DJO SURGICAL 521-01-246Recalls & reported problems
Encore Medical, L.P. · TURON PEGGED GLENOID, SZ 46MM, eplus · Class 2 · Implant
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 9
- Deaths reported
- 0
- Injuries reported
- 9
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 00888912145374), received between Aug 23, 2017 and Mar 2, 2026 — classified as 9 injuries.
The most frequently reported specific device problem is “Device Dislodged or Dislocated” (1 report).
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
- Appropriate Device Problem Term/Code Not Available4
- Adverse Event Without Identified Device or Use Problem2
- Device Dislodged or Dislocated1
- Human-Device Interface Problem1
- Improper or Incorrect Procedure or Method1
- Naturally Worn1
Patient problems
- Failure of Implant4
- Joint Laxity2
- Insufficient Information1
- Joint Dislocation1
- No Code Available1
- Unspecified Infection1
Recent adverse event reports
The 9 most recent of 9 reports, in the reporter's own words as published by the FDA.
InjuryMar 2, 2026Naturally Worn
InjurySep 10, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
REVISION SURGERY - DUE TO IMPLANT FAILURE.
Patient problems: Failure of Implant
MAUDE report 20186472 ↗InjuryDec 27, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryNov 16, 2021Appropriate Device Problem Term/Code Not Available
REVISION SURGERY - DUE TO FAILED SUBSCAP.
Patient problems: Insufficient Information
MAUDE report 12823908 ↗InjuryAug 9, 2021Appropriate Device Problem Term/Code Not Available
REVISION SURGERY - DUE TO POST OPERATION SUB SCAP FAILURE.
Patient problems: Failure of Implant
MAUDE report 12298419 ↗InjuryJun 21, 2019Appropriate Device Problem Term/Code Not Available
REVISION SURGERY - DUE TO PATIENT HAVING INFECTION AND IMPLANTING REVERSE.
Patient problems: Unspecified Infection
MAUDE report 8722988 ↗InjuryApr 27, 2018Device Dislodged or Dislocated
REVISION SURGERY - DUE TO THE PATIENT HAVING DISLOCATED.
Patient problems: Joint Dislocation; No Code Available
MAUDE report 7469362 ↗InjuryAug 23, 2017Improper or Incorrect Procedure or Method; Human-Device Interface Problem
REVISION SURGERY - THE SURGEON FOUND THE PATIENT NON-COMPLIANT WHICH CAUSED A FAILURE OF THE SUBSCAP/CUFF.
Patient problems: Failure of Implant
MAUDE report 6814997 ↗InjuryAug 23, 2017Appropriate Device Problem Term/Code Not Available
REVISION SURGERY - DUE TO ALL OF THE PREVIOUS IMPLANTS HAVING TO BE REMOVED. THE PATIENT HAD A FAILED ROTATOR CUFF THAT HAD TO BE REVISED TO A REVERSE SHOULDER.
Patient problems: Failure of Implant
MAUDE report 6814591 ↗
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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