UNKNOWN CPT STEM
Received Jul 21, 2026 · Event occurred Jul 7, 2026
Report 0001822565-2026-02655 · MDR key 25894562
Device
Generic name
Prosthesis, Hip
Manufacturer
Zimmer Biomet, Inc.Catalog number
UNKNOWN CPT STEM
Lot number
UNKNOWN
Product problems
- Loosening of Implant Not Related to Bone-Ingrowth
Patient
Not reported
- Insufficient Information
Narrative
Additional Manufacturer Narrative
(B)(4). G2: FOREIGN ¿ AUSTRALIA. H6: SUGGESTED COMPONENT CODE: MECHANICAL (G04) - STEM. THE CUSTOMER INDICATED THAT THE PRODUCT WAS DISCARDED AS A BIOHAZARD; THEREFORE, IT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A SUPPLEMENTAL MDR WILL BE SUBMITTED.
Description of Event or Problem
IT WAS REPORTED THAT PATIENT UNDERWENT A HIP REVISION APPROXIMATELY 1-YEAR POST-IMPLANTATION DUE TO LOOSENING. IT WAS NOTED THAT THE CPT STEM WAS REVISED. IT WAS CONFIRMED THAT NO FURTHER INFORMATION COULD BE PROVIDED.