PRIMA 1367.15.702Recalls & reported problems
Limacorporate SPA · PRIMA - 2mm ECCENTRICAL Adaptor with Screw · Class 2 · Implant
1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 08033390201827), received between Apr 30, 2025 and Apr 30, 2025 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Defective Device” (2 reports).
1 FDA recall record name this device's identifier, 1 still open.
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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Recalls naming this device
- May 19, 2025Open, Classified
There is the potential that the eccentrical adaptor with screw, black laser marking, use to identify the position may be missing.
Z-2024-2025 · Root cause: Process design · FDA record ↗
Most reported problems
Device problems
- Defective Device2
Patient problems
- No Clinical Signs, Symptoms or Conditions2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionApr 30, 2025Defective Device; Defective Device
INTRA-OPERATIVE ISSUE WAS DISCOVERED DURING A SURGERY PERFORMED ON (B)(6)2025, RELATED TO THE FOLLOWING COMPONENT: - PRIMA 2MM ECCENTRICAL ADAPTOR (PART CODE 1367.15.702, LOT NUMBER 2416658, STERILIZATION 2400195). THE BLACK LASER MARKING MEANT TO IDENTIFY THE POSITION OF THE OFFSET IS REPORTED AS NOT PRESENT IN THE LAST 2 CASES. THE SURGEON PROCEEDED ANYWAY TO IMPLANT THE DEVICE. THE PATIENT INVOLVED IN THE EVENT IS A FEMALE, DATE OF BIRTH (B)(6)1948. THE EVENT HAPPENED IN THE UNITED STATES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21934152 ↗MalfunctionApr 30, 2025Defective Device; Defective Device
INTRA-OPERATIVE ISSUE WAS DISCOVERED DURING A SURGERY PERFORMED ON (B)(6) 2025, RELATED TO THE FOLLOWING COMPONENT: PRIMA 2MM ECCENTRICAL ADAPTOR (PART CODE 1367.15.702, LOT NUMBER 2416658, STERILIZATION (B)(4). THE BLACK LASER MARKING MEANT TO IDENTIFY THE POSITION OF THE OFFSET IS REPORTED AS NOT PRESENT IN THE LAST 2 CASES. THE SURGEON PROCEEDED ANYWAY TO IMPLANT THE DEVICE. THE PATIENT INVOLVED IN THE EVENT IS A FEMALE, DATE OF BIRTH (B)(6) 1954. THE EVENT HAPPENED IN THE UNITED STATES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21933700 ↗
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: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.