ANATO STEM SZ 5 RIGHT ANTEVERT
Received Jul 30, 2021 · Event occurred Jul 6, 2021
Report 0002249697-2021-01296 · MDR key 12252143
Device
Generic name
Prosthesis, Hip, Semi-constrained, Metal/ceramic/polymer, Cemented Or Non-porous
Manufacturer
Stryker Orthopaedics-mahwahModel number
4845-7-105Catalog number
4845-7-105
Lot number
77565802
Product problems
- Appropriate Device Problem Term/Code Not Available
- Appropriate Device Problem Term/Code Not Available
Patient
72 YR
- Failure of Implant
- Failure of Implant
Narrative
Additional Manufacturer Narrative
REVIEW OF THE DEVICE HISTORY RECORDS INDICATE THAT DEVICES WERE MANUFACTURED AND ACCEPTED INTO FINAL STOCK WITH NO REPORTED DISCREPANCIES. THERE HAVE BEEN NO OTHER EVENTS FOR THE LOT REFERENCED. IF ADDITIONAL INFORMATION IS RECEIVED, IT WILL BE PROVIDED IN A SUPPLEMENTAL REPORT UPON COMPLETION OF THE INVESTIGATION.
Description of Event or Problem
AS REPORTED: "REVISION SURGERY...EXPLANTED THE ANATO STEM, 36 V40 -2.5 HEAD AND 36F 10° LINER. NO MORE INFORMATION AVAILABLE." SPOKE TO REP. SURGEON REPORTED THAT THE PATIENT'S STEM HAD SUBSIDED. THERE WERE NO ALLEGATIONS AGAINST THE REVISED HEAD OR LINER. REP CONFIRMED THAT NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.