DJO SURGICAL 530-06-108Recalls & reported problems
Encore Medical, L.P. · ALTIVATE REVERSE, HUMERAL STEM, STANDARD SHELL, SZ 6X108mm · Class 2 · Implant
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 14
- Deaths reported
- 0
- Injuries reported
- 14
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 00888912168243), received between Oct 18, 2016 and Apr 23, 2026 — classified as 14 injuries.
The most frequently reported specific device problem is “Fracture” (1 report).
3 other recalls cover devices cleared under the same FDA submission (K141990); 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
- Fracture1
- Loose or Intermittent Connection1
- Positioning Problem1
- Unstable1
Patient problems
- Joint Laxity4
- Bone Fracture(s)3
- Implant Pain2
- No Code Available2
- Pain2
- No Known Impact Or Consequence To Patient1
- Unspecified Infection1
Recent adverse event reports
The 14 most recent of 14 reports, in the reporter's own words as published by the FDA.
InjuryApr 23, 2026Fracture
REVISION SURGERY - DUE TO POST FRACTURE REVERSE CONSTRUCT. CEMENTED IN STEM FELL INTO VALGUS 3 YRS POST OP. PERFORATED HUMERAL CORTEX MEDIALLY. STEM REPLACED WITH STRYKER STEM AND 36MM GLENOSPHERE.
Patient problems: Bone Fracture(s)
MAUDE report 24974725 ↗InjuryMar 14, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryMar 10, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryOct 9, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
REVISION SURGERY - DUE TO PATIENT PRESENTED SEVEN YEARS POST OP OF REVERSE TOTAL SHOULDER WITH COMPLAINTS OF PAIN.
Patient problems: Implant Pain; Pain
MAUDE report 20413520 ↗InjuryApr 13, 2024Unstable; Adverse Event Without Identified Device or Use Problem; Unstable; Adverse Event Without Identified Device or Use Problem
InjuryFeb 16, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryJan 12, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryDec 14, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
REVISION SURGERY - DUE TO LOOSENING & INSTABILITY.
Patient problems: Joint Laxity
MAUDE report 18332394 ↗InjuryJul 6, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryJan 6, 2021Appropriate Device Problem Term/Code Not Available
REVISION SURGERY - PERIPROSTHETIC HUMERAL FRACTURE.
Patient problems: Bone Fracture(s)
MAUDE report 11125480 ↗InjuryAug 13, 2020Appropriate Device Problem Term/Code Not Available
SECOND REVISION SURGERY - THE REASON IS UNKNOWN.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 10401480 ↗InjuryJan 28, 2020Positioning Problem
REVISION SURGERY: PATIENT WAS EXPERIENCING PAIN, STEM APPEARED TO BE PRESSING AGAINST CORTICAL BONE LATERALLY.
Patient problems: Pain
MAUDE report 9636756 ↗InjuryApr 18, 2018Loose or Intermittent Connection
REVISION SURGERY - DUE TO THE STEM BECOMING LOOSE.
Patient problems: No Code Available
MAUDE report 7441114 ↗InjuryOct 18, 2016Adverse Event Without Identified Device or Use Problem
DUE TO THE PATIENT BEING NON COMPLIANT WITH THE SURGEONS POST- OPERATION ORDERS. INITIAL REVISION OF HEMI ARTHROPLASTY TO A REVERSE WAS A PRESS-FIT VERSUS CEMENTING.
Patient problems: No Code Available
MAUDE report 6038233 ↗
Recalls under the same FDA submission
These recalls involve devices cleared under K141990. One submission often covers many models, so check the product and lot details in each record.
- Z-1241-2018 · Jan 30, 2018 · TerminatedAltiVate Reverse INSTRUMENTATION, HUMERAL SOCKET SHELL TRIAL, STANDARD, REF 804-06-152, Qty: 01, Encore Medical, LP Orthopedic surgical instrument. Product Usage: The humeral soc
- Z-0626-2016 · Dec 8, 2015 · TerminatedAltiVate Reverse Humeral Broach, Size 10 Catalog number 804-06-040, Size 14 Catalog number 804-06-044, and Size 16 Catalog number 804-06-046. Orthopedic surgical instrument for us
- Z-0131-2016 · Sep 15, 2015 · TerminatedAltiVate Humeral Socket Shell Trial, Part Number 804-06-052 The glenoid baseplate is intended for cementless application with addition of screws for fixation. The humeral stem is
Other Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented devices
- DJO SURGICAL 509-02-032Encore Medical, L.P. · PROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED364 reports
- DELTA XTEND 130790036Depuy (Ireland) · PROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED171 reports
- DELTA XTEND 130770018Depuy (Ireland) · PROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED159 reports
- TRIGEN 71118200Smith & Nephew, Inc. · PROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED123 reports
- DJO SURGICAL 509-02-432Encore Medical, L.P. · PROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED119 reports
- DELTA XTEND 130738206Depuy (Ireland) · PROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED116 reports
- COMPREHENSIVE SHOULDER SYSTEM 113633Biomet Orthopedics, LLC · PROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED2 recalls4 reports
- DELTA XTEND 130742206Depuy (Ireland) · PROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED99 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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