11/13 S-ROM 40MM M SPEC+6
Received Oct 9, 2017 · Event occurred Sep 9, 2017
Report 1818910-2017-26181 · MDR key 6928043
Device
Generic name
Hip Femoral Head
Manufacturer
Depuy Intl.,ltd 8010379Catalog number
136544500
Lot number
2628717
Product problems
- Metal Shedding Debris
- Metal Shedding Debris
Patient
66 YR
- Foreign Body Reaction
- Foreign Body Reaction
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
DER STATES THAT SROM METAL ON METAL HIP IMPLANTED BY THE SURGEON APPROXIMATELY 9 YEARS AGO. ALL IMPLANTS WERE IN GOOD POSITION. PATIENT UNDERWENT REVISION SURGERY TO REPLACE THE MOM ARTICULATION. A METAL SROM HEAD OF THE SAME LENGTH WAS REIMPLANTED WITH A 40/60 + 4 10 DEGREE ALTRX LINER. THE PATIENT WAS THOUGHT TO HAVE AN ADVERSE METAL REACTION, CAUSED BY THE TRUNION OF THE STEM, THE MOM BEARING SURFACE SEEMED TO BE FINE AND NOT CAUSING ANY DEBRIS. UPDATE (B)(6) 2017 RECORDS REVIEWED. AS TRUNNION OF STEM WAS IMPLICATED AS LIKELY SOURCE OF METAL WEAR AND THE ADVERSE METAL REACTION, AN UNKNOWN S-ROM STEM HAS BEEN ADDED AND REPORTED FOR METAL BEARING WEAR AND METALLOSIS. COMPLAINT UPDATED ON: (B)(6) 2017.