CPT 12/14 STEM SIZE 1 COCR
Received Jun 23, 2026 · Event occurred May 29, 2026
Report 0002648920-2026-00120 · MDR key 25596022
Device
Generic name
Prosthesis, Hip
Manufacturer
Zimmer Manufacturing B.v.Catalog number
00811400100
Lot number
64464788
Product problems
- Adverse Event Without Identified Device or Use Problem
Patient
63 YR · Male
- Periprosthetic fracture
Narrative
Additional Manufacturer Narrative
(B)(4). H10: G7 NEUTRAL E1 LINER 36MM F. ITEM: 010000858. LOT: 6540483. G7 SCREW 6.5MM X 30MM. ITEM: 010000999. LOT: 6630191. G7 SCREW 6.5MM X 30MM. ITEM: 010000999. LOT: 6514781. G7 BONEMASTER LTD ACET SHL 54F. ITEM: 010000704. LOT: 6697800. ALLEN MEDULLARY CEMENT PLUGS 1-20 MM DIAMETER FLANGE/10 MM DIAMETER CORE STORE IN COOL DRY PLACE. ITEM: 00801102020. LOT: 64545191. G2: FOREIGN ¿ AUSTRALIA . H6: SUGGESTED COMPONENT CODE: MECHANICAL (G04) - STEM. THE PRODUCT WAS REQUESTED BUT WAS NOT RETURNED BY THE HOSPITAL AND WILL THEREFORE NOT BE SENT 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 THE PATIENT UNDERWENT A HIP REVISION APPROXIMATELY 6 YEARS POST IMPLANTATION DUE TO A PERIPROSTHETIC FRACTURE. IT WAS CONFIRMED THAT NO FURTHER INFORMATION COULD BE PROVIDED.