MalfunctionELE
COLLECT.NO.QAS HIP STEMS CENTEGA/ANTEGA
Received Jun 18, 2018 · Event occurred May 15, 2018
Report 9610612-2018-00261 · MDR key 7611563
Device
Generic name
Mplants Antega / Centega
Manufacturer
Aesculap AgModel number
AE-QAS-H546-26Catalog number
AE-QAS-H546-26
Product problems
- Break
- Fracture
- Break
- Fracture
Patient
71 YR
- No Known Impact Or Consequence To Patient
- No Known Impact Or Consequence To Patient
Narrative
Additional Manufacturer Narrative
EXEMPTION NUMBER: E2014018. MANUFACTURING SITE EVALUATION: EVALUATION ON-GOING. DEVICE NOT RETURNED
Description of Event or Problem
(B)(6). IT WAS REPORTED THAT 23Y PO FRACTURED ANTEGA SHAFT.