REF THREE HOLE SHELL 56MM
Received Jun 1, 2018 · Event occurred May 24, 2018
Report 1020279-2018-01024 · MDR key 7562941
Device
Generic name
Ultrasound, Sinus
Manufacturer
Smith & Nephew, Inc.Catalog number
71336456
Lot number
12HM06527
Product problems
- Adverse Event Without Identified Device or Use Problem
- Adverse Event Without Identified Device or Use Problem
Patient
80 YR
- Injury
- Injury
Narrative
Description of Event or Problem
IT WAS REPORTED THAT A REVISION SUGERY WAS PERFORMED DUE TO DAMAGED LINER. LINER AND CUP WERE REMOVED.
Additional Manufacturer Narrative
THE ASSOCIATED COMPLAINT DEVICES WERE RETURNED AND EVALUATED. A VISUAL INSPECTION OF THE DAMAGE AND EXPOSURE OF THE ZR2.5NB SUBSTRATE WERE OBSERVED ON THE FEMORAL HEAD. THE ACETABULAR LINER EXHIBITED A FRACTURE AROUND ROUGHLY 50% FOR THE LINER RIM. THE RIM FRAGMENT WAS RETURNED. ADDITIONAL DAMAGE OPPOSITE THE RIM FRAGMENT WAS OBSERVED, WHICH WAS LIKELY DUE TO IMPINGEMENT WITH THE FEMORAL STEM NECK. DARK DISCOLORATION, POSSIBLY CAUSED BY DEPOSITS OF METALLIC DEBRIS FROM THE DAMAGE HEAD WERE OBSERVED ON THE FACE OF THE POLY LINER. YELLOWISH DISCOLORATION, LIKELY CAUSED BY ABSORPTION OF BIOLOGICAL FLUID OBSERVED ON THE BACKSIDE OF THE LINER. FAINT WITNESS OF SCREW HOLE PATTERNS COULD BE SEEN. THE POROUS BEAD COATING ON OF THE METAL SHELL REVEALED BURNISHED AREAS INDICATING POTENTIAL MOVEMENT OF THE SHELL AGAINST THE ACETABULAR BONE. THE CLINICAL/MEDICAL TEAM CONCLUDED, BASED ON THE AVAILABLE INFORMATION THE ROOT CAUSE FOR THE COMPONENTS DAMAGE CANNOT BE CONCLUDED BUT IMPINGEMENT AND/OR EDGE LOADING CANNOT BE RULED OUT. HOWEVER, AS THE IMPLANTATION DATE IS NOT KNOWN AND NO CLINICAL/MEDICAL DOCUMENTS WERE PROVIDED, THE AGE OF THE PROSTHESIS AND/OR TRAUMA OR OVER USE CANNOT BE RULED OUT. NO INFORMATION ON THE CURRENT STATUS OF THE PATIENT HAS BEEN FORTHCOMING. A REVIEW OF THE PRODUCTION DOCUMENTATION FOR THE CORRESPONDING PRODUCTS DID NOT REVEAL ANY DEVIATION FROM THE STANDARD MANUFACTURING PROCESSES. A REVIEW OF COMPLAINT HISTORY FOR THE PARTS REVEALED NO PRIOR COMPLAINTS FOR THE LISTED BATCHES. BASED ON THIS INVESTIGATION, THE NEED FOR CORRECTIVE ACTION IS NOT INDICATED. NO FURTHER INVESTIGATION IS WARRANTED FOR THIS COMPLAINT; HOWEVER WE WILL CONTINUE TO MONITOR FOR FUTURE COMPLAINTS AND INVESTIGATE AS NECESSARY. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THE COMPLAINT WILL BE REOPENED. WE CONSIDER THIS INVESTIGATION CLOSED. CREDIT WILL NOT BE ISSUED FOR THE DEVICES.