DJO SURGICAL 509-01-032Recalls & reported problems
Encore Medical, L.P. · RSP SEMICONSTRAINED HUMERAL SOCKET INSERT, 32MM, HXe-plus · Class 2 · Implant
Quick summary
This is a DJO Surgical shoulder implant component used in reverse configuration shoulder replacement surgery. Its 51 reports mostly describe pain, infection at the implant site, and the joint dislocating or feeling unstable, with several patients needing revision surgery; no deaths were reported. One recall began in October 2023 over mislabeling linked to a packaging process control issue, and it is closed.
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
- 1
Summary
The FDA's MAUDE database contains 52 adverse event reports that list this exact device (DI 00888912144612), received between Dec 29, 2017 and Sep 11, 2026 — classified as 52 injuries.
The most frequently reported specific device problem is “Device Dislodged or Dislocated” (8 reports).
1 FDA recall record name this device's identifier.
4 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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Recalls naming this device
- Oct 5, 2023Completed
Mislabeling
Z-0625-2024 · Root cause: Packaging process control · FDA record ↗
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem23
- Appropriate Device Problem Term/Code Not Available16
- Device Dislodged or Dislocated8
- Insufficient Device Problem Information3
- Labelling, Instructions for Use or Training Problem2
- Unstable2
- Improper or Incorrect Procedure or Method1
- Inadequate User Interface1
Patient problems
- Unspecified Infection24
- Joint Dislocation6
- Pain6
- Medical device site infection4
- Failure of Implant3
- Joint Laxity3
- Implant Pain2
- Loss of Range of Motion2
Recent adverse event reports
The 25 most recent of 52 reports, in the reporter's own words as published by the FDA.
InjurySep 11, 2026Device Dislodged or Dislocated
Patient problems: Unspecified Infection
MAUDE report 50744262 ↗InjuryJun 23, 2026Unstable
InjuryJun 11, 2026Device Dislodged or Dislocated
InjuryJan 9, 2026Device Dislodged or Dislocated
InjuryNov 20, 2025Device Dislodged or Dislocated; Adverse Event Without Identified Device or Use Problem; Device Dislodged or Dislocated; Adverse Event Without Identified Device or Use Problem
InjuryOct 23, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
REVISION SURGERY: DUE TO PAIN/INFECTION.
Patient problems: Implant Pain; Unspecified Infection
MAUDE report 23367598 ↗InjurySep 11, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjurySep 23, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjurySep 16, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryMay 9, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryMar 28, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryMar 23, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryJan 5, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryDec 12, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryNov 27, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
REVISION SURGERY - INFECTED C-ACNES. IRRIGATION & DRAINAGE WITH POLYSWAP.
Patient problems: Medical device site infection
MAUDE report 18213162 ↗InjurySep 15, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryJul 11, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
REVISION SURGERY - DUE TO PATIENT WAS TOO TIGHT.
Patient problems: Loss of Range of Motion
MAUDE report 17302524 ↗InjuryJun 7, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
REVISION SURGERY - REVISION SURGERY/ REQUIRED INTERVENTION TO PREVENT IMPAIRMENT/DAMAGE.
Patient problems: Loss of Range of Motion
MAUDE report 17083747 ↗InjuryDec 5, 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 15917533 ↗InjuryDec 2, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
REVISION SURGERY - DUE TO CHRONIC DISLOCATION EVEN AFTER PRIOR REVISION.
Patient problems: Joint Dislocation
MAUDE report 15908466 ↗InjuryNov 29, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
REVISION SURGERY - PATIENT HAS POSSIBLE INFECTION AND SURGEON WANTED TO SWAP OUT TO NEW IMPLANTS.
Patient problems: Medical device site infection
MAUDE report 15880079 ↗InjuryOct 28, 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 15693216 ↗InjuryAug 29, 2022Labelling, Instructions for Use or Training Problem; Labelling, Instructions for Use or Training Problem
COMPLAINT - WHEN REPRESENTATIVE OPENED IMPLANT BOX THE ITEM DID NOT MATCH. SHOULD HAVE BEEN ITEM 509-01-032 HOWEVER IN THE BOX WAS A PATELLA IMPLANT REP MENTIONED DID NOT KNOW REFERENCE NUMBER FOR THE PATELLA ITEM SURGEON OPENED A RSP SEMI CONSTRAINED POLY AND THERE WAS A PATELLA POLY INSIDE OF IT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15314956 ↗InjuryAug 26, 2022Labelling, Instructions for Use or Training Problem; Labelling, Instructions for Use or Training Problem
COMPLAINT - SURGEON OPENED A SEALED SHOULDER LINER BOX AND THERE WAS A PATELLA INSIDE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15303758 ↗InjuryJul 21, 2022Appropriate Device Problem Term/Code Not Available
REVISION SURGERY PATIENT WAS INFECTED, PERFORMED POLY & GLENOID EXCHANGE WITH WASHOUT. REPLACE POLY & GLENOID.
Patient problems: Unspecified Infection
MAUDE report 15077184 ↗
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-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: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.