TEMA Elbow 1552.14.020Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 08033390126441), received between Jul 26, 2024 and Jul 26, 2024 — classified as 2 injuries.

The most frequently reported specific device problem is “Patient Device Interaction Problem” (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 16, 2026.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryJul 26, 2024Patient Device Interaction Problem; Patient Device Interaction Problem

  AFTER AN IRRIGATION AND DEBRIDEMENT PROCEDURE PERFORMED ON (B)(6) 2024, THE FOLLOW-UP VISIT ON (B)(6) 2024 HIGHLIGHTED PERSISTENT LUCENCY ABOUT THE PROXIMAL PROSTHESIS, POSSIBLE SYMPTOM OF LOOSENING (INFECTION NOT EXCLUDED). THE NEXT SURGERY WAS PERFORMED ON (B)(6) 2024, DUE TO INFECTION. THE FOLLOWING COMPONENTS WERE REMOVED AND REPLACED WITH THIRD-PARTY COMPONENTS AND AN ANTIBIOTIC SPACER: SMR MODULAR AUGMENT H.20 MM (PART CODE 1314.15.020, LOT NUMBER 2101626, STERILIZATION NUMBER (B)(4). ULNAR BODY LARGE LEFT + SCREW (PART CODE 1552.14.020, LOT NUMBER 2310984, STERILIZATION NUMBER (B)(4). ULNAR LINER - LARGE LEFT TEMA (PART CODE 1560.50.020, LOT NUMBER 18AT1Q3, STERILIZATION NUMBER (B)(4). AXLE #LARGE (PART CODE 1590.15.020, LOT NUMBER 2227696, STERILIZATION NUMBER (B)(4). CMD 22-1325 ULNAR AUGMENT (PART CODE 9618.14.0Q3, LOT NUMBER 2313059, STERILIZATION NUMBER (B)(4). CMD 22-1325 ULNAR FLANGE (PART CODE 9618.14.0Q4, LOT NUMBER 2313041, STERILIZATION NUMBER (B)(4). CMD 22-1325 HUMERAL STEM (PART CODE 9618.15.07U, LOT NUMBER 2313187, STERILIZATION NUMBER (B)(4). CMD 22-1325 HUMERAL IMPLANT (PART CODE 9618.15.07V, LOT NUMBER 2313191, STERILIZATION NUMBER (B)(4). CMD 22-1325 ULNAR

  Patient problems: Medical device site infection

  MAUDE report 19838074 ↗
• InjuryJul 26, 2024Patient Device Interaction Problem; Patient Device Interaction Problem

  AFTER A REVISION SURGERY, DURING THE FOLLOW-UP VISIT PERFORMED ON (B)(6) 2024, THE PATIENT REPORTED INCREASING PAIN AND FLUID COLLECTION WAS NOTICED. THE SURGEON RECOMMENDED AN IRRIGATION AND DEBRIDEMENT PROCEDURE AND CULTURES. THEREFORE, THE NEXT REVISION SURGERY WAS PERFORMED ON (B)(6) 2024, DUE TO SUSPECTED INFECTION. A CEMENT PLATE MADE WITH ANTIMICROBIAL CEMENT WAS IMPLANTED. THE FOLLOWING COMPONENTS, ALREADY IMPLANTED, WERE LEFT IN SITU: SMR MODULAR AUGMENT H.20 MM (PART CODE: 1314.15.020, LOT NUMBER: 2101626, STERILIZATION NUMBER: 2200113). ULNAR BODY LARGE LEFT + SCREW (PART CODE: 1552.14.020, LOT NUMBER: 2310984, STERILIZATION NUMBER: 2300136). ULNAR LINER - LARGE LEFT TEMA (PART CODE: 1560.50.020, LOT NUMBER: 18AT1Q3, STERILIZATION NUMBER: 1900225). AXLE #LARGE (PART CODE: 1590.15.020, LOT NUMBER: 2227696, STERILIZATION NUMBER: 2300054). CMD 22-1325 ULNAR AUGMENT (PART CODE: 9618.14.0Q3, LOT NUMBER: 2313059, STERILIZATION NUMBER: 2300129). CMD 22-1325 ULNAR FLANGE (PART CODE: 9618.14.0Q4, LOT NUMBER: 2313041, STERILIZATION NUMBER: 2300129). CMD 22-1325 HUMERAL STEM (PART CODE: 9618.15.07U, LOT NUMBER: 2313187, STERILIZATION NUMBER: 2300125). CMD 22-1325 HUMERAL IMPLANT (P

  Patient problems: Implant Pain

  MAUDE report 19836320 ↗