HIP MOLD STEM W/REINF 9X125
Received May 20, 2026 · Event occurred Oct 13, 2025
Report 0001825034-2026-01356 · MDR key 25231005
Device
Generic name
Bone Cement, Antibiotic
Manufacturer
Zimmer Biomet, Inc.Catalog number
431190
Lot number
66510982
Product problems
- Adverse Event Without Identified Device or Use Problem
Patient
NA · Male
- Bone Fracture(s)
Narrative
Additional Manufacturer Narrative
(B)(4). H10: FREEDOM CONSTR HD 36MM T1 STD, ITEM: 11-107018, LOT: 67230805. FREEDOM ALL POLY CUP 50MM, ITEM: 11-107122, LOT: 67107174. UNKNOWN SCREWS, UNKNOWN CEMENT, UNKNOWN 3.5MM RECON PLATE & SCREWS. H6: SUGGESTED COMPONENT CODE: MECHANICAL (G04) - STEM. THE LOCATION OF THE REPORTED DEVICE IS UNKNOWN; 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, APPROXIMATELY 8 MONTHS POSTOP, THE PATIENT PRESENTED WITH PERIPROSTHETIC INFECTION. A FIRST STAGE REVISION OCCURRED; ALL INITIAL IMPLANTS WERE REMOVED WITHOUT APPARENT COMPLICATION. AFTER REAMING THE FEMORAL CANAL, A NONDISPLACED FRACTURE IN THE PERITROCHANTERIC REGION WAS IDENTIFIED. AN UNKNOWN 3.5MM RECONSTRUCTION PLATE AND SCREWS WERE PLACED TO STABILIZE THE FRACTURE. NO FURTHER COMPLICATIONS WERE IDENTIFIED. FINAL INTRAOP X-RAYS INDICATED APPROPRIATE FRACTURE REDUCTION AND IMPLANT PLACEMENT. A CEMENT SPACER STEM WAS PLACED ALONG WITH AN ALL-POLY CUP, A CEMENTED CONSTRAINED LINER, AND ADDITIONAL SCREWS FOR FIXATION. DUE DILIGENCE IS IN PROGRESS FOR THIS COMPLAINT; TO DATE NO ADDITIONAL INFORMATION OR PRODUCT HAS BEEN RECEIVED.