UNKNOWN HIP FEMORAL STEM
Received Apr 9, 2018 · Event occurred Mar 12, 2018
Report 1818910-2018-56914 · MDR key 7406674
Device
Generic name
Hip Femoral Stem
Manufacturer
Depuy Orthopaedics Inc UsCatalog number
UNK HIP FEMORAL STEM
Lot number
UNKNOWN
Product problems
- Failure To Adhere Or Bond
- Failure To Adhere Or Bond
Patient
Not reported
- Not Applicable
- No Code Available
- Not Applicable
- No Code Available
Narrative
Additional Manufacturer Narrative
IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.
Description of Event or Problem
PATIENT WAS REVISED TO ADDRESS POLY WEAR AND STEM LOOSENING AT CEMENT TO IMPLANT INTERFACE. CEMENT MANUFACTURER IS UNKNOWN. ALL COMPONENTS WERE REMOVED. DOI: UNKNOWN; DOR: (B)(6) 2018; RIGHT HIP.
Additional Manufacturer Narrative
(B)(4). INVESTIGATION SUMMARY: NO DEVICE ASSOCIATED WITH THIS REPORT WAS RECEIVED FOR EXAMINATION. THE INFORMATION RECEIVED WILL BE RETAINED FOR POTENTIAL SERIES INVESTIGATIONS IF TRIGGERED BY TREND ANALYSIS, POST MARKET SURVEILLANCE, OR OTHER EVENTS WITHIN THE QUALITY SYSTEM. DEPUY CONSIDERS THE INVESTIGATION CLOSED. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THE INFORMATION WILL BE REVIEWED AND THE INVESTIGATION WILL BE RE-OPENED AS NECESSARY. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH , A FOLLOW-UP MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.