DURALOC 28MM ID 10 DEG HYLAMER
Received Jul 9, 2004 · Event occurred Jun 10, 2004
Report 1818910-2004-00416 · MDR key 25811114
Device
Generic name
Total Hip Replacement
Manufacturer
Depuy Orthopaedics, Inc.Model number
NACatalog number
866052
Lot number
3R1 0
Product problems
- Component(s), worn
- Device remains implanted
Patient
Male
Narrative
Description of Event or Problem
A REVISION OPERATION HAS BEEN SCHEDULED DUE TO RADIOLOGICAL INDICATION OF EXCESS WEAR TO ACETABULAR LINER COMPONENT.
Additional Manufacturer Narrative
DATE SENT TO FDA: 07/06/2004. THIS COMPLAINT IS STILL UNDER INVESTIGATION. DEPUY WILL NOTIFY THE FDA OF THE RESULTS OF THIS INVESTIGATION ONCE IT HAS BEEN COMPLETED.
Additional Manufacturer Narrative
CORRECTED: H1 REPORTABLE EVENT.
Additional Manufacturer Narrative
DATE SENT TO FDA: 10/27/2004 CORRECTED D1 BRAND NAME, D6 CATALOG # / LOT #, H4 DEVICE MANUFACTURE DATE. RECEIVED X-RAYS AND MEDICAL RECORDS FOR EXAMINATION; DEVICE HISTORY RECORDS WERE ALSO REVIEWED AND NO PROBLEMS WERE FOUND. THE INSERT WAS PART OF A 15-PIECE LOT THAT WAS MANUFACTURED IN JUNE 1990. THE STERILIZATION METHOD USED WAS GAMMA (IN AIR). THE SHELF AGE AT IMPLANTATION WAS APPROXIMATELY 6 1/3 YEARS. NO CORRECTIVE ACTION TAKEN, AS THE ROOT CAUSE COULD NOT BE IDENTIFIED. IN ADDITION, THE PRODUCT CODE IS A DISCONTINUED ITEM. SHOULD ADDITIONAL INFORMATION BE PROVIDED, THE INVESTIGATION WILL BE REOPENED. DEPUY CONSIDERS THE INVESTIGATION CLOSED.