DJO SURGICAL 508-36-101Recalls & reported problems
Encore Medical, L.P. · GLENOID, HEAD W/RETAINING SCREW, RSP, 36MM, NEUTRAL · Class 2 · Implant
Data updated Oct 18, 2026 from official FDA records · Editorial policy
Quick summary
This DJO reverse shoulder implant component is used in shoulder replacement, and its 503 reports often describe the joint dislocating or feeling unstable, with some implants loosening. Recent reports describe repeat surgery, often for dislocation, and others for infection. There are no deaths and 502 injuries reported, and 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
- 508
- Deaths reported
- 0
- Injuries reported
- 507
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 508 adverse event reports that list this exact device (DI 00888912024761), received between Sep 4, 2015 and Sep 11, 2026 — classified as 507 injuries, 1 malfunction.
The most frequently reported specific device problem is “Device Dislodged or Dislocated” (146 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 Problem223
- Device Dislodged or Dislocated146
- Appropriate Device Problem Term/Code Not Available107
- Unstable60
- Insufficient Device Problem Information13
- Loose or Intermittent Connection11
- Detachment of Device or Device Component8
- Break7
Patient problems
- Joint Dislocation209
- Joint Laxity61
- No Code Available61
- Unspecified Infection51
- Insufficient Information40
- Failure of Implant33
- No Known Impact Or Consequence To Patient22
- Pain18
Recent adverse event reports
The 25 most recent of 508 reports, in the reporter's own words as published by the FDA.
InjurySep 11, 2026Device Dislodged or Dislocated
Patient problems: Unspecified Infection
MAUDE report 50744265 ↗InjurySep 11, 2026Patient Device Interaction Problem
Patient problems: Failure of Implant
MAUDE report 50725174 ↗InjurySep 8, 2026Device Dislodged or Dislocated
Patient problems: Joint Dislocation
MAUDE report 50678679 ↗InjuryAug 7, 2026Unstable
InjuryJul 29, 2026Adverse Event Without Identified Device or Use Problem
InjuryJul 8, 2026Device Dislodged or Dislocated
InjuryJul 8, 2026Unstable
InjuryJun 29, 2026Device Dislodged or Dislocated
InjuryJun 23, 2026Loosening of Implant Not Related to Bone-Ingrowth
REVISION SURGERY - DUE TO IMPLANTS BEGIN TO LOOSEN.
Patient problems: Joint Laxity
MAUDE report 25601915 ↗InjuryJun 11, 2026Device Dislodged or Dislocated
InjuryJun 8, 2026Unstable
PATIENT PRESENTED TWO YEARS POST OP FOR REVERSE TOTAL SHOULDER. PATIENT SHOWED SYMPTOMS OF DISLOCATION. SURGEON OPTED TO REVISE TO LARGER GLENOSPHERE AND LINER. WHEN ORIGINAL LINER WAS EXPOSED, IT WAS DETERMINED THAT IT WAS DISENGAGED FROM THE STEM.
Patient problems: Joint Dislocation
MAUDE report 25429204 ↗InjuryJun 1, 2026Adverse Event Without Identified Device or Use Problem
InjuryMay 29, 2026Insufficient Device Problem Information
REVISION SURGERY DUE TO UNKNOWN REASON.
Patient problems: Insufficient Information
MAUDE report 25330042 ↗InjuryMay 8, 2026Detachment of Device or Device Component
REVISION SURGERY DUE TO GLENOSPHERE DISASSOCIATED.
Patient problems: Failure of Implant
MAUDE report 25131323 ↗InjuryMay 8, 2026Mechanical Problem
RETAINING SCREW BROKEN INSIDE GLENOSPHERE.
Patient problems: Failure of Implant
MAUDE report 25130872 ↗InjuryMay 5, 2026Loosening of Implant Not Related to Bone-Ingrowth
InjuryMay 4, 2026Device Dislodged or Dislocated
REVISION SURGERY DUE TO DISLOCATED GLENOSPHERE
Patient problems: Joint Dislocation
MAUDE report 25075574 ↗InjuryApr 24, 2026Patient Device Interaction Problem
REVISION SURGERY - DUE TO PATIENT PRESENTED TO DOCTORS OFFICE WITH PAIN AND SWELLING.
Patient problems: Implant Pain
MAUDE report 24990880 ↗InjuryApr 16, 2026Adverse Event Without Identified Device or Use Problem
REVISION SURGERY - DUE TO PATIENT WAS TIGHT FROM A PREVIOUS SURGERY FROM ANOTHER SURGEON.
Patient problems: Loss of Range of Motion
MAUDE report 24906081 ↗InjuryApr 16, 2026Unstable
InjuryApr 6, 2026Adverse Event Without Identified Device or Use Problem
InjuryMar 30, 2026Adverse Event Without Identified Device or Use Problem
InjuryMar 18, 2026Adverse Event Without Identified Device or Use Problem
HAS INEXPLICABLE PAIN PERSISTENT IN HER SHOULDER. 70 YR OLD FEMALE.
Patient problems: Implant Pain
MAUDE report 24631447 ↗InjuryMar 13, 2026Loosening of Implant Not Related to Bone-Ingrowth
InjuryMar 10, 2026Unstable
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 508-32-101Encore 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
- DJO SURGICAL 509-01-436Encore Medical, L.P. · shoulder prosthesis, reverse configuration1 recall62 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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