DJO SURGICAL 509-00-432Recalls & reported problems
Encore Medical, L.P. · RSP HUMERAL SOCKET INSERT, 32MM +4MM, STANDARD HXe-plus · 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 Surgical shoulder implant insert has 116 adverse event reports on file. Many describe infection, joint dislocation or instability, and several describe revision surgery, including one after the plastic insert was swapped. The reports include no deaths and 116 injuries. There is 1 open recall, which began in January 2026 over incorrect labels on some knee and shoulder socket implants.
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
- 117
- Deaths reported
- 0
- Injuries reported
- 117
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 117 adverse event reports that list this exact device (DI 00888912144575), received between Jan 12, 2016 and Sep 17, 2026 — classified as 117 injuries.
The most frequently reported specific device problem is “Unstable” (19 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
- Jan 15, 2026Class IIOpen, Classified
Knee and Humeral socket implants contain incorrect labeling.
Z-1458-2026 · Root cause: Process control · Recall details · FDA record ↗
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem54
- Appropriate Device Problem Term/Code Not Available34
- Unstable19
- Device Dislodged or Dislocated18
- Loose or Intermittent Connection4
- Contamination1
- Fracture1
- Loosening of Implant Not Related to Bone-Ingrowth1
Patient problems
- Unspecified Infection43
- Joint Dislocation22
- Joint Laxity18
- No Code Available14
- Insufficient Information10
- Failure of Implant5
- No Known Impact Or Consequence To Patient5
- Pain4
Recent adverse event reports
The 25 most recent of 117 reports, in the reporter's own words as published by the FDA.
InjurySep 17, 2026Device Dislodged or Dislocated
Patient problems: Joint Dislocation
MAUDE report 50812262 ↗InjurySep 13, 2026Adverse Event Without Identified Device or Use Problem
Patient problems: Unspecified Infection
MAUDE report 50747925 ↗InjurySep 10, 2026Unstable
Patient problems: Joint Laxity
MAUDE report 50724619 ↗InjuryJul 6, 2026Patient Device Interaction Problem
REVISION SURGERY DUE TO UNSTABLE AND INFECTED SHOULDER.
Patient problems: Joint Laxity; Unspecified Infection
MAUDE report 25727442 ↗InjuryMay 26, 2026Adverse Event Without Identified Device or Use Problem
REVISION SURGERY DUE TO INFECTED JOINT, WASHOUT AND IMPLANTS CHANGE. SINGLE STAGE REVISION.
Patient problems: Unspecified Infection
MAUDE report 25276477 ↗InjuryMay 26, 2026Adverse Event Without Identified Device or Use Problem
REVISION SURGERY DUE TO INFECTED. FULL REMOVAL, THE SURGEON PUT IN A SPACER.
Patient problems: Unspecified Infection
MAUDE report 25276472 ↗InjuryMay 19, 2026Device Dislodged or Dislocated
REVISION SURGERY DUE TO SHOULDER DISLOCATION.
Patient problems: Joint Dislocation
MAUDE report 25225294 ↗InjuryMar 20, 2026Device Dislodged or Dislocated
InjuryJan 13, 2026Unstable
InjuryJan 6, 2026Unstable
REVISION SURGERY - DUE TO INSTABILITY AND POSSIBPLE INFECTION.
Patient problems: Joint Laxity; Unspecified Infection
MAUDE report 23986275 ↗InjuryDec 8, 2025Unstable; Unstable
InjuryNov 26, 2025Unstable; Unstable
InjuryJul 25, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryJul 24, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryJul 9, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryJul 3, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryJun 20, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryJun 5, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryMay 28, 2025Unstable; Adverse Event Without Identified Device or Use Problem; Unstable; Adverse Event Without Identified Device or Use Problem
InjuryMar 18, 2025Unstable; Adverse Event Without Identified Device or Use Problem; Unstable; Adverse Event Without Identified Device or Use Problem
InjuryJan 30, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryJan 28, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryJan 28, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryJan 22, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryJan 10, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
REVISION SURGERY - DUE TO PATIENT PRESENTED WITH POSSIBLE INFECTION. POLY SWAP. AND GLENOID HEAD SWAP.
Patient problems: Unspecified Infection
MAUDE report 21132039 ↗
Other Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented devices
- DJO SURGICAL 508-32-204Encore Medical, L.P. · PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED1 recall544 reports
- 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
- 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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