DJO SURGICAL 521-01-238Recalls & reported problems
Encore Medical, L.P. · TURON PEGGED GLENOID, SZ 38MM, eplus · Class 2 · Implant
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 7
- Deaths reported
- 0
- Injuries reported
- 7
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00888912025096), received between Oct 11, 2017 and Dec 2, 2022 — classified as 7 injuries.
The most frequently reported specific device problem is “Loose or Intermittent Connection” (4 reports).
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.
Most reported problems
Device problems
- Loose or Intermittent Connection4
- Appropriate Device Problem Term/Code Not Available3
- Adverse Event Without Identified Device or Use Problem1
- Contamination1
- Fracture1
Patient problems
- Failure of Implant2
- No Code Available2
- Unspecified Infection2
- Insufficient Information1
- No Clinical Signs, Symptoms or Conditions1
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.
InjuryDec 2, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
REVISION SURGERY - DUE TO CONVERSION OF REVERSE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15901266 ↗InjuryDec 1, 2021Loose or Intermittent Connection; Appropriate Device Problem Term/Code Not Available
REVISION SURGERY - DUE TO LOOSE GLENOID IMPLANT.
Patient problems: Insufficient Information
MAUDE report 12913710 ↗InjuryAug 25, 2021Appropriate Device Problem Term/Code Not Available
REVISION SURGERY - DUE TO FAILED GLENOID CONVERTED TO REVERSE.
Patient problems: Failure of Implant
MAUDE report 12365533 ↗InjuryDec 3, 2019Loose or Intermittent Connection
REVISION SURGERY - DUE TO LOOSENING GLENOID.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 9405180 ↗InjuryMar 19, 2019Appropriate Device Problem Term/Code Not Available
REVISION SURGERY - DUE TO THE PATIENT HAVING AN INFECTION IN SHOULDER. THE SURGEON REMOVED ALL IMPLANTS AND REPLACED WITH A TURON HEMI.
Patient problems: Unspecified Infection
MAUDE report 8434335 ↗InjuryApr 9, 2018Contamination; Loose or Intermittent Connection
REVISION SURGERY - DUE TO THE PATIENT HAVING A LOW GRADE INFECTION, CAUSING LOOSE COMPONENTS.
Patient problems: Failure of Implant; No Code Available; Unspecified Infection
MAUDE report 7408749 ↗InjuryOct 11, 2017Fracture; Loose or Intermittent Connection
REVISION SURGERY - DUE TO A PERI PROSTHETIC FRACTURE DISTAL TO THE HUMERAL STEM THAT OCCURRED DURING THE PRIMARY SURGERY. AS WELL AS A LOOSE GLENOID COMPONENT.
Patient problems: No Code Available
MAUDE report 6941440 ↗
Other Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer + Additive, Cemented devices
- Comprehensive Reverse Shoulder 115310Biomet Orthopedics, LLC · prosthesis, shoulder, semi-constrained, metal/polymer + additive, cemented1 death99 reports
- INHANCE 5120-00-110Depuy (Ireland) · prosthesis, shoulder, semi-constrained, metal/polymer + additive, cemented75 reports
- Comprehensive® Reverse Shoulder XL-115364Biomet Orthopedics, LLC · prosthesis, shoulder, semi-constrained, metal/polymer + additive, cemented1 recall7 reports
- Comprehensive® Reverse Shoulder XL-115366Biomet Orthopedics, LLC · prosthesis, shoulder, semi-constrained, metal/polymer + additive, cemented1 recall4 reports
- Comprehensive® Reverse Shoulder 180550Biomet Orthopedics, LLC · prosthesis, shoulder, semi-constrained, metal/polymer + additive, cemented2 deaths43 reports
- Comprehensive® Reverse Shoulder 180551Biomet Orthopedics, LLC · prosthesis, shoulder, semi-constrained, metal/polymer + additive, cemented42 reports
- DJO SURGICAL 521-07-246Encore Medical, L.P. · prosthesis, shoulder, semi-constrained, metal/polymer + additive, cemented42 reports
- Comprehensive® 110031399Zimmer, Inc. · prosthesis, shoulder, semi-constrained, metal/polymer + additive, cemented1 death36 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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