PRIMARecalls & reported problems across all models

We found 4 models of PRIMA by Limacorporate SPA in the FDA's device registry (GUDID). Together they are named in 4 adverse event reports in the FDA's MAUDE database, received between Dec 5, 2023 and May 4, 2026 — classified as 2 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Defective Device” (2 reports).

2 FDA recall records name at least one of these models by its device identifier, 2 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

PRIMA recalls

FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.

1. 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-2025-2025 · Root cause: Process design · Recall details · FDA record ↗

2. 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 · Recall details · FDA record ↗

Most reported PRIMA problems

PRIMA models

4 models, most reported first. Each model has its own page with its reports, recalls and device details.

• PRIMA 1367.15.702

  Shoulder Prosthesis, Reverse Configuration
  1 recall2 reports
• PRIMA 1367.15.704

  Shoulder Prosthesis, Reverse Configuration
  1 recall0 reports
• PRIMA 1367.54.100

  Shoulder Prosthesis, Reverse Configuration
  1 report
• PRIMA 1367.54.200

  Shoulder Prosthesis, Reverse Configuration
  1 report

Recent PRIMA adverse event reports

The 4 most recent reports across all models, 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 ↗
• 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 ↗
• 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 Limacorporate SPA products

• PRIMA TT Glenoid16 models · 11 reports · 3 recalls
• SMR Shoulder67 models · 148 reports
• TEMA Elbow15 models · 23 reports · 2 recalls
• SMR System47 models · 97 reports
• SMR TT Hybrid Glenoid3 models · 2 reports · 1 recall