STEMLESS HUMERAL HEAD 47MM X 18MM X BETA
Received Feb 21, 2025 · Event occurred Jan 30, 2025
Report 1038671-2025-01136 · MDR key 21435972
Device
Generic name
Prosthesis, Total Anatomic Shoulder, Uncemented Metaphyseal Humeral Stem With No
Manufacturer
Exactech, Inc.Catalog number
310-61-47
Product problems
- Device Dislodged or Dislocated
- Insufficient Device Problem Information
- Device Dislodged or Dislocated
- Insufficient Device Problem Information
Patient
65 YR · Male
- Pain
- Subluxation
- Pain
- Subluxation
Narrative
Description of Event or Problem
IT WAS REPORTED THAT THIS PATIENT'S RIGHT SHOULDER WAS REVISED APPROXIMATELY 3 YEARS POST INITIAL OPERATION. PATIENT COMPLAINED OF PAIN AND HAD A FAILED IMPLANT. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT.
Additional Manufacturer Narrative
D10 - CONCOMITANTS: (B)(6), 300-60-02 - STEMLESS HUMERAL COMP LASER CAGE, SIZE 2, (B)(6), 314-13-13 - EQUINOXE CAGE GLENOID MEDIUM, BETA, (B)(6), 319-01-32 - STEINMANN PIN STERILE 3.2MM X 178MM, (B)(6), 531-78-20 - SHOULDR GPS HEX PINS KIT, 09004321074, (B)(6) - GPS IMPLANT KIT V2. H3: CUSTOMER HAS INDICATED THAT THE PRODUCT IS IN PROCESS OF BEING RETURNED FOR INVESTIGATION. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.
Additional Manufacturer Narrative
THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL AND CORRECTED INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED: B7. THE FOLLOWING SECTIONS WERE CORRECTED: B5, H6 - HEALTH EFFECT - CLINICAL CODE, MEDICAL DEVICE PROBLEM CODE, COMPONENT CODE.
Description of Event or Problem
IT WAS REPORTED THAT THIS PATIENT'S SHOULDER WAS REVISED APPROXIMATELY 3 YEARS POST INITIAL OPERATION. PATIENT COMPLAINED OF PAIN AND HAD A FAILED IMPLANT. IT WAS DETERMINED THAT THERE WAS A ROTATOR CUFF TEAR WITH JOINT SUBLUXATION. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT.