DJO SURGICAL 508-01-432Recalls & reported problems
Encore Medical, L.P. · RSP HUM SOCKET INSERT, 32MM +4MM, SEMI · Class 2 · Implant
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 18
- Deaths reported
- 0
- Injuries reported
- 18
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 18 adverse event reports that list this exact device (DI 00888912024723), received between Oct 6, 2016 and Mar 19, 2026 — classified as 18 injuries.
The most frequently reported specific device problem is “Device Dislodged or Dislocated” (6 reports).
5 other recalls cover devices cleared under the same FDA submission (K051075); 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 Problem7
- Device Dislodged or Dislocated6
- Appropriate Device Problem Term/Code Not Available3
- Unstable3
- Device Slipped1
- Loose or Intermittent Connection1
Patient problems
- No Code Available4
- Unspecified Infection4
- Joint Laxity3
- Failure of Implant2
- Fall2
- Arthralgia1
- Insufficient Information1
- Joint Dislocation1
Recent adverse event reports
The 18 most recent of 18 reports, in the reporter's own words as published by the FDA.
InjuryMar 19, 2026Unstable
InjurySep 10, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryApr 6, 2024Unstable; Adverse Event Without Identified Device or Use Problem; Unstable; Adverse Event Without Identified Device or Use Problem
InjuryOct 3, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryAug 21, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryJun 21, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryMar 14, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryAug 5, 2022Device Dislodged or Dislocated
REVISION SURGERY - POLY WEAR UNKNOWN CAUSE, POSSIBLY IMPINGEMENT/DISLOCATION.
Patient problems: Failure of Implant
MAUDE report 15176676 ↗InjuryJan 6, 2022Appropriate Device Problem Term/Code Not Available
REVISION SURGERY - DUE TO AN INFECTION.
Patient problems: Unspecified Infection
MAUDE report 13173654 ↗InjurySep 28, 2020Appropriate Device Problem Term/Code Not Available
REVISION SURGERY - RECURRENT DISLOCATIONS.
Patient problems: Joint Dislocation
MAUDE report 10593415 ↗InjurySep 17, 2020Appropriate Device Problem Term/Code Not Available
REVISION SURGERY - DUE TO INSTABILITY.
Patient problems: Insufficient Information
MAUDE report 10547473 ↗InjuryMar 17, 2020Device Dislodged or Dislocated
REVISION SURGERY - DUE TO THE FREQUENCY OF DISLOCATION, SURGEON DECIDED TO REPOSITION THE STEM AND THE SPACER AND ONLY CHANGED THE INSERT.
Patient problems: No Code Available
MAUDE report 9843123 ↗InjuryFeb 19, 2018Loose or Intermittent Connection
REVISION SURGERY - DUE TO THE STEM BEING LOOSE, MAKING THE SHOULDER UNSTABLE. THE STEM WAS REMOVED.
Patient problems: No Code Available
MAUDE report 7281175 ↗InjuryNov 16, 2017Device Dislodged or Dislocated
SECOND REVISION SURGERY - DUE TO THE PATIENT CHRONICALLY DISLOCATING SINCE LAST REVISION.
Patient problems: No Code Available
MAUDE report 7038794 ↗InjuryOct 5, 2017Device Dislodged or Dislocated
REVISION SURGERY: DUE TO THE PATIENT FALLING AND DISLOCATING.
Patient problems: Fall
MAUDE report 6919060 ↗InjuryJun 8, 2017Device Slipped; Unstable; Device Dislodged or Dislocated
REVISION SURGERY. DUE TO THE PATIENT FALLING RESULTING IN DISLOCATION. THE SHOULDER WAS LOOSE AND UNSTABLE; THE SURGEON REVISED TO A 8MM SPACER AND 32MM +4 SEMI INSERT.
Patient problems: Fall
MAUDE report 6626967 ↗InjuryApr 6, 2017Adverse Event Without Identified Device or Use Problem
REVISION SURGERY - DUE TO AN INFECTION.
Patient problems: Unspecified Infection
MAUDE report 6464236 ↗InjuryOct 6, 2016Device Dislodged or Dislocated
REVISION SURGERY - DUE TO THE PATIENT FALLING AND WAS DISLOCATING.
Patient problems: No Code Available
MAUDE report 6004364 ↗
Recalls under the same FDA submission
These recalls involve devices cleared under K051075. One submission often covers many models, so check the product and lot details in each record.
- Z-1460-2026 · Jan 15, 2026 · Open, ClassifiedBrand Name: Reverse Shoulder Prosthesis (RSP) Product Name: RSP STANDARD HUMERAL SOCKET INSERT, 36MM, HXe-plus Model/Catalog Number: 509-00-036
- Z-0625-2024 · Oct 5, 2023 · CompletedReverse Shoulder System e+, REF 509-01-032, RSP Humeral Socket Insert, Sz. 32mm, Semi-Constrained, Sterile H2o2, CE 2797
- Z-0282-2024 · Sep 25, 2023 · Open, ClassifiedRSP Humeral Socket Insert Size 36mm Semi-Constrained +4 mm, REF: 509-01-436, orthopedic shoulder implant component.
- Z-2606-2023 · Aug 4, 2023 · Open, ClassifiedDJO Surgical: Reverse Shoulder System (RSP) Semi Humeral Socket Insert, 32mm, REF: 508-01-032; Baseplate, Glenoid HA-Coat, RSP, 6.5mm X 30mm, REF: 508-32-104; Reverse Shoulder Syst
- Z-2739-2011 · Apr 18, 2011 · TerminatedReverse Shoulder Prosthesis System RSP Humeral Socket Shell DJO 9800 Metric Blvd. Austin, TX 78758 STERILE R Model numbers: 508-00-000 and 508-00-008. The Reverse Shoulder Prost
Other shoulder prosthesis, reverse configuration devices
- DJO SURGICAL 508-36-101Encore Medical, L.P. · shoulder prosthesis, reverse configuration508 reports
- DJO SURGICAL 508-32-101Encore Medical, L.P. · shoulder prosthesis, reverse configuration433 reports
- DJO SURGICAL 508-32-103Encore Medical, L.P. · shoulder prosthesis, reverse configuration421 reports
- DJO SURGICAL 509-00-036Encore Medical, L.P. · shoulder prosthesis, reverse configuration1 recall259 reports
- DJO SURGICAL 508-32-104Encore Medical, L.P. · shoulder prosthesis, reverse configuration1 recall203 reports
- DJO SURGICAL 509-00-032Encore Medical, L.P. · shoulder prosthesis, reverse configuration233 reports
- DELTA XTEND 130760000Depuy (Ireland) · shoulder prosthesis, reverse configuration223 reports
- DJO SURGICAL 508-00-032Encore Medical, L.P. · shoulder prosthesis, reverse configuration122 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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