DJO SURGICAL 508-36-103Recalls & reported problems
Encore Medical, L.P. · GLENOID, HEAD W/RETAINING SCREW, RSP, 36MM, -4MM · Class 2 · Implant
Data updated Oct 18, 2026 from official FDA records · Editorial policy
Quick summary
This is a DJO Surgical reverse-configuration shoulder implant, the glenosphere component that sits on the shoulder blade with a retaining screw. The 55 reports mostly describe the ball component coming apart or dislocating from its baseplate, and shoulders becoming unstable or dislocating, with several cases needing revision surgery and one report describing broken screw pieces left behind in the patient. All 55 reports describe injuries, and none report a death. 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
- 55
- Deaths reported
- 0
- Injuries reported
- 55
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 55 adverse event reports that list this exact device (DI 00888912024778), received between Mar 22, 2016 and Aug 31, 2026 — classified as 55 injuries.
The most frequently reported specific device problem is “Device Dislodged or Dislocated” (14 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 Problem19
- Device Dislodged or Dislocated14
- Appropriate Device Problem Term/Code Not Available12
- Unstable7
- Insufficient Device Problem Information2
- No Apparent Adverse Event2
- Compatibility Problem1
- Detachment of Device or Device Component1
Patient problems
- Joint Dislocation12
- No Code Available11
- Insufficient Information10
- Unspecified Infection6
- Joint Laxity5
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available2
- Failure of Implant2
- No Information2
Recent adverse event reports
The 25 most recent of 55 reports, in the reporter's own words as published by the FDA.
InjuryAug 31, 2026No Apparent Adverse Event
Revision surgery - Due to This was a revision surgery that the concern was the Exactech humeral stem. He just switched out the glenosphere, unknown reason.
Patient problems: Insufficient Information
MAUDE report 50533649 ↗InjuryApr 23, 2026Adverse Event Without Identified Device or Use Problem
InjuryMar 17, 2026Adverse Event Without Identified Device or Use Problem
PATIENT HAD A GLENOSPHERE DISASSOCIATE FROM THE BASEPLATE. THE SURGEON IMPACTED THE GLENOSPHERE ON THE TAPER AND REPLACED WITH A NEW LINER ALSO. 73 YR OLD MALE.
Patient problems: Joint Laxity
MAUDE report 24622298 ↗InjuryAug 21, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryAug 19, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryApr 2, 2025Mechanical Problem; Detachment of Device or Device Component; Mechanical Problem; Detachment of Device or Device Component
PRIMARY SURGERY - HEAD PORTION OF THE RETAINING SCREW BROKE OFF. THE SURGEON DECIDED TO USE THIS ITEM, HE FELT IT WAS SECURE TO USE, BROKEN/FRAGMENTED PIECES LEFT IN PATIENT.
Patient problems: Foreign Body In Patient; No Clinical Signs, Symptoms or Conditions
MAUDE report 21759179 ↗InjurySep 20, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryAug 28, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
REVISION SURGERY - DUE TO FRACTURED GLENOID.
Patient problems: Bone Fracture(s)
MAUDE report 20092803 ↗InjuryApr 2, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryMar 27, 2024Unstable; Adverse Event Without Identified Device or Use Problem; Unstable; Adverse Event Without Identified Device or Use Problem
InjuryDec 13, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryOct 14, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjurySep 22, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjurySep 15, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
REVISION SURGERY - DUE TO UNKNOWN REASON.
Patient problems: Insufficient Information
MAUDE report 17761636 ↗InjurySep 7, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
REVISION SURGERY - STAGED REVISION REQUIRING BONE GRAFTING. DJO BASEPLATE AND GLENOSPHERE IMPLANTED PREVIOUSLY, AND NOW PROXIMAL HUMERAL REPLACEMENT WAS DONE AND HEAD BALL SWAPPED OUT.
Patient problems: Insufficient Information
MAUDE report 17706212 ↗InjuryJun 13, 2023No Apparent Adverse Event; No Apparent Adverse Event
IT WAS REPORTED THERE WAS AT LEAST A 20 MINUTE DELAY IN SURGERY.
Patient problems: Insufficient Information
MAUDE report 17122120 ↗InjuryFeb 20, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryDec 9, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryNov 25, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
REVISION SURGERY - INSTABILITY AND DISLOCATION AFTER THE PREVIOUS REVISION SURGERY. CONVERTED TO A HEMI.
Patient problems: Joint Dislocation; Joint Laxity
MAUDE report 15865050 ↗InjurySep 2, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryAug 11, 2022Device Dislodged or Dislocated
REVISION SURGERY - INFERIOR DISPLACEMENT OF GLENOID HEAD.
Patient problems: Insufficient Information
MAUDE report 15210927 ↗InjuryJun 23, 2022Appropriate Device Problem Term/Code Not Available
REVISION SURGERY- DUE TO POSSIBLE INFECTION.
Patient problems: Unspecified Infection
MAUDE report 14794115 ↗InjuryMar 15, 2022Appropriate Device Problem Term/Code Not Available
REVISION SURGERY - THE SURGEON REMOVED A STEM AND DID A STAGED REVISION DUE TO BONE LOSS.
Patient problems: Insufficient Information
MAUDE report 13775083 ↗InjuryDec 16, 2021Fracture; Loosening of Implant Not Related to Bone-Ingrowth
REVISION SURGERY - PATIENT FRACTURED HER HUMERUS AND THE IMPLANT BECAME LOSE. SURGEON THOUGHT IT WAS INFECTED, BUT ENDED UP JUST BEING A FRACTURE.
Patient problems: Unspecified Infection
MAUDE report 13018319 ↗InjuryDec 9, 2021Appropriate Device Problem Term/Code Not Available
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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