DJO SURGICAL 508-01-032Recalls & reported problems
Encore Medical, L.P. · SOCKET, INSERT 32MM SEMI RSP HUMERAL · Class 2 · Implant
1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.
Quick summary
This is a DJO Surgical reverse-configuration shoulder prosthesis socket insert used in shoulder replacement surgery. The 39 reports mostly describe instability of the implant, dislocation, loosening and infection, with several patients needing revision surgery; no deaths were reported, and all 39 involved injuries. One open recall from August 2023 states the components were not sterilized before shipment, which can lead to infection and possible revision surgery.
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
- 40
- Deaths reported
- 0
- Injuries reported
- 40
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 40 adverse event reports that list this exact device (DI 00888912024693), received between Dec 23, 2015 and Sep 17, 2026 — classified as 40 injuries.
The most frequently reported specific device problem is “Unstable” (7 reports).
1 FDA recall record name this device's identifier, 1 still open.
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
- Aug 4, 2023Open, Classified
Orthopedic device components were not subjected to final sterilization before shipment, which if implanted may lead to varying degrees of infection, which may require treatment, prolonged monitoring, and may lead to revision surgery
Z-2606-2023 · Root cause: Nonconforming Material/Component · FDA record ↗
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem20
- Appropriate Device Problem Term/Code Not Available7
- Unstable7
- Device Dislodged or Dislocated5
- Insufficient Device Problem Information2
- Loosening of Implant Not Related to Bone-Ingrowth1
- Noise, Audible1
- Patient-Device Incompatibility1
Patient problems
- Unspecified Infection21
- Joint Laxity8
- Joint Dislocation3
- No Code Available3
- Fall2
- Implant Pain2
- Pain2
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available1
Recent adverse event reports
The 25 most recent of 40 reports, in the reporter's own words as published by the FDA.
InjurySep 17, 2026Adverse Event Without Identified Device or Use Problem
Patient problems: Unspecified Infection
MAUDE report 50812636 ↗InjuryJun 10, 2026Loosening of Implant Not Related to Bone-Ingrowth
InjuryMay 12, 2026Unstable
InjuryDec 8, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
THE PATIENT HAD A SUPERFICIAL INFECTION 5 MONTHS AFTER SURGERY. THE SURGEON WANTED TO ENSURE THAT IT DID NOT PROPAGATE TO THE JOINT AND WASHED IT OUT AND REPLACED THE POLY.
Patient problems: Unspecified Infection
MAUDE report 23743200 ↗InjurySep 14, 2024Unstable; Adverse Event Without Identified Device or Use Problem; Unstable; Adverse Event Without Identified Device or Use Problem
InjuryMay 18, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryMar 11, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryNov 7, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryOct 20, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
REVISION SURGERY - DUE TO LOOSENING AND INFECTION.
Patient problems: Joint Laxity; Unspecified Infection
MAUDE report 17981435 ↗InjuryAug 9, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
REVISION SURGERY - DUE TO INFECTION AND PAIN.
Patient problems: Implant Pain; Unspecified Infection
MAUDE report 17495073 ↗InjuryJul 7, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryJun 20, 2023Unstable; Unstable
REVISION SURGERY - DUE TO INSTABILITY AND INFECTION.
Patient problems: Joint Laxity; Unspecified Infection
MAUDE report 17167579 ↗InjuryJun 15, 2023Unstable; Adverse Event Without Identified Device or Use Problem; Unstable; Adverse Event Without Identified Device or Use Problem
InjuryMay 9, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryApr 25, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryMar 6, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
REVISION SURGERY - POLY WEAR.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 16491990 ↗InjuryFeb 24, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryOct 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 15544641 ↗InjuryMar 9, 2022Appropriate Device Problem Term/Code Not Available
REVISION SURGERY: DUE TO PATIENT WAS INFECTED.
Patient problems: Unspecified Infection
MAUDE report 13713717 ↗InjuryDec 14, 2021Appropriate Device Problem Term/Code Not Available
REVISION SURGERY - DUE TO AN INFECTION.
Patient problems: Unspecified Infection
MAUDE report 13002222 ↗InjuryNov 29, 2021Appropriate Device Problem Term/Code Not Available
InjurySep 22, 2021Unstable; Appropriate Device Problem Term/Code Not Available; Noise, Audible
REVISION SURGERY - PATIENT WAS UNSTABLE & HAD A "CLICKING SOUND". NO PRODUCT FAILURE.
Patient problems: Failure of Implant
MAUDE report 12514939 ↗InjuryJan 13, 2021Adverse Event Without Identified Device or Use Problem
InjurySep 16, 2020Adverse Event Without Identified Device or Use Problem
REVISION SURGERY - DUE TO THE PATIENT PRESENTING AT EMERGENCY ROOM WITH A DISLOCATED SHOULDER AFTER A FALL.
Patient problems: Fall; Joint Dislocation
MAUDE report 10542701 ↗InjurySep 16, 2020Adverse Event Without Identified Device or Use Problem
SECOND REVISION SURGERY - DUE TO AN INFECTION.
Patient problems: Unspecified Infection
MAUDE report 10541063 ↗
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-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.