PRIMA 1367.54.100Recalls & reported problems
Limacorporate SPA · PRIMA - Reverse Insert # SHORT Dia.36mm 0° Corr. · Class 2 · Implant
All models of PRIMA (4)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 08033390202954), received between May 4, 2026 and May 4, 2026 — classified as 1 injury.
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 16, 2026.
Reports received per month
Most reported problems
Device problems
- Device Dislodged or Dislocated1
Patient problems
- Joint Dislocation1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryMay 4, 2026Device Dislodged or Dislocated
REVISION SURGERY WAS PERFORMED ON (B)(6) 2026 DUE TO SHOULDER DISLOCATION. ORIGINAL SURGERY WAS PERFORMED ON THE SAME DAY TO IMPLANT A COMBINATION OF FOLLOWING PRIMA HUMERAL COMPONENTS AND DJO ALTIVATE REVERSE GLENOID: PRIMA SHORT STEM PLUS #1 (PN 1357.14.228, LOT 2524131, STERILIZATION (B)(6)) PRIMA REVERSE TRAY #SHORT (PN 1367.15.010, LOT 2518444, STERILIZATION (B)(6)) PRIMA LIMAVIT REVERSE INSERT #SHORT DIA 36MM CORR 0° (PN 1367.54.100, LOT 25AT2RE, STERILIZATION (B)(6)). DJO MODULAR BASEPLATER AND TAPER KIT (PN 508-65-001). DJO RSP GLENOID HEAD AND RETAINING SCREW 2MM LATERAL OFFSET SZ 36MM (PN 508-36-103). PATIENT DISLOCATED AND THE ABOVE MENTIONED PRIMA REVERSE TRAY AND LINER WERE REPLACED: SAME SIZE OF TRAY WAS CHOSEN BY SURGEON, WHILE THE NEW LINER WAS REPLACED WITH A RETENTIVE ONE (PN 1367.54.101). SURGERY WAS COMPLETED AS INTENDED. PATIENT IS MALE, DATE OF BIRTH (B)(6) 1957. THE EVENT OCCURRED IN THE UNITED STATES.
Patient problems: Joint Dislocation
MAUDE report 25067086 ↗
Other Shoulder Prosthesis, Reverse Configuration devices
- DJO SURGICAL 508-36-101Encore Medical, L.P. · shoulder prosthesis, reverse configuration508 reports
- DJO SURGICAL 508-32-101Encore Medical, L.P. · shoulder prosthesis, reverse configuration433 reports
- DJO SURGICAL 508-32-103Encore Medical, L.P. · shoulder prosthesis, reverse configuration421 reports
- DJO SURGICAL 509-00-036Encore Medical, L.P. · shoulder prosthesis, reverse configuration1 recall259 reports
- DJO SURGICAL 508-32-104Encore Medical, L.P. · shoulder prosthesis, reverse configuration1 recall203 reports
- DJO SURGICAL 509-00-032Encore Medical, L.P. · shoulder prosthesis, reverse configuration233 reports
- DELTA XTEND 130760000Depuy (Ireland) · shoulder prosthesis, reverse configuration223 reports
- DJO SURGICAL 508-00-032Encore Medical, L.P. · shoulder prosthesis, reverse configuration122 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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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