RINGLOC BI-POLAR 28X45MM
Received Jul 21, 2026 · Event occurred Jul 3, 2026
Report 0001825034-2026-02156 · MDR key 25888434
Device
Generic name
Prosthesis, Hip
Manufacturer
Zimmer Biomet, Inc.Catalog number
11-165214
Lot number
67401041
Product problems
- Device Dislodged or Dislocated
Patient
NA · Unknown
- Fall
- Joint Dislocation
Narrative
Description of Event or Problem
IT WAS REPORTED THAT THE PATIENT UNDERWENT A HIP REVISION APPROXIMATELY 38 DAYS POST-IMPLANTATION DUE TO JOINT DISLOCATION FOLLOWING A FALL THAT OCCURRED WITHIN ONE MONTH OF THE INITIAL OPERATION. IT WAS NOTED THAT THE SURGEON ATTEMPTED A CLOSED HIP REDUCTION; HOWEVER, THE HEAD AND CUP SEPARATED DURING THE PROCEDURE. SUBSEQUENTLY, THE SURGEON DECIDED TO PERFORM AN OPEN REVISION TO CORRECT THE JOINT DISLOCATION. IT WAS CONFIRMED THAT NO FURTHER INFORMATION COULD BE PROVIDED.
Additional Manufacturer Narrative
(B)(4) D10: UNKNOWN FEMORAL HEAD ITEM: UNKNOWN LOT: UNKNOWN . G2: FOREIGN ¿ TAIWAN CUSTOMER HAS INDICATED THAT THE PRODUCT IS IN PROCESS OF BEING RETURNED TO ZIMMER BIOMET FOR INVESTIGATION. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A SUPPLEMENTAL MDR WILL BE SUBMITTED.