DJO SURGICAL 508-32-204Recalls & reported problems
Encore Medical, L.P. · RSP BASEPLATE, 30MM, W/P2 COATING · 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 RSP shoulder baseplate from Encore Medical is the base piece of a shoulder replacement. The FDA database holds 538 reports for it, 533 of them describing injuries and no deaths. Many reports describe revision surgery for loosening, dislocation, infection or broken screws. One open recall, from September 2023, names this device over a baseplate coating that did not fit the surgical screwdrivers.
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
- 544
- Deaths reported
- 0
- Injuries reported
- 539
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 544 adverse event reports that list this exact device (DI 00888912144391), received between Sep 16, 2016 and Sep 30, 2026 — classified as 539 injuries, 5 malfunctions.
The most frequently reported specific device problem is “Break” (85 reports).
1 FDA recall record name this device's identifier, 1 still open.
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
- Sep 6, 2023Class IIOpen, Classified
Coating hex did not engage with the Straight Mod Hexdriver or with the Hex Head Screw Driver
Z-0532-2024 · Root cause: Component design/selection · Recall details · FDA record ↗
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem270
- Appropriate Device Problem Term/Code Not Available89
- Break85
- Unstable37
- Fracture33
- Loose or Intermittent Connection26
- Device Dislodged or Dislocated18
- Patient Device Interaction Problem17
Patient problems
- Failure of Implant164
- Joint Laxity88
- Insufficient Information79
- Unspecified Infection64
- No Code Available36
- Pain30
- Fall20
- No Known Impact Or Consequence To Patient20
Recent adverse event reports
The 25 most recent of 544 reports, in the reporter's own words as published by the FDA.
InjurySep 30, 2026Patient Device Interaction Problem
Patient problems: Failure of Implant
MAUDE report 50941457 ↗InjurySep 21, 2026No Apparent Adverse Event
Patient problems: Insufficient Information
MAUDE report 50846804 ↗InjurySep 17, 2026Patient Device Interaction Problem
Patient problems: Failure of Implant
MAUDE report 50812271 ↗InjurySep 17, 2026Patient Device Interaction Problem
Patient problems: Failure of Implant
MAUDE report 50812261 ↗InjurySep 14, 2026Fracture
Patient problems: Bone Fracture(s)
MAUDE report 50765485 ↗InjurySep 11, 2026Unstable
Patient problems: Joint Laxity
MAUDE report 50744264 ↗InjuryAug 18, 2026Loosening of Implant Not Related to Bone-Ingrowth
Revision Surgery due to Patient had failed/ broken center screw on baseplate.
Patient problems: Incompetent Cervix
MAUDE report 50311012 ↗InjuryJul 27, 2026Break
InjuryJul 6, 2026Device Dislodged or Dislocated
InjuryJun 30, 2026Adverse Event Without Identified Device or Use Problem
InjuryJun 30, 2026Adverse Event Without Identified Device or Use Problem
REVISION SURGERY DUE TO PATIENT HAD POLY SWAP AND WASHOUT FOR INFECTION.
Patient problems: Unspecified Infection
MAUDE report 25673181 ↗InjuryJun 24, 2026Loosening of Implant Not Related to Bone-Ingrowth
REVISION SURGERY - DUE TO PATIENT'S BASEPLATE WAS LOOSE.
Patient problems: Joint Laxity
MAUDE report 25614454 ↗InjuryJun 23, 2026Detachment of Device or Device Component
REVISION SURGERY - DUE TO NICKLE ALLERGY; BROKEN FRAGMENTED PIECES LEFT IN PATIENT.
Patient problems: Foreign Body In Patient
MAUDE report 25601914 ↗InjuryJun 22, 2026Unstable
InjuryJun 22, 2026Unstable
REVISION SURGERY DUE TO BROKEN IMPLANT / LOOSENING.
Patient problems: Failure of Implant; Joint Laxity
MAUDE report 25586571 ↗InjuryJun 11, 2026Adverse Event Without Identified Device or Use Problem
InjuryJun 11, 2026Adverse Event Without Identified Device or Use Problem
InjuryJun 10, 2026Unstable
InjuryJun 9, 2026Unstable
PATIENT COMPLAINED OF PAIN IN HER SURGICAL SHOULDER. AFTER AN X-RAY WAS TAKEN, IT APPEARED AS IF BASEPLATE AND GLENOSPHERE HAD LOOSENED.
Patient problems: Implant Pain; Joint Laxity
MAUDE report 25445762 ↗InjuryJun 8, 2026Unstable; Device Dislodged or Dislocated
REVISION SURGERY DUE TO INSTABILITY / DISLOCATION.
Patient problems: Joint Dislocation; Joint Laxity
MAUDE report 25435163 ↗InjuryJun 1, 2026Patient Device Interaction Problem
REVISION SURGERY DUE TO POTENTIAL INFECTION AND LOOSE BASEPLATE. REMOVED GLENOID COMPONENTS AND CONVERTED TO HEMI.
Patient problems: Joint Laxity; Unspecified Infection
MAUDE report 25356463 ↗InjuryJun 1, 2026Patient Device Interaction Problem
REVISION SURGERY - DUE TO BROKEN CENTRAL SCREW ON BASEPLATE.
Patient problems: Failure of Implant
MAUDE report 25355598 ↗InjuryMay 29, 2026Insufficient Device Problem Information
REVISION SURGERY DUE TO UNKNOWN REASON.
Patient problems: Insufficient Information
MAUDE report 25330059 ↗InjuryMay 27, 2026Device Dislodged or Dislocated
InjuryMay 27, 2026Patient Device Interaction Problem
REVISION SURGERY DUE TO IMPLANT BREAKAGE.
Patient problems: Failure of Implant
MAUDE report 25296448 ↗
Other PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED devices
- Comprehensive Reverse Shoulder 010000589Biomet Orthopedics, LLC · PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED1 recall142 reports
- DELTA XTEND 130738203Depuy (Ireland) · PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED175 reports
- DJO SURGICAL 509-00-432Encore Medical, L.P. · Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented1 recall117 reports
- Alliance® SBGL3007Zimmer, Inc. · PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED162 reports
- DELTA XTEND 130760138Depuy (Ireland) · PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED146 reports
- DELTA XTEND 130790030Depuy (Ireland) · PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED132 reports
- DJO SURGICAL 509-00-436Encore Medical, L.P. · Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented124 reports
- DELTA XTEND 130790024Depuy (Ireland) · PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED122 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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