DJO SURGICAL 520-42-216Recalls & reported problems
Encore Medical, L.P. · AltiVate Anatomic, Neutral Humeral Head, 42X16 · Class 2 · Implant
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 13
- Deaths reported
- 0
- Injuries reported
- 13
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 00190446176091), received between Nov 1, 2019 and Aug 17, 2026 — classified as 13 injuries.
The most frequently reported specific device problem is “Device Dislodged or Dislocated” (1 report).
6 other recalls cover devices cleared under the same FDA submission (K162024); 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
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem9
- Appropriate Device Problem Term/Code Not Available2
- Device Dislodged or Dislocated1
- No Apparent Adverse Event1
Patient problems
- Joint Dislocation3
- Unspecified Infection3
- Limb Fracture2
- Implant Pain1
- Insufficient Information1
- Joint Laxity1
- Loss of Range of Motion1
- No Code Available1
Recent adverse event reports
The 13 most recent of 13 reports, in the reporter's own words as published by the FDA.
InjuryAug 17, 2026Adverse Event Without Identified Device or Use Problem
Revision Surgery - Due to possible Infection.
Patient problems: Unspecified Infection
MAUDE report 50289090 ↗InjuryDec 19, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryJan 29, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryJul 19, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryJan 5, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryNov 14, 2023No Apparent Adverse Event; No Apparent Adverse Event
IT WAS REPORTED THERE WAS A 25 MINUTE DELAY IN SURGERY.
Patient problems: Insufficient Information
MAUDE report 18136941 ↗InjuryJul 10, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryJun 10, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryMay 3, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryApr 14, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjurySep 5, 2020Appropriate Device Problem Term/Code Not Available
REVISION SURGERY - PATIENT WAS STIFF MINIMAL RANGE OF MOTION, WENT BACK IN WITH SMALLER HEAD AND GLENOID.
Patient problems: Loss of Range of Motion
MAUDE report 10498122 ↗InjuryAug 19, 2020Appropriate Device Problem Term/Code Not Available
REVISION SURGERY - THE PATIENT DISLOCATED AND THE SURGEON DECIDED TO REPLACE THE PREVIOUS IMPLANTS AND PERFORM A REVERSE SHOULDER ARTHROPLASTY.
Patient problems: Joint Dislocation
MAUDE report 10426218 ↗InjuryNov 1, 2019Device Dislodged or Dislocated
Recalls under the same FDA submission
These recalls involve devices cleared under K162024. One submission often covers many models, so check the product and lot details in each record.
- Z-2331-2021 · Jun 28, 2021 · Open, ClassifiedAltiVate Anatomic Shoulder System for the following Part Numbers: 1. Part # 520-08-00, Rev. C., 2. Part # 520-10-000, 3. Part # 520-12-000, 4. Part # 520-14-000, 5. Part # 520-16
- Z-1257-2018 · Jan 29, 2018 · CompletedAltivate Anatomic(TM) INSTRUMENTATION, PEGGED GLENOID TRIAL, SIZE 42mm, REF 804-07-420 Product Usage: The AltiVate Anatomic Shoulder System is a total shoulder system indicated as
- Z-1256-2018 · Jan 29, 2018 · CompletedAltivate Anatomic(TM) INSTRUMENTATION, PEGGED GLENOID TRIAL, SIZE 38mm, REF 804-07-380 Product Usage: The AltiVate Anatomic Shoulder System is a total shoulder system indicated as
- Z-1258-2018 · Jan 29, 2018 · CompletedAltivate Anatomic(TM) INSTRUMENTATION, PEGGED GLENOID TRIAL, SIZE 46mm, REF 804-07-460 Product Usage: The AltiVate Anatomic Shoulder System is a total shoulder system indicated as
- Z-1260-2018 · Jan 29, 2018 · CompletedAltivate Anatomic(TM) INSTRUMENTATION, PEGGED GLENOID TRIAL, SIZE 54mm, REF 804-07-540 Product Usage: The AltiVate Anatomic Shoulder System is a total shoulder system indicated
- Z-1259-2018 · Jan 29, 2018 · CompletedAltivate Anatomic(TM) INSTRUMENTATION, PEGGED GLENOID TRIAL, SIZE 50mm, REF 804-07-500 Product Usage: The AltiVate Anatomic Shoulder System is a total shoulder system indicated as
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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