DJO SURGICAL 508-00-432Recalls & reported problems
Encore Medical, L.P. · RSP HUM SOCKET INSERT, 32MM, +4MM, STANDARD · Class 2 · Implant
Data updated Oct 18, 2026 from official FDA records · Editorial policy
Quick summary
This is a DJO Surgical shoulder socket insert, a plastic liner used in total shoulder replacement. The 51 reports mostly describe the shoulder becoming infected or unstable, with the joint dislocating or the implant loosening, and patients needing revision surgery to wash out infection or fix instability. There are 51 injuries and no deaths. 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
- 52
- Deaths reported
- 0
- Injuries reported
- 52
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 52 adverse event reports that list this exact device (DI 00888912024679), received between Sep 17, 2015 and Sep 18, 2026 — classified as 52 injuries.
The most frequently reported specific device problem is “Device Dislodged or Dislocated” (12 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 Problem15
- Appropriate Device Problem Term/Code Not Available15
- Device Dislodged or Dislocated12
- Unstable7
- Loose or Intermittent Connection3
- Insufficient Device Problem Information2
- Fracture1
- Improper or Incorrect Procedure or Method1
Patient problems
- Unspecified Infection22
- No Code Available15
- Failure of Implant7
- Joint Dislocation6
- Joint Laxity4
- Pain3
- Fall2
- Bone Fracture(s)1
Recent adverse event reports
The 25 most recent of 52 reports, in the reporter's own words as published by the FDA.
InjurySep 18, 2026Device Dislodged or Dislocated
Patient problems: Joint Dislocation
MAUDE report 50831072 ↗InjuryMay 21, 2026Adverse Event Without Identified Device or Use Problem
REVISION SURGERY DUE TO PATIENT WITH INFECTED SHOULDER WAS WASHED OUT AND THE DOCTOR DID A POLY SWAP.
Patient problems: Unspecified Infection
MAUDE report 25250357 ↗InjuryFeb 2, 2026Adverse Event Without Identified Device or Use Problem
InjuryDec 19, 2025Unstable; Unstable
InjuryOct 22, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryMay 21, 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
InjuryJul 20, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
REVISION SURGERY - DUE TO INFECTION, BROKEN BASEPLATE SCREW AND PAIN
Patient problems: Failure of Implant; Implant Pain; Unspecified Infection
MAUDE report 17357311 ↗InjuryDec 28, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
REVISION SURGERY - PATIENT HAD INSTABILITY THAT NEEDED TO BE ADDRESSED. ALL COMPONENTS WERE IN GOOD CONDITION WITH GOOD FIXATION WHEN THEY CAME OUT. SURGEON UPSIZED THE GLENOSPHERE AND ADDED A SPACER WITH A SEMI CONSTRAINED POLY TO GIVE THE PATIENT BETTER STABILITY.
Patient problems: Joint Laxity
MAUDE report 16061790 ↗InjuryOct 19, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
REVISION SURGERY - DUE TO AN INFECTION.
Patient problems: Medical device site infection
MAUDE report 15634080 ↗InjuryMar 31, 2022Naturally Worn; Appropriate Device Problem Term/Code Not Available
REVISION SURGERY - DUE TO WORN POLY AND JOINT INSTABILITY.
Patient problems: Insufficient Information
MAUDE report 13969342 ↗InjuryFeb 4, 2022Adverse Event Without Identified Device or Use Problem
REVISION SURGERY DUE TO POSSIBLE INFECTION.
Patient problems: Unspecified Infection
MAUDE report 13456488 ↗InjuryDec 23, 2021Appropriate Device Problem Term/Code Not Available
REVISION SURGERY: PATIENT COMPLAINED OF A CLUNKING WHEN MOVING THEIR ARM. APPEARED TO HAVE SOME POSTERIOR LAXITY. REPLACED INSERT, ADDED 8MM SPACER, AND A LARGER DIAMETER GLENOSPHERE.
Patient problems: Joint Laxity
MAUDE report 13079051 ↗InjuryNov 8, 2021Appropriate Device Problem Term/Code Not Available
InjuryAug 23, 2021Appropriate Device Problem Term/Code Not Available
REVISION SURGERY - DUE TO AN INFECTION. SURGEON CHOOSE TO REMOVE ALL THE ITEMS AND REPLACE WITH CEMENT SPACERS.
Patient problems: Unspecified Infection
MAUDE report 12356077 ↗InjuryMay 28, 2021Appropriate Device Problem Term/Code Not Available
REVISION SURGERY - INFECTION. IN ADDITION TO THE ITEM DETAILED ABOVE, THE RETAINING SCREW WAS REPLACED WITH A NEW ONE BUT THE ORIGINAL GLENOID HEAD WASN'T REMOVED.
Patient problems: Unspecified Infection
MAUDE report 11901605 ↗InjurySep 29, 2020Loose or Intermittent Connection
REVISION SURGERY - DUE TO STEM LOOSENING AND POSSIBLE INFECTION. REMOVED AND EXCHANGED OUT THE STEM, HEAD AND INSERT.
Patient problems: Failure of Implant; Unspecified Infection
MAUDE report 10600321 ↗InjuryJul 20, 2020Appropriate Device Problem Term/Code Not Available
REVISION SURGERY - THE PATIENT HAD AN INFECTION. ALL IMPLANTS WERE REMOVED AND THEY WERE NOT REPLACED AT THIS TIME. ALTHOUGH THERE ARE TWO GLENOID HEAD STICKERS, ONLY ONE WAS IMPLANTED.
Patient problems: No Code Available; Unspecified Infection
MAUDE report 10295574 ↗InjuryJul 13, 2020Appropriate Device Problem Term/Code Not Available
InjuryJul 8, 2020Unstable; Appropriate Device Problem Term/Code Not Available
REVISION SUREGRY - DUE TO JOINT INSTABILITY.
Patient problems: Failure of Implant
MAUDE report 10244594 ↗InjuryApr 13, 2020Adverse Event Without Identified Device or Use Problem
REVISION SURGERY - SURGEON REVISED FOR PAIN AND SUSPECTED INFECTION.
Patient problems: Pain; Unspecified Infection
MAUDE report 9954862 ↗InjuryApr 9, 2020Adverse Event Without Identified Device or Use Problem
InjuryMar 20, 2020Appropriate Device Problem Term/Code Not Available
REVISION SURGERY - PATIENT WAS COMPLAINING OF PAIN AND DISCOMFORT.
Patient problems: Discomfort; Pain
MAUDE report 9860734 ↗InjuryJan 24, 2020Appropriate Device Problem Term/Code Not Available
InjuryNov 12, 2019Appropriate Device Problem Term/Code Not Available
REVISION SURGERY - SUSPECTED INFECTION. POLY EXCHANGED AND PATIENT INCISION AND DRAINAGE.
Patient problems: Unspecified Infection
MAUDE report 9310734 ↗
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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