CMD 22-1166 PROMADE ELBOW

Additional Manufacturer Narrative

REVIEW OF MANUFACTURING RECORDS RELATED TO LOT NUMBER 2413260 DID NOT HIGHLIGHT ANY PRE-EXISTING ANOMALY OR NON-CONFORMITY. THE MANUFACTURER WILL SUBMIT A FINAL REPORT AS SOON AS THE INVESTIGATION IS COMPLETED.

Description of Event or Problem

CUSTOM MADE HUMERAL COMPONENT (CMD 22-1166 HUMERAL IMPLANT - PART CODE 9617.25.31F, LOT. 2413260, STER. (B)(4), THAT WAS ORIGINALLY IMPLANTED ON (B)(6) 2024, HAS BEEN REPORTED LOOSE AND REQUIRES REVISION SURGERY. THE SURGEON HAS REQUESTED A REPLACEMENT CUSTOM-MADE DEVICE (CMD 26-1246), SPECIFYING THAT THE PATIENT PRESENTS WITH ABSENCE OF METAPHYSEAL BONE. DURING ORIGINAL PROCEDURE PERFORMED ON (B)(6) 2024, THE PATIENT WAS IMPLANTED WITH THE FOLLOWING ADDITIONAL TEMA COMPONENTS: ULNAR STEM #U6.5 (PART CODE 1575.14.040, LOT. 2002823, STER. (B)(4); ULNAR BODY LARGE RIGHT + SCREW (PART CODE 1552.14.021, LOT. 2309994, STER. (B)(4); ULNAR LINER - LARGE RIGHT (PART CODE 1560.50.021, LOT. 19AT1CS, STER. (B)(4); HUMERAL BODY LARGE RIGHT+SCREW (PART CODE 1550.15.121, LOT. 2022001, STER. (B)(4); AXLE #LARGE (PART CODE 1590.15.020, LOT. 2227696, STER. (B)(4). REVISION SURGERY HAS NOT YET BEEN PLANNED. PATIENT IS FEMALE, DATE OF BIRTH (B)(6)1965. THE EVENT OCCURRED IN THE UNITED STATES.