CEMENTRALIZER 9.25MM
Received Jan 27, 2021 · Event occurred Jan 14, 2021
Report 1818910-2021-01907 · MDR key 11237935
Device
Generic name
Hip Miscellaneous : Cement Centralizer/plug
Manufacturer
Depuy Orthopaedics Inc UsModel number
1376-47-000Catalog number
137647000
Lot number
J92X53
Product problems
- Adverse Event Without Identified Device or Use Problem
- Adverse Event Without Identified Device or Use Problem
Patient
87 YR
- Joint Laxity
- Joint Laxity
Narrative
Additional Manufacturer Narrative
PRODUCT COMPLAINT # (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.
Additional Manufacturer Narrative
PRODUCT COMPLAINT #: (B)(4). 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
IT WAS REPORTED THAT THE HIP REVISION OF CEMENTED BIPOLAR CONSTRUCT DUE TO INSTABILITY AND DISLOCATION. STEM WAS REMOVED AND A NEW STEM WAS CEMENTED IN PLACE. THIS WAS IMPLANTED WITH A COMPETITORS DUAL MOBILITY CUP CONSTRUCT. DOI: (B)(6) 2020 - DOR: (B)(6) 2021 (LEFT HIP).