problems: Joint Dislocation
MAUDE report 50892494 ↗InjuryMay 26, 2026Insufficient Device Problem Information
REVISION SURGERY - PATIENT NEEDED A PROXIMAL HUMERUS ALLOGRAFT, SO WE CHANGED THE POLY AND PUT THE ALLOGRAFT ON.
Patient problems: Insufficient Information
MAUDE report 25293871 ↗InjuryMay 26, 2026Adverse Event Without Identified Device or Use Problem
REVISION SURGERY DUE TO INFECTED SHOULDER.
Patient problems: Unspecified Infection
MAUDE report 25276481 ↗InjuryMay 14, 2026Adverse Event Without Identified Device or Use Problem
REVISION SURGERY DUE TO IMPLANTS EXPLANTED AND ANTIBIOTIC SPACER IMPLANTED TO TREAT INFECTION.
Patient problems: Unspecified Infection
MAUDE report 25179177 ↗InjuryMay 12, 2026Device Dislodged or Dislocated
InjuryApr 30, 2026Adverse Event Without Identified Device or Use Problem
InjuryMar 31, 2026Adverse Event Without Identified Device or Use Problem
PATIENT HAD PAIN. SURGEON OPTED TO DO A POLY SWAP AND ADD SPACER. 64 YR OLD MALE.
Patient problems: Implant Pain
MAUDE report 24737985 ↗InjuryMar 24, 2026Adverse Event Without Identified Device or Use Problem
InjuryJan 13, 2026Adverse Event Without Identified Device or Use Problem
InjuryAug 28, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryAug 25, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryAug 7, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryJul 7, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryMay 12, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
REVISION SURGERY - DUE TO DISLOCATION AND INFECTION.
Patient problems: Joint Dislocation; Unspecified Infection
MAUDE report 22007091 ↗InjuryDec 6, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryAug 12, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryApr 2, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjurySep 19, 2023Adverse Event Without Identified Device or Use Problem; 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 LIMITED RANGE OF MOTION.
Patient problems: Implant Pain; Loss of Range of Motion
MAUDE report 17312893 ↗InjuryMay 16, 2022Appropriate Device Problem Term/Code Not Available
REVISION SURGERY - PATIENT WAS DISLOCATED. THE STANDARD POLY INSERT WAS REPLACED WITH A SEMI-CONSTRAINED POLY INSERT.
Patient problems: Joint Dislocation
MAUDE report 14408457 ↗InjuryJan 31, 2022Adverse Event Without Identified Device or Use Problem
REVISION SURGERY: PATIENT IS NEARLY TWO YEARS POST OPERATION OF REVERSE SHOULDER AND HAD MULTIPLE REVISIONS FOR INFECTION. INFECTION SEEMS TO BE EVIDENT AND REQUIRES ADDITIONAL IRRIGATION & DRAINAGE FOR INFECTION. HEAD AND LINER WAS REPLACED.
Patient problems: Unspecified Infection
MAUDE report 13403738 ↗InjuryNov 11, 2021Device Dislodged or Dislocated; Appropriate Device Problem Term/Code Not Available
REVISION SURGERY - PATIENT WAS DISLOCATED, SURGEON UPSIZED THE POLY.
Patient problems: Insufficient Information
MAUDE report 12798831 ↗InjuryJun 15, 2021Adverse Event Without Identified Device or Use Problem
REVISION SURGERY - DUE TO PATIENT HAS INFECTION.
Patient problems: Unspecified Infection
MAUDE report 12005599 ↗InjuryAug 19, 2020Device Markings/Labelling Problem; Appropriate Device Problem Term/Code Not Available
REVISION SURGERY - PATIENT WAS DISLOCATING. SCRUB TECH WAS LOOKING AT THE IMPLANTS REMOVED AND NOTICED THE INSERT HAD SIZE 36 +4 SEMI CONSTRAINED ON IT, BUT PER THE PRIMARY SURGERY STICKERS THE INSERT WAS SUPPOSED TO BE SIZE 44 STANDARD INSERT. IT IS BELIEVED THE WRONG IMPLANT WAS IN THE BOX, OR WRONG STICKER ON THE BOX.
Patient problems: Joint Dislocation
MAUDE report 10426215 ↗InjuryAug 17, 2020Inadequacy of Device Shape and/or Size; Device Dislodged or Dislocated
SECOND REVISION SURGERY - POLY DISLOCATED, CONVERTED WITH A LARGE SIZES FOR STABILITY.
Patient problems: Failure of Implant
MAUDE report 10414811 ↗
Recalls under the same FDA submission
These recalls involve devices cleared under K141006. One submission often covers many models, so check the product and lot details in each record.
- Z-3022-2020 · Aug 7, 2020 · Open, ClassifiedRSP Standard HUMERAL SOCKET INSERT, 40 MM plus 4MM, HXe-Plus, Part No. 509-00-440
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 · each recall links to the FDA recall notice
- 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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