VANGUARD 360 DST FM AG 60X5 RL/LM
Received May 16, 2024 · Event occurred Apr 26, 2018
Report 0001825034-2024-01261 · MDR key 19333691
Device
Generic name
Prosthesis Knee
Manufacturer
Zimmer Biomet, Inc.Model number
N/ACatalog number
185302
Lot number
304320
Product problems
- Adverse Event Without Identified Device or Use Problem
- Adverse Event Without Identified Device or Use Problem
Patient
NA · Female
- Wound Dehiscence
- Wound Dehiscence
Narrative
Additional Manufacturer Narrative
(B)(4). D10 - MEDICAL PRODUCT: VANGUARD SSK 360 L FEM 60MM CATALOG # 185282 LOT # 2485451 VNGD SSK 360 L FEM 60MM CATALOG # 185282 LOT # 2485451 G2: SPAIN CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED BECAUSE IT REMAINS IMPLANTED. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.
Description of Event or Problem
IT WAS REPORTED THAT THE PATIENT WAS OPERATED DUE TO DUE TO WOUND DEHISCENCE. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE BEEN MADE; HOWEVER, NO MORE IS AVAILABLE.
Additional Manufacturer Narrative
THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED: B4, B5, G3, G6, H1, H2, H3, H6, H11. IT IS EXPECTED THAT A WOUND HEALS IN STAGES AND SHOULD BE OF NORMAL APPEARANCE RELATED TO THE TIMEFRAME SINCE THE INCISION WAS MADE. A SURGICAL WOUND SHOULD BE WELL APPROXIMATED WITHOUT REDNESS, WARMTH, SWELLING AND/OR PURULENT DRAINAGE FOR THE DURATION OF ITS HEALING. THE EXPRESSION WOUND CONCERNS OR NON-HEALING WOUND WOULD IMPLY THAT THE APPEARANCE OF THE WOUND DEVIATES FROM WHAT A SURGICAL WOUND SHOULD APPEAR. IT MAY BE RED, HAVE DRAINAGE, ADDITIONAL PAIN, WARMTH AND SWELLING AS WELL AS HEALING TIME MAY BE DELAYED. THIS DEVIATION SIGNIFIES AN ALTERATION IN THE WOUND HEALING PROCESS WHICH CAN BE COMPLICATED BY PATIENT COMORBIDITIES SUCH AS DIABETES, OBESITY, SMOKING, AND OTHER CONDITIONS THAT ARE KNOWN TO SLOW A PERSON¿S ABILITY TO HEAL. WOUND COMPLICATIONS CAN BE TREATED CONSERVATIVELY OR MORE INVASIVELY WITH AN IRRIGATION AND DEBRIDEMENT (I&D) WHICH PROMOTES HEALING AT THE SITE AND PREVENTS FURTHER COMPLICATIONS. IF DEEPER EXPLORATION OF THE WOUND IS WARRANTED AND THE JOINT SPACE IS ENTERED, A POLY EXCHANGE IS TYPICALLY PERFORMED IN CONJUNCTION WITH THE I&D TO CLEAR OUT ANY DEBRIS, HEMATOMA FORMATION, OR TO PREVENT DEEP JOINT INFECTION. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.
Description of Event or Problem
NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.