DJO SURGICAL 508-32-104Recalls & reported problems
Encore Medical, L.P. · BASEPLATE, GLENOID HA-COAT, RSP, 6.5MM X 30MM · Class 2 · Implant
Data updated Oct 18, 2026 from official FDA records · Editorial policy
1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.
Quick summary
This DJO reverse shoulder baseplate has 201 adverse event reports, with no deaths and 200 injuries. Many reports describe revision surgery needed after the baseplate or its screws broke or loosened, or after infection weakened its hold. There is 1 recall, still open, started in August 2023, over parts shipped without final sterilization, which can lead to infection.
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
- 203
- Deaths reported
- 0
- Injuries reported
- 201
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 203 adverse event reports that list this exact device (DI 00888912024754), received between Sep 4, 2015 and Sep 25, 2026 — classified as 201 injuries, 2 malfunctions.
The most frequently reported specific device problem is “Break” (46 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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.
Reports received per month
Recalls naming this device
- Aug 4, 2023Class IIOpen, 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 · Recall details · FDA record ↗
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem68
- Break46
- Appropriate Device Problem Term/Code Not Available32
- Loose or Intermittent Connection14
- Device Dislodged or Dislocated12
- Fracture10
- Insufficient Device Problem Information10
- Unstable7
Patient problems
- No Code Available39
- Failure of Implant34
- Unspecified Infection29
- Joint Laxity26
- Pain25
- Fall13
- Implant Pain11
- Insufficient Information11
Recent adverse event reports
The 25 most recent of 203 reports, in the reporter's own words as published by the FDA.
InjurySep 25, 2026Unstable
Patient problems: Joint Laxity
MAUDE report 50905485 ↗MalfunctionSep 9, 2026Fracture
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50702452 ↗InjuryJul 9, 2026Patient Device Interaction Problem
REVISION SURGERY - DUE TO PATIENT FELT DISCOMFORT.
Patient problems: Implant Pain
MAUDE report 25772767 ↗InjuryJun 29, 2026Unstable
REVISION SURGERY DUE TO BASEPLATE CENTRAL SCREW AND 2/3 PERIPHERAL SCREWS BROKEN INSIDE SCAPULAR. BASEPLATE BECAME LOOSE, CAME OFF THE GLENOID.
Patient problems: Failure of Implant; Joint Laxity
MAUDE report 25650345 ↗InjuryJun 3, 2026Patient Device Interaction Problem
InjuryMar 25, 2026Adverse Event Without Identified Device or Use Problem
SURGEON SAID THERE WAS IMPLANT LOOSENING - THE BASEPLATE WAS NOT LOOSE (IT WAS DIFFICULT TO REMOVE) ONCE IN THERE. 81YRS FEMALE.
Patient problems: Insufficient Information
MAUDE report 24683481 ↗InjuryMar 23, 2026Adverse Event Without Identified Device or Use Problem
INFECTION WEAKENED BASEPLATE FIXATION TO GLENOID. GLENOID COMPONENTS REMOVED. ALLOGRAFT FILLED DEFECTS . NEW GLENOID COMPONENTS IMPLANTED.
Patient problems: Unspecified Infection
MAUDE report 24670300 ↗InjuryMar 11, 2026Loosening of Implant Not Related to Bone-Ingrowth
InjuryJan 27, 2026Patient Device Interaction Problem
REVISION SURGERY - DUE TO BASEPLATE BROKE.
Patient problems: Failure of Implant
MAUDE report 24196132 ↗InjuryDec 11, 2025Unstable; Detachment of Device or Device Component; Unstable; Detachment of Device or Device Component
InjuryNov 10, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryOct 12, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjurySep 15, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
REVISION SURGERY: DUE TO LOOSENING AND BONE LOSS.
Patient problems: Joint Laxity
MAUDE report 23059684 ↗InjuryAug 21, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryAug 12, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryAug 8, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryJul 31, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
REVISION SURGERY: DUE TO INFECTION, THE 6.5 SCREW BROKE OFF DURING THE REMOVAL OF BASEPLATE, 30 MINUTE DELAY IN SURGERY.
Patient problems: Failure of Implant; Unspecified Infection
MAUDE report 22682961 ↗MalfunctionJul 21, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
INSTRUMENT FAILURE: PATIENT WAS UNSTABLE AND THE CENTER SCREW OF THE BASEPLATE BROKE.
Patient problems: Failure of Implant
MAUDE report 22561980 ↗InjuryJun 20, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryJun 7, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
REVISION SURGERY - DUE TO THE GLENOID WEAR AND RIDING HIGH.
Patient problems: Joint Laxity
MAUDE report 22163109 ↗InjuryMay 15, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryMar 4, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
REVISION SURGERY - DUE TO BASEPLATE SCREWS AND CENTRAL SCREWS BROKE.
Patient problems: Failure of Implant
MAUDE report 21521219 ↗InjuryJan 15, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
REVISION SURGERY - DUE TO BROKEN BASEPLATE.
Patient problems: Failure of Implant
MAUDE report 21164340 ↗InjuryDec 11, 2024Mechanical Problem; Adverse Event Without Identified Device or Use Problem; Mechanical Problem; Adverse Event Without Identified Device or Use Problem
REVISION SURGERY DUE TO A FRACTURE IN THE CENTRAL SCREW.
Patient problems: Failure of Implant
MAUDE report 20909293 ↗InjuryNov 13, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
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 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 · each recall links to the FDA recall notice
- 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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