DJO SURGICAL 804-06-157Recalls & reported problems
Encore Medical, L.P. · AltiVate Reverse, Small Humeral Stem Implant Inserter Knob · Class 1
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 8
- Deaths reported
- 0
- Injuries reported
- 4
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 00190446269106), received between May 6, 2021 and Jan 16, 2026 — classified as 4 injuries, 4 malfunctions.
The most frequently reported specific device problem is “Break” (2 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.
Reports received per month
Most reported problems
Device problems
- Break2
- No Apparent Adverse Event2
- Detachment of Device or Device Component1
- Difficult to Remove1
- Material Deformation1
- Mechanical Problem1
- Therapeutic or Diagnostic Output Failure1
Patient problems
- Foreign Body In Patient4
- No Clinical Signs, Symptoms or Conditions3
- Insufficient Information1
Recent adverse event reports
The 8 most recent of 8 reports, in the reporter's own words as published by the FDA.
InjuryJan 16, 2026Detachment of Device or Device Component
INSTRUMENT FAILURE - STEM INSERTER KNOB FOR SMALL SHELL BROKE DURING IMPACTING OF THE STEM, RESULTING IN THREADED END BREAKING OFF INTO THE STEM WITH IMPLANT. POLY WAS STILL ABLE TO BE PUT ON, LEAVING THE PIECE IN PATIENT.
Patient problems: Foreign Body In Patient
MAUDE report 24090870 ↗InjuryAug 27, 2025Mechanical Problem; Mechanical Problem
COMPLAINT - PATIENT WAS UNDERGOING A REVERSE SHOULDER ARTHROPLASTY. SURGEON WAS IMPACTING STEM WITH MALLET WHEN THE THREADED INSERTER BROKE OFF IN THE IMPLANT. THERE WAS A 20 MINUTE DELAY IN SURGERY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22909891 ↗MalfunctionApr 8, 2024No Apparent Adverse Event; No Apparent Adverse Event
INSTRUMENT FAILURE - INSTRUMENT BROKE, PIECELEFT IN PATIENT.
Patient problems: Foreign Body In Patient
MAUDE report 19068589 ↗InjuryMar 5, 2024No Apparent Adverse Event; No Apparent Adverse Event
IT WAS REPORTED THERE WAS A 20 MINUTE DELAY IN SURGERY.
Patient problems: Insufficient Information
MAUDE report 18838655 ↗InjuryJun 1, 2023Material Deformation; Material Deformation
INSTRUMENT FAILURE PART LEFT IN THE PATIENT.
Patient problems: Foreign Body In Patient
MAUDE report 17044425 ↗MalfunctionDec 6, 2021Break
INSTRUMENT FAILURE - THE TIP OF THE SCREW BROKE OFF WHEN INSERTING THE STEM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12936843 ↗MalfunctionOct 25, 2021Break; Difficult to Remove
INSTRUMENT FAILURE : WHEN IMPACTING IN SMALL SHELL STEM, INSERTER KNOB BROKE. MORE SPECIFICALLY, THE THREADS THAT THREAD INTO STEM SNAPPED OFF. THEY COULDN'T BE REMOVED, SO WERE LEFT IN STEM. POLY WAS STILL ABLE TO FULLY SEAT INTO STEM.
Patient problems: Foreign Body In Patient
MAUDE report 12694743 ↗MalfunctionMay 6, 2021Therapeutic or Diagnostic Output Failure
INSTRUMENT FAILURE - DUE TO WHEN DISENGAGING THE STEM INSERTER FROM THE STEM, UPON REMOVAL, WE NOTICED SOME THREADS WERE STILL IN THE IMPLANT STEM. CASE WAS COMPLETED WITHOUT ANY HARM TO THE PATIENT OR TIMING. BROKEN INSTRUMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11782864 ↗
Other ORTHOPEDIC MANUAL SURGICAL INSTRUMENT devices
- AML EXCEL 2001-42-000Depuy (Ireland) · ORTHOPEDIC MANUAL SURGICAL INSTRUMENT2,009 reports
- NA 03.010.523Synthes GmbH · ORTHOPEDIC MANUAL SURGICAL INSTRUMENT1,208 reports
- EXPRESSEW 214141Medos International Sàrl · ORTHOPEDIC MANUAL SURGICAL INSTRUMENT1,166 reports
- N/A 9560524Medtronic Sofamor Danek, Inc. · ORTHOPEDIC MANUAL SURGICAL INSTRUMENT866 reports
- INHANCE 6500-11-104Depuy (Ireland) · Orthopedic manual surgical instrument831 reports
- INHANCE 6500-11-102Depuy (Ireland) · Orthopedic manual surgical instrument567 reports
- R3 71364450Smith & Nephew, Inc. · ORTHOPEDIC MANUAL SURGICAL INSTRUMENT520 reports
- N/A 9561524Medtronic Sofamor Danek, Inc. · ORTHOPEDIC MANUAL SURGICAL INSTRUMENT494 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.
How reports and recalls are matched · Editorial policy · Report an error on this page