FEM RASP TRIAL CO/FJD T11
Received Jul 20, 2018
Report 1818910-2018-64871 · MDR key 7706108
Device
Generic name
Miscellaneous Joint Instruments : Cutting Instruments
Manufacturer
Depuy France Sas - 3003895575Catalog number
L93211
Lot number
1358920
Product problems
- Fitting Problem
- Fitting Problem
Patient
Not reported
- No Consequences Or Impact To Patient
- No Consequences Or Impact To Patient
Narrative
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 SIZE 11 FEMORAL BROACH WAS USED AND IT WAS FLUSH, BUT WHEN PUT THE SIZE 11 IMPLANT WAS PROUD BY 5MM. MISMATCHED BETWEEN THE BROACH AND THE IMPLANT.
Additional Manufacturer Narrative
THIS PRODUCT WAS REPORTED IN ERROR. NO PATIENT DEATH, SERIOUS INJURY OR EVIDENCE OF REPORTABLE PRODUCT MALFUNCTION OCCURRED. DEPUY CONSIDERS THE INVESTIGATION CLOSED AT THIS TIME. SHOULD ANY ADDITIONAL INFORMATION BE RECEIVED TO CHANGE THE OUTCOME OF THE PERFORMED INVESTIGATION, THE COMPLAINT WILL BE RE-OPENED. PRODUCT COMPLAINT # : (B)(4).