PRIMA 1367.54.200Recalls & reported problems
Limacorporate SPA · PRIMA - Reverse Insert # SHORT Dia.40mm 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 08033390203340), received between Dec 5, 2023 and Dec 5, 2023 — 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.
InjuryDec 5, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated
SHOULDER REVISION SURGERY WAS PERFORMED ON (B)(6) 2023 FOR DISLOCATION. PATIENT DISLOCATED POST OP AND CAUSE WAS A STRETCHED-OUT SHOULDER CAPSULE. DEVICE WAS REVISED TO A THICKER COMPONENT. REVISION WAS A SUCCESS WITH NO COMPLICATIONS. AGENT STATED PATIENT ANATOMY IS SUSPECTED BUT THE DEVICES DID NOT FAIL. PREVIOUS SURGERY - (B)(6) 2023. PATIENT - MALE. DATE OF BIRTH - (B)(6). EVENT HAPPENED IN USA. EXPLANTED COMPONENTS. PRIMA REVERSE TRAY #SHORT, COMMERCIAL CODE 1367.15.010 - LOT #2308370 - STER. #2300107 . PRIMA REV.INSERT #SHORT D.40MM, COMMERCIAL CODE 1367.54.200 - LOT #23AT1BE - STER. #2300147.
Patient problems: Joint Dislocation
MAUDE report 18266826 ↗
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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